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|Dosage & Administration|
2.5 mg injected subcutaneously once weekly * After 4 weeks, increase to 5 mg injected SC once weekly *Increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. if needed. * Max dosage is 15 mg weekly.. Learn more.
Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg daily. If needed ↑ to 1.8 mg daily after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed ↑ to 1.2 mg daily; if further needed, ↑ to 1.8 mg daily after ≥ 1 wk at 1.2 mg dose.. Learn more.
Start: 2.5 mg SC weekly Wk 4: Increase to 5 mg SC weekly If more control needed, ↑ by 2.5 mg after ≥4 wks Max: 15 mg SC weekly Weekly dosing, any time, w/wo meals SC injection: abd, thigh, upper arm. Learn more.
Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg qd. If needed, ↑ to 1.8 mg qd after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed, ↑ to 1.2 mg qd; if further needed, ↑ to 1.8 mg qd after ≥ 1 wk at 1.2 mg dose.. Learn more.
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Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation. Immunogenicity-related events, including urticaria, were more common among VICTOZA®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.
Mechanism of Actions (MoA)
What are the risks associated with MOUNJARO use during pregnancy?
Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data). The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
What are the clinical considerations regarding pregnancy and MOUNJARO use?
Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
What animal data is available regarding MOUNJARO use during pregnancy?
In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide (0.03-, 0.07-, and 0.5-fold the MRHD of 15 mg once weekly based on AUC) during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg. In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically-mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F1 pups from F0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females.
What are the risks associated with MOUNJARO use during lactation?
There are no data on the presence of tirzepatide in animal or human milk, the effects on the breastfed 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 MOUNJARO and any potential adverse effects on the breastfed infant from MOUNJARO or from the underlying maternal condition.
How does MOUNJARO use affect oral hormonal contraceptives?
Use of MOUNJARO may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with MOUNJARO.
Is MOUNJARO safe and effective for pediatric patients?
Safety and effectiveness of MOUNJARO have not been established in pediatric patients (younger than 18 years of age).
Are there age-related differences in MOUNJARO use for geriatric patients?
In the pool of seven clinical trials, 1539 (30.1%) MOUNJARO-treated patients were 65 years of age or older, and 212 (4.1%) MOUNJARO-treated patients were 75 years of age or older at baseline. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Is dosage adjustment necessary for patients with renal impairment using MOUNJARO?
No dosage adjustment of MOUNJARO is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in tirzepatide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function when initiating or escalating doses of MOUNJARO in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Is dosage adjustment necessary for patients with hepatic impairment using MOUNJARO?
No dosage adjustment of MOUNJARO is recommended for patients with hepatic impairment. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide PK was observed.
What are the considerations regarding the use of VICTOZA® during pregnancy?
Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA® during pregnancy. VICTOZA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities. The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes is 6 to 10%. Clinical considerations include the increased risk of maternal and fetal complications associated with poorly controlled diabetes.
What are the considerations regarding the use of VICTOZA® during lactation?
There are no data on the presence of VICTOZA® in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in the milk of lactating rats. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VICTOZA® and any potential adverse effects on the breastfed infant from VICTOZA® or from the underlying maternal condition.
What is known about the safety and effectiveness of VICTOZA® in pediatric patients?
The safety and effectiveness of VICTOZA® as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA® for this indication is supported by clinical trials. The risk of hypoglycemia was higher with VICTOZA® in pediatric patients. VICTOZA® has not been established in pediatric patients less than 10 years of age.
Are there any age-related differences in the safety and effectiveness of VICTOZA®?
In clinical trials, no overall differences in safety or effectiveness for VICTOZA® have been observed between patients 65 years of age and older and younger patients.
How should VICTOZA® be used in patients with renal impairment?
No dose adjustment of VICTOZA® is recommended for patients with renal impairment. The safety and efficacy of VICTOZA® was evaluated in patients with moderate renal impairment. In clinical trials, no overall differences in safety or efficacy were seen in patients with renal impairment compared to patients with normal renal function. Use caution in patients who experience dehydration.
What are the recommendations for using VICTOZA® in patients with hepatic impairment?
There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, VICTOZA® should be used with caution in this patient population. No dose adjustment of VICTOZA® is recommended for patients with hepatic impairment.
How does VICTOZA® affect patients with gastroparesis?
VICTOZA® slows gastric emptying. VICTOZA® has not been studied in patients with pre-existing gastroparesis.
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