This label may not be the latest approved by FDA.

For current labeling information, please visit [Link]

HIGHLIGHTS OF PRESCRIBING INFORMATION  Clostridioides difficile-Associated Diarrhea (CDAD): May be
These highlights do not include all the information needed to use associated with an increased risk; use the shortest duration of
VOQUEZNA® safely and effectively. See full prescribing treatment appropriate to the condition. (5.3)
information for VOQUEZNA.  Bone Fracture, including Osteoporosis-related Fracture: Use the
shortest duration of treatment appropriate to the condition. (5.4)
VOQUEZNA (vonoprazan) tablets, for oral use
 Severe Cutaneous Adverse Reactions: Discontinue at the first signs
Initial U.S. Approval: 2022
or symptoms of severe cutaneous adverse reactions or other signs
----------------------------INDICATIONS AND USAGE ---------------------------- of hypersensitivity and consider further evaluation. (5.5)
VOQUEZNA is a potassium-competitive acid blocker indicated:  Vitamin B12 (Cobalamin) Deficiency: Long-term use may lead to
 for healing of all grades of erosive esophagitis and relief of malabsorption or deficiency; consider further workup if clinical
heartburn associated with erosive esophagitis in adults. (1) symptoms are present. (5.6)
 to maintain healing of all grades of erosive esophagitis and relief of  Hypomagnesemia and Mineral Metabolism: Consider monitoring
heartburn associated with erosive esophagitis in adults. (1) magnesium levels prior to starting treatment and periodically if
 in combination with amoxicillin and clarithromycin for the treatment prolonged treatment is expected, or if concomitant use of digoxin or
of Helicobacter pylori (H. pylori) infection in adults. (1) other drugs that cause hypomagnesemia. (5.7)
 in combination with amoxicillin for the treatment of H. pylori infection  Interactions with Investigations for Neuroendocrine Tumors:
in adults. (1) Increased chromogranin A (CgA) levels may interfere with
diagnostic investigations; temporarily stop VOQUEZNA at least 14
----------------------- DOSAGE AND ADMINISTRATION ----------------------- days before assessing CgA levels. (5.8, 7)
Recommended Dosage:  Fundic Gland Polyps: Risk increases with long-term use; use the
 Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks. (2.1) shortest duration of treatment appropriate to the condition. (5.9)
 Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up
to 6 months. (2.1) ------------------------------ ADVERSE REACTIONS ------------------------------
 Treatment of H. pylori Infection: see full prescribing information. Most common adverse reactions in VOQUEZNA-treated patients are:
(2.1)  Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal
 See also full prescribing information for the recommended dosage distension, abdominal pain, and nausea. (6.1)
by indication for patients with renal or hepatic impairment. (2.2, 2.3)  Maintenance of Healed Erosive Esophagitis (≥3%): gastritis,
abdominal pain, dyspepsia, hypertension, and urinary tract infection.
Administration Instructions: (6.1)
 Take with or without food. (2.4)  Treatment of H. pylori Infection (≥2%): diarrhea, dysgeusia,
 Swallow whole; do not chew or crush. (2.4) vulvovaginal candidiasis, abdominal pain, headache, hypertension,
and nasopharyngitis. (6.1)
--------------------- DOSAGE FORMS AND STRENGTHS ---------------------
Tablets: 10 mg and 20 mg of vonoprazan. (3) To report SUSPECTED ADVERSE REACTIONS, contact Phathom
Pharmaceuticals, Inc. at toll-free phone 1-888-775-7428 or FDA at
-------------------------------CONTRAINDICATIONS ------------------------------- 1-800-FDA-1088 or [Link]/medwatch.
 Known hypersensitivity to vonoprazan or any component of
VOQUEZNA. (4) ------------------------------DRUG INTERACTIONS--------------------------------
 Rilpivirine-containing products. (4, 7) See full prescribing information for a list of clinically important drug
interactions. (7)
----------------------- WARNINGS AND PRECAUTIONS------------------------
 Gastric Malignancy: Symptomatic response to treatment does not ------------------------USE IN SPECIFIC POPULATIONS-----------------------
preclude the presence of gastric malignancy; consider additional Lactation: Breastfeeding not recommended during treatment. (8.2)
follow-up and diagnostic testing. (5.1)
 Acute Tubulointerstitial Nephritis: Discontinue treatment and See 17 for PATIENT COUNSELING INFORMATION and FDA-
evaluate patients. (5.2) approved patient labeling.

Revised: 11/2023

FULL PRESCRIBING INFORMATION: CONTENTS* 8.4 Pediatric Use

1 INDICATIONS AND USAGE 8.5 Geriatric Use
2 DOSAGE AND ADMINISTRATION 8.6 Renal Impairment
2.1 Recommended Dosage 8.7 Hepatic Impairment
2.2 Recommended Dosage in Patients with Renal Impairment 11 DESCRIPTION
2.3 Recommended Dosage in Patients with Hepatic Impairment 12 CLINICAL PHARMACOLOGY
2.4 Administration Instructions 12.1 Mechanism of Action
3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics
4 CONTRAINDICATIONS 12.3 Pharmacokinetics
5 WARNINGS AND PRECAUTIONS 12.4 Microbiology
5.1 Presence of Gastric Malignancy 13 NONCLINICAL TOXICOLOGY
5.2 Acute Tubulointerstitial Nephritis 13.1 Carcinogenesis, Mutagenesis,
5.3 Clostridioides difficile-Associated Diarrhea Impairment of Fertility
5.4 Bone Fracture 13.2 Animal Toxicology and/or Pharmacology
5.5 Severe Cutaneous Adverse Reactions 14 CLINICAL STUDIES
5.6 Vitamin B12 (Cobalamin) Deficiency 14.1 Healing of Erosive Esophagitis and
5.7 Hypomagnesemia and Mineral Metabolism Relief of Heartburn
5.8 Interactions with Diagnostic Investigations for 14.2 Maintenance of Healed Erosive
Neuroendocrine Tumors Esophagitis and Relief of Heartburn
5.9 Fundic Gland Polyps 14.3 Treatment of Helicobacter pylori
6 ADVERSE REACTIONS Infection
6.1 Clinical Trials Experience 16 HOW SUPPLIED/STORAGE AND
6.2 Postmarketing Experience HANDLING
7 DRUG INTERACTIONS 17 PATIENT COUNSELING INFORMATION
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy * Sections or subsections omitted from the full prescribing
8.2 Lactation information are not listed

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FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
VOQUEZNA is indicated:
 for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive
esophagitis in adults.
 to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with
erosive esophagitis in adults.
 in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H.
pylori) infection in adults.
 in combination with amoxicillin for the treatment of H. pylori infection in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Healing of Erosive Esophagitis and Relief of Heartburn
 The recommended adult oral dosage is VOQUEZNA 20 mg once daily for 8 weeks.

Maintenance of Healed Erosive Esophagitis and Relief of Heartburn

 The recommended adult oral dosage is VOQUEZNA 10 mg once daily for up to 6 months.

Treatment of H. pylori Infection

 Triple Therapy: The recommended adult oral dosage is VOQUEZNA 20 mg plus amoxicillin
1,000 mg plus clarithromycin 500 mg, each given twice daily (in the morning and evening, 12
hours apart) for 14 days.
 Dual Therapy: The recommended adult oral dose is VOQUEZNA 20 mg given twice daily (in the
morning and evening) plus amoxicillin 1,000 mg three times daily (in the morning, mid-day, and
evening) for 14 days.
 Also refer to the amoxicillin and clarithromycin full prescribing information.

2.2 Recommended Dosage in Patients with Renal Impairment

Healing of Erosive Esophagitis
The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in
Table 1 below [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Healing of
Erosive Esophagitis
Estimated glomerular filtration rate (GFR) Recommended Dosage
30 mL/minute or greater 20 mg once daily
Less than 30 mL/minute 10 mg once daily

Maintenance of Healed Erosive Esophagitis

The recommended dosage of VOQUEZNA in adult patients with renal impairment is the same as for
adult patients with normal renal function [see Dosage and Administration (2.1)].

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Treatment of H. pylori Infection

The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table
2 below [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 2: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Treatment of
H. pylori Infectiona
Estimated GFR Recommended Dosage
30 mL/minute or greater 20 mg twice daily
Less than 30 mL/minute Use is not recommended
a
Also refer to the Dosage and Administration section of the amoxicillin and clarithromycin prescribing information for dosage
recommendations in patients with renal impairment.

2.3 Recommended Dosage in Patients with Hepatic Impairment

Healing of Erosive Esophagitis
The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in
Table 3 below [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 3: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Healing of
Erosive Esophagitis
Classification Recommended Dosage
Child-Pugh Class A 20 mg once daily
Child-Pugh Class B 10 mg once daily
Child-Pugh Class C 10 mg once daily

Maintenance of Healed Erosive Esophagitis

The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is the same as for
patients with normal hepatic function [see Dosage and Administration (2.1)].
Treatment of H. pylori Infection
The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in
Table 4 below [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 4: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Treatment
of H. pylori Infection
Classification Recommended Dosage
Child-Pugh Class A 20 mg twice daily
Child-Pugh Class B Use is not recommended
Child-Pugh Class C Use is not recommended

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2.4 Administration Instructions

 Take VOQUEZNA with or without food [see Clinical Pharmacology (12.3)].
 Swallow VOQUEZNA tablets whole; do not chew or crush the tablet.
 Missed doses:
o For the healing or maintenance of healed erosive esophagitis: If a dose is missed,
administer VOQUEZNA as soon as possible within 12 hours after the missed dose. If
more than 12 hours have passed, skip the missed dose and administer the next dose at
the regularly scheduled time.
o For the treatment of H. pylori infection: If a dose is missed, administer VOQUEZNA as
soon as possible within 4 hours after the missed dose. If more than 4 hours have passed,
skip the missed dose and administer the next dose at the regularly scheduled time.
Continue the normal dosing schedule until the treatment is completed.
3 DOSAGE FORMS AND STRENGTHS
Tablets:
 10 mg of vonoprazan: pale yellow, oval, film-coated tablets debossed V10 on one side and
plain on the other side.
 20 mg of vonoprazan: pale red, oval, film-coated tablets debossed V20 on one side and plain
on the other side.
4 CONTRAINDICATIONS
 VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any
component of VOQUEZNA. Reactions have included anaphylactic shock [see Adverse
Reactions (6.2) and Description (11)].
 VOQUEZNA is contraindicated with rilpivirine-containing products [see Drug Interactions (7)].
 For information about contraindications of antibacterial agents (clarithromycin and amoxicillin)
indicated in combination with VOQUEZNA, refer to the Contraindications section of the
corresponding prescribing information.
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
In adults, symptomatic response to therapy with VOQUEZNA does not preclude the presence of
gastric malignancy. Consider additional follow-up and diagnostic testing in patients who have a
suboptimal response or an early symptomatic relapse after completing treatment with VOQUEZNA. In
older patients, also consider endoscopy.
5.2 Acute Tubulointerstitial Nephritis
Acute tubulointerstitial nephritis (TIN) has been reported with VOQUEZNA [see Adverse Reactions
(6.1)]. If suspected, discontinue VOQUEZNA and evaluate patients with suspected acute TIN.
5.3 Clostridioides difficile-Associated Diarrhea
Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with
an increased risk of Clostridioides difficile-associated diarrhea (CDAD), especially in hospitalized

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patients. VOQUEZNA, another drug that blocks the proton pump to inhibit gastric acid production,
may also increase the risk of CDAD. Consider CDAD in patients with diarrhea that does not improve
[see Adverse Reactions (6.2)]. Use the shortest duration of VOQUEZNA appropriate to the condition
being treated.
CDAD has been reported with use of nearly all antibacterial agents. For more information specific to
antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with
VOQUEZNA, refer to Warnings and Precautions section of the corresponding prescribing information.
5.4 Bone Fracture
Several published observational studies suggest that PPI therapy may be associated with an
increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was
increased in patients who received high-dose, defined as multiple daily doses, and long-term therapy
(a year or longer). Bone fracture, including osteoporosis-related fracture, has also been reported with
vonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition being treated [see
Dosage and Administration (2.1)]. Patients at risk for osteoporosis-related fractures should be
managed according to the established treatment guidelines.
5.5 Severe Cutaneous Adverse Reactions
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN) have been reported with VOQUEZNA [see Adverse Reactions (6.2)].
Discontinue VOQUEZNA at the first signs or symptoms of severe cutaneous adverse reactions or
other signs of hypersensitivity and consider further evaluation.
5.6 Vitamin B12 (Cobalamin) Deficiency
Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo-
or achlorhydria. Vitamin B12 deficiency has been reported postmarketing with vonoprazan [see
Adverse Reactions (6.2)]. If clinical symptoms consistent with Vitamin B12 deficiency are observed in
patients treated with VOQUEZNA consider further workup.
5.7 Hypomagnesemia and Mineral Metabolism
Hypomagnesemia has been reported postmarketing with vonoprazan [see Adverse Reactions (6.2)].
Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying
hypocalcemia in at-risk patients.
Consider monitoring magnesium levels prior to initiation of VOQUEZNA and periodically in patients
expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in
the presence of hypomagnesemia (e.g., digoxin), or drugs that may cause hypomagnesemia (e.g.,
diuretics). Treatment of hypomagnesemia may require magnesium replacement and discontinuation
of VOQUEZNA.
Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA and periodically
while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism).
Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment,
consider discontinuing VOQUEZNA.
5.8 Interactions with Diagnostic Investigations for Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.
The increased CgA level may cause false positive results in diagnostic investigations for
neuroendocrine tumors. Temporarily discontinue VOQUEZNA treatment at least 14 days before

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Page 6 of 27

assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are
performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as
reference ranges between tests may vary [see Drug Interactions (7) and Clinical Pharmacology
(12.2)].
5.9 Fundic Gland Polyps
Use of VOQUEZNA is associated with a risk of fundic gland polyps that increases with long-term use,
especially beyond one year. Fundic gland polyps have been reported with vonoprazan in clinical trials
and postmarketing use with PPIs. Most patients who developed fundic gland polyps were
asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest
duration of VOQUEZNA appropriate to the condition being treated [see Dosage and Administration
(2.1)].
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in labeling:
 Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]
 Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.3)]
 Bone Fracture [see Warnings and Precautions (5.4)]
 Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)]
 Vitamin B12 (Cobalamin) Deficiency [see Warnings and Precautions (5.6)]
 Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.7)]
 Fundic Gland Polyps [see Warnings and Precautions (5.9)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.
Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis
The safety of VOQUEZNA was evaluated in a randomized, active-controlled, double-blind two phase
trial for the healing of erosive esophagitis (2 to 8 weeks) and maintenance of healed erosive
esophagitis (through 24 weeks) conducted in the United States and Europe [see Clinical Studies
(14.1), (14.2)].
Adverse reactions reported in at least 2% of patients in the VOQUEZNA arm in the healing phase are
presented in Table 5.

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Table 5: Adverse Reactionsa in a Clinical Trial of Adult Patients with All Grades of Erosive
Esophagitisb (2 to 8 Week Healing Phase)
Adverse Reactions VOQUEZNA Lansoprazole
20 mg Once Daily 30 mg Once Daily
N=514 N=510
% %
c
Gastritis 3 2
c
Diarrhea 2 3
Abdominal distension 2 1
Abdominal painc 2 1
Nausea 2 1
a
Reported in at least 2% of patients in the VOQUEZNA arm.
b
The trial was not designed to support comparative claims for VOQUEZNA for the adverse reactions reported in this
table.
c
Represents a grouped term and includes related terms.
Adverse reactions reported in at least 3% of patients in the VOQUEZNA arm of the maintenance
phase are shown in Table 6.
Table 6: Adverse Reactionsa in a Clinical Trial of Adult Patients with All Grades of Erosive
Esophagitisb (24 Week Maintenance Phase)
Adverse Reactions VOQUEZNA Lansoprazole
10 mg Once Daily 15 mg Once Daily
N=296 N=297
% %
Gastritisc 6 3
c
Abdominal pain 4 2
Dyspepsia 4 3
Hypertensionc 3 2
Urinary tract infection 3 2
a
Reported in at least 3% of patients in the VOQUEZNA arm.
b
The trial was not designed to support comparative claims for VOQUEZNA for the adverse reactions reported in this
table.
c
Represents grouped term and includes related terms.
COVID-19
COVID-19 was reported in the healing phase in 11 (2%) VOQUEZNA-treated subjects and 9 (2%)
lansoprazole-treated subjects; and in the maintenance phase in 18 (6%) VOQUEZNA-treated
subjects and 20 (7%) lansoprazole-treated subjects.
Other Clinical Trials of Erosive Esophagitis
Adverse reactions reported in the United States trial were similar to those reported in 4 additional
randomized, active-controlled, double-blind studies of vonoprazan compared to lansoprazole
conducted outside of the United States (two eight-week trials of healing of erosive esophagitis and
two 24-week maintenance of healed erosive esophagitis trials).

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Less Common Adverse Reactions

Adverse reactions reported in 1% or less of VOQUEZNA-treated patients in the healing or
maintenance phase of the United States trial are:
Blood and lymphatic system disorders: anemia, lymphocytosis
Cardiac disorders: tachycardia
Ear and labyrinth disorders: vertigo
Gastrointestinal disorders: duodenal polyp, dry mouth, dysphagia, eructation, flatulence, gastric
polyps, vomiting
General disorders and administrative site conditions: asthenia, peripheral edema
Infections and infestations: upper respiratory infection
Investigations: increased liver function test
Metabolism and nutritional disorders: diabetes mellitus
Musculoskeletal system: bone fracture
Nervous system disorders: dizziness, headache, syncope
Psychiatric disorders: depression, insomnia
Renal and urinary disorders: tubulointerstitial nephritis
Skin and subcutaneous tissue disorders: eczema, rash, urticaria
Treatment of H. pylori Infection
The safety of VOQUEZNA, amoxicillin and clarithromycin was evaluated in 675 adult patients (aged
20 to 82 years) in clinical trials in the United States, Europe and Japan and VOQUEZNA and
amoxicillin was evaluated in 348 adult patients (aged 20 to 80 years) in a clinical trial in the United
States and Europe. All of the patients were screened and found to be positive for H. pylori infection.
The safety of VOQUEZNA, amoxicillin and clarithromycin (triple therapy) and VOQUEZNA and
amoxicillin (dual therapy) was evaluated in a randomized, controlled, double-blind (triple
therapy)/open-label (dual therapy) study conducted in the United States and Europe in treatment-
naïve H. pylori-positive adult patients [see Clinical Studies (14.3)].
Adverse Reactions Leading to Discontinuation
Treatment discontinuation due to an adverse reaction occurred in 2.3% (8/346) of the patients treated
with VOQUEZNA, amoxicillin and clarithromycin, 0.9% (3/348) of the patients treated with
VOQUEZNA and amoxicillin, and 1.2% (4/345) of the patients treated with lansoprazole, amoxicillin
and clarithromycin. The most common adverse reactions leading to discontinuation of VOQUEZNA,
amoxicillin and clarithromycin were diarrhea (0.6%) and hypertension (0.6%) and the most common
adverse reaction leading to discontinuation of VOQUEZNA and amoxicillin was rash (0.6%).
Most Common Adverse Reactions
Adverse reactions reported in at least 2% of patients in any treatment arm are described in Table 7.

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Table 7: Adverse Reactionsa in Adult Patients with H. pylori Infectionb

Adverse VOQUEZNA and VOQUEZNA, Lansoprazole,
Reactions Amoxicillin Amoxicillin, and Amoxicillin, and
Clarithromycin Clarithromycin
N=348 N=346 N=345
% % %
Diarrhea 5 4 10
c
Dysgeusia 1 5 6
Vulvovaginal 2 3 1
c
candidiasis
Abdominal 3 2 3
c
pain
Headache 1 3 1
c
Hypertension 1 2 1
Nasopharyngitis 2 <1 1
a
Reported in at least 2% of patients in any treatment arm.
b
These trials were not designed to support comparative claims for VOQUEZNA-containing treatment arms for the
adverse reactions reported in this table.
c
Represents grouped term and includes related terms.
Less Common Adverse Reactions
Other adverse reactions reported in less than 2% of patients treated with VOQUEZNA, amoxicillin,
and clarithromycin or VOQUEZNA and amoxicillin are listed below by body system:
Blood and lymphatic system disorders: anemia, leukocytosis, leukopenia, neutropenia
Cardiac disorders: QT prolongation, tachycardia
Eye disorders: orbital edema
Gastrointestinal disorders: abdominal distension, constipation, dry mouth, duodenal polyp, duodenal
ulcer, dyspepsia, flatulence, gastric ulcer, gastroesophageal reflux disease, hematochezia, large
intestine polyp, rectal polyp, nausea, stomatitis, tongue discomfort, vomiting
General disorders and administration site conditions: fatigue, pyrexia
Immune system disorders: drug hypersensitivity
Infections and infestations: anal fungal infection, gastrointestinal viral infection, oral fungal infection,
pneumonia, tongue fungal infection, upper respiratory tract infection, urinary tract infection, viral
infection
Investigations: increased liver function test
Metabolism and nutrition disorders: decreased appetite
Musculoskeletal system: bone fracture
Nervous system disorders: ageusia, dizziness, tension headache
Psychiatric disorders: anxiety, depression, insomnia
Renal and urinary disorders: renal hypertrophy, tubulointerstitial nephritis
Reproductive system and breast disorders: vaginal discharge

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Respiratory, thoracic and mediastinal disorders: cough, nasal polyps, oropharyngeal pain
Skin and subcutaneous tissue disorders: dermatitis, dry skin, rash
For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin,
refer to Adverse Reactions section of the corresponding prescribing information.
6.2 Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of
vonoprazan outside of the United States. Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure.
Blood and lymphatic system disorders: thrombocytopenia
Immune system disorders: anaphylactic shock [see Contraindications (4)]
Infections and infestations: C. difficile (with concomitant antibacterials) [see Warnings and
Precautions (5.3)]
Investigation: hypomagnesemia, hypokalemia, hypocalcemia, vitamin B12 deficiency [see Warnings
and Precautions (5.6), (5.7)]
Hepatobiliary disorders: hepatic injury, hepatic failure, jaundice
Skin and subcutaneous tissue disorders: drug eruption, erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis [see Warnings and Precautions (5.5)]
7 DRUG INTERACTIONS
Table 8 and Table 9 include drugs with clinically important drug interactions and interaction with
diagnostics when administered concomitantly with VOQUEZNA and instructions for preventing or
managing them.
These recommendations are based on either drug interaction trials or predicted interactions due to
the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy
[see Clinical Pharmacology (12.3)].
Consult the labeling of concomitantly used drugs to obtain further information about interactions with
vonoprazan.
Table 8: Drug Interactions Affecting Drugs Co-Administered with VOQUEZNA and Interactions
with Diagnostics
Drugs Dependent on Gastric pH for Absorption
Antiretrovirals
Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2)]
which may alter the absorption of antiretroviral drugs leading to changes in the
safety and/or effectiveness.
Prevention or Rilpivirine-containing products Concomitant use with VOQUEZNA is
Management contraindicated.

Atazanavir Avoid concomitant use with VOQUEZNA.

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Nelfinavir
Other antiretrovirals See the prescribing information of other
antiretroviral drugs dependent on gastric pH
for absorption prior to concomitant use with
VOQUEZNA.
Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil,
ketoconazole/itraconazole)

Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2)],
which may decrease the absorption of drugs reducing their effectiveness.

Prevention or See the prescribing information for other drugs dependent on gastric pH for
Management absorption.

Combination Therapy with Clarithromycin and/or Amoxicillin

Clinical Effect Concomitant administration of clarithromycin with other drugs can lead to
serious adverse reactions, including potentially fatal arrhythmias, and are
contraindicated. Amoxicillin also has drug interactions.
Prevention or See Contraindications and Warnings and Precautions in the prescribing
Management information for clarithromycin.
See Drug Interactions in the prescribing information for amoxicillin.
Certain CYP3A Substrates where minimal concentration changes may lead to serious
toxicities

Clinical Effect Vonoprazan is a weak CYP3A inhibitor [see Clinical Pharmacology (12.3)].
Vonoprazan may increase exposure of CYP3A4 substrates, which may
increase the risk of adverse reactions related to these substrates.
Prevention or Frequent monitoring for concentrations and/or adverse reactions related to the
Management substrate drugs when used with VOQUEZNA. Dosage reduction of substrate
drugs may be needed.
See prescribing information for the relevant substrate drugs.
CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol)

Clinical Effect Vonoprazan is a CYP2C19 inhibitor [see Clinical Pharmacology (12.3)].

Vonoprazan may reduce plasma concentrations of the active metabolite of
clopidogrel and may cause reduction in platelet inhibition. Vonoprazan may
increase exposure of CYP2C19 substrate drugs (e.g., citalopram, cilostazol).
Prevention or Clopidogrel Carefully monitor the efficacy of clopidogrel and
Management consider alternative anti-platelet therapy.

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Citalopram and Cilostazol Carefully monitor patients for adverse reactions

associated with citalopram and cilostazol. See the
prescribing information for dosage adjustments.
Chromogranin (CgA) Test for Neuroendocrine Tumors
Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2)],
which increases CgA levels and may cause false positive results in diagnostic
investigations for neuroendocrine tumors.
Prevention or Assess CgA levels at least 14 days after stopping VOQUEZNA treatment and
Management repeat the test if initial CgA levels are high. If serial tests are performed (e.g.,
for monitoring), use the same commercial laboratory for testing, as reference
ranges between tests may vary.
Interaction with Secretin Stimulation Test
Clinical Effect Hyper-response in gastrin secretion in response to secretin stimulation test,
falsely suggesting gastrinoma.
Prevention or Temporarily stop VOQUEZNA at least 14 days before assessing to allow
Management gastrin levels to return to baseline [see Clinical Pharmacology (12.2)].

Table 9: Drug Interactions Affecting VOQUEZNA When Co-Administered with Other Drugs
Strong or Moderate CYP3A4 Inducers
Clinical Effect Vonoprazan is a CYP3A substrate. Strong or moderate CYP3A inducers
decrease vonoprazan exposure [see Clinical Pharmacology (12.3)], which
may reduce the effectiveness of VOQUEZNA.
Prevention or Avoid concomitant use with VOQUEZNA.
Management

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Risk Summary
There are no adequate and well-controlled studies of vonoprazan in pregnant women. Available data
from pharmacovigilance reports with vonoprazan-containing products use in pregnant women are not
sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or other adverse
maternal or fetal outcomes.
In pregnant rats, no adverse effects were noted after oral administration of vonoprazan during
organogenesis at approximately 27-times the maximum recommended human dose (MRHD) based
on AUC exposure comparisons.
In a pre- and postnatal development (PPND) study, pups from dams orally administered vonoprazan
during organogenesis and through lactation, exhibited liver discoloration, which in follow-up
mechanistic animal studies was associated with necrosis, fibrosis, and hemorrhage at a dose

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approximately 22-times the MRHD based on AUC comparisons which were likely attributable to
exposure during lactation [see Use in Specific Populations (8.2)]. These effects were not observed at
the next lower dose in this study, which was approximately equal to the MRHD based on AUC
comparison, however they were seen at clinically relevant exposures in dose range finding studies in
rats (see Data).
The estimated background risks of major birth defects and miscarriage for the indicated population
are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse
outcomes. In the United States general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,
respectively.
Report pregnancies to the Phathom Pharmaceuticals, Inc. Adverse Event reporting line at 1-888-775-
7428.
Data
Animal Data
Pregnant rats were orally administered vonoprazan at doses of 30, 100, or 300 mg/kg/day (7-, 27-,
130-times the MRHD based on AUC comparison at the same doses from unmated female rats from
separate studies) during the period of organogenesis from gestation day (GD) 6 to 17. During
maternal dosing, one high-dose female died and decreased body weight and food consumption
occurred at the middle and highest doses. No embryo-fetal lethality was observed but decreased fetal
body weight was observed in the highest dose group. Fetal abnormalities were limited to the 300
mg/kg/day and included ventricular septal defect and mal-positioned subclavian artery in fetuses in a
majority (15/19) of litters, as well as tail abnormalities and small anal opening. No adverse embryo-
fetal effects were observed at the 100 mg/kg/day.
Pregnant rabbits were orally administered vonoprazan at doses of 3, 10, or 30 mg/kg/day (0.04-, 1.5-,
10-times the MRHD based on AUC comparison) during the period of organogenesis from GD 6 to 18.
Two animals aborted at the highest dose and decreased body weight and food consumption occurred
at the mid and high doses. No embryo-fetal mortality or toxicity occurred. There were no external,
visceral or skeletal abnormalities.
In a PPND study, pregnant female rats were orally administered vonoprazan at doses of 1, 3, 10, or
100 mg/kg/day (0.01-, 0.18-, 1.1-, 22-times the MRHD based on AUC comparison) from GD 6 to
lactation day (LD) 21. Decreased body weight gain and food consumption were present in dams at
the highest dose during lactation. Decreased body weight gain compared to controls was observed in
the offspring from dams in the high dose group. Liver discoloration occurred in offspring from the high
dose group at LD 4 but was not present in animals examined after weaning. Similarly, in dose range
finding studies in rats and follow-up mechanistic animal studies, the liver discoloration was observed
and characterized as necrosis, fibrosis, and hemorrhage at equal to or greater than clinically relevant
exposures based on AUC comparisons. The mechanistic studies further demonstrated the effect was
likely attributable to vonoprazan exposure during lactation [see Use in Specific Populations (8.2)]. The
clinical relevance of the liver findings is uncertain.
Exposure margins from vonoprazan between the animal and clinical studies for vonoprazan,
amoxicillin and clarithromycin used in combination may be lower due to increased vonoprazan
exposure from concomitant use with clarithromycin in patients [see Clinical Pharmacology (12.3)].
8.2 Lactation
Risk Summary

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There are no data regarding the presence of vonoprazan in human milk, the effects on the breastfed
infant, or the effects on milk production. Vonoprazan and its metabolites are present in rat milk. Liver
injury occurred in offspring from pregnant and lactating rats administered oral vonoprazan at AUC
exposures approximately equal to and greater than the MRHD (see Data). When a drug is present in
animal milk, it is likely that the drug will be present in human milk. Because of the potential risk of
adverse liver effects shown in animal studies with vonoprazan, advise patients not to breastfeed
during treatment with VOQUEZNA.
Data
Animal Data
In a PPND study in rats, in which the dams were administered oral vonoprazan during gestation and
through lactation at up to 22-times the MRHD (based on AUC comparison), liver discoloration
occurred in offspring from the high dose group [see Use in Specific Populations (8.1)].
Liver discoloration associated with necrosis, fibrosis, and hemorrhage in the offspring of dosed rats
was also seen in dose-range finding studies and follow-up, mechanistic studies, including offspring in
lactation only studies. These effects were reported in pups on LD 4 at doses from 3 to 100 mg/kg/day
(approximately 0.2- to 22-fold the MRHD based on AUC values extrapolated from the PPND study)
and on LD 14 at doses from 10 to 100 mg/kg/day dose groups (approximately 1- to 22-fold the MRHD
based on an extrapolated AUC comparisons). In mechanistic studies, liver effects were observed in
offspring treated only during lactation but not in offspring from animals only treated during gestation.
In some of these studies, this finding was associated with increased offspring stomach weights that
was reversed along with liver discoloration by concomitant treatment with a gastrointestinal prokinetic
agent.
8.4 Pediatric Use
The safety and effectiveness of VOQUEZNA have not been established in pediatric patients.
8.5 Geriatric Use
There were 200 patients aged 65 years and older in the clinical trial for erosive esophagitis and relief
of heartburn [see Clinical Studies (14.1)]. Of the total number of vonoprazan-treated patients there
were 93 (18%) patients aged 65 years of age and older and 10 (2%) patients aged 75 years of age
and older.
There were 218 patients aged 65 years and older in the clinical trial for the treatment of H. pylori
infection [see Clinical Studies (14.3)]. Of the total number of vonoprazan-treated patients, there were
153 (22%) patients aged 65 years of age and older and 18 (3%) patients aged 75 years of age and
older.
No overall differences in safety or effectiveness were observed between these patients and younger
adult patients, and other reported clinical experience has not identified differences in responses
between the geriatric and younger adult patients, but greater sensitivity of some older individuals
cannot be ruled out.
No clinically meaningful differences in the pharmacokinetics of vonoprazan are predicted in patients
65 years of age and older compared to younger adult patients [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
Healing of Erosive Esophagitis

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No dosage adjustment of VOQUEZNA for the healing of erosive esophagitis is recommended in

patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Dosage reduction is
recommended in patients with severe renal impairment (eGFR < 30 mL/min) [see Dosage and
Administration (2.2) and Clinical Pharmacology (12.3)].
Maintenance of Healed Erosive Esophagitis
No dosage adjustment of VOQUEZNA for the maintenance of healed erosive esophagitis is
recommended in patients with any degree of renal impairment.
Treatment of H. pylori Infection
Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with severe
renal impairment (eGFR < 30 mL/min) [see Dosage and Administration (2.2) and Clinical
Pharmacology (12.3)].
8.7 Hepatic Impairment
Healing of Erosive Esophagitis
No dosage adjustment of VOQUEZNA for the healing of erosive esophagitis is recommended in
patients with mild hepatic impairment (Child-Pugh A). Dosage reduction is recommended in patients
with moderate to severe hepatic impairment (Child-Pugh Class B and C) [see Dosage and
Administration (2.3) and Clinical Pharmacology (12.3)].
Maintenance of Healed Erosive Esophagitis
No dosage adjustment of VOQUEZNA for the maintenance of healed erosive esophagitis is
recommended in patients with any degree of hepatic impairment.
Treatment of H. pylori Infection
Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with
moderate to severe hepatic impairment (Child-Pugh Class B and C) [see Dosage and Administration
(2.3) and Clinical Pharmacology (12.3)].
11 DESCRIPTION
Vonoprazan (as the fumarate), is a potassium-competitive acid blocker. Chemically, it is 1H-pyrrole-3-
methanamine, 5-(2-fluorophenyl)-N-methyl-1-(3-pyridinylsulfonyl)-, (2E)-2-butenedioate (1:1). Its
empirical formula is C17H16FN3O2S•C4H4O4 with a molecular weight of 461.5. Vonoprazan fumarate
has the following structure:

Vonoprazan fumarate is white to nearly white crystals or crystalline powder which melts at 194.8°C.
Vonoprazan fumarate is soluble in dimethyl sulfoxide; sparingly soluble in N,N–dimethylacetamide,
slightly soluble in N,N-dimethylformamide, methanol and water; very slightly soluble in ethanol
(99.5%); and practically insoluble in 2-propanol, acetone, 1-octanol, and acetonitrile.
VOQUEZNA (vonoprazan) tablets are available in two dosage strengths for oral administration: 10
mg of vonoprazan (equivalent to 13.36 mg of vonoprazan fumarate) and 20 mg of vonoprazan
(equivalent to 26.72 mg of vonoprazan fumarate). Each film-coated tablet contains the following

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inactive ingredients: ascorbic acid, croscarmellose sodium, ferric oxide red (only in 20 mg tablets),
ferric oxide yellow (only in 10 mg tablets), fumaric acid, hydroxypropyl cellulose, hypromellose,
magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 8000, and titanium
dioxide.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the
gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium
competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal
cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks
the final step of acid production. Vonoprazan does not require activation by acid. Vonoprazan may
selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan
binds to the active pumps in a noncovalent and reversible manner.
12.2 Pharmacodynamics
Antisecretory Activity
Following a single 10 mg or 20 mg dose of vonoprazan, the onset of the antisecretory effect as
measured by intragastric pH occurs within 2 to 3 hours. The elevated intragastric pH levels compared
to placebo increase with dose and are maintained for over 24 hours after dosing. The inhibitory effect
of vonoprazan on acid secretion increases with repeated daily dosing and steady state is achieved by
Day 4. The antisecretory effect of vonoprazan decreases following drug discontinuation although
intragastric pH remained elevated compared to placebo for 24 to 48 hours following the dose on Day
7.
The effects of vonoprazan 10 mg or 20 mg once daily for 7 days on 24-hour intragastric pH in healthy
subjects are shown in Table 10.
Table 10: Effect of VOQUEZNA 10 mg or 20 mg Once Daily on 24-Hour Intragastric pH at
Baseline and on Days 1 and 7 in Healthy Subjects
VOQUEZNA VOQUEZNA
10 mg Once Daily 20 mg Once Daily
Parameter
(N=9) (N=9)
Baseline Day 1 Day 7 Baseline Day 1 Day 7
Mean Intragastric pH 2.0 3.7 4.6 1.9 4.5 5.9
% Time Intragastric 6.8 43.1 60.2 7.4 62.7 85.2
pH>4 (hours) (2 h) (10 h) (14 h) (2 h) (15 h) (20 h)
% Time Intragastric 1.3 20.7 34.3 0.9 29.0 57.8
pH>6 (hours) (<1 h) (5 h) (8 h) (<1 h) (7 h) (14 h)

Cardiac Electrophysiology
At a single dose of 120 mg (6-times the maximum recommended dose), vonoprazan does not prolong
the QT interval to any clinically relevant extent.

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Serum Gastrin Effects

The effect of vonoprazan on serum gastrin concentrations was evaluated in 514 patients for up to 8
weeks (healing phase) and in 592 patients for up to 6 months (maintenance phase). During the
healing phase, the mean fasting gastrin levels at Week 2 increased from baseline after treatment with
VOQUEZNA 20 mg and levels were similar at Week 2 and Week 8. In the 6-month maintenance
phase, the mean gastrin levels remained elevated with VOQUEZNA 10 mg and 20 mg and the mean
serum gastrin levels returned to normal within 4 weeks of discontinuation of treatment.
Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum CgA levels. The
increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine
tumors [see Warnings and Precautions (5.8) and Drug Interactions (7)].
Enterochromaffin-Like Cell (ECL) Effects
Human gastric biopsy specimens were obtained from 135 patients treated with vonoprazan 10 mg or
20 mg once daily for up to 260 weeks. An increase in the incidence of hyperplasia of the parietal cells
and G-cells was observed, which is consistent with the pharmacological action of a potassium-
competitive acid blocker. No neoplastic changes were observed [see Nonclinical Toxicology (13.1),
(13.2)].
12.3 Pharmacokinetics
Steady state pharmacokinetic (PK) parameters for vonoprazan 10 mg or 20 mg following once daily
administration and vonoprazan 20 mg following twice daily administration from data collected across
multiple studies are summarized in Table 11.
Table 11: Mean (%CV) Steady State Pharmacokinetic Parameters For Vonoprazan Following
Once or Twice Daily Dosing
PK Parameter Vonoprazan 10 mg Vonoprazan 20 mg
Once Daily Once Daily Twice Daily
(N=30) (N=68) (N=32)
Tmax(h) median 1.5 (0.75,3.0) 2.0 (0.75, 5.0) 3.0 (1.0-6.0)
(min, max)
Cmax (ng/mL) 11.7 (27.5) 26.1 (35.2) 37.8 (36.1)
AUC 92.9 (33.1)a 230.9 (41.3)a 272.5 (30.5)b
(hr*ng/mL)
t1/2z (h) 7.7 (27.1) 7.9 (22.6) 6.8 (22.7)
CL/F (L/h) 120.2 (35.2) 100.2 (38.3) 81.3 (35.7)
Vz/F (L) 1270.7 (26.6) 1114.0 (39.6) 782.7 (34.4)
a
AUC0-24h
b
AUC0-12h
Cmax = Maximum plasma concentration; AUC0-24h = Area under the plasma concentration-time curve from time 0 to end of
the 24-hour dosing interval; AUC0-12h = Area under the plasma concentration-time curve from time 0 to the end of the 12-
hour dosing interval; Tmax = Time to reach Cmax, t1/2 = Elimination half-life, CL/F = Apparent oral clearance, Vz/F = Apparent
oral volume of distribution
Absorption
Vonoprazan exhibits time independent pharmacokinetics and steady state concentrations are
achieved by Day 3 to 4. After multiple doses of vonoprazan ranging from 10 to 40 mg (twice the
maximum recommended dose) once daily for 7 days in healthy subjects, Cmax and area under the

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plasma concentration time curve (AUC) values for vonoprazan increased in an approximately dose-
proportional manner.
There is little accumulation in plasma after once daily multiple doses, with an accumulation index ratio
of less than 1.2 based on AUC for doses ranging from 10 to 40 mg (twice the maximum
recommended dose).
Steady state plasma exposure of vonoprazan following 20 mg twice daily dosing (AUC0-12h = 273
hr*ng/mL, N=10) was approximately 1.8-fold higher compared to the mean estimate from the same
subjects on Day 1 (AUC0-12h = 155 hr*ng/mL, N=10).
Effect of Food
In a food effect study in healthy subjects (N=24) who received vonoprazan 20 mg, a high-fat meal
resulted in a 5% increase in Cmax, a 15% increase in AUC, and a delay in median Tmax of 2 hours.
These changes are not considered to be clinically significant [see Dosage and Administration (2.4)].
Distribution
Plasma protein binding of vonoprazan ranged from 85 to 88% in healthy subjects and was
independent of concentration from 0.1 to 10 mcg/mL.
Elimination
Metabolism
Vonoprazan is metabolized to inactive metabolites via multiple pathways by a combination of
cytochrome P450 (CYP) isoforms (CYP3A4/5, CYP2B6, CYP2C19, CYP2C9 and CYP2D6) along
with sulfo- and glucuronosyl-transferases. CYP2C19 polymorphisms have been evaluated in clinical
studies and there were no considerable differences in the pharmacokinetics of vonoprazan based on
CYP2C19 metabolizer status.
Excretion
Following oral administration of radiolabeled vonoprazan, approximately 67% of the radiolabeled
dose (8% as unchanged vonoprazan) was recovered in urine and 31% (1.4% as unchanged
vonoprazan) was recovered in feces.
Specific Populations
Geriatric Patients
No clinically meaningful differences in the pharmacokinetics of vonoprazan are predicted in patients
65 years of age and older compared to younger adult patients.
Sex, Race or Ethnicity
There were no clinically significant differences in the pharmacokinetics of vonoprazan based on sex
or race/ethnicity.
Patients with Renal impairment
The pharmacokinetics of vonoprazan administered as a single 20 mg dose in patients with mild
[eGFR 60 to <90 mL/min/1.73m2 (N=8)], moderate [eGFR 30 to <60 mL/min/1.73m2 (N=8)], or severe
[eGFR 15 to <30 mL/min/1.73m2 (N=8)] renal impairment were compared to those with normal renal
function [eGFR ≥90 mL/min/1.73m2 (N=13)]. Compared to subjects with normal renal function,
systemic exposure (AUC0-inf) was 1.7-, 1.3-, and 2.4-times greater in patients with mild, moderate,
and severe renal impairment, respectively. In subjects requiring dialysis (N=8), AUC0-inf estimates

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were 1.3-fold greater compared to estimates from subjects with normal renal function [see Dosage
and Administration (2.2)]. Protein binding of vonoprazan is not affected by impaired renal function. In
patients requiring dialysis, vonoprazan was present in the dialysate and represented 0.94% of the
dose administered.
Patients with Hepatic Impairment
The pharmacokinetics of vonoprazan administered as a single 20 mg dose in patients with mild
[Child-Pugh Class A (N=8)], moderate [Child-Pugh Class B (N=8)], or severe [Child-Pugh Class C
(N=6)] hepatic impairment were compared to those with normal hepatic function (N=12). Compared to
subjects with normal hepatic function, systemic exposure (AUC0-inf) of vonoprazan was 1.2-, 2.4-, and
2.6-times greater in patients with mild, moderate, and severe hepatic impairment, respectively [see
Dosage and Administration (2.3)]. Protein binding of vonoprazan is not affected by impaired hepatic
function.
Drug Interaction Studies
In Vitro Studies
Cytochrome P450 (CYP450) Enzymes
In vitro studies have shown that vonoprazan directly and time-dependently inhibits CYP2B6,
CYP2C19, and CYP3A4/5.
Transporter Systems
Vonoprazan inhibits multidrug and toxin extrusion protein 1 (MATE1) and organic cation transporter 1
(OCT1), but only at concentrations higher than clinically relevant.
Clinical Studies
Combination Therapy with Vonoprazan, Amoxicillin, and Clarithromycin
When vonoprazan 20 mg, amoxicillin 750 mg and clarithromycin 400 mg were co-administered twice
daily for 7 days (N=11), there was no effect on pharmacokinetics of amoxicillin compared to
amoxicillin alone. However, vonoprazan Cmax and AUC0-12h increased by 87% and 85%, respectively,
and clarithromycin Cmax and AUC0-12h increased by 64% and 45% respectively, compared to
administration of each component alone.
Effect of Vonoprazan on CYP3A4 Substrates
When a single oral dose of midazolam 2 mg was administered following vonoprazan 20 mg twice
daily for 7 days (N=20), midazolam AUC0-inf increased 93% compared to administration of midazolam
alone.
Effect of CYP3A Inhibitors on Vonoprazan
When a single dose of 40 mg vonoprazan (twice the maximum recommended dose) was
administered with clarithromycin 500 mg twice daily for 7 days (N=16), vonoprazan AUC0-inf increased
58% compared to administration of vonoprazan alone.
Coadministration of Vonoprazan with NSAIDs or Low Dose Aspirin
When a single dose of 40 mg vonoprazan (twice the maximum recommended dose) was co-
administered with diclofenac 25 mg, meloxicam 10 mg, or aspirin 100 mg, there were no clinically
meaningful changes in exposure of vonoprazan, diclofenac, meloxicam, or aspirin compared to
administration of each drug alone.

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Model-Informed Approaches
Effect of CYP3A Inducers on Vonoprazan
Vonoprazan exposures are predicted to be 80% lower when co-administered with a strong CYP3A4
inducer such as rifampicin and 50% lower when co-administered with a moderate CYP3A4 inducer
such as efavirenz.
12.4 Microbiology
Antimicrobial Activity
Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of H.
pylori infection [see Clinical Studies (14.3)]. The following in vitro data are available, but their clinical
significance is unknown. Clarithromycin and amoxicillin are active in vitro against most isolates of H.
pylori.
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods
and quality control standards recognized by FDA for this drug, please see: [Link]
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity
In a 24-month carcinogenicity study in mice, vonoprazan at daily oral doses of 6, 20, 60, and 200
mg/kg/day (approximately 0.4-, 4-, 19-, and 93-times the MRHD based on AUC) produced
hyperplasia of neuroendocrine cells, gastropathy and benign and/or malignant neuroendocrine cell
tumors (carcinoids) in the stomach at all doses in males and at 60 mg/kg/day and greater in females.
In liver, increased incidences of hepatocellular adenoma and carcinomas were observed at doses of
20 mg/kg/day and greater in males and 60 mg/kg/day and greater in females.
In a 24-month carcinogenicity study in Sprague-Dawley rats, vonoprazan at daily oral doses of 5, 15,
50, and 150 mg/kg/day (approximately 0.6-, 4-, 19-, and 65-times the MRHD based on AUC)
produced benign and/or malignant neuroendocrine cell tumors in the stomach in both male and
female rats at doses of 5 mg/kg/day or more. Increased incidence of hepatocellular adenoma and
carcinomas and hepatocholangiocellular adenomas and carcinomas were observed at doses of 50
and 150 mg/kg/day.
In both mice and rats, neuroendocrine tumors in the stomach occurred in association with
neuroendocrine hyperplasia and gastropathy in the stomach and increased plasma gastrin
concentrations that are consistent with inhibition of gastric acid secretion. Carcinoid tumors have also
been observed in rats subjected to fundectomy or long-term treatment with proton pump inhibitors or
high doses of H2-receptor antagonists.
Mutagenesis
Vonoprazan was negative for mutagenicity in the in vitro Ames test, in an in vitro clastogenecity assay
in Chinese Hamster cells and in vivo in a rat bone marrow micronucleus study.
Impairment of Fertility
Vonoprazan at oral doses up to 300 mg/kg/day in rats (approximately 133-times the MRHD based on
AUC from a separate study in nonpregnant animals administered the same dose) was found to have

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no effect on fertility and reproductive performance. Elongation of the estrous cycle was observed in
rats at doses equivalent to 133-times the MRHD based on AUC.
13.2 Animal Toxicology and/or Pharmacology
During lifetime exposure of mice and rats dosed daily with up to 200 mg/kg/day and 150 mg/kg/day of
vonoprazan respectively, increases in gastrin levels and marked neuroendocrine hyperplasia and
gastropathy were observed followed by formation of carcinoid tumors [see Nonclinical Toxicology
(13.1)]. This finding is considered to be a rodent-specific phenomenon.
14 CLINICAL STUDIES
14.1 Healing of Erosive Esophagitis and Relief of Heartburn
The effectiveness and safety of VOQUEZNA was evaluated in a randomized, active-controlled,
double-blind, eight-week study conducted in the United States and Europe in 1024 adult patients with
endoscopically confirmed erosive esophagitis (NCT04124926). Severity of the disease was classified
based on the Los Angeles (LA) Classification Grading System (Grades A through D). Patients were
randomized to one of the following treatment groups: VOQUEZNA 20 mg once daily or lansoprazole
30 mg once daily for 2 to 8 weeks. Patients who were positive for H. pylori infection or who had
Barrett’s esophagus and/or definite dysplastic changes in the esophagus at baseline were excluded
from the study. Based on the LA Classification, 66% of patients had mild erosive esophagitis (Grades
A or B) and 34% of patients had moderate to severe erosive esophagitis (Grades C or D) prior to
randomization. Patients in the trial had a mean age of 51 years (range 18 to 84 years); 53% were
female; 12% identified as Hispanic or Latino; 91% identified as White, 6% as Black or African
American, and 3% identified as another racial group.
Healing of erosive esophagitis was assessed at Week 2 and Week 8 and resolution of heartburn
symptoms was evaluated daily over the 8-week period. If endoscopic healing of erosive esophagitis
was confirmed at Week 2, the patient entered the maintenance phase of the study. If endoscopic
healing was not confirmed at Week 2, the patient continued to receive randomized treatment until
Week 8. Only patients with confirmed endoscopic healing entered the maintenance phase. All
endoscopies were centrally read and adjudicated.
Healing of All Grades of Erosive Esophagitis
The primary endpoint, was endoscopically confirmed complete healing of all grades of erosive
esophagitis at Week 2 or Week 8, as shown in Table 12.
Table 12: Rates of Healing of All LA Grades of Erosive Esophagitis at Week 2 or Week 8
Timepoint Treatment Group
VOQUEZNA Lansoprazole Treatment Difference
20 mg Once Daily 30 mg Once Daily (95% Confidence Interval)
N=514 N=510
% %
Week 2 or 8 93 85 8a
(4.5, 12.2)
Week 2 74 68
a
Demonstrated noninferiority to lansoprazole.
Healing of Erosive Esophagitis in Subgroups with LA Grade C or D Esophagitis
For the secondary endpoint of complete healing of erosive esophagitis at Week 2, superiority was
demonstrated in the subgroup of patients with LA Grade C or D disease, 70% of 177 VOQUEZNA

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treated patients and 53% of 174 lansoprazole treated patients achieved healing (18% treatment
difference; 95% CI 7.4, 27.4).
Complete healing of erosive esophagitis at either Week 2 or Week 8 in the subgroup of patients with
LA Grade C or D disease was 92% in patients treated with VOQUEZNA and 72% in patients treated
with lansoprazole. This endpoint was not statistically significant under the prespecified multiple testing
procedure.
Relief of Heartburn in Patients with Erosive Esophagitis During the Healing Phase
The percentage of 24-hour heartburn-free days through Week 8 was evaluated as a secondary
endpoint and results are shown in Table 13.
Table 13: Percentage of 24-Hour Heartburn-Free Days in Patients with Erosive Esophagitis
through Week 8
Treatment Group
VOQUEZNA Lansoprazole Treatment Difference
Parameter
20 mg Once Daily 30 mg Once Daily (95% Confidence Interval)
N=514 N=510
% %
Mean ± SD 67 ± 35 64 ± 35 3a
(-1.6, 7.0)
Median 81 78
a
Demonstrated noninferiority to lansoprazole.
Other Healing of Erosive Esophagitis Studies
Two additional randomized, active-controlled, double-blind studies conducted outside of the United
States, of similar design to the United States trial, also demonstrated non-inferiority of vonoprazan 20
mg once daily compared to lansoprazole 30 mg once daily for the primary endpoint of healing of all
grades of erosive esophagitis by Week 8.
14.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn
Patients who completed the healing phase of the erosive esophagitis study (NCT04124926) and
showed endoscopically confirmed healed erosive esophagitis at Week 2 or Week 8 were re-
randomized in the maintenance phase [Link] to either VOQUEZNA 10 mg once daily, a higher dosage
of VOQUEZNA, or lansoprazole 15 mg once daily. Maintenance of healing and resolution of
heartburn symptoms were evaluated over 24 weeks. The higher VOQUEZNA dose group did not
demonstrate additional treatment benefit compared to VOQUEZNA 10 mg once daily.
Maintenance of Healed Erosive Esophagitis
The primary endpoint was maintenance of healed erosive esophagitis (all grades) through Week 24.
A secondary endpoint was maintenance of healed erosive esophagitis in the subgroup of patients
with LA Grade C or D disease prior to randomization in the healing phase of the study.
The maintenance rates of healed erosive esophagitis are shown in Table 14.

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Table 14: Maintenance Rates of Healed Erosive Esophagitis in Adults through Week 24
Treatment Group
Treatment Difference
VOQUEZNA Lansoprazole
(95% Confidence Interval)
Baseline Severity 10 mg Once Daily 15 mg Once Daily
All LA Grades: N=293 N=294
Week 24 79% 72% 7a
(0.2, 14.1)
LA Grade C or D: N=95 N=96
Week 24 75% 61% 13b
(0.02, 26.1)
a
Demonstrated non-inferiority and superiority to lansoprazole.
b
Demonstrated superiority to lansoprazole.
Relief of Heartburn During Maintenance of Healed Erosive Esophagitis
The percentage of 24-hour heartburn-free days through Week 24 was evaluated for non-inferiority as
a secondary endpoint as shown in Table 15.
Table 15: Percentage of 24-Hour Heartburn-Free Days through Week 24
Treatment Group
VOQUEZNA Lansoprazole
Parameter 10 mg Once Daily 15 mg Once Daily Treatment Difference
N=293 N=294 (95% Confidence Interval)
% %
Mean ± SD 81 ± 29 79 ± 27 2a
(-2.3, 6.8)
Median 95 89
a
Demonstrated non-inferiority to lansoprazole.
Other Maintenance of Healed Erosive Esophagitis Studies
Two additional randomized, active-controlled, double-blind studies conducted outside of the United
States, of similar design to the United States trial, also demonstrated non-inferiority of vonoprazan 10
mg once daily compared to lansoprazole 15 mg once daily for the primary endpoint of maintenance of
healed erosive esophagitis (all grades) through Week 24.
14.3 Treatment of Helicobacter pylori Infection
The effectiveness and safety of VOQUEZNA, amoxicillin and clarithromycin (triple therapy) and
VOQUEZNA and amoxicillin (dual therapy) were evaluated in a randomized, controlled, double-blind
(triple therapy)/open-label (dual therapy) study conducted in the United States and Europe in
treatment-naïve H. pylori-positive adult patients with at least one clinical condition: dyspepsia lasting
at least 2 weeks, functional dyspepsia, recent/new diagnosis of peptic ulcer, peptic ulcer not treated
for H. pylori infection, or a stable dose of long-term NSAID treatment (NCT04167670). Patients were
randomized [Link] to one of the following regimens administered for 14 consecutive days:
 VOQUEZNA 20 mg twice daily plus, amoxicillin 1,000 mg twice daily, and clarithromycin 500
mg twice daily
 VOQUEZNA 20 mg twice daily and amoxicillin 1,000 mg three times daily

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 lansoprazole 30 mg twice daily, amoxicillin 1,000 mg twice daily, and clarithromycin 500 mg
twice daily
H. pylori infection at baseline was defined as positive by 13C urea breath test (UBT) and follow-up
upper endoscopy (culture or histology). H. pylori eradication was confirmed with a negative 13C UBT
test-of-cure at least 27 days post-therapy. Patients with negative test results were considered
treatment successes. Patients who tested positive for H. pylori infection and patients with missing
results from the test-of-cure visit were considered treatment failures.
A total of 346 patients received VOQUEZNA, amoxicillin, and clarithromycin, 348 patients received
VOQUEZNA and amoxicillin, and 345 patients received lansoprazole, amoxicillin, and clarithromycin.
These patients had a mean age of 51 years (range 20 to 87 years); 62% were female; 27% identified
as Hispanic or Latino; 89% identified as White, 7% as Black or African American, 2% as Asian, and
2% identified as another racial group.
VOQUEZNA, amoxicillin, and clarithromycin and VOQUEZNA and amoxicillin were shown to be
noninferior to lansoprazole, amoxicillin, and clarithromycin in patients who did not have a
clarithromycin or amoxicillin resistant strain of H. pylori at baseline. VOQUEZNA, amoxicillin, and
clarithromycin and VOQUEZNA and amoxicillin were shown to be superior to lansoprazole,
amoxicillin, and clarithromycin in patients who had a clarithromycin resistant strain of H. pylori at
baseline and in the overall population.
H. pylori eradication rates at least 27 days post-therapy are shown in Table 16.

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Table 16: Eradication Rates of H. pylori in Adult Patients at least 27 Days Post-Therapy - mITT
VOQUEZNA VOQUEZNA and Lansoprazole,
Amoxicillin, and Amoxicillin Amoxicillin, and
Clarithromycin Clarithromycin
(LAC)

% % %
(n) (n) (n)

Patients with H. pylori 85 79 79

infection who did not have a (222) (208) (201)
clarithromycin or amoxicillin
resistant strain at baselinea
Treatment Difference from LAC 6b -0.3c
(95% CI) (-0.8, 12.6) (-7.4, 6.8)
All randomized patients with 81 77 69
H. pylori infection at baseline (273) (250) (226)
Treatment Difference from LAC 12d 9e
(95% CI) (5.7, 18.8) (1.9, 15.4)
Patients with H. pylori 66 70 32
infection who had a (48) (39) (23)
clarithromycin resistant strain
of H. pylori at baseline
Treatment Difference from LAC 34f 38f
(95% CI) (17.7, 48.1) (20.5, 52.6)
CI = confidence interval calculated via the Miettinen and Nurminen method
Modified intent to treat (mITT) population: Patients were included in the mITT analysis if they had documented H. pylori
infection at baseline.
a
Clarithromycin resistant strains of H. pylori were considered those with an MIC ≥ 1 mcg/mL; amoxicillin resistant strains
were considered those with an MIC > 0.125 mcg/mL.
b
p<0.0001 for test of non-inferiority versus LAC.
c
p<0.01 for test of non-inferiority versus LAC.
d
p=0.0003 for test of superiority versus LAC.
e
p=0.01 for test of superiority versus LAC.
f
p<0.0001 for test of superiority versus LAC.

16 HOW SUPPLIED/STORAGE AND HANDLING

VOQUEZNA (vonoprazan) tablets:
10 mg of vonoprazan: pale yellow, oval, film-coated tablets debossed V10 on one side and plain on
the other side. Bottles of 30 (NDC 81520-100-30).
20 mg of vonoprazan: pale red, oval, film-coated tablets debossed V20 on one side and plain on the
other side. Bottles of 30 (NDC 81520-200-30).

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Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F
and 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients of the following:
Acute Tubulointerstitial Nephritis
To call their healthcare provider if they experience signs and/or symptoms associated with acute
tubulointerstitial nephritis [see Warnings and Precautions (5.2)].
Clostridioides difficile-Associated Diarrhea
To immediately call their healthcare provider if they experience diarrhea that does not improve [see
Warnings and Precautions (5.3)].
Bone Fracture
To report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see
Warnings and Precautions (5.4)].
Severe Cutaneous Adverse Reactions
To discontinue VOQUEZNA and report to their healthcare provider at first appearance of a severe
cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions (5.5)].
Vitamin B12 (Cobalamin) Deficiency
To report any clinical symptoms that may be associated with Vitamin B12 deficiency to their
healthcare provider, if they have been receiving VOQUEZNA long-term [see Warnings and
Precautions (5.6)].
Hypomagnesemia and Mineral Metabolism
To report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or
hypokalemia to their healthcare provider [see Warnings and Precautions (5.7)].
Drug Interactions
To report to their healthcare provider if they start treatment with rilpivirine-containing products [see
Contraindications (4)].
Pregnancy
To contact Phathom Pharmaceuticals, Inc. if exposed to VOQUEZNA during pregnancy [see Use in
Specific Populations (8.1)].
Lactation
To not breastfeed during treatment with VOQUEZNA [see Use in Specific Populations (8.2)].
Important Administration Instructions
• VOQUEZNA can be taken with or without food [see Dosage and Administration (2) and Clinical
Pharmacology (12.3)].
• Swallow VOQUEZNA tablets whole; do not to chew or crush the tablet.
• Missed doses:

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o For the healing or maintenance of healed erosive esophagitis: If a dose is missed,

administer VOQUEZNA as soon as possible within 12 hours after the missed dose. If more
than 12 hours have passed, skip the missed dose and take your next dose at your regularly
scheduled time [see Dosage and Administration (2)].
o For the treatment of H. pylori infection: If a dose is missed, administer VOQUEZNA as soon
as possible within 4 hours after the missed dose. If more than 4 hours have passed, skip the
missed dose and administer your next dose at the regularly scheduled time. Continue the
normal dosing schedule until the treatment is completed [see Dosage and Administration
(2)].

VOQUEZNA is manufactured for and distributed by

Phathom Pharmaceuticals, Inc.
Buffalo Grove, IL 60089, U.S.A.

VOQUEZNA, the VOQUEZNA logo, and Phathom Pharmaceuticals are registered trademarks of
Phathom Pharmaceuticals, Inc.
© 2023 Phathom Pharmaceuticals, Inc. All rights reserved.
VOQ222 V1

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Page 1 of 2

PATIENT INFORMATION
VOQUEZNA® (voe kwez nah)
(vonoprazan)
tablets, for oral use
What is VOQUEZNA?
VOQUEZNA is a prescription medicine called a potassium-competitive acid blocker. VOQUEZNA reduces the
amount of acid in your stomach.
VOQUEZNA is used in adults:
 for 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis) and for
relief of heartburn related to erosive esophagitis.
 for up to 6 months to maintain healing of erosive esophagitis and for relief of heartburn related to erosive
esophagitis.
 for 14 days with the antibiotics amoxicillin and clarithromycin to treat an infection caused by bacteria called
Helicobacter pylori (H. pylori).
 for 14 days with the antibiotic amoxicillin to treat an infection caused by bacteria called H. pylori.
It is not known if VOQUEZNA is safe and effective in children.
Do not take VOQUEZNA if you are:
 allergic to vonoprazan or any of the ingredients in VOQUEZNA. See the end of this Patient Information
leaflet for a complete list of ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble
breathing, rash, itching and swelling of your face, lips, tongue, or throat.
 taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSY, CABENUVA)
used to treat HIV-1 (Human Immunodeficiency Virus).
Before taking VOQUEZNA, tell your healthcare provider about all of your medical conditions, including if
you:
 have low magnesium, calcium, or potassium in your blood or you are taking a medicine to increase urine
(diuretic).
 have kidney problems.
 have liver problems.
 are pregnant, think you may be pregnant or plan to become pregnant. It is not known if VOQUEZNA will
harm your unborn baby. Call the Phathom Pharmaceuticals, Inc. Adverse Event reporting line at 1-888-
775-7428 if you become pregnant while taking VOQUEZNA.
 are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You
and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do
both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and
pharmacist when you get a new medicine. VOQUEZNA may affect how other medicines work, and other
medicines may affect how VOQUEZNA works.
How should I take VOQUEZNA?
 Take VOQUEZNA exactly as your healthcare provider tells you to take it.
 Do not change your dose or stop taking VOQUEZNA without talking to your healthcare provider first.
 Take VOQUEZNA with or without food.
 Swallow VOQUEZNA tablets whole. Do not chew or crush the tablet.
 For the treatment of erosive esophagitis:
o If you miss a dose of VOQUEZNA, take it as soon as possible within 12 hours after the missed
dose. If more than 12 hours have passed, skip the missed dose and take the next dose at the
regularly scheduled time.
 For the treatment of H. pylori infection:
o If you miss a dose of VOQUEZNA, take it as soon as possible within 4 hours after the missed
dose. If more than 4 hours have passed, skip the missed dose and take the next dose at the
regularly scheduled time. Continue your regular dosing schedule until the treatment is completed.
What are the possible side effects of VOQUEZNA?
VOQUEZNA may cause serious side effects, including:
 A type of kidney problem (acute tubulointerstitial nephritis). Some people who take VOQUEZNA may
develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away
if you have a decrease in the amount that you urinate or if you have blood in your urine.

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 Diarrhea caused by an infection (Clostridioides difficile) in your intestines. Call your healthcare
provider right away if you have watery stools, stomach pain, or fever that does not go away.
 Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people
who take multiple daily doses of another type of medicine that reduces acid in your stomach known as
proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare
provider if you have a bone fracture, especially in the hip, wrist, or spine.
 Severe skin reactions. VOQUEZNA can cause rare but severe skin reactions that may affect any part of
your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
o Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your
lips, eyes, mouth, nose, genital, hands or feet).
o You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.
If you have any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away.
These symptoms may be the first sign of a severe skin reaction.
 Low Vitamin B-12 levels. VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is
needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin
B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the
arms and legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare
provider about the risk of low Vitamin B12 levels if you have been on VOQUEZNA for a long time.
 Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare
provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular
heartbeat, jitteriness, muscle aches or weakness, or spasms of hands, feet, or voice.
 Stomach growths (fundic gland polyps). A certain type of stomach growth called fundic gland polyps
may happen in people who take VOQUEZNA for a long time (more than a year). Talk with your healthcare
provider about the risk of fundic gland polyps if you have been on VOQUEZNA for a long time.
The most common side effects of VOQUEZNA for treatment of erosive esophagitis include:
 stomach inflammation  nausea
 diarrhea  indigestion
 stomach bloating  high blood pressure
 stomach pain  urinary tract infection
The most common side effects of VOQUEZNA when used with antibiotics for treatment of H. pylori
infection include:
 diarrhea  headache
 temporary changes in sense of taste  high blood pressure
 vaginal yeast infection  cold-like symptoms
 stomach pain
These are not all the possible side effects of VOQUEZNA.
For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VOQUEZNA?
 Store VOQUEZNA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep VOQUEZNA and all medicines out of the reach of children.
General information about the safe and effective use of VOQUEZNA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not
use VOQUEZNA for a condition for which it was not prescribed. Do not give VOQUEZNA to other people, even if
they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about VOQUEZNA that is written for health
professionals.
What are the ingredients of VOQUEZNA?
Active ingredient: vonoprazan
Inactive ingredients: ascorbic acid, croscarmellose sodium, ferric oxide red (only in 20 mg tablets), ferric oxide
yellow (only in 10 mg tablets), fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol,
microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.
VOQUEZNA is manufactured for and distributed by:
Phathom Pharmaceuticals, Inc.
Buffalo Grove, IL 60089, U.S.A.
VOQUEZNA, the VOQUEZNA logo, and Phathom Pharmaceuticals are registered trademarks of Phathom Pharmaceuticals, Inc.
© 2023 Phathom Pharmaceuticals, Inc. All rights reserved.
This Patient Information has been approved by the U.S. Food and Drug Administration Issued 11/2023

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