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Drug overview for ZEPBOUND (tirzepatide):
Generic name: tirzepatide (tir-ZEP-a-tide)
Drug class: Diet Aids
Therapeutic class: Weight Loss/Gain Agents
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide 1 (GLP-1) receptor agonist.
No enhanced Uses information available for this drug.
Generic name: tirzepatide (tir-ZEP-a-tide)
Drug class: Diet Aids
Therapeutic class: Weight Loss/Gain Agents
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide 1 (GLP-1) receptor agonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
ZEPBOUND 15 MG/0.5 ML PEN
ZEPBOUND 12.5 MG/0.5 ML PEN
ZEPBOUND 10 MG/0.5 ML PEN
ZEPBOUND 7.5 MG/0.5 ML PEN
ZEPBOUND 5 MG/0.5 ML PEN
ZEPBOUND 2.5 MG/0.5 ML PEN
ZEPBOUND 10 MG/0.5 ML VIAL
ZEPBOUND 7.5 MG/0.5 ML VIAL
The following indications for ZEPBOUND (tirzepatide) have been approved by the FDA:
Indications:
Obstructive sleep apnea syndrome
Weight loss management for obese patient (body mass index 30 or greater)
Weight loss management for overweight patient with bmi 27 to 29 and weight-related comorbidity
Professional Synonyms:
Obstructive sleep apnea
Indications:
Obstructive sleep apnea syndrome
Weight loss management for obese patient (body mass index 30 or greater)
Weight loss management for overweight patient with bmi 27 to 29 and weight-related comorbidity
Professional Synonyms:
Obstructive sleep apnea
The following dosing information is available for ZEPBOUND (tirzepatide):
No enhanced Dosing information available for this drug.
Tirzepatide is administered via subcutaneous injection once weekly with or without meals. Tirzepatide for the treatment of type 2 diabetes (Mounjaro(R)) is available in pre-filled single-dose pens or single-dose vials in the following strengths per 0.5 mL: 2.5
mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.
Tirzepatide for weight management (Zepbound(R)) is available in pre-filled single-dose pens in the following strengths per 0.5 mL: 2.5 mg, 5 mg, 7.5
mg, 10 mg, 12.5 mg, and 15 mg. Tirzepatide is a clear, colorless to slightly yellow solution; do not use if particulate matter or discoloration is seen.
Train patients and/or caregivers on proper injection technique. Inject subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites with each dose.
Instruct patients using the single-dose vial to use an appropriate syringe for administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL dose). When using tirzepatide with insulin, administer as separate injections and do not mix in the same syringe. Injections of tirzepatide and insulin can be given in the same body region but the injections should not be adjacent to one other.
If a dose is missed, administer as soon as possible within 4 days (96 hours) after the missed dose; then, resume the regular once weekly dosing schedule. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. The day of weekly administration can be changed, if necessary, as long as the time between the 2 doses is at least 3 days (72 hours).
Store tirzepatide vials and prefilled injection pens in a refrigerator at 2-8degreesC. If necessary, the drug can be stored out of the refrigerator at temperatures not to exceed 30degreesC for up to 21 days. Do not freeze or use if frozen. Store in the original carton to protect the drug from light.
mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.
Tirzepatide for weight management (Zepbound(R)) is available in pre-filled single-dose pens in the following strengths per 0.5 mL: 2.5 mg, 5 mg, 7.5
mg, 10 mg, 12.5 mg, and 15 mg. Tirzepatide is a clear, colorless to slightly yellow solution; do not use if particulate matter or discoloration is seen.
Train patients and/or caregivers on proper injection technique. Inject subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites with each dose.
Instruct patients using the single-dose vial to use an appropriate syringe for administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL dose). When using tirzepatide with insulin, administer as separate injections and do not mix in the same syringe. Injections of tirzepatide and insulin can be given in the same body region but the injections should not be adjacent to one other.
If a dose is missed, administer as soon as possible within 4 days (96 hours) after the missed dose; then, resume the regular once weekly dosing schedule. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. The day of weekly administration can be changed, if necessary, as long as the time between the 2 doses is at least 3 days (72 hours).
Store tirzepatide vials and prefilled injection pens in a refrigerator at 2-8degreesC. If necessary, the drug can be stored out of the refrigerator at temperatures not to exceed 30degreesC for up to 21 days. Do not freeze or use if frozen. Store in the original carton to protect the drug from light.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZEPBOUND 2.5 MG/0.5 ML VIAL | Maintenance | Adults inject 0.5 milliliter (2.5 mg) by subcutaneous route once weekly for 4 weeks |
| ZEPBOUND 5 MG/0.5 ML VIAL | Maintenance | Adults inject 0.5 milliliter (5 mg) by subcutaneous route once weekly |
| ZEPBOUND 7.5 MG/0.5 ML VIAL | Maintenance | Adults inject 0.5 milliliter (7.5 mg) by subcutaneous route once weekly |
| ZEPBOUND 10 MG/0.5 ML VIAL | Maintenance | Adults inject 0.5 milliliter (10 mg) by subcutaneous route once weekly |
| ZEPBOUND 15 MG/0.5 ML PEN | Maintenance | Adults inject 15 mg by subcutaneous route once weekly |
| ZEPBOUND 12.5 MG/0.5 ML PEN | Maintenance | Adults inject 12.5 mg by subcutaneous route once weekly |
| ZEPBOUND 10 MG/0.5 ML PEN | Maintenance | Adults inject 10 mg by subcutaneous route once weekly |
| ZEPBOUND 7.5 MG/0.5 ML PEN | Maintenance | Adults inject 7.5 mg by subcutaneous route once weekly |
| ZEPBOUND 5 MG/0.5 ML PEN | Maintenance | Adults inject 5 mg by subcutaneous route once weekly |
| ZEPBOUND 2.5 MG/0.5 ML PEN | Maintenance | Adults inject 2.5 mg by subcutaneous route once weekly for 4 weeks |
No generic dosing information available.
The following drug interaction information is available for ZEPBOUND (tirzepatide):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Antidiabetic Agents/Gatifloxacin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of gatifloxacin may result in hypoglycemia and/or hyperglycemia.(1-4) Hypoglycemia is more common during the first three days of concurrent therapy. Hyperglycemia is more common after the first three days of concurrent therapy.(2) PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction.(2) PATIENT MANAGEMENT: Patients receiving concurrent gatifloxacin should be closely monitored for hypoglycemia during the first three days of concurrent therapy and for hyperglycemia after the first three days of concurrent therapy. Patients should be instructed to discontinue gatifloxacin if hypoglycemia or hyperglycemia occur.(2) DISCUSSION: Hypoglycemia has been reported with gatifloxacin and glyburide(1,5,6) or glimepiride.(7) In a study in patients with type 2 diabetes mellitus, concurrent gatifloxacin (400 mg daily for 10 days) had no effect on the pharmacokinetics of glyburide (steady state daily regimen); however, pharmacodynamic interactions have been reported.(2) Health Canada has received 19 reports of hypoglycemia in patients taking gatifloxacin. Seventeen of these involved concurrent hypoglycemic agents. Health Canada has received 2 reports of hyperglycemia in patients taking gatifloxacin and hypoglycemic agents. Health Canada has received 2 reports of patients experiencing hypoglycemia and hyperglycemia during concurrent gatifloxacin and hypoglycemic agents.(3) In a study, 13 reports of dysglycemia were reported in patients taking gatifloxacin. Ten of these patients had diabetes mellitus and were on concurrent hypoglycemic agents. Of these ten patients, nine patients experienced hypoglycemia, while one patient experienced hyperglycemia.(8) |
GATIFLOXACIN SESQUIHYDRATE |
| Oral Contraceptives/Tirzepatide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tirzepatide delays gastric emptying, which may result in decreased oral contraceptive absorption.(1,2) CLINICAL EFFECTS: Tirzepatide may result in decreased levels and effectiveness of oral contraceptives.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of tirzepatide states patients should be advised to switch from oral hormonal contraceptives to a non-oral contraceptive method or to add a barrier method of contraception. Patients should use a non-oral contraceptive or barrier method of contraception for 4 weeks after starting tirzepatide and for 4 weeks after each dose escalation of tirzepatide.(1,2) Hormonal contraceptives that are not administered orally are not expected to be affected by tirzepatide.(1) DISCUSSION: In a pharmacokinetic study, a single dose of tirzepatide 5 mg with combined oral contraceptive (0.035 mg ethinyl estradiol and 0.25 mg norgestimate) decreased the mean concentration maximum (Cmax) of ethinyl estradiol, norgestimate, and norelgestromin by 59%, 66%, and 55%, respectively, while mean area-under-curve (AUC) was reduced by 20%, 21%, and 23%, respectively.(1,2) A study in pregnant rats, tirzepatide caused fetal growth restrictions and fetal abnormalities at clinical exposure. A study in pregnant rabbits, tirzepatide caused fetal growth restrictions at clinically relevant exposures.(1) |
2-METHOXYESTRADIOL, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMILA, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DEBLITANE, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DOLISHALE, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, ELINEST, ELLA, EMZAHH, ENPRESSE, ENSKYCE, ERRIN, ESTARYLLA, ESTRADIOL, ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRIOL, ESTRIOL MICRONIZED, ESTRONE, ETHINYL ESTRADIOL, ETHYNODIOL-ETHINYL ESTRADIOL, FALMINA, FEIRZA, FEMLYV, FINZALA, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HEATHER, ICLEVIA, INCASSIA, ISIBLOOM, JAIMIESS, JASMIEL, JENCYCLA, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KELNOR 1-50, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEENA, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LEVORA-28, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUTERA, LYLEQ, LYZA, MARLISSA, MERZEE, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MINZOYA, MONO-LINYAH, NATAZIA, NECON, NEXTSTELLIS, NIKKI, NORA-BE, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NYLIA, OCELLA, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, RECLIPSEN, RIVELSA, SAFYRAL, SETLAKIN, SHAROBEL, SIMLIYA, SIMPESSE, SLYND, SPRINTEC, SRONYX, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TRIVORA-28, TULANA, TURQOZ, TYBLUME, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, YASMIN 28, YAZ, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Selected Antidiabetic Agents/Selected Quinolones SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of quinolones and antidiabetic agents may result in severe hypoglycemia.(1-7) Hypoglycemia can lead to coma. PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction.(5) PATIENT MANAGEMENT: Patients maintained on antidiabetic agents who require concurrent therapy with a quinolone should be closely monitored for hypoglycemia.(1-4) Patients should be instructed to discontinue quinolone use and contact their doctor if hypoglycemia occurs.(2,4) Signs of hypoglycemia may include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, or unusual anxiety. DISCUSSION: Hypoglycemia has been reported with concurrent ciprofloxacin and glyburide,(1,8,9) levofloxacin and glyburide,(2,10,11) norfloxacin and glyburide,(3) levofloxacin and glipizide (12) as well as levofloxacin and metformin-glibenclamide.(14) There has been one report of fatal hypoglycemia with concurrent levofloxacin and glyburide(9) and one of the above reports of hypoglycemia with concurrent levofloxacin and glyburide resulted in hypoxic brain injury.(11) A review of postmarketing adverse event data for the fluoroquinolones and hypoglycemic coma identified 56 reports in FAERS search from October 1987- April 2017 and 11 additional cases in the medical literature. Most patients had risk factors for hypoglycemia. 41 patients were taking one or more hypoglycemic drugs. 13 deaths occurred (some of these patients had renal insufficiency). 9 patients did not fully recover and had resultant disability.(13) |
AVELOX IV, BAXDELA, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, LEVOFLOXACIN, LEVOFLOXACIN HEMIHYDRATE, LEVOFLOXACIN-D5W, MOXIFLOXACIN, MOXIFLOXACIN HCL, OFLOXACIN |
| Selected Antidiabetic Agents/Chloroquine; Hydroxychloroquine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. Chloroquine and hydroxychloroquine may increase insulin sensitivity by inhibiting insulin metabolism and inflammation and increasing cellular uptake of glucose and glycogen synthesis.(1,2) These effects may result in additive hypoglycemia with anti-diabetic agents. CLINICAL EFFECTS: Concurrent use of chloroquine or hydroxychloroquine and antidiabetic agents may result in severe hypoglycemia.(3) Hypoglycemia can lead to coma. PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction. PATIENT MANAGEMENT: Patients maintained on antidiabetic agents who require concurrent therapy with chloroquine or hydroxychloroquine should be closely monitored for hypoglycemia. A decrease in the dose of insulin or other anti-diabetic medications may be required. Patients should be advised of the risk and symptoms of hypoglycemia and to contact their doctor if hypoglycemia occurs.(3) Signs of hypoglycemia may include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, or unusual anxiety. DISCUSSION: Hydroxychloroquine has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening.(3) Concomitant hypoglycemic agents may increase the risk and/or severity of this effect. A 77 year old man who was stable on twice daily insulin suffered two episodes of hypoglycemic coma 2 weeks after starting prednisone 5 mg daily and hydroxychloroquine 400 mg daily for rheumatoid arthritis. His insulin dosage required a decrease of 37%.(4) Many studies have investigated the glucose-lowering effect of hydroxychloroquine. In a clinical trial of type II diabetics on maximal doses of sulfonylureas, addition of hydroxychloroquine lowered hemoglobin A1C (HbA1C) up to 1% more than placebo.(5) Another clinical trial of type II diabetics on metformin and glimepiride or gliclazide found that hydroxychloroquine 400 mg daily reduced fasting blood glucose (FBG), post-prandial glucose (PPG), and HbA1C to a similar degree as pioglitazone 15 mg daily at 24 weeks.(6) In a prospective observational study, 250 uncontrolled type II diabetics on metformin, glimepiride, pioglitazone, sitagliptin, and a SGLT-2 inhibitor received hydroxychloroquine 400 mg daily for 48 weeks. HbA1C decreased from 8.83% to 6.44%, FBG decreased by 40.78%, and PPG decreased by 58.95%. The doses of metformin were reduced by 50%, glimepiride and sitagliptin by 75%, and SGLT-2 inhibitors were discontinued in most patients.(7) |
CHLOROQUINE PHOSPHATE, HYDROXYCHLOROQUINE SULFATE, PLAQUENIL, SOVUNA |
| Anesthesia Agents/GLP-1 Receptor Agonists SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: GLP-1 receptor agonists can cause delayed gastric emptying.(1,2) CLINICAL EFFECTS: Gastric contents may remain in the stomach after preoperative fasting, which could increase the risk of regurgitation and aspiration.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The American Society of Anesthesiologists (ASA) recommends the following for patients receiving elective procedures: - For patients on daily dosing, consider holding GLP-1 agonists on the day of the procedure. For patients on weekly dosing, consider holding GLP-1 agonists a week prior to the procedure. - Consult an endocrinologist for patients taking GLP-1 agonists for diabetes management if the GLP-1 agonist is held longer than the dosing schedule to avoid hyperglycemia. - For patients requiring urgent or emergent procedures, proceed and treat the patient as 'full stomach.'(3) DISCUSSION: In one case report, a 31-year-old patient taking semaglutide followed preoperative fasting guidelines but food residue was discovered upon endoscopy, leading to cancellation of the surgical procedure.(4) In a case report, a semaglutide-treated patient experienced regurgitation upon induction of general anesthesia despite a 20 hour preoperative fasting period. The patient received semaglutide two days before the scheduled procedure.(5) A case report of a 42-year-old patient after fasting for 18 hours showed substantial gastric content upon endoscopy. The patient experienced intraoperative pulmonary aspiration of gastric contents which were suctioned from the trachea and bronchi using bronchoscopy.(6) |
AMIDATE, ANECTINE, ATRACURIUM BESYLATE, BREVITAL SODIUM, CISATRACURIUM BESYLATE, DESFLURANE, DEXMEDETOMIDINE HCL, DEXMEDETOMIDINE-0.9% NACL, DEXMEDETOMIDINE-D5W, DIPRIVAN, ETOMIDATE, FORANE, ISOFLURANE, METHOHEXITAL SODIUM, METHOHEXITAL-STERILE WATER, NIMBEX, PRECEDEX, PROPOFOL, QUELICIN, SEVOFLURANE, SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE-NACL, SUPRANE, TERRELL, ULTANE, VECURONIUM BROMIDE, VECURONIUM BROMIDE-WATER |
The following contraindication information is available for ZEPBOUND (tirzepatide):
Drug contraindication overview.
*Personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). *Known serious hypersensitivity to tirzepatide or any excipients.
*Personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). *Known serious hypersensitivity to tirzepatide or any excipients.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Family history of medullary thyroid carcinoma |
| Medullary thyroid carcinoma |
| Multiple endocrine neoplasia type 2 |
| Pregnancy |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Depression |
| Pancreatitis |
| Suicidal ideation |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Dehydration |
| Hypoglycemic disorder |
The following adverse reaction information is available for ZEPBOUND (tirzepatide):
Adverse reaction overview.
Adverse reactions reported in >=5% of patients receiving tirzepatide for type 2 diabetes mellitus include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. Adverse reactions reported in >=5% of patients receiving tirzepatide for chronic weight management include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
Adverse reactions reported in >=5% of patients receiving tirzepatide for type 2 diabetes mellitus include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. Adverse reactions reported in >=5% of patients receiving tirzepatide for chronic weight management include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acute kidney injury Acute pancreatitis Anaphylaxis Angioedema Biliary calculus Dehydration Gallbladder disease Hypersensitivity drug reaction Ileus |
There are 24 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anorexia Constipation Diarrhea Dyspepsia Nausea Vomiting |
Abdominal distension Alopecia Dizziness Elevated serum amylase Elevated serum lipase Eructation Fatigue Flatulence Gastroesophageal reflux disease Injection site sequelae |
| Rare/Very Rare |
|---|
|
Dysgeusia Eczema Hypoglycemic disorder Hypotension Tachycardia Urticaria Weight loss |
The following precautions are available for ZEPBOUND (tirzepatide):
Safety and effectiveness of tirzepatide have not been established in pediatric patients (<18 years of age).
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data with tirzepatide use in pregnant women are insufficient to inform 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 exposure to tirzepatide during pregnancy. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities (including external, visceral, and skeletal malformations) occurred at clinically relevant exposures based on AUC.
In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. Tirzepatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. Tirzepatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There are no data on the presence of tirzepatide in animal or human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tirzepatide and any potential adverse effects on the breast-fed infant from tirzepatide or from the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients. In clinical trials of tirzepatide for diabetes mellitus, 30.1% of tirzepatide-treated patients were >=65 years of age and 4.1%
were >=75 years of age. In clinical trials of tirzepatide for chronic weight management, 9% of tirzepatide-treated patients were >=65 years of age and 0.5% were >=75 years of age. No overall differences in safety or efficacy have been observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
were >=75 years of age. In clinical trials of tirzepatide for chronic weight management, 9% of tirzepatide-treated patients were >=65 years of age and 0.5% were >=75 years of age. No overall differences in safety or efficacy have been observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The following prioritized warning is available for ZEPBOUND (tirzepatide):
WARNING: This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication.
Do not use this medication if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2). While using this medication, tell your doctor right away if you notice any signs of thyroid tumors, including an unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.
WARNING: This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication.
Do not use this medication if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2). While using this medication, tell your doctor right away if you notice any signs of thyroid tumors, including an unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.
The following icd codes are available for ZEPBOUND (tirzepatide)'s list of indications:
| Obstructive sleep apnea syndrome | |
| G47.33 | Obstructive sleep apnea (adult) (pediatric) |
| P28.42 | Obstructive apnea of newborn |
| Weight loss management for obese patient (bmi >= 30) | |
| E66 | Overweight and obesity |
| E66.0 | Obesity due to excess calories |
| E66.01 | Morbid (severe) obesity due to excess calories |
| E66.09 | Other obesity due to excess calories |
| E66.1 | Drug-induced obesity |
| E66.2 | Morbid (severe) obesity with alveolar hypoventilation |
| E66.8 | Other obesity |
| E66.81 | Obesity class |
| E66.811 | Obesity, class 1 |
| E66.812 | Obesity, class 2 |
| E66.813 | Obesity, class 3 |
| E66.89 | Other obesity not elsewhere classified |
| E66.9 | Obesity, unspecified |
| Z68.3 | Body mass index [BMi] 30-39, adult |
| Z68.30 | Body mass index [BMi] 30.0-30.9, adult |
| Z68.31 | Body mass index [BMi] 31.0-31.9, adult |
| Z68.32 | Body mass index [BMi] 32.0-32.9, adult |
| Z68.33 | Body mass index [BMi] 33.0-33.9, adult |
| Z68.34 | Body mass index [BMi] 34.0-34.9, adult |
| Z68.35 | Body mass index [BMi] 35.0-35.9, adult |
| Z68.36 | Body mass index [BMi] 36.0-36.9, adult |
| Z68.37 | Body mass index [BMi] 37.0-37.9, adult |
| Z68.38 | Body mass index [BMi] 38.0-38.9, adult |
| Z68.39 | Body mass index [BMi] 39.0-39.9, adult |
| Z68.4 | Body mass index [BMi] 40 or greater, adult |
| Z68.41 | Body mass index [BMi] 40.0-44.9, adult |
| Z68.42 | Body mass index [BMi] 45.0-49.9, adult |
| Z68.43 | Body mass index [BMi] 50.0-59.9, adult |
| Z68.44 | Body mass index [BMi] 60.0-69.9, adult |
| Z68.45 | Body mass index [BMi] 70 or greater, adult |
| Z68.55 | Body mass index [BMi] pediatric, 120% of the 95th percentile for age to less than 140% of the 95th percentile for age |
| Z68.56 | Body mass index [BMi] pediatric, greater than or equal to 140% of the 95th percentile for age |
| Wt loss mgmt, pt with bmi 27-29 & wt-related comorbidity | |
| E66.3 | Overweight |
| Z68.27 | Body mass index [BMi] 27.0-27.9, adult |
| Z68.28 | Body mass index [BMi] 28.0-28.9, adult |
| Z68.29 | Body mass index [BMi] 29.0-29.9, adult |
Formulary Reference Tool