Puregon

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.  

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.

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.

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.

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.

Follitropin beta may result in pregnancy and birth of multiple babies.

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.

Treatment will be given with hCG.

The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent