BRUCK PHARMA PVT. LTD.

CARTON SPECIFICATION
Generic Name : PEG L-ASPARAGINASE INJECTION 3750 IU/5ML
Brand Name : PEG BRUGINASE
Correction No: 01 Barcode : Board Style : FBB/320gsm
A/W Initiate Date : 09-05-2023 Country : Export Aqua F: Yes UV : Spot UV :
Date : 09-05-2023 Carton Back Side Printing : No Texture Finishing (Dripp-of) : Yes
No. Colour : CMYK Artwork Code : 400/PM4180/00 Lamination - Matt / PVC
Job Size : 66 (L) X 33 (W) X 85 (H) Reason For Issue: Embossing / Braille Embossing
Designer Name : Sunil Pawar Pack Style : 1x1 Vial, 5ml moulded Foil :- Foil Colour:-
Path :
Note : Size / Image / Emboss / Backside / Foil / Brail Check Carefully.

400/PM4180/00

3750 IU/5 ML
PEG L-ASPARAGINASE INJECTION
PEG BRUGINASE
1 Vial

Composition: Mfg.lic. No. : DD/794

Each ml contains:
PEG L-Asparaginase …….. 750 IU Batch No.:
Excipients …………………..q.s.
NVZ AREA
Mfg. Date:
27x22mm
1 Vial 1 Vial
Dosage: Exp. Date:
As directed by an Oncologist.

PEG BRUGINASE Note : Please refer accompanying PEG BRUGINASE

85.00 mm

package insert for detailed dosage,

PEG L-ASPARAGINASE INJECTION directions for use and precautions PEG L-ASPARAGINASE INJECTION
3750 IU/5 ML 3750 IU/5 ML
For intravenous or intramuscular use. Storage: For intravenous or intramuscular use. 8906045922012
Store at 2°C to 8°C (36°F to 46°F).
Single-use vial. Single-use vial.
Do not shake or freeze product.
Discard unused portion. Protect from light Discard unused portion.

Manufactured by:

Do not use if it contains visible

particulate matter.
BRUCK PHARMA PVT. LTD.
(A WHO-GMP & AN ISO 9001:2015
CERTIFIED COMPANY)
Survey No. 188/1 to 6, 189/1, 190/2 to

CYTOTOXIC KEEP OUT OF REACH OF CHILDREN. CYTOTOXIC 4, Atiyawad, Dabhel, Daman and
Diu-396210, INDIA.

66.00 mm 33.00 mm

Approved by:
Prepared by: Checked by: Checked by: Approved by:
PD RA QA QA-Head

Sign/Date Sign/Date Sign/Date Sign/Date

 Path :
Date : 22-05-2023
Correction No: 01

No. Colour : CMYK

Composition:

Job Size : 60 (L) X 20 (H)

Each ml contains :
PEG L-Asparaginase................750 IU

Designer Name : Sunil Pawar

Excipients.....................................q.s.
A/W Initiate Date : 22-05-2023

Dosage: As directed by an Oncologist.

Brand Name : PEG BRUGINASE

Note : Please refer accompanying

PD
package insert for detailed dosage,
directions for use and precautions

Sign/Date
Prepared by:
Storage: Store at 2°C to 8°C
(36°F to 46°F). Do not shake or freeze
product. Protect from light. 20.00 mm
Composition:
Each ml contains :
Do not use if it contains visible
PEG L-Asparaginase................750 IU
particulate matter. Excipients.....................................q.s.
Dosage: As directed by an Oncologist.
Note : Please refer accompanying

Approved by:
KEEP OUT OF REACH OF CHILDREN. package insert for detailed dosage,
directions for use and precautions
Barcode :

Storage: Store at 2°C to 8°C

(36°F to 46°F). Do not shake or freeze
product. Protect from light.

RA
Do not use if it contains visible
particulate matter.

KEEP OUT OF REACH OF CHILDREN.

Sign/Date
Checked by:
Country : Export

Single-use vial.
Reason For Issue:

3750 IU/5 ML
Single-use vial.
3750 IU/5 ML

Discard unused portion.

Discard unused portion.
For intravenous or intramuscular use.
PEG L-ASPARAGINASE INJECTION
1 Vial

PEG BRUGINASE

CYTOTOXIC
Generic Name : PEG L-ASPARAGINASE INJECTION 3750 IU/5ML

For intravenous or intramuscular use.

60.00 mm

Mfg. Lic. No.: DD/794

Batch No. :
NVZ

PEG L-ASPARAGINASE INJECTION

Mfg. Date :

1 Vial

PEG BRUGINASE
Artwork Code :400/PM4179/00

16 x 8 mm

CYTOTOXIC
Exp. Date :
Carton Back Side Printing : No

QA
Manufactured by:
Pack Style : 1x1 Vial, 5ml moulded

Sign/Date
BRUCK PHARMA PVT. LTD.
Mfg. Lic. No.: DD/794

Checked by:
(A WHO-GMP & AN ISO 9001:2015
400/PM4179/00

CERTIFIED COMPANY)
BRUCK PHARMA PVT. LTD.

Batch No. : Survey No. 188/1 to 6, 189/1, 190/2 to 4,

Atiyawad, Dabhel, Daman and
Diu-396210, INDIA.
LABEL SPECIFICATION

Mfg. Date :
NVZ
Exp. Date :
16 x 8 mm
Manufactured by:
Foil :-

BRUCK PHARMA PVT. LTD.

QA-Head

Sign/Date
Note : Size / Image / Emboss / Backside / Foil / Brail Check Carefully.

(A WHO-GMP & AN ISO 9001:2015

400/PM4179/00

Approved by:
CERTIFIED COMPANY)
Survey No. 188/1 to 6, 189/1, 190/2 to 4,
Atiyawad, Dabhel, Daman and
Diu-396210, INDIA.
Lamination - Matt / PVC

Foil Colour:-
Embossing / Braille Embossing
Board Style : Sticker Paper Label

Texture Finishing (Dripp-of) : Yes

 BRUCK PHARMA PVT. LTD.
LEAFLET SPECIFICATION
Generic Name : PEG L-ASPARAGINASE INJECTION 3750 IU/5ML
Brand Name : PEG BRUGINASE
Correction No: 01 Barcode : Board Style : Maplitho Paper
A/W Initiate Date : 22-05-2023 Country : Export Aqua F: Yes UV : Spot UV :
Date : 22-05-2023 Carton Back Side Printing : No Texture Finishing (Dripp-of) : Yes
No. Colour : BLACK Artwork Code : PEG/PM4181/00 Lamination - Matt / PVC
Job Size : (L) X 90 X 223.616 mm (H) Reason For Issue: Embossing / Braille Embossing
Designer Name : Sunil Pawar Pack Style : 1x1 Vial, 5ml moulded Foil :- Foil Colour:-
Path :
Note : Size / Image / Emboss / Backside / Foil / Brail Check Carefully.

90.00 mm

Dosage and Administration Glucose Intolerance Geriatric Use

PEG BRUGINASE
Recommended Dosage Glucose intolerance can occur in patients receiving PEG BRUGINASE. In some cases, Clinical studies of PEG BRUGINASE did not include sufficient numbers of subjects aged 65
Patients 21 Years of Age or Younger glucose intolerance is irreversible. Monitor serum glucose years and older to determine whether they respond differently than younger subjects.
The recommended dose of PEG BRUGINASE for patients up to and including 21 years of Overdosage
PEG L-ASPARAGINASE INJECTION age is 2,500 International Units/m2 intramuscularly or intravenously no more frequently than
every 14 days.
Hemorrhage
Three patients received 10,000 International Units/m2 of PEG BRUGINASE as an
Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia
3750 IU/5 ML Patients More Than 21 Years of Age can occur in patients receiving PEG BRUGINASE. Evaluate patients with signs and
intravenous infusion. One patient experienced a slight increase in liver enzymes. A second
patient developed a rash 10 minutes after the start of the infusion, which was controlled
The recommended dose of PEG BRUGINASE for adult patients more than 21 years of age symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. with the administration of an antihistamine and by slowing down the infusion rate. A third
is 2,000 International Units/m2 intramuscularly or intravenously no more frequently than Consider appropriate replacement therapy in patients with severe or symptomatic patient did not experience any adverse reactions.
every 14 days. coagulopathy. Discontinue PEG BRUGINASE for severe or life-threatening hemorrhage
There is no specific antidote for PEG BRUGINASE overdosage. In case of overdose,
monitor patients closely for signs and symptoms of adverse reactions, and appropriately
Composition Recommended Premedication Hepatotoxicity manage with symptomatic and supportive treatment.
PEG L-Asparaginase ………………….. 750 IU Hepatotoxicity and abnormal liver function, including elevations of transaminase, elevations
Premedicate patients with acetaminophen, an H-1 receptor blocker (such as Storage: Store at 2°C to 8°C (36°F to 46°F).
Excipients ………………………………..q.s. of bilirubin (direct and indirect), reduced serum albumin, and reduced plasma fibrinogen
diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to Do not shake or freeze product. Protect from light
administration of PEG BRUGINASE to decrease the risk and severity of both infusion and can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment
Description that include PEG BRUGINASE through at least 6 weeks after the last dose of PEG
hypersensitivity reactions Shelf life: 24 months
Pegaspargase is a conjugate of monomethoxypolyethylene glycol (mPEG) and L- BRUGINASE. In the event of serious liver toxicity, discontinue treatment with PEG
Recommended Monitoring and Dosage Modifications for Adverse Reactions BRUGINASE and provide supportive care
asparaginase (L-asparagine amidohydrolase), an asparagine specific enzyme. L-
Monitor patients at least weekly, with bilirubin, transaminases, glucose and clinical For intravenous or intramuscular use.
asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists Adverse Reactions
examinations until recovery from the cycle of therapy. Single-use vial.
of identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG are linked to L-
The following clinically significant adverse reactions are described elsewhere in the Discard unused portion.
asparaginase; the molecular weight of each mPEG molecule is about 5 kDa. PEG
Preparation and Administration labeling:
BRUGINASE activity is expressed in International Units.
· Anaphylaxis and serious hypersensitivity reactions
PEG BRUGINASE injection is supplied as a clear, colorless, preservative-free, isotonic Administer PEG BRUGINASE in a healthcare setting with appropriate medical support and · Thrombosis
sterile solution in phosphate-buffered saline, pH 7.3, for intramuscular use or for dilution resuscitation equipment to manage hypersensitivity reactions, should they occur. · Pancreatitis KEEP OUT OF REACH OF CHILDREN
prior to intravenous infusion. Each vial of PEG BRUGINASE contains 3,750 International PEG BRUGINASE is a clear and colorless solution. Visually inspect parenteral drug · Glucose intolerance
Units of pegaspargase in 5 mL of solution. Each milliliter contains 750 International Units of products for particulate matter, cloudiness, or discoloration prior to administration. If any of · Hemorrhage
pegaspargase, dibasic sodium phosphate, USP (5.58 mg), monobasic sodium phosphate, these are present, discard the vial. · Hepatotoxicity
USP (1.20 mg), and Sodium Chloride, USP (8.50 mg) in Water for Injection, USP.
When PEG BRUGINASE is administered intramuscularly:
Drug Interactions
Clinical pharmacology · Limit the volume at a single injection site to 2 mL.
Glucocorticoids
Mechanism of action · If the volume to be administered is greater than 2 mL, use multiple injection sites.
L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine Pegaspargase may increase the risk of glucocorticoid-induced toxicities, including
223.62 mm

into aspartic acid and ammonia. The pharmacological effect of PEG BRUGINASE is When PEG BRUGINASE is administered intravenously: osteonecrosis, through a potential increase in exposure of dexamethasone
thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. · Dilute PEG BRUGINASE with 100 mL of 0.9% Sodium Chloride Injection, USP or 5%
Leukemic cells with low expression of asparagine synthetase have a reduced ability to Dextrose Injection, USP, using aseptic technique.
synthesize asparagine, and therefore depend on an exogenous source of asparagine for Use in Specific Population
survival. · After dilution, administer immediately into a running infusion of either 0.9% Sodium Pregnancy
Chloride, USP or 5% Dextrose Injection, USP, respectively. Administer over a period Based on published literature studies with L-asparaginase in pregnant animals, PEG
Pharmacokinetics BRUGINASE can cause fetal harm when administered to a pregnant woman. There are no
of 1-2 hours. Do not infuse other drugs through the same intravenous line during
Pharmacokinetic assessments were based on an enzymatic assay measuring available data on PEG BRUGINASE use in pregnant women to evaluate for a drug-
administration of PEG BRUGINASE. associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
asparaginase activity after intramuscular (IM, CCG-1962) and intravenous (IV, AALL07P4)
administration of 2,500 International Units/m2 in patients with ALL. · The diluted solution should be used immediately. If immediate use is not possible, the Published literature studies in pregnant animals suggest asparagine depletion may cause
diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 harm to the animal offspring. Advise pregnant women of the potential risk to a fetus.
Absorption
The mean maximum asparaginase activity (Cmax) was reached at approximately 1 IU/mL hours. Protect infusion bags from direct sunlight.
(n=45-52) on Day 5 after a single IM injection. The mean half-life of absorption from the IM Lactation
PEG BRUGINASE does not contain a preservative. Use only one dose per vial;
site was 1.7 days. The relative bioavailability was 82% following the first IM dose and 98% There are no data on the presence of pegaspargase in human milk, the effects on the
following repeat dosing. discard unused product. breastfed child, or the effects on milk production. Because of the potential for adverse
The mean Cmax and the area under the curve (AUC0-inf) was 1.6 IU/mL and 16.6 reactions in the breastfed child, advise women not to breastfeed during treatment with PEG
IU/mL*day, respectively, after a single IV infusion (n=47) during the induction phase. Warning and Precautions BRUGINASE and for 1 month after the last dose.
Anaphylaxis and Serious Hypersensitivity Reactions
Distribution Females and Males of Reproductive Potential
Anaphylaxis and serious hypersensitivity reactions can occur in patients receiving PEG
The mean volume of distribution at steady state was estimated to be 1.86 L/m2 after a PEG BRUGINASE can cause fetal harm when administered to a pregnant woman
BRUGINASE. The risk of serious hypersensitivity reactions is higher in patients with known
single IM injection and approximately 2 L after a single IV infusion based on non- Pregnancy
hypersensitivity to (E.) coli derived L-asparaginase formulations. Other hypersensitivity
compartmental analysis.
reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure Pregnancy testing is recommended in females of reproductive potential prior to initiating
Elimination decreased, bronchospasm, dyspnea, pruritus, and rash PEG BRUGINASE.
The mean elimination half-life was approximately 5.8 days following a single IM injection Contraception
and 5.3 days following a single IV infusion. The clearance was 0.17 L/m2/day and 0.2 L/day, Thrombosis
respectively, for a single IM and IV dose. Advise females of reproductive potential to use effective non-hormonal contraceptive
Serious thrombotic events, including sagittal sinus thrombosis can occur in patients methods during treatment with PEG BRUGINASE and for 3 months after the last dose.
receiving PEG BRUGINASE. Discontinue PEG BRUGINASE in patients with serious Pediatric Use
Indication and usage thrombotic events
The safety and effectiveness of PEG BRUGINASE in the treatment of ALL have been
First Line Acute Lymphoblastic Leukemia (ALL) established in pediatric patients. Use of PEG BRUGINASE in these age groups is
Pancreatitis supported by evidence of efficacy as first-line treatment from one adequate and well- Manufactured by :
PEG BRUGINASE® is indicated as a component of a multi-agent chemotherapeutic
regimen for the first-line treatment of pediatric and adult patients with ALL. Pancreatitis can occur in patients receiving PEG BRUGINASE. Hemorrhagic or necrotizing controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to

PEG/PM4181/00
pancreatitis with fatal outcomes have been reported. Inform patients of the signs and asparaginase from four adequate and well-controlled trials, and safety data from 7 total
symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase trials. The pediatric patients
Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase treated with PEG BRUGINASE 2,500 International Units/m2 on these trials included 26
and/or lipase levels to confirm early signs of pancreatic inflammation. Discontinue PEG BRUCK PHARMA PVT. LTD.
PEG BRUGINASE is indicated as a component of a multi-agent chemotherapeutic regimen BRUGINASE in patients where pancreatitis is suspected. If pancreatitis is confirmed, do infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 (A WHO-GMP & AN ISO 9001:2015 CERTIFIED COMPANY)
for the treatment of pediatric and adult patients with ALL and hypersensitivity to native not resume PEG BRUGINASE adolescents (12 to 17 years old). Survey No. 188/1 to 6, 189/1, 190/2 to 4, Atiyawad, Dabhel,
forms of L-asparaginase. Daman and Diu-396210, INDIA.

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