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Overview: Follitropin alfa is used as part of fertility treatments to help people get pregnant. It works by signaling the body to grow eggs or make sperm. Common side effects include headache, nausea, and stomach pain or swelling. Serious side effects may include blood clots or severe ovary problems.

Uses

What is follitropin alfa used for?

Follitropin alfa is commonly used for fertility problems, in the following situations.

  • To help people get pregnant who are having fertility treatments like in vitro fertilization (IVF)
  • To help induce ovulation, which is when the ovaries release eggs, in people assigned female at birth who have certain fertility problems
  • To help produce sperm in people assigned male at birth who have certain fertility problems

These uses may vary depending on the specific follitropin alfa product prescribed. Follitropin alfa may also be used for other conditions as determined by your health care provider.

How does follitropin alfa work (mechanism of action)?

Follitropin alfa is similar to a natural hormone called follicle-stimulating hormone (FSH). It signals the body to prepare eggs or sperm. In females, follitropin alfa helps eggs grow and develop, which gets them ready for ovulation. In males, follitropin alfa helps to signal the production of sperm.

How is follitropin alfa supplied (dosage forms)?

Brands and other names

  • Gonal-f
  • Gonal-f RFF
  • Gonal-f RFF Redi-ject

Dosage forms and strengths

  • 75 IU, 450 IU, or 1050 IU per vial
  • 300 IU/0.48 mL, 450 IU/0.72 mL, or 900 IU/1.44 mL injection, Redi-ject pen

How should I store follitropin alfa?

Vials. Store unmixed vials of follitropin alfa in the refrigerator or at room temperature, between 36 F and 77 F (2 C to 25 C). Protect from light. After mixing, some follitropin alfa products must be used right away, while other products can be kept in the refrigerator or at room temperature for up to 28 days. Ask your pharmacist if you are unsure how to store your follitropin alfa vial.

Pens. Store follitropin alfa injection pen in the refrigerator between 36 F and 46 F (2 C to 8 C) until the labeled expiration date. Alternatively, you can store it at room temperature, between 68 F to 77 F (20 C to 25 C) for up to three months or until the labeled expiration date. After the first injection, follitropin alfa can be stored either in the refrigerator or at room temperature. Protect from light. Recap the pen between uses. Avoid freezing.

Side Effects

What are the most common side effects of follitropin alfa?

The most common side effects of follitropin alfa are listed below.  These side effects may vary depending on the specific condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Stomach pain and swelling
  • A fluid-filled sac (cyst) that forms on or in the ovaries
  • Nausea, diarrhea, or gas
  • Vaginal bleeding
  • Ovarian hyperstimulation syndrome (see below)
  • Pain, itching, swelling, or bruising near the injection site
  • Acne
  • Tiredness
  • Enlarged breast tissue (gynecomastia)
  • Itchy, flaky skin rash

There may be other side effects of follitropin alfa that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of follitropin alfa?

While less common, the most serious side effects of follitropin alfa are described below, along with what to do if they happen.

Severe Allergic Reactions. Follitropin alfa may cause allergic reactions, which can be serious. Stop using follitropin alfa and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Ovarian Hyperstimulation Syndrome. Follitropin alfa can cause a condition called ovarian hyperstimulation syndrome in people who have ovaries. This condition can be serious and causes the ovaries to become swollen and painful, and they may leak fluid. Using follitropin alfa may also cause other problems with the ovaries, such as swelling, twisting, or cysts. This can sometimes result in serious breathing problems. Stop using follitropin alfa and tell your health care provider right away if you have any of the following symptoms.

  • Stomach pain or swelling
  • Trouble breathing
  • Nausea or vomiting
  • Rapid weight gain
  • Less urine (pee) than usual
  • Vaginal bleeding
  • Pain in the lower back or pelvis that may be sharp and sudden
  • Fast breathing or heart rate

Blood Clots. Follitropin alfa may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop using follitropin alfa and tell your health care provider right away if you have any of the following symptoms.

  • Trouble breathing
  • Feeling lightheaded or faint
  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes

Warnings & Precautions

Who should not use follitropin alfa?

Allergies to Ingredients. People who are allergic to any of the following should not use follitropin alfa.

  • Follitropin alfa
  • Gonal-f
  • Gonal-f RFF
  • Gonal-f RFF Redi-ject
  • Any other medicine known as an FSH product
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific follitropin alfa products they stock.

Pregnancy. Do not use follitropin alfa if you are pregnant or think you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.

Current and Past Health Conditions. People with the following health problems should not use follitropin alfa.

  • High level of FSH in your blood
  • Problem with hormone glands, such as your thyroid, pituitary, or adrenal glands, that is not controlled with medicine
  • Certain types of brain tumors
  • Abnormal vaginal bleeding without a known cause
  • Ovarian cysts not caused by polycystic ovary syndrome, or enlarged ovaries without a known cause
  • Tumors that depend on hormones to grow and affect the reproductive system

What should I know about follitropin alfa before using it?

Do not use follitropin alfa unless it has been prescribed to you by a health care provider. Use it as prescribed and attend all appointments, including lab tests, as directed.

Do not share follitropin alfa with other people, even if they have the same condition as you. It may harm them.

Follitropin alfa is injected under the skin. There are multiple forms of follitropin alfa available. Read and follow the instructions for the product you have and make sure you understand how to use it properly. If you have any questions, talk to your health care provider.

Keep follitropin alfa out of the reach of children. Since this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

What should I tell my health care provider before using follitropin alfa?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if follitropin alfa is right for you.

In particular, make sure that you discuss any of the following.

Past Use of Fertility Medicines. Using this medicine more than once to get pregnant may raise your risk of developing tumors or cancer in your ovaries. Tell your health care provider if you have used follitropin alfa or similar fertility medicines in the past.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney or liver problems
  • Asthma
  • Ovary problems or surgery on your stomach area
  • Blood clotting disorders, severe obesity, blood clots, or someone in your family with blood clots

Multiple Births. Using follitropin alfa to help you get pregnant raises the chances of becoming pregnant with more than one baby, especially twins. This can increase the risk of complications during pregnancy or childbirth. Discuss and consider these risks with your health care provider before using follitropin alfa.

Pregnancy. Follitropin alfa is commonly used when people are trying to get pregnant. But using it during pregnancy may cause harm to an unborn baby. Tell your health care provider if you are or plan to become pregnant.

Breastfeeding. It is not known if follitropin alfa passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should stop breastfeeding or stop follitropin alfa.

Interactions

Does follitropin alfa interact with foods or drinks?

There are no known interactions between follitropin alfa and foods or drinks.

It is unknown if drinking alcohol will affect follitropin alfa.

Does follitropin alfa interact with other medicines (drug interactions)?

There are no known interactions between follitropin alfa and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much follitropin alfa?

If you or someone else has used too much follitropin alfa, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of follitropin alfa?

Follitropin alfa is meant to be used only as instructed for your treatment. Use it as your health care provider recommends. Do not use double or extra doses. If you miss a dose, call your health care provider right away to learn what to do.