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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.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- breastfeeding (PO form)
- medullary thyroid CA hx
- medullary thyroid CA family hx
- multiple endocrine neoplasia syndrome type 2
- diabetes mellitus, type 1
- caution: hypersensitivity to GLP-1 agonists
- caution: renal impairment
- caution: volume depletion
- caution: gastroparesis, severe
- caution: pancreatitis risk
- caution: pancreatitis hx
- caution: diabetic retinopathy
- caution: pts of childbearing potential
- caution: surgery
Drug Interactions .
Overview
semaglutide
GLP-1 agonist
- antidiabetic agent
- caution advised w/ oral drugs, esp. narrow therapeutic index; oral/SC semaglutide delays gastric emptying, may alter absorption of concomitant oral drugs
- admin. oral semaglutide at least 30 min before other oral drugs; combo may decr. oral semaglutide absorption, efficacy
Avoid/Use Alternative
- dulaglutide
- exenatide
- liraglutide
- semaglutide
- tirzepatide
Monitor/Modify Tx
- acebutolol
- alclometasone topical
- aloe
- alogliptin
- alpelisib
- amcinonide topical
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- arsenic trioxide
- asenapine
- ashwagandha
- asparaginase
- aspirin
- atazanavir
- benazepril
- berberine
- betamethasone
- betamethasone topical
- bismuth subsalicylate
- bortezomib
- brentuximab vedotin
- brexpiprazole
- brigatinib
- bromocriptine
- budesonide
- bumetanide
- calaspargase
- canagliflozin
- capivasertib
- cariprazine
- carvedilol
- cassia cinnamon
- ceritinib
- chloroquine
- chlorothiazide
- chlorthalidone
- chromium
- ciprofloxacin
- clarithromycin
- clobetasol topical
- clocortolone topical
- clozapine
- colesevelam
- copanlisib
- corticotropin
- cortisone
- dabrafenib
- danazol
- darunavir
- decitabine
- deflazacort
- delafloxacin
- desogestrel (contraceptive)
- desonide topical
- desoximetasone topical
- dexamethasone
- diazoxide
- dienogest (contraceptive)
- diflorasone topical
- disopyramide
- drospirenone (contraceptive)
- eleuthero
- enfortumab vedotin
- ensartinib
- ephedra
- epinephrine
- ertugliflozin
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethacrynic acid
- ethanol
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethionamide
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- everolimus
- fenugreek
- flaxseed
- fludrocortisone
- fluocinolone otic
- fluocinolone topical
- fluocinonide topical
- fluoxetine
- flurandrenolide topical
- fluticasone propionate topical
- fosamprenavir
- fosphenytoin
- furosemide
- garlic
- ginkgo
- ginseng, American
- ginseng, Asian
- glimepiride
- glipizide
- glyburide
- goserelin
- gymnema
- halcinonide topical
- halobetasol topical
- histrelin
- hydrochlorothiazide
- hydrocortisone
- hydrocortisone topical
- hydroxychloroquine
- iloperidone
- inavolisib
- indapamide
- insulin
- isocarboxazid
- isoniazid
- lanreotide
- leuprolide
- levofloxacin
- levonorgestrel (contraceptive)
- levothyroxine
- linagliptin
- linezolid
- liothyronine
- lisinopril
- lopinavir/ritonavir
- lorlatinib
- lumateperone
- lurasidone
- lurbinectedin
- lutetium Lu 177 dotatate
- mecasermin
- medroxyprogesterone (contraceptive)
- megestrol
- methylprednisolone
- methyltestosterone
- metolazone
- metreleptin
- milk thistle
- mometasone topical
- moxifloxacin
- nadolol
- nateglinide
- nelfinavir
- niacin (vitamin B3)
- norelgestromin (contraceptive)
- norepinephrine
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- octreotide
- ofloxacin
- olanzapine
- paliperidone
- pasireotide
- pegaspargase
- peginterferon alfa 2a
- pegvisomant
- pentamidine
- phenelzine
- phenylephrine
- phenytoin
- pindolol
- pioglitazone
- pramlintide
- prednicarbate topical
- prednisolone
- prednisone
- pseudoephedrine
- quetiapine
- quinine
- repaglinide
- ribose
- risperidone
- ritonavir
- rosiglitazone
- sacrosidase
- saxagliptin
- segesterone (contraceptive)
- sirolimus albumin-bound
- sitagliptin
- somapacitan
- somatrogon
- somatropin
- sotagliflozin
- sotalol
- spironolactone
- sucralfate
- sunitinib
- temsirolimus
- teprotumumab
- tesamorelin
- testosterone
- thyroid
- timolol
- tipranavir
- torsemide
- tramadol
- trandolapril
- tranylcypromine
- triamcinolone
- triamcinolone topical
- triamterene
- triptorelin
- turmeric
- vamorolone
- vorinostat
- ziprasidone
Adverse Reactions .
Serious Reactions
- thyroid C-cell tumor (animal studies)
- medullary thyroid CA risk
- hypersensitivity rxn
- anaphylaxis
- angioedema
- acute kidney injury
- GI rxn, severe
- pancreatitis
- cholelithiasis
- cholecystitis
- ileus
- syncope
- perioperative aspiration
Common Reactions
- nausea
- vomiting
- diarrhea
- abdominal pain
- constipation
- diabetic retinopathy
- eructation
- appetite decr. (PO form)
- hypoglycemia (pen form)
- dyspepsia
- abdominal distension (PO form)
- GERD
- flatulence
- gastritis
- amylase incr.
- lipase incr.
- injection site rxn (pen form)
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of fetal harm, incl. teratogenicity and fetal death, based on animal data at <1x MRHD
Individuals of Reproductive Potential
D/C tx at least 2mo before conception in pts of childbearing potential
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available to assess risk of infant harm, though inactive ingredient excreted into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: proteolytic degradation; CYP450: none
Excretion: urine (3% unchanged), feces; Half-life: 1wk
Subclass: Diabetes: GLP-1 Agonists
Mechanism of Action
activates glucagon-like-peptide-1 (GLP-1) receptor, increasing insulin secretion, decreasing glucagon secretion, and delaying gastric emptying (incretin mimetic)
Formulary .
No Formulary Selected
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