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Soliqua®(insulin glargine / lixisenatide)
|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.
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.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.. 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.
1. What are the pregnancy risks associated with SOLIQUA 100/33?
Based on animal studies, there may be fetal risks from exposure to lixisenatide during pregnancy. SOLIQUA 100/33 should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Limited data are available, and there is no clear association with major birth defects or miscarriage risk.
2. What is the risk of major birth defects and miscarriage in pregnant women with diabetes?
The estimated background risk of major birth defects is 6%–10% in women with pregestational diabetes and HbA1c >7, and it can be as high as 20%–25% with HbA1c >10. The background risk of miscarriage for this population is unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage is 2%–4% and 15%–20%, respectively.
3. What are the maternal and fetal risks associated with poorly controlled diabetes during pregnancy?
Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. The fetal risk includes major birth defects, stillbirth, and macrosomia-related morbidity.
4. What fetal risks are associated with lixisenatide exposure during pregnancy?
Lixisenatide exposure in pregnant rats and rabbits was associated with visceral closure and skeletal defects. These effects were observed at exposures higher than the highest clinical dose. Decreases in maternal food intake and weight gain were also observed. However, the relevance of these findings to human risk assessment is confounded by concurrent maternal effects.
5. Is there any information about lixisenatide and insulin glargine in human milk?
There is no information about the presence of lixisenatide and insulin glargine in human milk, their effects on the breastfed infant, or their effects on milk production. Lixisenatide is present in rat milk.
6. Is SOLIQUA 100/33 safe and effective for pediatric patients?
Safety and effectiveness of SOLIQUA 100/33 have not been established in pediatric patients.
7. What should be considered for geriatric patients using SOLIQUA 100/33?
While no overall differences in effectiveness and safety were observed in geriatric patients, caution should be exercised. In elderly patients with diabetes, dosing should be conservative to avoid hypoglycemic reactions, as hypoglycemia may be difficult to recognize in the elderly.
8. What are the considerations for patients with renal impairment using SOLIQUA 100/33?
Frequent glucose monitoring and dose adjustment may be necessary for SOLIQUA 100/33 in patients with renal impairment. Patients with severe renal impairment should be closely monitored for adverse reactions and changes in renal function.
9. How does hepatic impairment affect the use of SOLIQUA 100/33?
The effect of hepatic impairment on the pharmacokinetics of SOLIQUA 100/33 has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for patients with hepatic impairment.
10. Can SOLIQUA 100/33 be used in patients with gastroparesis?
SOLIQUA 100/33 is not recommended for patients with severe gastroparesis. Lixisenatide, a component of SOLIQUA 100/33, slows gastric emptying.
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