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Zepbound
tirzepatide
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: INJ (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): 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 pts or overweight pts w/ wt-related comorbidity; recommended maint. 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 pts; recommended maint. 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 hx
- medullary thyroid CA family hx
- multiple endocrine neoplasia syndrome type 2
- suicidality hx
- suicidal ideation
- caution: hypersensitivity to GLP-1 agonists
- caution: volume depletion
- caution: GI dz, severe
- caution: gastroparesis, severe
- caution: pancreatitis hx
- caution: diabetic retinopathy hx
- caution: surgery
Drug Interactions .
Overview
tirzepatide
GLP-1/GIP agonist
- antidiabetic agent
- decreases gastrointestinal motility
- caution advised w/ oral drugs, esp. 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)
- 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
- histrelin
- hydrochlorothiazide
- hydrocortisone
- hydrocortisone topical
- iloperidone
- inavolisib
- indapamide
- insulin
- isoniazid
- lanreotide
- leuprolide
- levofloxacin
- levothyroxine
- liothyronine
- lopinavir/ritonavir
- lorlatinib
- lumateperone
- lurasidone
- lurbinectedin
- lutetium Lu 177 dotatate
- medroxyprogesterone (contraceptive)
- megestrol
- methylprednisolone
- metolazone
- mometasone topical
- moxifloxacin
- nadolol
- nateglinide
- nelfinavir
- niacin (vitamin B3)
- norelgestromin (contraceptive)
- norepinephrine
- octreotide
- ofloxacin
- olanzapine
- omacetaxine mepesuccinate
- paliperidone
- pasireotide
- pegaspargase
- peginterferon alfa 2a
- pentamidine
- phenylephrine
- phenytoin
- pindolol
- 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
- lefamulin
- linezolid
- metoclopramide
- metronidazole
- mexiletine
- minocycline
- omadacycline
- penicillin V
- potassium acid phosphate
- potassium gluconate
- potassium phosphate
- rifabutin
- rifampin
- rifapentine
- sarecycline
- secnidazole
- sulfadiazine
- sulfamethoxazole
- sulfasalazine
- tedizolid phosphate
- tetracycline
- tinidazole
- trimethoprim
Adverse Reactions .
Serious Reactions
- thyroid C-cell tumor (animal studies)
- medullary thyroid CA risk
- hypersensitivity rxn
- anaphylaxis
- angioedema
- GI rxn, severe
- cholelithiasis
- cholecystitis
- pancreatitis
- ileus
- acute kidney injury
- chronic renal failure exacerbation
- perioperative aspiration
Common Reactions
- nausea
- diarrhea
- constipation
- vomiting
- abdominal pain
- dyspepsia
- injection site rxn
- fatigue
- hypersensitivity rxn
- eructation
- alopecia
- GERD
- flatulence
- abdominal distension
- hypoglycemia
- dizziness
- hypotension
- HR incr.
- amylase incr.
- lipase incr.
Safety/Monitoring .
Monitoring Parameters
s/sx depression, behavior changes, suicidality; glucose at baseline if diabetes, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; maternal wt loss 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 pts or encourage pts to enroll in Zepbound Pregnancy Registry at 1-800-545-5979
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: proteolytic degradation, oxidation, hydrolysis; CYP450: unknown
Excretion: 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
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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