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AI-Generated response:

is wegovy use indicated in children

Answer generated on June 4, 2024

The AI-generated responses are for illustration purposes only and should not be used for medical purposes.

Yes, Wegovy is indicated for use in pediatric patients aged 12 years and older with obesity.

  • Wegovy is approved for pediatric patients with an initial BMI at the 95th percentile or more for age and sex.[1]

  • The recommended dosage regimen for pediatric patients starts with 0.25 mg subcutaneously once weekly, escalating to a maintenance dose of 2.4 mg once weekly.[1-2]

  • In clinical trials, pediatric patients experienced adverse reactions such as cholelithiasis, cholecystitis, hypotension, rash, and urticaria.[2]

  • Pediatric use is supported by a 68-week, double-blind, placebo-controlled clinical trial and studies in adult patients.[2]

  • Safety and effectiveness have not been established in pediatric patients less than 12 years of age.[2]

Additional info

The use of Wegovy in pediatric patients is specifically tailored to those who meet certain criteria of obesity, reflecting its targeted approach in managing this condition. The clinical trial data supporting its use in this age group provides a foundation for its application, ensuring that the treatment is both evidence-based and aligned with regulatory standards. It's important to monitor for the mentioned adverse reactions and adjust treatment as necessary, considering the unique physiological and developmental characteristics of pediatric patients. This information should assist in making informed decisions regarding the management of pediatric obesity with Wegovy.

References

Reference 1

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: May 3, 2024.

Indications And Dosage NOTE: Wegovy is indicated in adults with an initial body mass index (BMI) of 30 kg/m2 or more or 27 kg/m2 or more in the presence of other risk factors (e.g., hypertension, type 2 diabetes, or dyslipidemia) and pediatric patients age 12 years and older with an initial BMI at the 95th percentile or more for age and sex. Subcutaneous dosage (e.g., Wegovy) Adults: 0.25 mg subcutaneously once weekly for weeks 1 through 4, then 0.5 mg subcutaneously once weekly for weeks 5 through 8, then 1 mg subcutaneously once weekly for weeks 9 through 12, and then 1.7 mg subcutaneously once weekly for weeks 13 through 16. From week 17 and onward, a maintenance dose of 2.4 mg (recommended) or 1.7 mg subcutaneously once weekly. Consider delaying dose escalation for 4 weeks if a dose increase is not tolerated. Assess treatment response and tolerability when selecting the maintenance dose. Children and Adolescents 12 to 17 years: 0.25 mg subcutaneously once weekly for weeks 1 through 4, then 0.5 mg subcutaneously once weekly for weeks 5 through 8, then 1 mg subcutaneously once weekly for weeks 9 through 12, then 1.7 mg subcutaneously once weekly for weeks 13 through 16, and then 2.4 mg subcutaneously once weekly. Consider delaying dose escalation for 4 weeks if a dose increase is not tolerated. May decrease dose to 1.7 mg subcutaneously once weekly if the 2.4 mg dose is not tolerated. Discontinue use if the 1.7 mg dose is not tolerated.

Reference 2

2.

Food and Drug Administration (DailyMed).

Publish date: March 5, 2024.

Dosage And Administration • The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation dosages and are not approved as maintenance dosages. Table 2. Recommended Dosage Regimen for Pediatric Patients Aged 12 Years and Older Treatment Weeks Once weekly Subcutaneous Dosage Initiation 1 through 4 0.25 mg a Escalation 5 through 8 0.5 mg a 9 through 12 1 mg a 13 through 16 1.7 mg b Maintenance 17 and onward 2.4 mg a Not approved as maintenance dosages b See Dosage Modifications for Adverse Reactions Maintenance Dosage • The maintenance dosage of WEGOVY (semaglutide) in pediatric patients aged 12 years and older is 2.4 mg once weekly. Dosage Modifications for Adverse Reactions • If patients do not tolerate the 2.4 mg once weekly maintenance dosage, the maintenance dosage may be reduced to 1.7 mg once weekly. • Discontinue WEGOVY (semaglutide) if the patient cannot tolerate the 1.7 mg once-weekly dosage. 2.4 Recommendations Regarding Missed Dose • If one dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer WEGOVY (semaglutide) as soon as possible. If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Resume dosing on the regularly scheduled day of the week. • If 2 or more consecutive doses are missed, resume dosing as scheduled or, if needed, reinitiate WEGOVY (semaglutide) and follow the dose escalation schedule, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.

Pediatric Use 8.4 Pediatric Use The safety and effectiveness of WEGOVY (semaglutide) as an adjunct to a reduced calorie diet and increased physical activity for weight reduction and long-term maintenance have been established in pediatric patients aged 12 years and older with obesity. Use of WEGOVY (semaglutide) for this indication is supported by a 68-week, double-blind, placebo-controlled clinical trial in 201 pediatric patients aged 12 years and older with a BMI corresponding to ≥95th percentile for age and sex and from studies in adult patients with obesity [see Clinical Studies (14.3) ]. Adverse reactions with WEGOVY (semaglutide) treatment in pediatric patients aged 12 years and older were generally similar to those reported in adults. Pediatric patients aged 12 years and older treated with WEGOVY (semaglutide) had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with WEGOVY (semaglutide) [see Adverse Reactions ( 6.1 )]. There are insufficient data in pediatric patients with type 2 diabetes treated with WEGOVY (semaglutide) for obesity to determine if there is an increased risk of hypoglycemia with WEGOVY (semaglutide) treatment similar to that reported in adults. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In pediatric patients aged 12 years and older with type 2 diabetes, monitor blood glucose prior to starting WEGOVY (semaglutide) and during WEGOVY (semaglutide) treatment. When initiating WEGOVY (semaglutide) in pediatric patients aged 12 years and older with type 2 diabetes, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.4 )]. The safety and effectiveness of WEGOVY (semaglutide) have not been established in pediatric patients less than 12 years of age.

Use In Specific Populations Data In lactating rats, WEGOVY (semaglutide) was detected in milk at levels 3-12-fold lower than in maternal plasma. 8.3 Females and Males of Reproductive Potential Because of the potential for fetal harm, discontinue WEGOVY (semaglutide) in patients at least 2 months before they plan to become pregnant to account for the long half-life of WEGOVY (semaglutide) [see Use in Specific Populations ( 8.1 )]. 8.4 Pediatric Use The safety and effectiveness of WEGOVY (semaglutide) as an adjunct to a reduced calorie diet and increased physical activity for weight reduction and long-term maintenance have been established in pediatric patients aged 12 years and older with obesity. Use of WEGOVY (semaglutide) for this indication is supported by a 68-week, double-blind, placebo-controlled clinical trial in 201 pediatric patients aged 12 years and older with a BMI corresponding to ≥95th percentile for age and sex and from studies in adult patients with obesity [see Clinical Studies (14.3) ]. Adverse reactions with WEGOVY (semaglutide) treatment in pediatric patients aged 12 years and older were generally similar to those reported in adults. Pediatric patients aged 12 years and older treated with WEGOVY (semaglutide) had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with WEGOVY (semaglutide) [see Adverse Reactions ( 6.1 )]. There are insufficient data in pediatric patients with type 2 diabetes treated with WEGOVY (semaglutide) for obesity to determine if there is an increased risk of hypoglycemia with WEGOVY (semaglutide) treatment similar to that reported in adults. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In pediatric patients aged 12 years and older with type 2 diabetes, monitor blood glucose prior to starting WEGOVY (semaglutide) and during WEGOVY (semaglutide) treatment.

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