Medication Guide

What is the most important information I should know about FENSOLVI?

FENSOLVI may cause serious side effects, including:

• In the first few weeks after your child receives their first FENSOLVI injection, FENSOLVI can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child including vaginal bleeding. Call your child’s healthcare provider if signs of puberty continue after 2 months of receiving FENSOLVI.
• Some people taking gonadotropin releasing hormone (GnRH) agonists like FENSOLVI have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
  • crying
  • irritability
  • restlessness (impatience)
  • anger
  • acting aggressively

Call your child’s healthcare provider right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.

• Some people taking GnRH agonists like FENSOLVI have had seizures. The risk of seizures may be higher in people who:
  • have a history of seizures
  • have a history of epilepsy
  • have a history of brain tumors or brain vessel (cerebrovascular) problems
  • are taking a medicine that has been associated with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

Seizures have also happened in people who have not had any of these problems.

Call your child’s healthcare provider right away if your child has a seizure while taking FENSOLVI.

• Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including FENSOLVI. Call your child’s doctor right away if your child has any of the following symptoms during treatment with FENSOLVI:

 What is FENSOLVI?

• FENSOLVI is a prescription gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
• It is not known if FENSOLVI is safe and effective in children younger than 2 years of age.

• allergic to GnRH, GnRH agonist medicines, or any ingredients in FENSOLVI. See the end of this Medication Guide for a complete list of ingredients in FENSOLVI.
       
  Call your child’s healthcare provider or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction:

• pregnant or becomes pregnant. FENSOLVI can cause birth defects or loss of the baby. If your child becomes pregnant, call your healthcare provider.
  

Before your child receives FENSOLVI, tell your child’s healthcare provider about all of your child’s medical conditions, including if they:

• have a history of mental (psychiatric) problems.
• have a history of seizures.
• have a history of epilepsy.
• have a history of brain vessel (cerebrovascular) problems.
• have a history of brain or spinal cord (central nervous system) problems or tumors.
• are breastfeeding or plan to breastfeed. It is not known if FENSOLVI passes into breastmilk.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will your child receive FENSOLVI?

• FENSOLVI will be given to your child by a healthcare provider.
• FENSOLVI is injected under the skin (subcutaneous) every 6 months.
• Keep all scheduled visits to the healthcare provider. If you miss a scheduled dose, your child may start having signs of puberty again. The healthcare provider will do regular exams and blood tests to check for signs of puberty.

The most common side effects of FENSOLVI include:

These are not all the possible side effects of FENSOLVI. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.