Semaglutide oral
RYBELSUS
Pronunciation: sem-a-GLOO-tide (reb-EL-sus)
What it isOral GLP-1 receptor agonist that enhances glucose-dependent insulin signaling; type 2 diabetes.
Why this oneIt brings GLP-1 therapy to a tablet for patients who wish to avoid injections.
What limits itStrict fasting administration is essential; nausea and vomiting often limit treatment, and delayed gastric emptying affects other drugs.
FDA label
Read the full label on DailyMed ↗
| 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
Available strengths
- tab 3, 7, 14 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
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 3 mg | tab | 30 qd | — | $995.70 | not offered |
| 7 mg | tab | 30 qd | — | $995.80 | not offered |
| 14 mg | tab | 30 qd | — | $995.66 | not offered |
Other forms: Semaglutide (OZEMPIC, WEGOVY) · Semaglutide (obesity) (WEGOVY) · Semaglutide oral (obesity) (WEGOVY (oral))
⚠ BOXED WARNING
- Thyroid C-cell tumors in rodents
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGI intolerance, gallbladder disease and rare pancreatitis; hypoglycemia is uncommon without insulin or sulfonylureas.