Reference: 1. Victoza® Professional Information.
Scheduling status: Name of the medicine: Victoza®. Qualitative and quantitative composition: Liraglutide 6 mg/ml. Therapeutic indications: Glycaemic control: Adjunct to diet & exercise to achieve glycaemic control in type 2 diabetes mellitus, as monotherapy, combination therapy with one or more oral antidiabetic medicines (metformin, sulphonylureas, SGLT2i or a thiazolidinedione) when previous therapy does not provide adequate glycaemic control or combination therapy with insulin in patients not achieving adequate glycaemic control with Victoza® and metformin. Prevention of cardiovascular events: Victoza® is indicated to prevent Major Adverse Cardiovascular Events (MACE) (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus at high cardiovascular risk, as an adjunct to standard of care therapy. Posology and method of administration: Monotherapy: Administration SC once daily at any time. Initiate 0,6 mg for at least one week, thereafter increase to 1,2 mg based on clinical response and after at least one week, may be increased to 1,8 mg to achieve maximum efficacy. Daily doses higher than 1,8 mg are not recommended. Combination therapy: Victoza® can be used in combination with other glucose lowering agents and no dose adjustments are required for metformin, thiazolidinedione and SGLT2i therapy. When Victoza® is added to a sulphonylurea therapy or insulin, a reduction in the dose of sulphonylurea or insulin should be considered to reduce the risk of hypoglycaemia 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 Victoza® is therefore not recommended for use in these patients. Contraindications: Hypersensitivity to liraglutide or any of its excipients, a history of previous pancreatitis, Type 1 diabetes mellitus, pregnancy and lactation. Special warnings and precautions for use: Not to be used for the treatment of DKA and Type 1 Diabetic patients. Not for IM/IV administration. There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Victoza® is therefore not for use recommended in these patients, not recommended in patients with inflammatory bowel disease/ diabetic gastroparesis. Blood glucose self-monitoring is advised when initiating therapy with sulphonylurea or insulin, possible development of anti-liraglutide antibody, warning of signs and symptoms of acute pancreatitis, discontinue therapy if suspected, reduce concomitant sulphonylurea or insulin dosage to reduce hypoglycaemia risk, no dose adjustment is required for patients with hepatic impairment, caution is advised in patients pre-existing thyroid disease. Safety and efficacy of Victoza® in patients below 18 years of age. There is no therapeutic experience in patients with end-stage renal disease, and Victoza® is therefore not recommended for use in these patients. The use of Victoza® has been associated with a risk of developing acute pancreatitis. Once acute pancreatitis is confirmed, Victoza® or any other GLP-1 receptor agonist should never again be restarted. Victoza® is not a substitute for insulin. Interaction with other medicines and other forms of interaction: Increased hypoglycaemia risk with concomitant sulphonylurea or insulin. Upon initiation of Victoza® treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of INR is recommended. Fertility, pregnancy and lactation: Victoza® is contraindicated during pregnancy and lactation. Treatment to be discontinued if a woman wishes to become pregnant/pregnancy occurs. Crossed the placental barrier in rabbits, reproductive toxicity in animals, excreted in milk of lactating rabbits. Undesirable effects: Fatigue, cholelithiasis, cholecystitis, increased lipase/increased amylase, malaise, anaphylactic reaction, urticaria, pruritus, renal failure, increased heart rate, dehydration, GI disturbances including eructation, headache, URTI, hypoglycaemia especially in combination with sulphonylurea, bronchitis, osteomyelitis, prostate/ breast cancer, thrombocytopenia, decreased appetite, CVA, syncope, cataract, cardiac disorders including MI/CCF/ supraventricular tachycardia, pulmonary embolism, appendicitis with perforation, inguinal hernia, pancreatitis, intervertebral disc protrusion, osteoarthritis, chest pain, fall, injection site reactions, thyroid adverse events including neoplasms, antibody formation. Overdose: With overdose, the patients reported severe nausea, vomiting and diarrhoea, but recovered without complications. Severe hypoglycaemia has been observed. Reg. No.: 43/21.13/0781. For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.
Novo Nordisk (Pty) Ltd. Reg. No.: 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196, South Africa. Tel: (011) 202 0500. Fax: (011) 807 7989. www.novonordisk.com. 15272T. ZA21VZ00003 January 2021.