Leuprolide

What it is used for

VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.

The most important thing to know

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. Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like FENSOLVI. Stop FENSOLVI and call your child’s healthcare provider right away if your child has any of the following signs or symptoms during treatment with FENSOLVI: skin rash or acne dry skin itching blisters on your skin redness or swelling of your face, hands, or soles of your feet blisters or sores in your mouth peeling of your skin fever muscle or joint aches swollen glands 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: headache eye problems, including blurred vision, double vision and decreased eyesight eye pain ringing in the ears dizziness nausea 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. FENSOLVI should not be received if your child is: 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: skin rashes, redness, or swelling swelling of face, mouth, and tongue trouble breathing or swallowing hives throat tightness, hoarseness sweating severe itching dizziness or fainting fast heartbeat 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 s

Side effects, and when to stop

FENSOLVI may cause serious side effects. The most common side effects of FENSOLVI include: injection site pain abdominal pain sudden shortness of breath or wheezing (bronchospasm) nasal congestion, sore throat, and runny nose (nasopharyngitis) nausea productive cough fever (pyrexia) constipation sudden strong feelings of heat and sweating (hot flush) headache vomiting cough upper respiratory tract infection 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.