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Zepbound
tirzepatide
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: INJ (auto-injector): 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg; INJ (KwikPen pen): 2.5 mg per injection, 5 mg per injection, 7.5 mg per injection, 10 mg per injection, 12.5 mg per injection, 15 mg per injection; INJ (vial): 10 mg per 2.4 mL, 20 mg per 2.4 mL, 30 mg per 2.4 mL, 40 mg per 2.4 mL, 50 mg per 2.4 mL, 60 mg per 2.4 mL, 2.5 mg per 0.5 mL, 5 mg per 0.5 mL, 7.5 mg per 0.5 mL, 10 mg per 0.5 mL, 12.5 mg per 0.5 mL, 15 mg per 0.5 mL
weight management, chronic
- [5-15 mg SC qwk]
- Start: 2.5 mg SC qwk x4wk, then 5 mg SC qwk, then may incr. by 2.5 mg/wk no more frequently than q4wk; Max: 15 mg/wk; Info: for obese patients or overweight patients with wt-related comorbidity; recommended maintenance dose is 5 mg, 10 mg, or 15 mg SC qwk
obstructive sleep apnea, moderate-severe
- [10-15 mg SC qwk]
- Start: 2.5 mg SC qwk x4wk, then 5 mg SC qwk, then incr. by 2.5 mg/wk no more frequently than q4wk; Max: 15 mg/wk; Info: for obese patients; recommended maintenance dose is 10 mg or 15 mg SC qwk
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
- pregnancy
- medullary thyroid CA history
- medullary thyroid CA family history
- multiple endocrine neoplasia syndrome type 2
- caution: hypersensitivity to GLP-1 agonists
- caution: volume depletion
- caution: GI disease, severe
- caution: gastroparesis, severe
- caution: pancreatitis history
- caution: diabetic retinopathy history
- caution: surgery
- caution: visual impairment (self-administration with pen form)
Drug Interactions .
Overview
tirzepatide
GLP-1/GIP agonist
- antidiabetic agent
- decreases gastrointestinal motility
- caution advised with oral drugs, especially narrow therapeutic index; tirzepatide delays gastric emptying, may alter absorption of concomitant oral drugs
Contraindicated
- potassium chloride
- potassium citrate
Avoid/Use Alternative
- desogestrel (contraceptive)
- dienogest (contraceptive)
- drospirenone (contraceptive)
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- exenatide
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- liraglutide
- lixisenatide
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- semaglutide
- ulipristal (post-coital contraceptive)
Monitor/Modify Tx
- alclometasone topical
- alpelisib
- amcinonide topical
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- arsenic trioxide
- asenapine
- asparaginase
- atazanavir
- betamethasone
- betamethasone topical
- bortezomib
- brentuximab vedotin
- brexpiprazole
- brigatinib
- budesonide
- bumetanide
- calaspargase
- capivasertib
- cariprazine
- carvedilol
- ceritinib
- chlorothiazide
- chlorthalidone
- ciprofloxacin
- clobetasol topical
- clocortolone topical
- clozapine
- copanlisib
- corticotropin
- cortisone
- dabrafenib
- danazol
- darunavir
- decitabine
- deflazacort
- delafloxacin
- desonide topical
- desoximetasone topical
- dexamethasone
- diazoxide
- diflorasone topical
- digoxin
- enfortumab vedotin
- ensartinib
- ephedra
- epinephrine
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethacrynic acid
- ethinyl estradiol (hormone replacement)
- etonogestrel (contraceptive)
- everolimus
- fludrocortisone
- fluocinolone otic
- fluocinolone topical
- fluocinonide topical
- flurandrenolide topical
- fluticasone propionate topical
- fosamprenavir
- fosphenytoin
- furosemide
- ginkgo
- glimepiride
- glipizide
- glyburide
- goserelin
- halcinonide topical
- halobetasol topical
- hydrochlorothiazide
- hydrocortisone
- hydrocortisone topical
- iloperidone
- inavolisib
- indapamide
- insulin
- isoniazid
- lanreotide
- leuprolide
- levofloxacin
- levothyroxine
- liothyronine
- lopinavir/ritonavir
- lorlatinib
- lumateperone
- lurasidone
- lutetium Lu 177 dotatate
- medroxyprogesterone (contraceptive)
- megestrol
- methylprednisolone
- metolazone
- milsaperidone
- mometasone topical
- moxifloxacin
- nadolol
- nateglinide
- nelfinavir
- niacin (vitamin B3)
- norelgestromin (contraceptive)
- norepinephrine
- octreotide
- ofloxacin
- olanzapine
- paliperidone
- paltusotine
- pasireotide
- pegaspargase
- peginterferon alfa 2a
- pentamidine
- phenylephrine
- phenytoin
- pindolol
- plozasiran
- prednicarbate topical
- prednisolone
- prednisone
- pseudoephedrine
- quetiapine
- repaglinide
- risperidone
- ritonavir
- sacrosidase
- segesterone (contraceptive)
- sirolimus albumin-bound
- somapacitan
- somatrogon
- somatropin
- sotalol
- spironolactone
- sucralfate
- temsirolimus
- teprotumumab
- tesamorelin
- thyroid
- tipranavir
- torsemide
- triamcinolone
- triamcinolone topical
- triamterene
- triptorelin
- vamorolone
- vorinostat
- warfarin
- ziprasidone
Caution Advised
- acetaminophen
- amoxicillin
- ampicillin
- azithromycin
- barium
- bedaquiline
- cefaclor
- cefadroxil
- cefdinir
- cefixime
- cefpodoxime
- cefprozil
- cefuroxime axetil
- cephalexin
- clarithromycin
- clindamycin
- cycloserine
- dapsone
- demeclocycline
- dicloxacillin
- doxazosin
- doxycycline
- erythromycin
- ethionamide
- fosfomycin oral
- gepotidacin
- lefamulin
- linezolid
- metoclopramide
- metronidazole
- mexiletine
- minocycline
- omadacycline
- penicillin V
- pivmecillinam
- potassium acid phosphate
- potassium gluconate
- potassium phosphate
- rifabutin
- rifampin
- rifapentine
- sarecycline
- secnidazole
- sulfadiazine
- sulfamethoxazole
- sulfasalazine
- sulopenem
- tedizolid
- tetracycline
- tinidazole
- trimethoprim
- zoliflodacin
Adverse Reactions .
Serious Reactions
- thyroid C-cell tumor (animal studies)
- medullary thyroid CA risk
- hypersensitivity reaction
- anaphylaxis
- angioedema
- GI reaction, severe
- cholelithiasis
- cholecystitis
- pancreatitis
- ileus
- intestinal obstruction
- acute kidney injury
- perioperative aspiration
Common Reactions
- nausea
- diarrhea
- constipation
- vomiting
- abdominal pain
- dyspepsia
- injection site reaction
- fatigue
- hypersensitivity reaction
- eructation
- alopecia
- GERD
- flatulence
- abdominal distension
- hypoglycemia
- dizziness
- hypotension
- HR incr.
- 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; risk of teratogenicity and decr. fetal wt based on animal data at recommended human dose
Pregnancy Registry
enroll patients or encourage patients to enroll in Zepbound Pregnancy Registry at 1-800-545-5979
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for tirzepatide: proteolytic degradation, oxidation, hydrolysis; CYP450: unknown
Excretion: for tirzepatide: urine (none unchanged), feces (none unchanged); Half-life: 5-6 days
Subclass: Obesity/Weight Management: GIP/GLP-1 Agonists ; Sleep-related Breathing Disorders
Mechanism of Action
for tirzepatide: selectively binds to and activates glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, regulating appetite and caloric intake
Formulary .
No Formulary Selected
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