Adult: Adjunct to diet and exercise to improve glycaemic control: Monotherapy (if metformin is considered inappropriate due to contraindications or intolerance) or in combination with other antidiabetic agents: Initially, 3 mg once daily for 1 month, then increased to 7 mg once daily for at least 1 month. If additional glycaemic control is necessary, may further increase dose up to Max 14 mg once daily. Take one 14 mg tab to achieve the 14 mg dose; taking two 7 mg tab to reach the 14 mg dose is not recommended.
Subcutaneous Type 2 diabetes mellitus
Adult: Adjunct to diet and exercise to improve glycaemic control, or to reduce risk of major CV events: Monotherapy (if metformin is considered inappropriate due to contraindications or intolerance) or in combination with other antidiabetic agents: Initially, 0.25 mg once weekly for 4 weeks, then increased to 0.5 mg once weekly for at least 4 weeks. If glycaemic control is inadequate after at least 8 weeks of initiating treatment, may further increase dose up to Max 1 mg once weekly. Doses are injected at any time of the day, on the same day each week, with or without meals. If changing the day of weekly administration is necessary, allow at least 2 or 3 days (>48 or >72 hours) between 2 doses. Dosing administration may vary between countries (refer to detailed product guideline).
ESRD: Not recommended.
Tab: Should be taken on an empty stomach. Take at least 30 min before the first food/drink/medication of the day w/ plain water only. Swallow whole, do not chew/crush/cut.
Multiple endocrine neoplasia syndrome type 2 (MEN2), personal or family history of medullary thyroid carcinoma (MTC), type 1 diabetes mellitus, diabetic ketoacidosis. Pregnancy and lactation.
Patient with history of angioedema or anaphylaxis to other GLP-1 agonists, history of pancreatitis, history of diabetic retinopathy. Not a substitute for insulin (SC). Not recommended in patients with CHF NYHA class IV and ESRD. Severe hepatic impairment. Discontinue treatment at least 2 months before a planned pregnancy.
Significant: Hypersensitivity reactions (e.g. anaphylaxis, angioedema), hypoglycaemia, gallbladder and bile duct disease, cholelithiasis, acute or chronic pancreatitis, diabetic retinopathy complications, gastrointestinal effects (e.g. nausea, diarrhoea, vomiting), acute kidney injury, chronic renal failure exacerbation, increase risk of thyroid C-cell tumours, including MTC. Gastrointestinal disorders: Abdominal pain or distension, constipation, dyspepsia, GERD, eructation, flatulence, gastritis, dysgeusia. General disorders and administration site conditions: Fatigue, inj site reactions (e.g. rash, erythema). Investigations: Increased lipase and amylase, decreased weight, increased heart rate. Metabolism and nutrition disorders: Decreased appetite. Nervous system disorders: Dizziness.
Patient Counseling Information
When used in combination with other medicines for diabetes, this drug may cause hypoglycaemia, if affected, do not drive or operate machinery.
Monitor plasma glucose, HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting treatment goals); renal function, triglycerides. Assess for signs and symptoms of thyroid tumours, pancreatitis and gallbladder disease.
Symptoms: Nausea and other gastrointestinal disorders. Management: Symptomatic and supportive treatment. Prolonged period of observation and treatment may be necessary.
Increased risk of hypoglycemia with insulin and sulfonylureas. Delays the gastric emptying rate which may alter the absorption rate of other concurrently administered oral drugs (e.g. paracetamol, levothyroxine).
Absorption may be decreased when taken with food or large volume of water.
Description: Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which acts on the same receptor as the endogenous hormone incretin. It selectively binds to and activates the GLP-1 receptors to increase glucose-dependent insulin secretion, decrease inappropriate glucagon secretion, and slows gastric emptying. Pharmacokinetics: Absorption: May decrease absorption when taken with food or large volume of water (oral). Bioavailability: Approx 0.4-1% (oral); 89% (SC). Time to peak plasma concentration: 1 hour (oral); 1-3 days (SC). Distribution: Volume of distribution: Approx 8 L (oral); approx 12.5 L (SC). Plasma protein binding: >99% mainly to albumin. Metabolism: Extensively metabolised via proteolytic cleavage of the peptide backbone with sequential β-oxidation of the fatty acid side chain. Excretion: Via urine (approx 3% as unchanged drug); faeces. Elimination half-life: Approx 1 week.
Tab: Store between 20-25°C. Protect from moisture and light. SC inj: Prior to 1st use, store between 2-8°C. After 1st use, may store between 2-8°C or 15-30°C. Do not freeze. Protect from light, excessive heat or direct sunlight.