Dosage form:

Prefilled syringe

300, 450, 900 IU

Powder and solvent for solution for injection

75, 300, 450, 900 IU

What this drug is:
This product contains a medicine called “follitropin alfa”. Follitropin alfa is a type of “Follicle Stimulating Hormone” (FSH) which belongs to the family of hormones called “gonadotropins”. Gonadotropins are involved in reproduction and fertility.

What is this drug used for?

In adult women:

• To help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not respond to treatment with a medicine called “clomiphene citrate”.
• Together with another medicine called “lutropin alfa” (“Luteinizing Hormone” or LH) to help release egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
• To help develop several follicles (each containing an egg) in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilization”, “gamete intrafallopian transfer” or “zygote intra-fallopian transfer”.

In adult men:

• Together with another medicine called “human Chorionic Gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.

Women:

• If your ovaries no longer make eggs (primary ovarian failure).
• If you have any of these health problems: A tumor in your female organs, enlarged ovaries or ovarian cysts, or vaginal bleeding where the cause is not known.
• If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
• If you are breast-feeding or plan to breast-feed.
• Concomitant use of this drug with other medicinal products used to stimulate ovulation (e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitization may increase the dose of GONAL-f needed to elicit an adequate ovarian response. Talk with your doctor about taking any medications during GONAL-f therapy.

Men:

• If you are not able to make sperm or you have a tumor in your male organs.

This is not a list of all drugs or health problems that interact with this drug.  Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. This drug is not indicated for use in children.

Powder and solvent form:

• IMPORTANT NOTE – This drug should not be administered as a mixture with other medicines in the same injection, except for lutropin alfa. Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected. Talk to your doctor.

What are some things I need to know or do while I take this drug?

For all patients taking this drug:

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.

Women:

• You will need to have ultrasounds done while using this drug. Talk with your doctor.
• This drug may raise the chance of getting pregnant with more than one baby.
• This drug may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• If your ovaries get too big, your doctor may tell you that you need to avoid sex. This may cause an ovarian cyst to burst. Talk with your doctor.
• This drug may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• The rate of pregnancy loss (miscarriage) is higher in women using drugs like this one than in women who have a natural pregnancy. Talk with the doctor.
• If you have used drugs like this one more than 1 time to get pregnant, the chance of having tumors in your ovaries or other sex organs may be raised.
• This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.

Men:

• This drug should not be used when an effective response cannot be obtained.

Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking this drug:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Breast pain.
• A heartbeat that does not feel normal.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Pale skin.
• Swelling of belly.
• Mood changes.
• • Severe lung problems have happened with this drug. Rarely, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough, or fever.
  • Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

  Women:

  • Vaginal bleeding that is not normal.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use this drug. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.

  Men:

  • Enlarged breasts.

   

  What can I do if I forget to use this drug?

  If you forget to use the drug, do not take a double dose to make up for a forgotten dose. Please talk to your doctor as soon as you notice that you forgot a dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

   

  How should I store and/or discard this drug?

  • Store in the original package, in order to protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs.

  Prefilled syringe:

  • Store in a refrigerator (2°C-8°C). Do not freeze.
  • Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months at or below 25°C. The product must be discarded if it has not been used after 3 months.
  • Once opened, the medicinal product may be stored for a maximum of 28 days at or below 25°C.

  Powder and solvent:

  • Store at room temperature or in a refrigerator. Do not freeze.
  • Do not use the drug if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
  • The medicine must be administered immediately after