Semaglutide


Generic Medicine Info
Indications and Dosage
Oral
Type 2 diabetes mellitus
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).
Renal Impairment
ESRD: Not recommended.
Administration
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.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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.
Monitoring Parameters
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.
Overdosage
Symptoms: Nausea and other gastrointestinal disorders. Management: Symptomatic and supportive treatment. Prolonged period of observation and treatment may be necessary.
Drug Interactions
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).
Food Interaction
Absorption may be decreased when taken with food or large volume of water.
Action
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.
Chemical Structure

Chemical Structure Image
Semaglutide

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 56843331, Semaglutide. https://pubchem.ncbi.nlm.nih.gov/compound/Semaglutide. Accessed Mar. 25, 2021.

Storage
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.
MIMS Class
ATC Classification
A10BJ06 - semaglutide ; Belongs to the class of glucagon-like peptide-1 (GLP-1) analogues. Used in the treatment of diabetes.
References
Anon. Semaglutide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/02/2021.

Buckingham R (ed). Semaglutide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/02/2021.

Joint Formulary Committee. Semaglutide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/02/2021.

Ozempic 0.25 mg, 0.5 mg, and 1 mg Solution for Injection in Pre-filled Pen (Novo Nordisk A/S). European Medicines Agency [online]. Accessed 05/02/2021.

Ozempic 1.34 mg/mL (0.25 mg, 0.5 mg/dose) Solution for Injection in Pre-Filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/02/2021.

Ozempic Injection, Solution (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/02/2021.

Rybelsus 3 mg, 7 mg, and 14 mg Tablets (Novo Nordisk A/S). European Medicines Agency [online]. Accessed 05/02/2021.

Rybelsus Tablet (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/02/2021.

Disclaimer: This information is independently developed by MIMS based on Semaglutide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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