Follitropin alfa Subcutaneous

In the U.S.

• Gonal-F
• Gonal-F RFF
• Gonal-F RFF Redi-ject

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Follitropin alfa is a hormone identical to follicle-stimulating hormone (FSH) produced by the pituitary gland. FSH helps to develop eggs in the ovaries.

Follitropin alfa is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation. Also, many women wanting to become pregnant will use follitropin alfa while enrolled in a fertility program (assisted reproductive technology [ART]) that uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin alfa may be used with other medicines for these purposes.

Follitropin alfa is also used as a fertility medicine to help men with low sperm counts produce more sperms. Treatment with human chorionic gonadotropin should come before treatment with follitropin alfa. This pretreatment elevates the amount of testosterone to the correct level. Treatment with human chorionic gonadotropin should continue as long as follitropin alfa is being used.

Some patients may be treated with another hormone called gonadotropin-releasing hormone agonist (GnRHa) before starting treatment with follitropin alfa. GnRHa reduces the amount of FSH released from the pituitary gland. This is done so that the doctor can replace their FSH with follitropin alfa in the proper amounts each day to achieve fertility.

follitropin alfa is available only with your doctor's prescription.

To make using follitropin alfa as safe and reliable as possible, you should understand how and when to use follitropin alfa and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of follitropin alfa. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes follitropin alfa can be given by injection at home. If you are using follitropin alfa at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.
• Wash yours hands with soap and water and use a clean work area to prepare your injection.
• Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.
• Do not inject more or less of the medicine than your doctor ordered.
• Remember to move the site of injection to different areas to prevent skin problems from developing.
• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of follitropin alfa. Follitropin alfa often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of follitropin alfa is given. Your doctor will give you follitropin alfa or arrange for you to get follitropin alfa at the right time.

Dosing

The dose of follitropin alfa will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of follitropin alfa. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For treatment of female infertility:
    • Adults—75 international units (IU) injected under the skin once a day for approximately fourteen days. The dose may be increased at weekly intervals by 37.5 IU, up to a total dose of 300 IU once a day. Using follitropin alfa for longer than fourteen days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later. If abdominal pain occurs with the use of follitropin alfa, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.
  • For use with assisted reproductive technology (ART) procedures:
    • Adults—150 international units (IU) injected under the skin once a day for five days beginning on Day 2 or Day 3 of your menstrual cycle. After five days, your dose may be increased by 75 to 150 IU every three to five days, up to a total dose of 450 IU once a day, for up to five more days. Some patients may start treatment at a dose of 225 IU once a day. Using follitropin alfa for longer than ten days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later.
  • For treatment of male infertility
    • Adults— 150 international units (IU) injected under the skin three times a week in conjunction with 1000 USP Units of human chorionic gonadotropin (hCG) three times a week. Your dose may be increased up to 300 IU three times a week, and the treatment may last up to eighteen months.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking follitropin alfa and get emergency help immediately if any of the following effects occur:

• Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal bloating
• diarrhea
• flu or cold-like symptoms, such as body aches or pain, coughing, fever, headache, loss of voice, runny nose, and unusual tiredness or weakness
• nausea
• passing of gas
• vaginal bleeding between menstrual periods

• Acne
• breast pain or tenderness
• mood swings

• Dizziness
• painful menstrual periods
• redness, pain, or swelling at injection site
• sleepiness
• vaginal bleeding unrelated to menstrual periods (heavy)
• white vaginal discharge

• Fainting
• light-headedness
• migraine headache
• nervousness
• stomach discomfort

• Fast, racing heartbeat
• itching of skin
• loss of appetite
• thirst (unusual)

After you stop using follitropin alfa, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: gonadorelin.