Orlistat Prescribing and Medication Review Guidelines for adult over 16 years of
age
Background Information
The National Institute for Health and Care Excellence (NICE) recommends pharmacological
treatment as an option for the management of obesity for people who have not reached their
target weight loss or have reached a plateau following dietary, activity and behavioural changes
[1]. Orlistat is the only licensed product currently approved for use across Cambridgeshire and
Peterborough.
Orlistat is a lipase inhibitor which prevents the absorption of fats from the gastrointestinal and
can also be used as an adjunct to lifestyle modifications for weight loss and chronic weight
management. It is available on prescription as 120mg capsules (Xenical). There is also a low
dose (60mg capsules) non-prescription brand available, Alli, over the counter in Pharmacies [2-
4].
Key Recommendations
Prescribe Orlistat ONLY as part of a weight management plan (which includes diet modification,
activity and behavioural approaches) for managing obesity in adults.
Patients must be motivated to engage with a weight management plan and meet one of the
following criteria:
o BMI ≥28kg/m2 with comorbidities, e.g. type 2 diabetes, hypertension, sleep apnoea
o BMI ≥30kg/m2
Starting Orlistat Therapy
Organic causes of obesity, such as hypothyroidism, should be ruled out prior to prescribing
orlistat, and should be treated as per clinical standards of care.
Prescribe orlistat ONLY if the patient is motivated to engage with treatment and review plan.
Before prescribing orlistat, the prescriber should discuss the following with the patient;
o discuss potential benefits, risks and limitations of treatment
o explain how the drug works / possible adverse side effects
o explain side-effects and low-fat dietary advice
o explain and establish a MONTHLY review plan delivered by the practice OR if the client is
seen by the existing Tier 3 weight management team; progress reports will be provided
on a 3-monthly basis in line with NICE guidance.
Nutritional Advice
o Recommend a low fat (30%) diet, e.g. 22g of fat per meal (based on a diet of 2000
calories and 3 meals per day).
o Take Orlistat with meals (immediately before, during or up to 1 hour after a meal)
1
o Distribute fat from the diet evenly over the 3 main meals Avoid fatty foods in between
meals, e.g. cakes, biscuits, crisps.
o DO NOT take Orlistat if a meal is missed or does not contain fat.
For patients who are BMI>40kg/m2 or BMI>35 kg/m2 with co-morbidities or if they are an obese
individual with complex needs who has not responded to previous Tier 3 interventions consider
referring to Cambridgeshire or Peterborough Tier 3 Weight Management service [5]. For
Cambridgeshire: Everyone Health. See https://www.everyonehealth.co.uk/cambridgeshire-
county-council/adult-weight-management
For Peterborough: Solutions for Health https://www.healthypeterborough.org.uk/201920.
Email: [email protected]. Telephone number 01733 894540
Recommended Dose & Cost
Orlistat (oral treatment) 120mg, TDS [2-3]. The co-prescribing of orlistat with other drugs
aimed at weight loss is not recommended.
Potential adverse effects include: abdominal distension and pain (gastro-intestinal effects
minimised by reduced fat intake); anxiety; faecal incontinence; faecal urgency; flatulence;
gingival disorders; headache, hypoglycaemia; liquid stools; malaise; menstrual disturbances;
oily leakage from rectum; oily stools; respiratory infections; tooth disorders; urinary tract
infection [2-4, 6].
Monitor renal function and hepatic function in patients at risk of these conditions.
Monitor weight [2-4, 6].
Reviewing Orlistat
Orlistat should be monitored regularly, at monthly intervals and diet and lifestyle changes
should be reinforced at each review:
Continue treatment >3 months ONLY if people achieve at least 5% weight loss from their initial
body weight during the treatment (less strict goals may be considered for those with type 2
diabetes).
Long term treatment should only continue past 12 months for weight maintenance after
discussing benefits, risks and limitations with the patient and any whilst weight loss achieved is
maintained or improved further
Stopping Orlistat
Orlistat should be discontinued if only weight loss of <5% of total body weight is achieved after
the first 12 weeks or if the patient regains weight at any time whilst receiving drug treatment.
Less strict goals may be considered for those with type 2 diabetes.
If treatment is withdrawn, please offer alternative support such as reviews at the practice or
other local groups which patients may wish to use for support. Consider referral to local Tier 3
weight management services if they meet the criteria.
Contraindications
Orlistat is not recommended for people taking acarbose [2-4, 6].
Orlistat is contraindicated in patients who have demonstrated a hypersensitivity reaction to
orlistat or any of the active or inactive ingredients [2-4, 6].
Orlistat should not be used in patients who are breastfeeding or who have or have a past
history of cholestasis & chronic malabsorption syndrome.
Orlistat should not be used routinely in pregnancy as there is limited evidence available. Weight
loss is not recommended during pregnancy due to potential harm to the health of the unborn
child. However, a healthy controlled weight gain during pregnancy is very important if BMI is
above 30kg/m2 at dating scan, please consider referral to local Tier 3 weight management
service if this is applicable.
Cautions and potential drug interactions:
Orlistat is minimally absorbed into the systemic bloodstream. However, it may interfere with
the absorption of other drugs resulting in a change in therapeutic effect or safety profile [2-4,
6].
Orlistat may impair absorption of vitamins such as vitamin A, E, and D. Vitamin
supplementation (especially of vitamin D) may be considered if there is concern about
deficiency of fat-soluble vitamins. A general multivitamin should be considered in the first
instance and can be purchased over the counter and should be taken at least two hours after
the administration of orlistat or at bedtime, to minimise the risk of orlistat interfering with
vitamin absorption [.2-4, 6].
Particular care should also be taken with the following drugs:
Anticoagulant drugs (e.g. warfarin), ciclosporin, iodine salts, levothyroxine (cases of
hypothyroidism and/or reduced control of hypothyroidism may occur), amiodarone,
antiretrovirals, and antiepileptic drugs. Additional monitoring should be completed to ensure
effectiveness of these concomitant medications [2-4, 6].
Orlistat does not appear to affect oral contraceptives and orlistat in specific drug-drug
interaction studies. However, orlistat may indirectly reduce the availability of oral
contraceptives and lead to unexpected pregnancies in some individual cases.
An additional contraceptive method is recommended in cases of severe diarrhoea [.2-4, 6].
Orlistat should be used with caution in pregnancy and also patients with chronic kidney disease.
Monitor renal function when prescribing orlistat to patients at risk for renal impairment and
use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
Some patients may develop increased levels of urinary oxalate following treatment with
orlistat, and cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have
been reported. Patients taking orlistat who present with urinary tract pain or with difficulty
passing urine may need to be evaluated for the presence of kidney stone [2-4, 6].
Use caution when orlistat is used in patients with a concurrent seizure disorder [2-4, 6].
Patients who have undergone an organ transplant must not take non-prescription orlistat, as
use may cause interference with medications that prevent transplant rejection. Such patients
should use orlistat under prescription only and be very carefully monitored.
If orlistat is required for a patient receiving immunosuppression treatment for prevention of
organ rejection following transplant, then they need to be referred to a specialist service prior
to initiation, due to the potential risk of orlistat interfering with the absorption of the
immunosuppressant drugs and potentially causing organ rejection with devastating
consequences [.2-4, 6].
All patients with complex needs who require weight management support, should be referred
to an appropriate service.
There have been rare post marketing reports of serious liver injury, hepatotoxicity, and
hepatocellular necrosis, particularly in patients with potential risks for liver injury with some of
these cases resulting in acute hepatic failure, liver transplant, or death.
Carefully consider the risk benefit of using orlistat in patient with hepatic disease or at risk of
hepatic disease [2-4, 6].
All patients should be instructed to report any symptoms of hepatic dysfunction (anorexia,
pruritus, jaundice, dark urine, light-coloured stools, or right upper quadrant pain) while taking
orlistat. When these symptoms occur, orlistat and other suspect medications should be
discontinued immediately and liver function tests (LFTs), including ALT and AST levels, obtained
[2-4, 6].
This document is intended for use in primary care as a guide on the appropriate use of orlistat.
This is not a substitute for clinical judgement, or any advice given by a clinician. The information
provided here such as costs and presentations are correct at the time of publishing and will
undergo periodic reviews to ensure that it remains up to date [2-4, 6].
Date: July 2020
Recommended Review Date: July 2023
Acknowledgements
Based on original work by NHS Barnsley Clinical Commissioning Group. Available at
https://www.barnsleyccg.nhs.uk/CCG%20Downloads/Members/Medicines%20management/Ar
ea%20prescribing%20committee/201805%20-%20APC%20Memo%20Enclosure%20-
%20Barnsley%20Orlistat%20Guide%20-%20May%202018.pdf
References
1. National Institute for Health and Care Excellence (NICE) (CG189) (2014) Obesity: identification,
assessment and management. London. [Available at: https://www.nice.org.uk/guidance/cg189
2. British National Formulary (BNF) (2020) BNF Accessed via https://bnf.nice.org.uk/drug/orlistat.html
3. Summary of Product Characteristics for Xenical (orlistat). Cheplapharm Arzneimittel GmbH. Last Updated
May 2017. Accessed 24th July 2020 via https://www.medicines.org.uk/emc/product/2592/smpc
4. Summary of Product Characteristics for Alli 60 mg hard capsules (orlistat OTC) Last updated November
2018. Accessed 24th July via https://www.medicines.org.uk/emc/product/6533/smpc
5. Orlistat Clinical Key Gold Standard Drug Monograph. Last Updated 11th July 2020. Accessed via
https://www.clinicalkey.com/ - !/content/drug_monograph/6-s2.0-770 July 2020.
6. C & P Clinical Policy: Bariatric Surgery Referral for Tier 3 Weight Management. March 2018. Accessed via
https://www.cambridgeshireandpeterboroughccg.nhs.uk/health-professionals/clinical-policies-and-
thresholds/clinical-policies/
