Follitropin Alfa Injectable Solution 600 units/mL

Instructions

This medicine is given as an injection.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

Do not shake the medicine before using.

Store at room temperature or in refrigerator. Do not freeze. Protect from light.

If your medicine is stored in the refrigerator, take it out of the refrigerator before use to warm to room temperature.

Injecting cold drug may be uncomfortable.

After first use, discard vial with any unused medicine after 28 days.

Never use any medicine that has expired.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Wash your hands before and after handling this medicine.

You or a family member can be trained to give this medicine at home.

Do not inject into skin that is red, swollen or itchy.

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

Do not rub or massage the area where the injection was given.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

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.

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

Cautions

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

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

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

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

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.

• bloating
• breast pain or swelling
• headaches
• pain, redness, swelling near injection
• stomach pain

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

• chest or jaw pain
• confusion
• dizziness
• swelling of the legs, feet, and hands
• fainting
• flu-like symptoms
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• shortness of breath
• difficulty speaking
• severe stomach or bowel pain
• urinating less often
• excessive vaginal bleeding
• sudden change or loss of vision
• weakness on one side of the body
• sudden or unexplained weight gain

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.