Rybelsus

Rybelsus

semaglutide

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma

Marketer:

Novo Nordisk
Concise Prescribing Info
Contents
Semaglutide
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM.
Dosage/Direction for Use
Initially 3 mg once daily for 1 mth. Maintenance dose: 7 mg once daily for at least 1 mth, may be increased to 14 mg once daily. Max recommended single daily dose: 14 mg.
Administration
Should be taken on an empty stomach: Wait at least 30 min before eating/drinking/taking other oral medicinal products. Swallow whole w/ sip of water. Do not split/crush/chew.
Contraindications
Hypersensitivity. Patients w/ personal or family history of medullary thyroid carcinoma (MTC) or w/ multiple endocrine neoplasia syndrome type 2.
Special Precautions
Discontinue use if serious hypersensitivity reactions (eg, anaphylaxis, angioedema) occur; pancreatitis is suspected & not to be restarted if confirmed. Not to be used in patients w/ previous hypersensitivity; type 1 DM or for diabetic ketoacidosis. Not recommended in patients w/ CHF NYHA class IV. Pulmonary aspiration in patients undergoing general anaesth or deep sedation. Increased risk of hypoglycaemia; developing diabetic retinopathy complications. Acute pancreatitis. Potential risk of dehydration; MTC & thyroid tumor symptoms (eg, neck mass, dysphagia, dyspnea, persistent hoarseness). Avoid fluid depletion. Patients w/ bariatric surgery; on restricted Na diet. History of pancreatitis; angioedema or anaphylaxis w/ another GLP-1 receptor agonist. Closely monitor patients w/ diabetic retinopathy. May affect ability to drive & use machines when used w/ sulfonylurea or insulin. Severe renal & hepatic impairment. Not recommended in patients w/ ESRD. Women of childbearing potential should use contraception during treatment. Discontinue at least 2 mth before planned pregnancy. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly ≥75 yr.
Adverse Reactions
Hypoglycaemia (when used w/ insulin or sulfonylurea); nausea, diarrhoea. Hypoglycaemia (when used w/ other oral antidiabetics), decreased appetite; diabetic retinopathy complications; vomiting, abdominal pain & distension, constipation, dyspepsia, gastritis, GERD, flatulence; fatigue; increased lipase & amylase; dizziness.
Drug Interactions
Increased AUC of thyroxine. Decreased INR w/ acenocoumarol. Concomitant use w/ warfarin or other coumarin derivatives (frequent monitoring of INR is recommended).
MIMS Class
Antidiabetic Agents
ATC Classification
A10BJ06 - semaglutide ; Belongs to the class of glucagon-like peptide-1 (GLP-1) analogues. Used in the treatment of diabetes.
Presentation/Packing
Form
Rybelsus tab 14 mg
Packing/Price
30's
Form
Rybelsus tab 3 mg
Packing/Price
30's
Form
Rybelsus tab 7 mg
Packing/Price
30's
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