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Rybelsus
semaglutide
Black Box Warnings .
Thyroid C-cell Tumor Risk
contraindicated in patients with medullary thyroid carcinoma (MTC) history or family history, or in patients with 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 patients of potential MTC risk and thyroid tumor symptoms (e.g., neck mass, dysphagia, dyspnea, persistent hoarseness)
Adult Dosing .
Dosage forms: TAB: 3 mg, 7 mg, 14 mg
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable with semaglutide 1.5 mg, 4 mg, 9 mg tabs; do not substitute on a mg to mg basis
diabetes mellitus, type 2
- [semaglutide-naive patients]
- 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 with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 4 mg PO qam]
- Dose: 7 mg PO qam; Start: day after last 4 mg dose; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 9 mg PO qam]
- Dose: 14 mg PO qam; Start: day after last 9 mg dose; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 0.5 mg SC qwk]
- Dose: 7-14 mg PO qam; Start: 1wk after last injection; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
cardiovascular event risk reduction - DM type 2 patients at high risk
- [semaglutide-naive patients]
- 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 if additional glycemic control needed; give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 4 mg PO qam]
- Dose: 7 mg PO qam; Start: day after last 4 mg dose; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 9 mg PO qam]
- Dose: 14 mg PO qam; Start: day after last 9 mg dose; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve tab
- [conversion from semaglutide 0.5 mg SC qwk]
- Dose: 7-14 mg PO qam; Start: 1wk after last injection; Info: give on empty stomach with up to 4 oz water >30min before food/drink/med; do not cut/crush/chew/dissolve 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.