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GLP-1 Receptor Agonist Pregnancy: UK SPC section 4.6, verbatim: 'There are no adequate data from the use of liraglutide in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Liraglutide injection should be discontinued.' Breast-feeding: 'It is not known whether liraglutide is excreted in human milk. Animal studies have shown that the transfer of liraglutide and metabolites of close structural relationship into milk is low. Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups. Because of lack of experience, Liraglutide injection should not be used during breast-feeding.' Fertility: 'Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.' The US label section 8.1 is worded less absolutely: 'Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide injection during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.' It records early embryonic deaths and fetal abnormalities in rats at doses approximating clinical exposures at the maximum recommended human dose of 1.8 mg/day, and decreased fetal weight with increased major fetal abnormalities in rabbits at exposures below human exposures at that dose. The UK wording ('should not be used during pregnancy') is the stricter of the two and should lead on a UK page.

Liraglutide

Brand names: Victoza (T2DM), Saxenda (obesity)

Liraglutide is a GLP-1 receptor agonist (a daily injection) used in type 2 diabetes and, at higher doses, for weight management; it lowers glucose with weight loss.

Adult dose

Dose: Type 2 diabetes (glycaemic control), adults, subcutaneous once daily. UK SPC section 4.2, verbatim: 'To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended.' The US label agrees, section 2.1: 'The recommended starting dosage of liraglutide injection is 0.6 mg injected subcutaneously once daily for one week. The 0.6 mg once daily dosage is intended to reduce the risk of gastrointestinal adverse reactions during initial titration and is not effective for glycemic control in adults. After one week at the 0.6 mg once daily dosage, increase the dosage to 1.2 mg injected subcutaneously once daily. If additional glycemic control is required, increase the dosage to the maximum recommended dosage of 1.8 mg injected subcutaneously once daily after at least one week of treatment with the 1.2 mg once daily dosage.'
Route: Subcutaneous injection in the abdomen, in the thigh or in the upper arm. 'Liraglutide injection must not be administered intravenously or intramuscularly.' 'The injection site and timing can be changed without dose adjustment.' US section 2.3 adds: 'Rotate injection sites within the same region in order to reduce the risk of cutaneous amyloidosis'; 'When using liraglutide injection with insulin, administer as separate injections. Never mix. It is acceptable to inject liraglutide injection and insulin in the same body region but the injections should not be adjacent to each other'; and 'Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles.' SCOPE: this is the type 2 diabetes presentation only - see sourceUsed and notes.
Frequency: Once daily, at any time of day, independent of meals. 'However, it is preferable that liraglutide injection is injected around the same time of the day, when the most convenient time of the day has been chosen.'
Max: Maximum recommended dosage 1.8 mg once daily (US label section 2.1, verbatim: 'increase the dosage to the maximum recommended dosage of 1.8 mg injected subcutaneously once daily'). The UK SPC states the same ceiling: 'Daily doses higher than 1.8 mg are not recommended.' This ceiling belongs to the type 2 diabetes indication and to the 6 mg/ml presentation in this bundle.
Only the type 2 diabetes regimen is covered by this bundle. No obesity-indication SPC was fetched, so the 3 mg figures and the weight-management titration are NOT re-sourced and must not be treated as verified by this draft. The 1.8 mg ceiling published above is explicitly the type 2 diabetes ceiling and must not be applied to a weight-management prescription. CONCOMITANT THERAPY: 'When liraglutide injection is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia. Combination therapy with sulfonylurea is only valid for adult patients.' 'A stepwise approach to insulin dose reduction is recommended.' SELF-MONITORING: 'Self-monitoring of blood glucose is not needed in order to adjust the dose of liraglutide injection. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when liraglutide injection therapy is started and insulin is reduced.' MISSED DOSE (US section 2.2): 'Instruct patients who miss a dose of liraglutide injection to resume the once-daily dosage regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose. If more than 3 days have elapsed since the last liraglutide injection dose, reinitiate liraglutide injection at 0.6 mg once daily.' ELDERLY: 'Elderly patients (>65 years old): No dose adjustment is required based on age.' NOT FOR: 'Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Liraglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin.' 'There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients. There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis. Use of liraglutide is not recommended in these patients.'

Paediatric dose

Route: Subcutaneous injection in the abdomen, thigh or upper arm; must not be given intravenously or intramuscularly
Frequency: Once daily
Max: The maximum recommended dosage is 1.8 mg injected subcutaneously once daily (US label section 2.1, paediatric patients aged 10 years and older)
Concentration: 6 mg/ml
NOT WEIGHT-BASED - fixed milligram steps delivered by a pen with 0.6 mg, 1.2 mg and 1.8 mg settings - so dosePerKg is null and no volume calculation is required. UK SPC section 4.2, verbatim: 'Paediatric population: No dose adjustment is required for adolescents and children aged 10 years and above. No data are available for children below 10 years of age.' - i.e. the adult titration applies unchanged from 10 years. US label section 2.1 (Pediatric Patients Aged 10 Years and Older), verbatim: 'The recommended starting dosage of liraglutide injection is 0.6 mg injected subcutaneously once daily. If additional glycemic control is required, increase the dosage in 0.6 mg increments after at least one week on the current dosage, to reduce the risk of gastrointestinal adverse reactions. The maximum recommended dosage is 1.8 mg injected subcutaneously once daily.' US section 8.4: safety and effectiveness for glycaemic control in type 2 diabetes 'have been established in pediatric patients 10 years of age and older', supported by a 26-week placebo-controlled trial and open-label extension in 134 patients aged 10 to 17; 'The safety and effectiveness of liraglutide injection have not been established in pediatric patients less than 10 years of age'; and 'The risk of hypoglycemia was higher with liraglutide injection in pediatric patients regardless of insulin and/or metformin use.' Note also that combination with a sulfonylurea 'is only valid for adult patients' (UK section 4.2). Both sources in this bundle support paediatric type 2 diabetes use from 10 years of age; the obesity indication is not in this bundle at all. Verify all paediatric dosing against a children's formulary and specialist paediatric advice before prescribing.

Dose adjustments

Renal

UK SPC section 4.2, verbatim: 'Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment. There is no therapeutic experience in patients with end-stage renal disease, and liraglutide injection is therefore not recommended for use in these patients.' Section 4.4 adds: 'Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with liraglutide. Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.' US section 5.5: 'Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.'

Hepatic

UK SPC section 4.2, verbatim: 'Hepatic impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Liraglutide injection is not recommended for use in patients with severe hepatic impairment.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Adult Patients: Initiate at 0.6 mg injected subcutaneously once daily for one week then increase to 1.2 mg daily. If additional glycemic control is required, increase the dose to 1.8 mg daily after one week of treatment with the 1.2 mg daily dose. ( 2.1 ) Pediatric Patients: Initiate at 0.6 mg injected subcutaneously once daily for at least one week. If additional glycemic control is required increase the dose to 1.2 mg daily and if additional glycemic control is still required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. ( 2.1 ) Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-11-13. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (UK SPC section 4.3 - this is the ONLY contraindication in the UK SPC in this bundle, and section 4.3 was retrieved complete)
  • Personal or family history of medullary thyroid carcinoma (MTC), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (US label section 4 - NOT listed as a contraindication in this UK SPC; the divergence is real and should be resolved before publication)
  • Serious hypersensitivity reaction to liraglutide or to any of the excipients - 'Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide injection' (US label section 4)
  • Not for type 1 diabetes mellitus and not for the treatment of diabetic ketoacidosis; 'Liraglutide is not a substitute for insulin.' (UK SPC section 4.4 - stated as a warning rather than a formal contraindication, so it is recorded here with that qualification)
  • Not recommended in congestive heart failure NYHA class IV, in end-stage renal disease, in severe hepatic impairment, or in inflammatory bowel disease and diabetic gastroparesis (UK SPC sections 4.2 and 4.4 - 'not recommended', not contraindicated)

Side effects

  • Nausea and diarrhoea - very common; 'At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days or weeks on continued treatment'
  • Vomiting, dyspepsia, upper abdominal pain, constipation, gastritis, flatulence, abdominal distension, gastro-oesophageal reflux disease, abdominal discomfort, toothache - common
  • Hypoglycaemia - common, and very common when liraglutide is used in combination with a sulfonylurea; 'Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea'
  • Headache and nasopharyngitis - common; bronchitis, dizziness, decreased appetite, anorexia, fatigue, injection site reactions - common
  • Increased heart rate - common
  • Cholelithiasis - common; cholecystitis - uncommon
  • Rash, urticaria, pruritus
  • Delayed gastric emptying, dehydration, dysgeusia, malaise, renal impairment - uncommon
  • Pancreatitis (including necrotising pancreatitis) - rare; intestinal obstruction - rare; acute renal failure - rare
  • Anaphylactic reactions - rare
  • Increased lipase and increased amylase (from controlled phase 3b and 4 trials where they were measured)
  • US label section 6.1: most common adverse reactions (incidence 5% or more) are nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation. US warnings additionally flag risk of thyroid C-cell tumours, acute pancreatitis, acute gallbladder disease, severe gastrointestinal adverse reactions and pulmonary aspiration during general anaesthesia or deep sedation

Monitoring

  • 'Self-monitoring of blood glucose is not needed in order to adjust the dose of liraglutide injection. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when liraglutide injection therapy is started and insulin is reduced.' (UK SPC section 4.2)
  • Watch for pancreatitis - 'Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, liraglutide should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted.' (UK SPC section 4.4)
  • Renal function - 'Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.' (US label section 5.5); advise patients of the risk of dehydration from gastrointestinal side effects (UK section 4.4)
  • Thyroid - 'Thyroid adverse events, such as goitre, have been reported in clinical trials and in particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with caution in these patients.' (UK SPC section 4.4)
  • Hypoglycaemia risk when combined with a sulfonylurea or insulin; 'The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea or insulin.' (UK SPC section 4.4). In paediatric patients 10 years and older the risk was higher regardless of insulin and/or metformin use (US section 5.4)
  • Gallbladder - 'If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.' (US label section 5.8)
  • Never share a pen between patients, even if the needle is changed (US label section 5.3)
  • 'Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles.' (US label section 2.3)

Clinical monograph

How it works

It mimics GLP-1 — increasing glucose-dependent insulin secretion, suppressing glucagon, slowing gastric emptying and reducing appetite.

Prescribing in practice

  • Gastrointestinal effects (nausea, vomiting) are common during dose escalation — titrate slowly.
  • Delayed gastric emptying is relevant around anaesthesia or sedation and can affect oral drugs; rare pancreatitis.
  • Hypoglycaemia risk is low alone but higher with a sulfonylurea or insulin (reduce those); it is not for type 1 diabetes or DKA.

Monitoring

Monitor HbA1c and weight; review gastrointestinal tolerance and remain alert to pancreatitis.

Counselling the patient

  • It is a once-daily injection; nausea is common at first and usually improves.
  • Tell anaesthetic or endoscopy teams you take it.
  • Report severe, persistent abdominal pain.

Evidence & guidelines

A GLP-1 receptor agonist for type 2 diabetes (NICE NG28) with cardiovascular benefit (LEADER), and licensed for weight management.

Reference: LEADER Trial (Marso et al, NEJM 2016); SCALE Trial; NICE TA664; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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