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Foundayo
orforglipron
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); thyroid C-cell tumors observed in rodents at clinically relevant exposures with pharmacologically active GLP-1 agonists, but human relevance unknown; orforglipron did not produce tumors, but is not pharmacologically active in rodents; 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: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, 17.2 mg
weight management, chronic
- [5.5-17.2 mg PO qd]
- Start: 0.8 mg PO qd, then incr. to 2.5 mg PO qd after at least 30 days, then incr. to 5.5 mg PO qd after at least 30 days, then may incr. to next incremental dose after at least 30 days on current dose; Max: 17.2 mg/day; Info: for obese patients or overweight patients with wt-related comorbidity; restart tx at lower dose if >7 consecutive doses missed; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- breastfeeding
- medullary thyroid CA history
- medullary thyroid CA family history
- multiple endocrine neoplasia syndrome type 2
- hepatic impairment, Child-Pugh Class C
- caution: hypersensitivity to GLP-1 agonists
- caution: patients of childbearing potential
- caution: volume depletion
- caution: gastroparesis, severe
- caution: diabetic retinopathy
- caution: surgery
Drug Interactions .
Overview
orforglipron
GLP-1 agonist
- CYP3A4 substrate
- OATP1B1 substrate
- OATP1B3 substrate
- decreases gastrointestinal motility
- hypoglycemic effects
Contraindicated
- potassium chloride
- potassium citrate
Avoid/Use Alternative
- adagrasib
- apalutamide
- atazanavir
- belumosudil
- bempedoic acid
- butalbital
- carbamazepine
- ceftobiprole
- ceritinib
- chloramphenicol
- clarithromycin
- clopidogrel
- cobicistat
- cyclosporine
- darolutamide
- darunavir
- desogestrel (contraceptive)
- dienogest (contraceptive)
- drospirenone (contraceptive)
- elexacaftor/tezacaftor/ivacaftor
- eltrombopag
- eluxadoline
- enasidenib
- encorafenib
- enzalutamide
- erythromycin
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- exenatide
- fosphenytoin
- fostemsavir
- gemfibrozil
- glecaprevir
- idelalisib
- irbesartan
- itraconazole
- ivosidenib
- ketoconazole
- leflunomide
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- liraglutide
- lixisenatide
- lonafarnib
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- midostaurin
- mifepristone
- mitotane
- nefazodone
- nelfinavir
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- orforglipron
- pentobarbital
- phenobarbital
- phenytoin
- pibrentasvir
- posaconazole
- pretomanid
- primidone
- relacorilant
- resmetirom
- ribociclib
- rifabutin
- rifampin
- rilzabrutinib
- ritonavir
- semaglutide
- St. John's wort
- teriflunomide
- tipranavir
- tucatinib
- ulipristal (post-coital contraceptive)
- vadadustat
- velpatasvir
- voclosporin
- voriconazole
- voxilaprevir
Monitor/Modify Tx
- bosentan
- cenobamate
- dabrafenib
- digoxin
- efavirenz
- etravirine
- fexinidazole
- glimepiride
- glipizide
- glyburide
- insulin
- lorlatinib
- mavacamten
- mitapivat
- modafinil
- nafcillin
- nateglinide
- pacritinib
- pexidartinib
- repaglinide
- repotrectinib
- rifapentine
- simvastatin
- sotorasib
Caution Advised
- acetaminophen
- amoxicillin
- ampicillin
- azithromycin
- barium
- bedaquiline
- cefaclor
- cefadroxil
- cefdinir
- cefixime
- cefpodoxime
- cefprozil
- cefuroxime axetil
- cephalexin
- ciprofloxacin
- clindamycin
- cycloserine
- dapsone
- delafloxacin
- demeclocycline
- dicloxacillin
- doxazosin
- doxycycline
- ethionamide
- fosfomycin oral
- gepotidacin
- lefamulin
- levofloxacin
- linezolid
- metoclopramide
- metronidazole
- mexiletine
- minocycline
- moxifloxacin
- ofloxacin
- omadacycline
- penicillin V
- pivmecillinam
- potassium acid phosphate
- potassium gluconate
- potassium phosphate
- sarecycline
- secnidazole
- sulfadiazine
- sulfamethoxazole
- sulfasalazine
- sulopenem
- tedizolid
- tetracycline
- tinidazole
- trimethoprim
- zoliflodacin
Adverse Reactions .
Serious Reactions
- thyroid C-cell tumor risk
- medullary thyroid CA risk
- hypersensitivity reaction
- anaphylaxis
- angioedema
- GI reaction, severe
- cholelithiasis
- cholecystitis
- pancreatitis
- ileus
- intestinal obstruction
- hypoglycemia
- acute kidney injury
- perioperative aspiration
Common Reactions
- nausea
- constipation
- diarrhea
- vomiting
- dyspepsia
- abdominal pain
- headache
- abdominal distension
- fatigue
- eructation
- GERD
- flatulence
- alopecia
- dizziness
- tachycardia
- hypoglycemia
- hypotension
- amylase incr.
- lipase incr.
Safety/Monitoring .
Monitoring Parameters
glucose at baseline if diabetes, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; wt loss during pregnancy offers no benefit and may result in fetal harm; inadequate human data available; possible risk of fetal harm, including external malformations and decr. wt, based on animal data at 14x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Pregnancy Exposure Registry at 1-800-545-5979
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx in patients of childbearing potential
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for orforglipron: liver; CYP450: 3A4 (primary), 2J2 substrate
Excretion: for orforglipron: feces 87% (none unchanged), urine <1%; Half-life: 29-49h
Subclass: Obesity/Weight Management: GLP-1 Agonists
Mechanism of Action
for orforglipron: activates glucagon-like-peptide-1 (GLP-1) receptor, regulating appetite and caloric intake (incretin mimetic)
Formulary .
No Formulary Selected
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