Pharmacy Diabetes

G-5.5 GLP-1 Analogues- formulation(Liraglutide-victoza)

Name of medication
Liraglutide
Presentation
Victoza is a solution for injection in a pre-filled pen. One mL solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide. Each pen contains 3 mL of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Key Practice Points
Therapeutic indications:
  • Please note Victoza is not PBS listed – private prescription.
  • As an adjunct to healthy eating and physical activity to improve glycaemic management in individuals 10 years and older with type 2 diabetes mellitus.
  • To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
Dose:
  • VICTOZA® can be injected subcutaneously in the abdomen, thigh, or upper arm once daily (at approximately the same time each day) at any time of day, without regard to meals.
  • Insulin and Victoza can be injected at the same time of the day in the same region of the body but must never be mixed. Inject separately.
  • Missed dose: If a dose is missed, resume the once-daily regimen as soon the dose is remembered (at the same time), Do not take an extra dose to make up for any missed doses. If more than 3 days have been missed restart VICTOZA® at 0.6 mg and titrate as per initial starting schedule to reduce chances of gastrointestinal side effects. Note: Diabetes MedsCheck for missed doses.
  • Adult Dosage: Initiate VICTOZA® with a dose of 0.6 mg daily for one week to help reduce the likelihood of gastrointestinal symptoms. After one week at 0.6 mg per day, increase the dose to 1.2 mg daily. If additional glycaemic management is required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. Note: Diabetes MedsCheck on how to use pen delivery device.
  • Paediatric Dosage: Inject VICTOZA® with a dose of 0.6 mg daily. After at least one week at 0.6 mg daily, the dose may be increased to 1.2 mg daily if additional. glycaemic management is required. Further adjustment to 1.8mg after at least one week can then occur if needed.
  • Victoza and Saxenda both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda should also not be used in combination with another GLP-1 receptor agonist.
Contraindications:
  • Hypersensitivity to liraglutide or any active ingredient.
  • Medullary Thyroid Carcinoma VICTOZA® is contraindicated in those with a personal or family history of medullary thyroid carcinoma (MTC) or in individuals with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Precautions:
  • Thyroid C-cell tumours: Liraglutide causes thyroid C-cell tumours at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumours has not been determined.
    Note: Diabetes MedsCheck to ensure relevant referral pathways and screening occurs.
  • Pancreatitis: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. After initiation of Victoza, observe carefully for signs and symptoms. Do not restart Victoza if pancreatitis is confirmed.
    Note: MedsCheck to counsel on side effect profile and how to manage if it happens.
  • Hypoglycaemia with concomitant use of diabetes therapy: The risk of serious hypoglycaemia is increased when Victoza is used in combination with insulin secretagogues (e.g., sulfonylureas) in individuals with type 2 diabetes. The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea.
    Note: Diabetes MedsCheck, counselling to ensure individual understands hypoglycaemia signs and symptoms, blood glucose monitoring, referral pathways to allied health.
  • Dehydration, renal impairment, and acute renal failure: Individuals treated with Victoza should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. In those treated with GLP-1 receptor agonists, including liraglutide, there have been reports of acute renal injury/failure and worsening of chronic renal failure.
    Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.
  • Acute Gallbladder Disease: In the LEADER 3.1% of VICTOZA®-treated individuals versus 1.9% of placebo-treated individuals reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. Most events required hospitalization or cholecystectomy.
    Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.
Adverse Events:
  • Risk of Thyroid C-cell Tumours
  • Pancreatitis
  • Hypoglycaemia
  • Renal Impairment
  • Hypersensitivity Reactions (especially at injection site)
Pharmacokinetic Properties-Summary
Absorption:
Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 8-12 hours post dosing.
Distribution:
The mean apparent volume of distribution after subcutaneous administration of VICTOZA® 0.6 mg is approximately 13 L. Liraglutide is extensively bound to plasma protein (>98%).
Metabolism:
During the 24 hours following administration of a single liraglutide dose to healthy individuals, the major component in plasma was intact liraglutide. Two minor plasma metabolites were also detected.
Excretion:

Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination. The elimination half-life is approximately 13 hours.
For more detailed information on this product please consult the product information.
https://www.novo-pi.com/victoza.pdf

More Information

For more detailed information on this product please consult the source product information.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=victoza&r=/