Follitropin alfa (Injection)

Introduction

Follitropin Alfa (fol-i-TROE-pin AL-fa)

Gonal-f? RFF treats female infertility. Gonal-f? treats both male and female infertility. This medicine is a hormone.

Brand Name(s)

Gonal-f, Gonal-F, Gonal-f RFF, Gonal-F RFF

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Gonal-f? RFF comes in a prefilled syringe. No mixing or measuring of the medicine is necessary.

If a dose is missed:

• The timing of when you use this medicine is very important in how well it will work. Use the medicine on the exact day and at the exact time your doctor has ordered.
• Try not to miss any doses, and keep all appointments with your doctor.
• If you do miss a dose, call your doctor for instructions.

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it in the refrigerator or at room temperature, away from heat and direct light. Do not freeze. If you store this medicine in the refrigerator, let it adjust to room temperature before you use it. Do not store the medicine in the syringe.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed. The liquid medicine expires 28 days after you first use it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Using this medicine if you are already pregnant can harm your unborn baby.
• Make sure your doctor knows if you have liver disease, heart disease, or a history of breathing problems such as asthma. Make sure your doctor knows if you have ever had a stroke, or problems with blood clots.
• This medicine may cause you to become pregnant with more than one baby (twins, triplets, or more).
• Along with using this medicine, you will need to visit your doctor for regular tests and procedures. It may take several months for you to become pregnant.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breakthrough vaginal bleeding.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Fever, chills, cough, runny or stuffy nose, body aches, or sore throat.
• Pain in your lower leg (calf).
• Pain or swelling in your lower abdomen.
• Painful or difficult breathing.
• Rapid weight gain.
• Vomiting, stomach pain, or diarrhea.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Acne.
• Breast pain or enlargement.
• Headache or fatigue.
• Nausea.
• Pain or swelling where the shot is given.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088