Follitropin Beta

Follitropin beta is a prescription medication used to increase fertility in men and women. 

Follitropin beta belongs to a group of drugs called gonadotropins. It works in women by stimulating the ovaries to develop and release eggs. In men, it helps to bring about the production and development of sperm.

This medication comes in an injectable form in a cartridge with a pen injector device. It is injected just under the skin, usually once daily.

Common side effects include headache, nausea, and pain at the injection site.

Follitropin beta is a prescription medication used to increase fertility in men and women.  

Follitropin Beta may be found in some form under the following brand names:

• Follistim

• Follistim AQ

• Puregon

Follitropin beta may cause serious side effects.

Serious side effects in women include:

• Ovarian enlargement
• Ovarian hyperstimulation syndrome (OHSS). OHSS is a serious medical problem that can happen when the ovaries are over stimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call your healthcare provider right away if you have:
  • pain in your lower stomach area
  • nausea
  • vomiting
  • weight gain
  • diarrhea
  • decreased urine output
  • trouble breathing
• Lung problems. Follitropin beta can cause you to have fluid in your lungs (atelectasis) and trouble breathing (acute respiratory distress syndrome).
• Blood clots. Follitropin beta may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
  • blood vessel problems (thrombophlebitis)
  • stroke
  • loss of your arm or leg
  • blood clot in your lungs (pulmonary embolus)
  • heart attack
• Ovarian torsion. Follitropin beta may increase the chance of twisting of the ovaries in women with certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of the ovary could cause the blood flow to the ovary to be cut off.
• Pregnancy and birth of multiple babies. Having a pregnancy with more than one baby at a time increases the health risk for you and your babies. Discuss your chances of multiple births with your healthcare provider.
• Birth defects. A woman's age, certain sperm problems, genetic background of both parents and a pregnancy with multiple babies can increase the chance that your baby might have birth defects.
• Ectopic pregnancy (pregnancy outside of the womb). The chance of a pregnancy outside of the womb is increased in women with damaged fallopian tubes.
• Miscarriage. The chance of loss of an early pregnancy may be increased in women who have difficulty with becoming pregnant at all.

The most common side effects of follitropin beta include:

In women:

• headache
• nausea
• stomach pain
• discomfort or pain in the lower stomach area
• cyst (closed sac) in the ovary
• feeling tired

In men:

• headache
• pain at the injection site
• bruising, swelling or redness at the injection site
• breast enlargement
• acne

These are not all the possible side effects of follitropin beta. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider immediately if you get worsening or strong pain in the lower stomach area (abdomen). Also, call your healthcare provider immediately if this happens some days after the last injection has been given.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Do not take follitropin beta if you are a woman or man who:

• is allergic to recombinant human FSH products
• has a high level of follicle-stimulating hormone (FSH) in your blood indicating that your ovaries (women only) or testes (men only) may be permanently damaged and do not work at all
• has uncontrolled thyroid, pituitary, or adrenal gland problems
• is allergic to streptomycin or neomycin (types of antibiotics)
• has a tumor of the hypothalamus, pituitary gland, breast, uterus (women only), ovary (women only), or testis (men only)

Do not take follitropin beta if you are a woman who:

• is pregnant or think you may be pregnant
• has heavy or irregular vaginal bleeding and the cause is not known
• has ovarian cysts or enlarged ovaries, not due to polycystic ovary syndrome (PCOS)

Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of follitropin beta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take follitropin beta, tell your healthcare provider if you:

• have an increased risk of blood clots (thrombosis)
• have ever had a blood clot (thrombosis), or anyone in your immediate family has ever had a blood clot (thrombosis)
• had stomach (abdominal) surgery
• had twisting of your ovary (ovarian torsion)
• had or have a cyst in your ovary
• have polycystic ovary disease
• have any other medical conditions
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Follitropin beta falls into category X. This medication should not be used during pregnancy. Stop using this medicine if you become pregnant.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if follitropin beta passes into your breast milk. You and your healthcare provider should decide if you will take follitropin beta or breastfeed. You should not do both.

• Be sure that you read, understand, and follow the "Patient Instructions for Use" that come with follitropin beta.
• Use follitropin beta exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much follitropin beta to use, how to inject it, and how often it should be injected.
• Do not inject follitropin beta at home until your healthcare provider has taught you the right way to put the cartridge and pen device together and to inject yourself.
• Do not mix any other medicines into the cartridge.
• Do not change your dose of follitropin beta unless your healthcare provider tells you to.
• Call your healthcare provider immediately if you use too much follitropin beta.
• If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
• Use follitropin beta only with the pen it is intended to be used with.
• Do not use the pen if you are blind or visually impaired unless you have assistance from an individual with good vision who is trained in the right way to use the pen.
• Do not re-use the BD Micro-Fine™ Pen Needle.
• Your healthcare provider will do blood and urine hormone tests while you are taking follitropin beta. Make sure you follow-up with your healthcare provider to have your blood and urine tested when told to do so.

Women:

• Your healthcare provider may do ultrasound scans of your ovaries. Make sure you follow-up with your healthcare provider to have your ultrasound scans.

Men:

• Your healthcare provider may test your semen while you are taking follitropin beta. Make sure you follow-up with your healthcare provider to give a semen sample for testing.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose will be individualized for each woman. The dose your doctor recommends may be based how you respond to this medication.

Women Undergoing Ovulation Induction (who were not ovulating)

The recommended starting dose of follitropin beta is 50 international units administered under the skin daily for at least the first 7 days.

Dosage adjustments will be made at weekly intervals based upon ovarian response. The maximum daily dose of follitropin beta is 250 international units.

Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation

The recommended starting dose of follitropin beta is 200 international units administered under the skin daily for at least the first 7 days of treatment. Dosage adjustments will be made based upon ovarian response.

The maximum daily dose of follitropin beta is 500 international units.

Production and development of sperm

The recommended dose of follitropin beta is 450 international units per week.

If you take too much follitropin beta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store follitropin beta in the refrigerator between 2°– 8°C (36° – 46°F) until the expiration date.
• Follitropin beta can be stored at or below 25°C (77°F) for 3 months or until the expiration date, whichever comes first. Once the rubber inlay of the follitropin beta has been pierced by a needle, the product may be stored only for a maximum of 28 days at 2° – 25°C (36° – 77°F).
• Keep follitropin beta away from light.
• Do not freeze.

Keep follitropin beta and all medicines out of the reach of children.