Fensolvi® (leuprolide acetate) for injectable suspension

Now Approved

Fensolvi® delivers an all-in-one treatment experience.

Indication

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.

Important Safety Information

FENSOLVI should not be given to children:

  • 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 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.

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