Fensolvi

Fensolvi

What is Fensolvi?

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

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

Side effects of Fensolvi

If necessary, get emergency medical helpSigns of an allergic reaction(hives, difficulty breathing, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

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

When you start using Fensolvi, your symptoms may temporarily worsen, including new or worsening sexual development symptoms in children. Tell your doctor if this persists for more than 2 months.

Fensolvi can cause serious side effects. Call your doctor immediately 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 fits, anger, irritability);

• sudden chest pain or discomfort, wheezing, dry cough or urge to cough;

• painful or difficult urination;

• pain or unusual sensations in the back, numbness, weakness, or tingling in the legs or feet;

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

• Problems with your pituitary gland – sudden severe headaches, 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 feeling of pressure, pain spreading to the 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:

• problems with the pituitary gland;

• Acne, itching, rash, white scales (seborrhea);

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

• Fractures, ligament strains;

• fever, tiredness, malaise;

• stomach pain, nausea, vomiting, diarrhea, constipation;

• Wheezing, chest tightness, difficulty breathing;

• breast tenderness, hot flashes, sweating;

• Dizziness, sleep problems, mood swings;

• headache, general pain;

• vaginal swelling, itching, or discharge;

• weight changes;

• reduced testicle size;

• irregular menstruation, decreased interest in sex; or

• Redness, pain, swelling or oozing at the injection site.

Fensolvi can affect the growth of children. Tell your doctor if your child does not grow normally while using Fensolvi.

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

Warnings

When you start using Fensolvi, your symptoms may temporarily worsen, including new or worsening sexual development symptoms in children. Tell your doctor if this persists for more than 2 months.

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

Do not use if pregnant.Use effective contraception. Do not use if you have unusual vaginal bleeding that has not been checked by a doctor.

Before you take this medicine

You should not use Fensolvi if you are allergic to Fensolvi or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have unusual 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 disease of the blood vessels;

• a brain tumor or spinal cord injury;

• heart disease, heart failure, long QT syndrome;

• an electrolyte imbalance (e.g. low levels of potassium or magnesium in your blood); or

• Risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol consumption, long-term use of steroids or anti-seizure medications).

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

Call your doctor if your period continues while you are taking this medicine.

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

Ask a doctor whether breast-feeding is safe while using this medication.

How should I use Fensolvi?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

There are many brands, strengths, or forms of leuprolide used to treat various medical conditions. Avoid medication errors by only taking the medications your doctor prescribes.

Fensolvi is usually given by a healthcare provider.

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

Your symptoms may temporarily worsen as your hormones adjust to Fensolvi. A child taking this medicine may experience increased signs of puberty (e.g. vaginal bleeding) in the first few weeks of treatment.

Frequent medical examinations may be necessary while using Fensolvi.

Do not reuse a needle or syringe. Place them in a puncture-resistant sharps container and dispose of in accordance with state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with Fensolvi. Your pharmacist can give you more information about storing this medicine.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when using Fensolvi?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect Fensolvi?

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

Other medicines may affect Fensolvi, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.