Fensolvi® delivers an all-in-one treatment experience for children with central precocious puberty (CPP).

  • 6-month dosing
  • Subcutaneous injection
  • Leuprolide acetate
  • Comprehensive patient support

FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

IMPORTANT SAFETY INFORMATION
FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

Please see Full Prescribing Information for FENSOLVI or see full Prescribing Information for FENSOLVI Pre-Connected Syringe System, for additional important safety information.

Fensolvi is the first and only subcutaneous injection of leuprolide acetate for CPP

Administered just twice a year1

Learn More

To learn more about Fensolvi, please visit the official Fensolvi website.

Important Safety Information for FENSOLVI – PATIENT/PARENT/CAREGIVER

FENSOLVI is a type of medicine known as a gonadotropin releasing hormone (GnRH) agonist. It is used to treat central precocious puberty (CPP) in children 2 years of age and older and is administered as an injection under the skin (subcutaneously) by your child’s healthcare provider.

FENSOLVI should not be given to children who are:

  • Who are sensitive to GnRH, GnRH agonists or any of the ingredients in FENSOLVI (your child’s doctor can help you know this)
    • Call your child’s doctor or get emergency medical help right away if your child has any symptoms of a serious allergic reaction
  • Who are pregnant. FENSOLVI can cause birth defects or loss of the baby

During the first few weeks of treatment, an increase in signs and symptoms of puberty, including vaginal bleeding in girls, may occur.

Some children may have emotional changes with FENSOLVI, including crying, irritability, impatience, anger, or aggression. Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking FENSOLVI

There have been reports of convulsions (uncontrolled movements due to rapid contraction and relaxation of muscles) in children taking GnRH agonists. Convulsions may occur in children who have not had them before. If your child has a convulsion, call your child’s doctor, or get emergency help right away 

The most common side effects seen in studies with FENSOLVI were colds, headache, fever, cough, belly pain, constipation, nausea, tightening of the airways, vomiting, bronchitis, sore throat, sinus infection, and hot flashes. Let your child’s doctor know of any side effects.

Idiopathic Intracranial Hypertension (unexplained elevated pressure in the brain) has been reported in pediatric patients receiving GnRH agonists. Call your child’s doctor right away if your child has headaches and/or vision issues

The most common side effects seen in studies with FENSOLVI were injection site pain/redness, colds/sore throat, fever, headache, cough, stomach pain, nausea, constipation, vomiting, wheezing, wet cough and hot flush. Tell your child’s doctor about any side effects

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

Please see Full Prescribing Information for additional Important Safety Information. 

 

Reference:
1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.

 

TPI.2020.2314.v2