{"site":"TirzRx","url":"https://tirzrx.com","format":"evidence-manifest/v1","claim_count":104,"claims":[{"id":"admin-inspect","text":"Zepbound should appear clear and colorless to slightly yellow; do not use it if particulate matter or discoloration is seen.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"admin-sites","text":"Zepbound is injected subcutaneously in the abdomen or thigh, or another person may inject in the back of the upper arm; injection sites should be rotated with each dose.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"admin-timing","text":"Zepbound is administered once weekly, at any time of day, with or without meals.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"admin-vial-syringe","text":"Patients using Zepbound vials are instructed to use a syringe appropriate for dose administration, for example a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose, and to always use a new syringe and needle for each injection.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"ae-common","text":"The most common adverse reactions with Zepbound, reported in 5% or more of treated patients, are nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"ae-discontinue","text":"Across the two pooled trials, 4.8%, 6.3%, and 6.7% of patients on Zepbound 5 mg, 10 mg, and 15 mg permanently discontinued treatment due to adverse reactions versus 3.4% on placebo, mostly during the first months due to gastrointestinal reactions.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"ae-escalation","text":"The majority of nausea, vomiting, and diarrhea events occurred during dose escalation and decreased over time.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"ae-hairloss","text":"Hair loss adverse reactions were associated with weight reduction and were reported more frequently in female than male patients (7.1% versus 0.5% on Zepbound).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"ae-rates","text":"In pooled 72-week placebo-controlled trials, rates by dose (5 mg, 10 mg, 15 mg) versus placebo were: nausea 25%, 29%, 28% versus 8%; diarrhea 19%, 21%, 23% versus 8%; vomiting 8%, 11%, 13% versus 2%; and constipation 17%, 14%, 11% versus 5%.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"boxed-human-unknown","text":"It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"boxed-rat","text":"In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"animal","grade_label":"Animal","used_on":["https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"boxed-symptoms","text":"The label instructs counseling patients on the potential risk of MTC and on symptoms of thyroid tumors: a mass in the neck, difficulty swallowing, shortness of breath, or persistent hoarseness.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"cls-dual","text":"Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/entity","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"contra-hypersens","text":"Tirzepatide products are contraindicated in patients with known serious hypersensitivity to tirzepatide or any of the excipients; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"contra-mtc","text":"Tirzepatide products are contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"cvot-kidney","text":"In pre-specified exploratory analyses of SURPASS-CVOT (median follow-up 4.0 years), the risk of a composite kidney outcome was 23% lower with tirzepatide than dulaglutide (6.0% versus 7.6% of participants; hazard ratio 0.77, 95% CI 0.68 to 0.88).","source_url":"https://pubmed.ncbi.nlm.nih.gov/42114520/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"cvot-mace","text":"In SURPASS-CVOT (13,299 randomized patients with type 2 diabetes and atherosclerotic cardiovascular disease), a primary endpoint event (cardiovascular death, myocardial infarction, or stroke) occurred in 12.2% on tirzepatide versus 13.1% on dulaglutide: hazard ratio 0.92 (95.3% CI 0.83 to 1.01), establishing noninferiority (P=0.003) but not superiority (P=0.09).","source_url":"https://pubmed.ncbi.nlm.nih.gov/41406444/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com","https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"disclosure-approved","text":"Tirzepatide is FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (chronic weight management).","source_url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA217806%22&limit=1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/entity","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"disclosure-compounded","text":"Compounded or 'research' tirzepatide is not the FDA-approved product.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/entity","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"dose-day-change","text":"The day of weekly administration can be changed if necessary, as long as the time between the two doses is at least 3 days (72 hours).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-escalation","text":"After 4 weeks at 2.5 mg, increase the dosage to 5 mg once weekly; the dosage may then be increased in 2.5 mg increments after at least 4 weeks on the current dose, following the escalation schedule to reduce the risk of gastrointestinal adverse reactions.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-lower-maint","text":"If patients do not tolerate a maintenance dosage, the label advises considering a lower maintenance dosage.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-maint-osa","text":"For obstructive sleep apnea, the recommended maintenance dosage of Zepbound is 10 mg or 15 mg injected subcutaneously once weekly.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-maint-weight","text":"For weight reduction and long-term maintenance, the recommended maintenance dosage of Zepbound is 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly, selected by treatment response and tolerability.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-max","text":"The maximum dosage of Zepbound for all indications is 15 mg injected subcutaneously once weekly.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-missed","text":"If a dose is missed, the label instructs administering Zepbound as soon as possible within 4 days (96 hours) after the missed dose; if more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-mjr","text":"Mounjaro starts at 2.5 mg once weekly, increases to 5 mg after 4 weeks, and may be increased in 2.5 mg increments after at least 4 weeks on the current dose if additional glycemic control is needed; the maximum is 15 mg once weekly in adults and 10 mg once weekly in pediatric patients.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22MOUNJARO%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"dose-start","text":"The recommended starting dosage of Zepbound for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks; the 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"forms-multi","text":"Zepbound multi-dose vials and single-patient-use KwikPens each contain 4 doses of 0.6 mL per dose, in total strengths of 10 mg/2.4 mL (4.17 mg/mL), 20 mg/2.4 mL (8.33 mg/mL), 30 mg/2.4 mL (12.5 mg/mL), 40 mg/2.4 mL (16.7 mg/mL), 50 mg/2.4 mL (20.8 mg/mL), and 60 mg/2.4 mL (25 mg/mL).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"forms-single","text":"Zepbound single-dose pens and single-dose vials are supplied in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg, each in 0.5 mL.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"ind-coadmin","text":"Coadministration of Zepbound with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"ind-mjr","text":"Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22MOUNJARO%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"ind-zep-osa","text":"Zepbound is indicated, in combination with a reduced-calorie diet and increased physical activity, to treat moderate to severe obstructive sleep apnea in adults with obesity.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"ind-zep-weight","text":"Zepbound is indicated, in combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight in the presence of at least one weight-related comorbid condition.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"int-insulin","text":"When starting tirzepatide, the label advises considering a reduction in the dose of concomitant insulin or insulin secretagogues such as sulfonylureas to reduce the risk of hypoglycemia.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"int-narrow-ti","text":"The label advises monitoring patients on oral medications dependent on threshold concentrations for efficacy or with a narrow therapeutic index, such as warfarin, when co-administered with tirzepatide.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"int-oral-contraceptives","text":"The label advises patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method, for 4 weeks after starting tirzepatide and for 4 weeks after each dose escalation, because delayed gastric emptying can reduce oral contraceptive absorption.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"mech-albumin","text":"Tirzepatide contains a C20 fatty diacid that enables albumin binding and prolongs its half-life; it selectively binds to and activates both the GIP and GLP-1 receptors.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"mech-appetite","text":"Per the FDA label, GLP-1 is a physiological regulator of appetite and caloric intake, both GIP and GLP-1 receptors are found in areas of the brain involved in appetite regulation, and nonclinical studies suggest the addition of GIP may further contribute to regulation of food intake.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"mech-engineered","text":"Tirzepatide (development code LY3298176) is a fatty-acid-modified peptide engineered for dual GIP and GLP-1 receptor agonist activity; in preclinical models its weight and food-intake effects were significantly greater than a selective GLP-1 receptor agonist, and phase 1 pharmacokinetics supported once-weekly dosing.","source_url":"https://pubmed.ncbi.nlm.nih.gov/30473097/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"mech-gastric","text":"Tirzepatide delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"mech-insulin","text":"In type 2 diabetes, tirzepatide enhances first- and second-phase insulin secretion and reduces glucagon levels, both in a glucose-dependent manner.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22MOUNJARO%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"mmo-ongoing","text":"SURMOUNT-MMO, a phase 3, randomized, double-blind, placebo-controlled trial of tirzepatide on morbidity and mortality in 15,374 adults with obesity, is active (not recruiting) with primary completion estimated in October 2027.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT05556512","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"osa-ahi","text":"In the two 52-week SURMOUNT-OSA trials, tirzepatide reduced the apnea-hypopnea index by 25.3 events per hour versus 5.3 with placebo (trial 1, no PAP therapy) and by 29.3 versus 5.5 (trial 2, on PAP therapy): estimated treatment differences of 20.0 and 23.8 events per hour (P<0.001).","source_url":"https://pubmed.ncbi.nlm.nih.gov/38912654/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"osa-n","text":"The Zepbound OSA approval was based on two randomized, double-blind, placebo-controlled studies of 469 adults with moderate to severe obstructive sleep apnea and obesity, without type 2 diabetes.","source_url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/monograph"]},{"id":"osa-secondary","text":"In SURMOUNT-OSA, tirzepatide also reduced body weight, hypoxic burden, high-sensitivity C-reactive protein concentration, and systolic blood pressure, and improved sleep-related patient-reported outcomes versus placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/38912654/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"pk-bioavail","text":"The mean absolute bioavailability of tirzepatide following subcutaneous administration is 80%, with similar exposure from injection in the abdomen, thigh, or upper arm.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"pk-halflife","text":"The apparent population mean clearance of tirzepatide is 0.061 L/h with an elimination half-life of approximately 5 days, enabling once-weekly dosing.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22MOUNJARO%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"pk-halflife-obesity","text":"In patients with overweight or obesity, and in patients with OSA and obesity, the elimination half-life of tirzepatide is approximately 5 to 6 days.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"pk-steady","text":"Steady-state plasma tirzepatide concentrations are achieved following 4 weeks of once-weekly administration, and exposure increases in a dose-proportional manner.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"pk-tmax","text":"Following subcutaneous administration, the median time to maximum plasma concentration of tirzepatide is 24 hours, with a range of 8 to 72 hours.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"pk-vd","text":"The mean apparent steady-state volume of distribution of tirzepatide in patients with type 2 diabetes is approximately 10.3 L, and tirzepatide is highly bound to plasma albumin (99%).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22MOUNJARO%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"preg-animal","text":"In pregnant rats and rabbits given tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinically relevant exposures, coinciding with pharmacological effects on maternal weight and food consumption.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"animal","grade_label":"Animal","used_on":["https://tirzrx.com/monograph"]},{"id":"preg-data-limited","text":"Available human data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"preg-registry","text":"A pregnancy exposure registry monitors pregnancy outcomes in women exposed to Zepbound; exposed patients and clinicians are encouraged to contact Eli Lilly at 1-800-545-5979.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"preg-risk","text":"The Zepbound label states that weight loss offers no benefit to a pregnant patient and may cause fetal harm, and advises discontinuing Zepbound when a pregnancy is recognized.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"reg-compounded","text":"Compounded drugs are not FDA approved: FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed, and FDA has stated that unapproved versions of GLP-1 drugs, including tirzepatide, do not undergo FDA review before marketing.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"reg-compounded-storage","text":"FDA has received complaints that certain compounded GLP-1 drugs arrived warm or with inadequate ice packs, and recommends patients not use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/monograph"]},{"id":"reg-compounded-when","text":"FDA states compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug, with a prescription from a doctor filled at a state-licensed pharmacy.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/decision-aid","https://tirzrx.com/monograph"]},{"id":"reg-mjr-approval","text":"FDA approved Mounjaro (tirzepatide, NDA 215866) as a new molecular entity on May 13, 2022.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA215866%22&limit=1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/entity","https://tirzrx.com/monograph"]},{"id":"reg-osa-approval","text":"On December 20, 2024, FDA approved Zepbound for moderate to severe obstructive sleep apnea in adults with obesity, the first drug treatment option approved for obstructive sleep apnea.","source_url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/entity","https://tirzrx.com/monograph"]},{"id":"reg-zep-approval","text":"FDA approved Zepbound (tirzepatide, NDA 217806) on November 8, 2023 for chronic weight management in adults with obesity (BMI 30 or greater) or overweight (BMI 27 or greater) with at least one weight-related condition, in addition to a reduced-calorie diet and increased physical activity.","source_url":"https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/decision-aid","https://tirzrx.com/entity","https://tirzrx.com/monograph"]},{"id":"reta-hr","text":"In the retatrutide phase 2 trial, gastrointestinal adverse events were dose-related and mostly mild to moderate, and dose-dependent increases in heart rate peaked at 24 weeks and declined thereafter.","source_url":"https://pubmed.ncbi.nlm.nih.gov/37366315/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison"]},{"id":"reta-not-approved","text":"FDA states that retatrutide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition; FDA has warned telehealth companies, ingredient distributors, and outsourcing facilities over marketing or handling retatrutide.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison"]},{"id":"reta-p2","text":"In a 48-week phase 2 trial of 338 adults with obesity, retatrutide, a triple agonist of the GIP, GLP-1, and glucagon receptors, produced least-squares mean weight changes of -17.1% (4 mg), -22.8% (8 mg), and -24.2% (12 mg) versus -2.1% with placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/37366315/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison"]},{"id":"reta-phase3","text":"TRIUMPH-Outcomes (NCT06383390), a phase 3, randomized, double-blind, placebo-controlled trial of retatrutide on cardiovascular and kidney outcomes in an estimated 10,000 adults, is active with primary completion estimated in February 2029.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06383390","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tirzrx.com/comparison"]},{"id":"select-mace","text":"In SELECT (17,604 patients with preexisting cardiovascular disease and overweight or obesity, without diabetes), semaglutide 2.4 mg reduced the primary cardiovascular composite endpoint versus placebo: 6.5% versus 8.0%, hazard ratio 0.80 (95% CI 0.72 to 0.90), P<0.001.","source_url":"https://pubmed.ncbi.nlm.nih.gov/37952131/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"sm1-3y-t2d","text":"Over 176 weeks, 1.3% of tirzepatide-treated participants with prediabetes progressed to type 2 diabetes versus 13.3% with placebo (hazard ratio 0.07, 95% CI 0.0 to 0.1); after 17 weeks off treatment the rates were 2.4% versus 13.7% (hazard ratio 0.12).","source_url":"https://pubmed.ncbi.nlm.nih.gov/39536238/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm1-3y-weight","text":"In the 176-week SURMOUNT-1 extension in 1,032 participants with obesity and prediabetes, mean weight change was -12.3% (5 mg), -18.7% (10 mg), and -19.7% (15 mg) versus -1.3% with placebo, showing weight reduction sustained across 3 years of treatment.","source_url":"https://pubmed.ncbi.nlm.nih.gov/39536238/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"sm1-disc","text":"In SURMOUNT-1, adverse events caused treatment discontinuation in 4.3%, 7.1%, and 6.2% of participants on tirzepatide 5, 10, and 15 mg versus 2.6% on placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/35658024/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm1-responders","text":"In SURMOUNT-1, 85%, 89%, and 91% of participants on tirzepatide 5, 10, and 15 mg lost 5% or more of body weight versus 35% with placebo, and 50% and 57% of the 10 mg and 15 mg groups lost 20% or more versus 3% with placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/35658024/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm1-weight","text":"In SURMOUNT-1 (2,539 adults with obesity or overweight without diabetes, 72 weeks), mean weight change was -15.0% (5 mg), -19.5% (10 mg), and -20.9% (15 mg) versus -3.1% with placebo (P<0.001 for all comparisons).","source_url":"https://pubmed.ncbi.nlm.nih.gov/35658024/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"sm2-weight","text":"In SURMOUNT-2 (938 adults with obesity or overweight and type 2 diabetes, 72 weeks), mean weight change was -12.8% (10 mg) and -14.7% (15 mg) versus -3.2% with placebo, and 79 to 83% of tirzepatide-treated participants lost 5% or more versus 32% with placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/37385275/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm3-weight","text":"In SURMOUNT-3 (579 adults who had already lost at least 5% of body weight in a 12-week intensive lifestyle program), tirzepatide produced an additional 18.4% mean weight reduction over 72 weeks versus a 2.5% regain with placebo, an estimated difference of 20.8 percentage points.","source_url":"https://pubmed.ncbi.nlm.nih.gov/37840095/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm4-maintain","text":"In SURMOUNT-4, 89.5% of participants who continued tirzepatide maintained at least 80% of the weight lost during the lead-in period at week 88, versus 16.6% of those switched to placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/38078870/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sm4-regain","text":"In SURMOUNT-4, after a 36-week tirzepatide lead-in with 20.9% mean weight reduction, participants switched to placebo regained 14.0% from week 36 to week 88 while those continuing tirzepatide lost a further 5.5%; total change from week 0 to 88 was -25.3% with continued tirzepatide versus -9.9% after switching to placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/38078870/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/limits","https://tirzrx.com/monograph"]},{"id":"sm5-ae","text":"In SURMOUNT-5, the most common adverse events in both the tirzepatide and semaglutide groups were gastrointestinal, mostly mild to moderate, occurring primarily during dose escalation.","source_url":"https://pubmed.ncbi.nlm.nih.gov/40353578/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"sm5-waist","text":"In SURMOUNT-5, waist circumference decreased by 18.4 cm with tirzepatide versus 13.0 cm with semaglutide (P<0.001), and participants on tirzepatide were more likely to achieve weight reductions of at least 10%, 15%, 20%, and 25%.","source_url":"https://pubmed.ncbi.nlm.nih.gov/40353578/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"sm5-weight","text":"In SURMOUNT-5 (751 adults with obesity, without diabetes, 72 weeks, open-label), the least-squares mean weight change was -20.2% with tirzepatide versus -13.7% with semaglutide 2.4 mg (maximum tolerated dose), P<0.001; tirzepatide was superior for weight reduction.","source_url":"https://pubmed.ncbi.nlm.nih.gov/40353578/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"sp1-a1c","text":"In SURPASS-1 (478 adults with early type 2 diabetes, 40 weeks, placebo-controlled), tirzepatide monotherapy lowered HbA1c from baseline by 1.87 (5 mg), 1.89 (10 mg), and 2.07 (15 mg) percentage points versus a 0.04-point rise with placebo, with dose-dependent weight loss of 7.0 to 9.5 kg and no clinically significant or severe hypoglycemia reported.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34186022/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sp2-a1c","text":"In SURPASS-2 (1,879 patients with type 2 diabetes, 40 weeks), tirzepatide lowered HbA1c by 2.01 (5 mg), 2.24 (10 mg), and 2.30 (15 mg) percentage points versus 1.86 points with semaglutide 1 mg; tirzepatide was noninferior and superior to semaglutide at all three doses.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34170647/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"sp2-gi","text":"In SURPASS-2, gastrointestinal adverse events were the most common in both groups and mostly mild to moderate: nausea 17 to 22% with tirzepatide versus 18% with semaglutide 1 mg, diarrhea 13 to 16% versus 12%, and vomiting 6 to 10% versus 8%.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34170647/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison"]},{"id":"sp2-weight","text":"In SURPASS-2, weight reductions were greater with tirzepatide than semaglutide 1 mg, with estimated treatment differences of 1.9 kg (5 mg), 3.6 kg (10 mg), and 5.5 kg (15 mg), all P<0.001.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34170647/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"sp3-a1c","text":"In SURPASS-3 (1,444 randomized, 52 weeks, open-label), tirzepatide reduced HbA1c by 1.93 (5 mg), 2.20 (10 mg), and 2.37 (15 mg) percentage points versus 1.34 points with titrated once-daily insulin degludec.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34370970/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sp4-a1c","text":"In SURPASS-4 (2,002 randomized adults with type 2 diabetes and high cardiovascular risk, 52-week primary endpoint), tirzepatide reduced HbA1c by 2.43 (10 mg) and 2.58 (15 mg) percentage points versus 1.44 points with titrated insulin glargine.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34672967/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sp4-hypo","text":"In SURPASS-4, hypoglycemia (glucose below 54 mg/dL or severe) occurred in 6 to 9% of tirzepatide-treated participants versus 19% with insulin glargine, and in 1 to 3% versus 16% among participants not on sulfonylureas.","source_url":"https://pubmed.ncbi.nlm.nih.gov/34672967/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"sp5-a1c","text":"In SURPASS-5 (475 patients on titrated insulin glargine, 40 weeks), adding tirzepatide reduced HbA1c by 2.11 (5 mg), 2.40 (10 mg), and 2.34 (15 mg) percentage points versus 0.86 points with placebo, with body weight changes of -5.4 kg, -7.5 kg, and -8.8 kg versus +1.6 kg.","source_url":"https://pubmed.ncbi.nlm.nih.gov/35133415/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tirzrx.com/monograph"]},{"id":"storage-freeze","text":"Do not freeze Zepbound and do not use it if it has been frozen; protect it from heat and light and store it in the original carton.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"storage-fridge","text":"Store Zepbound single-dose pens and single-dose vials in a refrigerator at 2°C to 8°C (36°F to 46°F).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"storage-multi30","text":"An opened Zepbound multi-dose vial or single-patient-use KwikPen must be thrown away after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, whichever comes first.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"storage-rt21","text":"If needed, each Zepbound single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days, then discarded.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph","https://tirzrx.com/tools"]},{"id":"warn-aki","text":"There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, mostly in patients who experienced gastrointestinal reactions leading to dehydration; the label advises monitoring renal function in patients reporting reactions that could lead to volume depletion.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-aspiration","text":"There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists who were undergoing elective surgery or procedures with general anesthesia or deep sedation; patients should tell their clinicians about planned procedures.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-gallbladder","text":"In pooled weight-reduction trials, cholelithiasis was reported in 1.1% of Zepbound-treated patients versus 1% with placebo, cholecystitis in 0.7% versus 0.2%, and cholecystectomy in 0.2% versus none; acute gallbladder events were associated with weight reduction.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-gi","text":"In a pool of two placebo-controlled weight-reduction trials, gastrointestinal adverse reactions occurred in 56% of Zepbound-treated patients at each dose versus 30% with placebo, and severe gastrointestinal adverse reactions were reported in 1.7% (5 mg), 2.5% (10 mg), and 3.1% (15 mg) versus 1% with placebo; Zepbound is not recommended in patients with severe gastroparesis.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-hypersens-rate","text":"In pooled weight-reduction trials, immediate hypersensitivity reactions occurred in 2.1% of Zepbound-treated patients versus 0.4% with placebo; most hypersensitivity reactions in trials were skin reactions such as rash and itching.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-hypo","text":"Zepbound lowers blood glucose and can cause hypoglycemia; in the trial in type 2 diabetes, hypoglycemia with plasma glucose below 54 mg/dL was reported in 4.2% of Zepbound-treated patients versus 1.3% with placebo, rising to 10.3% in patients also taking a sulfonylurea.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-pancreatitis","text":"Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed with GLP-1 receptor agonists and with tirzepatide; in pooled weight-reduction trials adjudication-confirmed acute pancreatitis occurred in 0.2% of Zepbound-treated patients and 0.2% of placebo-treated patients, and the label instructs discontinuing if pancreatitis is suspected.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"warn-retinopathy","text":"Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy; tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema, and patients with a history of diabetic retinopathy should be monitored.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZEPBOUND%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/monograph"]},{"id":"wgv-ae","text":"The most common adverse reactions with Wegovy (5% or more) include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEGOVY%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison"]},{"id":"wgv-dose","text":"Wegovy is initiated at 0.25 mg once weekly and escalated every 4 weeks (0.25, 0.5, 1, 1.7 mg) to a maintenance dosage of 2.4 mg (recommended) or 1.7 mg once weekly in adults, reaching maintenance from week 17.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEGOVY%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison"]},{"id":"wgv-ind-cv","text":"Wegovy (semaglutide 2.4 mg) is indicated to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, in addition to its weight-management indication.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEGOVY%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com","https://tirzrx.com/monograph"]},{"id":"wgv-mech","text":"Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1 and acts as a selective GLP-1 receptor agonist.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEGOVY%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph"]},{"id":"wgv-missed","text":"For Wegovy, a missed dose is taken as soon as possible only if the next scheduled dose is more than 2 days (48 hours) away; if 2 or more consecutive doses are missed, re-initiation of the escalation schedule may be needed.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEGOVY%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tirzrx.com/comparison","https://tirzrx.com/monograph","https://tirzrx.com/tools"]}]}