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Mounjaro
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
diabetes mellitus, type 2
- [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
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ (auto-injector): 2.5 mg, 5 mg, 7.5 mg, 10 mg; INJ (KwikPen pen): 2.5 mg per injection, 5 mg per injection, 7.5 mg per injection, 10 mg per injection
diabetes mellitus, type 2
- [10 yo and older]
- Dose: 5-10 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: 10 mg/wk
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- medullary thyroid CA history
- medullary thyroid CA family history
- multiple endocrine neoplasia syndrome type 2
- diabetes mellitus, type 1
- 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)
- caution: peds patients (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
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- thyroid C-cell tumor (animal studies)
- medullary thyroid CA risk
- hypersensitivity reaction
- anaphylaxis
- angioedema
- GI reaction, severe
- cholelithiasis
- pancreatitis
- ileus
- intestinal obstruction
- acute kidney injury
- perioperative aspiration
Common Reactions
- abdominal pain
- nausea
- diarrhea
- vomiting
- appetite decr.
- tachycardia
- hypoglycemia (peds patients)
- dyspepsia
- constipation
- injection site reaction
- hypersensitivity reaction
- eructation
- flatulence
- abdominal distension
- GERD
- amylase incr.
- lipase incr.
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of teratogenicity and decr. fetal wt based on animal data at 0.2-0.5x MRHD
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 days
Subclass: Diabetes: GIP/GLP-1 Agonists
Mechanism of Action
for tirzepatide: activates glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, increasing insulin secretion, decreasing glucagon secretion, increasing insulin sensitivity, and delaying gastric emptying
Formulary .
No Formulary Selected
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