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Soliqua®(insulin glargine / lixisenatide)
|Dosage & Administration|
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.
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.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
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.
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 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.
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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