BOXED WARNING Risk of thyroid C-cell tumors: semaglutide causes thyroid C-cell tumors in rodents; human relevance not determined. Contraindicated in patients with personal/family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
FDA dosing
Population
Start
Target
Max
Type 2 diabetes (glycemic control) / reduce MACE risk
Adults — Rybelsus
3 mg QD x30 days (not effective for glycemic control)
7 mg QD (day 31+); may increase to 14 mg QD
14 mg QD
Type 2 diabetes (glycemic control) / reduce MACE risk
Adults — Ozempic tablets
1.5 mg QD x30 days (not effective for glycemic control)
4 mg QD (day 31+); may increase to 9 mg QD
9 mg QD
Titration Escalate no sooner than every 30 days
Renal No adjustment needed
Hepatic No adjustment needed
Do not take more than one tablet per day; if a dose is missed, skip it and take next dose the following day
Instructions
Take once daily on an empty stomach in the morning with up to 4 oz (≤120 mL) of water only; no other liquids
Swallow whole; do not split, crush, chew, or dissolve
Wait at least 30 minutes before eating, drinking, or taking other oral medications
Rybelsus and Ozempic tablets are not substitutable mg-to-mg
Contraindications
Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Cautions
Acute pancreatitis
Diabetic retinopathy complications
Hypoglycemia with concomitant insulin secretagogues or insulin
Acute kidney injury due to volume depletion
Severe gastrointestinal reactions (not recommended in severe gastroparesis)
Hypersensitivity reactions
Acute gallbladder disease
Pulmonary aspiration during general anesthesia/deep sedation
Adverse reactions
Nausea
Abdominal pain
Diarrhea
Decreased appetite
Vomiting
Constipation
Pregnancy Insufficient human data; potential fetal risk from animal studies; use only if benefit justifies risk; discontinue ≥2 months before a planned pregnancy
Lactation Semaglutide below quantification in milk but SNAC present; breastfeeding not recommended