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Rybelsus
semaglutide
Black Box Warnings .
Thyroid C-cell Tumor Risk
contraindicated in pts w/ medullary thyroid carcinoma (MTC) hx or family hx, or in pts w/ multiple endocrine neoplasia syndrome type 2 (MEN 2); dose-related and duration-dependent incr. in thyroid C-cell tumor incidence observed in rodents, but human relevance unknown; uncertain value of routine serum calcitonin or thyroid ultrasound monitoring; advise pts of potential MTC risk and thyroid tumor sx (e.g., neck mass, dysphagia, dyspnea, persistent hoarseness)
Adult Dosing .
Dosage forms: TAB (R1): 3 mg, 7 mg, 14 mg; TAB (R2): 1.5 mg, 4 mg, 9 mg
Special Note
- [formulation clarification]
- Info: semaglutide R1 and R2 tab forms not interchangeable; do not substitute on a mg to mg basis; see pkg insert to switch between oral forms
diabetes mellitus, type 2
- [semaglutide-naive pts, R1 tab form]
- Dose: 7-14 mg PO qam; Start: 3 mg PO qam x30 days, then incr. dose to 7 mg PO qam; Info: may incr. dose to 14 mg PO qam after at least 30 days on 7 mg PO qam; give on empty stomach w/ up to 4 oz water >30min before food/drink/med; do not cut/crush/chew tab
- [semaglutide-naive pts, R2 tab form]
- Dose: 4-9 mg PO qam; Start: 1.5 mg PO qam x30 days, then incr. dose to 4 mg PO qam; Info: may incr. dose to 9 mg PO qam after at least 30 days on 4 mg PO qam; give on empty stomach w/ up to 4 oz water >30min before food/drink/med; do not cut/crush/chew tab
- [conversion from semaglutide 0.5 mg SC qwk, R1 tab form]
- Dose: 7-14 mg PO qam; Start: 1wk after last injection; Info: give on empty stomach w/ up to 4 oz water >30min before food/drink/med; do not cut/crush/chew tab
- [conversion from semaglutide 0.5 mg SC qwk, R2 tab form]
- Dose: 4-9 mg PO qam; Start: 1wk after last injection; Info: give on empty stomach w/ up to 4 oz water >30min before food/drink/med; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.