Fensolvi

Fensolvi is used in adult males to help with the symptoms of advanced prostate cancer. In adult females, this medicine is used alone or with other treatments to manage endometriosis (which is the growth of uterine lining outside of the uterus) or along with iron therapy to treat anemia caused by uterine fibroids.

Fensolvi can also treat precocious (early-onset) puberty in both male and female children who are at least 2 years old.

Fensolvi may also be used for other reasons that are not mentioned in this medication guide.

Your symptoms may get temporarily worse when you first start using Fensolvi, which may include new or worsening symptoms of sexual development in children. Tell your doctor if this lasts for more than 2 months.

Call your doctor right away if you have a seizure, unusual changes in mood or behavior, severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Do not use if you are pregnant. Use effective birth control. Do not use if you have abnormal vaginal bleeding that has not been checked by a doctor.

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.

Tell your doctor if you have or 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).

Fensolvi usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

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

May cause birth defects. Do not use if you are pregnant. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor right away if you have a seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Your symptoms may temporarily get worse when you first start using Fensolvi, including new or worsening symptoms of sexual development in children. Tell your doctor if this lasts more than 2 months.

Fensolvi may cause serious side effects. Call your doctor right away if you have:

• 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;
• pain or unusual sensations in your back, numbness, weakness, or tingling in your legs or feet;
• muscle weakness or loss of muscle use, loss of bladder or bowel control;
• problems with your pituitary gland—sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• high blood sugar— increased thirst, increased urination, hunger, dry mouth, fruity breath odor;
• 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, severe headache, slurred speech, problems with vision or balance.

Common side effects of Fensolvi may include:

• pituitary gland problems;
• acne, itching, rash, white scales (seborrhea);
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fractures, ligament sprain;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• wheezing, chest tightness, trouble breathing;
• breast tenderness, hot flashes, sweating;
• dizziness, sleep problems, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• irregular menstrual periods, decreased interest in sex; or
• redness, pain, swelling, or oozing where the medicine was injected.

Fensolvi can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Fensolvi.

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

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

There are many brands, strengths, or forms of leuprolide used to treat different conditions. Avoid medication errors by using only the medicine your doctor prescribes.

Fensolvi is usually administered by a healthcare provider.

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

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.

You may need frequent medical tests while using Fensolvi.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with Fensolvi. Your pharmacist can provide more information about how to store this medicine.

Call your doctor for guidance if you miss a dose or miss your injection appointment.

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

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Fensolvi can lead to a serious heart issue. Your risk might be greater if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other medications may impact Fensolvi, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.