Liraglutide (Weight Management) (Saxenda)

1. Health Canada Product Monograph — Liraglutide (Weight Management)

• As an adjunct to a reduced-calorie diet and increased physical activity, for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.
• Also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents 12 years of age and older with obesity — confirm the current adolescent-specific eligibility and dosing before prescribing in this population.
• Do not substitute for Victoza (liraglutide for type 2 diabetes, maximum dose 1.8 mg daily) or use the two products interchangeably.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Contraindicated. Discontinue at least 2 months before a planned pregnancy given the potential for continued drug exposure into early pregnancy and the theoretical risk that treatment-related weight loss itself could harm the fetus.

• Not recommended. Liraglutide is a large protein molecule and would be expected to transfer into breast milk only in very small amounts, but no human lactation data are available to confirm safety.

• No specific dose adjustment is required based on age alone; clinical trial experience in patients over 75 years is limited.

• Approved for adolescents 12 years of age and older with obesity, as described under Indication. Not established in children under 12 years of age.

• Initiate at 0.6 mg subcutaneously once daily for at least 1 week.
• Increase in increments of 0.6 mg at intervals of at least 1 week: 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4), then the 3 mg once-daily maintenance dose from week 5 onward.
• If a dose increase is not tolerated, delay escalation to the next dose by an additional week before trying again. Do not exceed 3 mg once daily.
• Evaluate response after 12 weeks on the 3 mg maintenance dose: if the patient has not lost at least 5% of baseline body weight, discontinue treatment, since continued use is unlikely to produce clinically meaningful further weight loss.
• Inject subcutaneously into the abdomen, thigh, or upper arm; rotate injection sites within the chosen area. May be administered at any time of day, independent of meals.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Overdoses of up to 72 mg (24 times the recommended maintenance dose) have been reported, producing severe nausea and vomiting; hypoglycemia risk is increased if a glucose-lowering medication is also being taken. Manage with supportive care and blood glucose monitoring.

• Nausea, vomiting, diarrhea, constipation, decreased appetite, headache, and injection site reactions. Gastrointestinal effects are most frequent during dose escalation and are minimized by adhering to the recommended slow titration schedule.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Acute pancreatitis — persistent severe abdominal pain, with or without radiation to the back, warrants immediate discontinuation and evaluation; do not restart if pancreatitis is confirmed.
• Cholelithiasis and cholecystitis.
• Acute kidney injury, usually secondary to dehydration from severe vomiting or diarrhea.
• Increased heart rate.
• Suicidal ideation or new/worsening mood symptoms — assess promptly if reported.

• History of gallbladder disease.
• Renal impairment, or any condition predisposing to volume depletion, given the gastrointestinal adverse-effect profile.
• History of depression or suicidal ideation.
• Concurrent insulin or sulfonylurea therapy — hypoglycemia risk may require a dose reduction of the concurrent agent.

• Personal or family history of medullary thyroid carcinoma.
• Multiple endocrine neoplasia syndrome type 2 (MEN 2).
• Pregnancy and breastfeeding.
• Known hypersensitivity to liraglutide or any excipient.

• Delays gastric emptying, which can affect the rate of absorption of concurrently administered oral medications, including oral contraceptives — monitor efficacy of narrow-therapeutic-index oral drugs.
• Increased hypoglycemia risk when combined with insulin or a sulfonylurea; a dose reduction of the concurrent agent may be required.
• No clinically significant cytochrome P450-mediated interactions have been identified.

• None specific — unlike orlistat, efficacy does not depend on meal fat content or timing relative to meals.

• Any time of day; choosing a consistent daily time supports adherence.

• Store unopened pens refrigerated at 2-8°C; do not freeze. Once in use, a pen may be kept at room temperature (below 30°C) or refrigerated for up to 1 month, then discarded regardless of remaining volume.

• This is a different product, at a different (higher) dose, than the liraglutide used for diabetes (Victoza) — the two must not be substituted for one another.
• Nausea is common when starting or increasing the dose and usually improves with time; report severe or persistent abdominal pain right away.
• This medication is intended for long-term, ongoing use — stopping it typically leads to weight regain.