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 medicine. 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:
- sensitive to any drug that is in the same class as FENSOLVI (your child’s doctor can help you determine this), or to children who are allergic to any of the ingredients in FENSOLVI
- If your child has trouble breathing, swallowing, throat tightness or hoarseness after taking FENSOLVI, get emergency help right away
- pregnant or become pregnant. FENSOLVI can cause birth defects or loss of the baby
Symptoms of early puberty may worsen for a short time after treatment begins. New symptoms can also occur, including vaginal bleeding in girls.
Some children may have emotional changes with FENSOLVI, including crying, irritability, restlessness, impatience, anger, and/or acting aggressively. Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.
There have been a small number of reports of children taking GnRH agonists having convulsions (uncontrolled movements due to muscles contracting and relaxing). Convulsions may happen in children who have not had them before. If this happens, 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.
Side effects at the injection site were also reported, including burning and stinging (for a short time), pain, bruising, and redness. Let your child’s doctor know if injection site reactions last longer than a couple of days, or if a rash appears.
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.
1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.