Fensolvi overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. This medicine reduces the amount of testosterone in men or estrogen in women.

Fensolvi is used in men to treat the symptoms of prostate cancer (but does not treat the cancer itself). This medicine is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Fensolvi is also used to treat precocious (early-onset) puberty in both male and female children at least 2 years old.

Fensolvi may also be used for purposes not listed in this medication guide.

Your symptoms may become temporarily worse when you first start using Fensolvi. Tell your doctor if this continues for longer than 2 months.

Call your doctor at once if you have a seizure, or unusual changes in mood or behavior.

Do not use if you are pregnant.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Different brands or strengths of leuprolide are used to treat different conditions. It is very important that you receive exactly the brand and strength your doctor has prescribed. Always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Fensolvi is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider can teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Fensolvi if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Your symptoms may become temporarily worse as your hormones adjust to Fensolvi. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

Keep using the medicine as directed, and tell your doctor if your condition is still worse after 2 months of using this medicine.

You may need frequent medical tests while using Fensolvi. Bone growth may need to be checked in a child treated with Fensolvi.

Store Lupron in the original carton at room temperature, away from moisture and heat. Protect from light.

Store Eligard or Fensolvi in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. Mixed medicine must be used within 30 minutes.

You may also store Eligard or Fensolvi in its original packaging at room temperature for up to 8 weeks.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use Fensolvi if you are allergic to Fensolvi or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Fensolvi can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength.

Tell your doctor if you have ever had:

• depression, mental illness or psychosis;

• seizures or epilepsy;

• a blood vessel disorder;

• a brain tumor or spinal cord injury;

• heart disease, congestive heart failure, long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Do not give this medicine to any child without medical advice.

Fensolvi usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy. This medicine can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings).

Call your doctor if your periods continue while you are being treated with this medicine.

You should not breast-feed while using this medicine.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, sweating, fast heartbeats, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Fensolvi may cause serious side effects. Call your doctor at once if you have:

• problems with your pituitary gland--sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;

• bone pain, loss of movement in any part of your body;

• swelling, rapid weight gain;

• a seizure;

• unusual changes in mood or behavior (crying spells, anger, feeling irritable);

• sudden chest pain or discomfort, wheezing, dry cough or hack;

• painful or difficult urination; or

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

Rare but serious side effects may occur. Call your doctor if you have:

• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use, loss of bowel or bladder control;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech.

Common side effects of Fensolvi may include:

• pituitary gland problems;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;

• fever, tiredness, not feeling well;

• stomach pain, nausea, vomiting, constipation;

• wheezing, chest tightness, trouble breathing;

• hot flashes, sweating;

• dizziness, mood changes;

• headache, general pain;

• vaginal swelling, itching, or discharge;

• weight changes;

• decreased testicle size;

• decreased interest in sex; or

• redness, pain, swelling, or oozing where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fensolvi can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect Fensolvi, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.