Tirzepatide

Tirzepatide is a prescription medication indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Tirzepatide is available under the following different brand names: Mounjaro

Common side effects of Tirzepatide include:

• nausea
• diarrhea
• decreased appetite
• vomiting
• constipation
• indigestion
• abdominal pain

Serious side effects of Tirzepatide include:

• nausea
• vomiting
• stomach pain
• difficulty in breathing or swallowing
• fast heartbeat
• heartburn
• recurrent fever
• skin itching, rash, or redness
• stomach fullness
• swelling of the face, throat, or tongue
• vomiting
• yellow eyes or skin

Rare side effects of Tirzepatide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution (prefilled, single-dose pen)

• 2.5 mg/0.5 mL
• 5 mg/0.5 mL
• 7.5 mg/0.5 mL
• 10 mg/0.5 mL
• 12.5 mg/0.5 mL
• 15 mg/0.5 mL

Type 2 diabetes mellitus

Adult dosage

• 2.5 mg SC every week for 4 weeks initially; THEN increase to 5 mg SC every week
• If additional glycemic control is needed, increase by 2.5-mg increments after at least 4 weeks at the current dose
• Maximum dose: 15 mg SC every week
• Note: The initial 2.5-mg dose is intended for treatment initiation and is not effective for glycemic control

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tirzepatide has severe interactions with no other drugs
• Tirzepatide has serious interactions with no other drugs
• Tirzepatide has moderate interactions with the following drug:
  • lonapegsomatropin
• Tirzepatide has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome types 2
• Known hypersensitivity to tirzepatide or any of the product components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tirzepatide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tirzepatide?”

Cautions

• Based on findings in rats and mice, may cause thyroid C-cell tumors, including MTC, in humans; the human relevance of tripeptide-induced rodent thyroid C-cell tumors has not been determined
• Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, observed in patients treated with GLP-1 receptor agonists; after initiating, monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain, which sometimes radiates to the back and may or may not be accompanied by vomiting); if pancreatitis suspected, discontinue and do not restart if confirmed
• Rapid improvement in glucose control associated with a temporary worsening of diabetic retinopathy; tirzepatide has not been studied in patients with no proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema; monitor patients with a history of diabetic retinopathy
• Gastrointestinal (GI) adverse reactions, sometimes severe, reported; has not been studied in patients with severe GI disease, including severe gastroparesis, and is not recommended in these patients
• Acute gallbladder disease (eg, cholelithiasis, cholecystitis) reported in GLP-1 receptor agonist trials and postmarketing surveillance; if suspected, gallbladder studies and appropriate clinical follow-up are indicated
• Kidney injury
  • Acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists, have been described
  • Most reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration
  • Events were also reported in patients without known underlying renal disease
  • Monitor renal function when initiating or escalating doses in patients reporting severe adverse GI reactions
• Hypersensitivity
  • Serious hypersensitivity reactions reported with GLP-1 receptor agonists; caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist
  • Unknown whether such patients will be predisposed to these reactions with tirzepatide
  • If hypersensitivity reactions occur, discontinue treatment, treat promptly, and monitor until signs and symptoms resolve
• Drug interaction overview
  • Insulin secretagogues or insulin
  • May require dosage modification
  • Coadministration with insulin secretagogues (e.g., sulfonylureas) or insulin may increase the risk of hypoglycemia
  • Consider a lower dose of secretagogue or insulin to reduce the risk of hypoglycemia
  • Inform patients using concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
  • Oral drugs with a narrow therapeutic index
• Caution/dosage modification
  • Tirzepatide may delay gastric emptying, thereby potentially impacting oral absorption
  • Caution with drugs having a narrow therapeutic index (e.g., warfarin)
  • Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or to add a barrier method of contraception for 4 weeks after initiation and 4 weeks after each Tirzepatide dose escalation

Pregnancy and Lactation

• Data are insufficient regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Based on animal reproduction studies, there may be risks to the fetus from tirzepatide exposure during pregnancy
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Clinical considerations
  • Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
  • Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Contraception
  • Tirzepatide may reduce the efficacy of oral hormonal contraceptives owing to delayed gastric emptying
  • This delay is the largest after the first dose and diminishes over time
  • Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or to add a barrier method of contraception for 4 weeks after initiation and 4 weeks after each dose escalation
• Lactation
  • Data are unavailable on the presence of drugs in animal or human milk, effects on breastfed infants or effects on milk production