Fensolvi Prefilled Syringe 120 mg/mL (0.375 mL)

Uses

This medicine is used for the following purposes:

• gender dysphoria
• hormone imbalance
• cancer

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Store at room temperature or in the refrigerator. Do not freeze.

You may store this medicine at room temperature for up to 2 months. Do not put back in refrigerator.

This medicine should be given by a trained health care provider.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

It may take several weeks for this medicine to fully work.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This medicine is not approved for use in children younger than 2.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

You may notice more signs of puberty in your child during the first few weeks of treatment. Contact the doctor if these symptoms do not go away after 2 months.

Do not breastfeed while on this medicine.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• acne
• breast pain or swelling
• feeling of heat or flushing
• fever
• headaches
• pain, redness, swelling near injection
• joint or muscle pain
• stuffy nose
• sore throat
• vaginal dryness or irritation
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• anger or hostile feelings
• wheezing or difficulty breathing
• difficulty concentrating
• cough that does not go away
• crying
• depression or feeling sad
• fainting
• severe or persistent headache
• irritability
• mood changes
• restlessness
• suicidal thoughts
• blurring or changes of vision
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it. Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions. Always follow their advice. There is a more complete description of this medicine available in English. Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist. The display and use of this drug information is subject to Terms of Use. Copyright(c) 2023 First Databank, Inc.