What Follistim AQ is used for and how to use it
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Follistim AQ - Consumer Medicine Information

Manufacture: Merck and Co., Inc.
Country: United States
Condition: Follicle Stimulation, Hypogonadism, Male, Ovulation Induction
Class: Gonadotropins
Form: Liquid solution, Subcutaneous (SC)
Ingredients: follitropin beta, sucrose, sodium citrate, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide

Follistim (Fol´-lis-tim) AQ

(follitropin beta injection)

Single-Use Vial

What is Follistim AQ

Follistim AQ is a prescription medicine that contains follicle-stimulating hormone (FSH).

Follistim AQ is Used

In women

  • to help healthy ovaries to develop (mature) and release eggs
  • as part of an Assisted Reproductive Technology (ART) program to help the ovaries produce more mature eggs

In men

  • to help bring about the production and development of sperm

Who Should Not take Follistim AQ

Do not take Follistim AQ if you are a Woman or Man who:

  • is allergic to recombinant human FSH products
  • has a high level of 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 Follistim AQ 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.

What should I Tell My Healthcare Provider Before Taking Follistim AQ

Before you take Follistim AQ, 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. It is not known if Follistim AQ passes into your breast milk. You and your healthcare provider should decide if you will take Follistim AQ or breastfeed. You should not do both.

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

Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.

How should I Use Follistim AQ

  • Be sure that you read, understand, and follow the “Patient Instructions for Use” that come with Follistim AQ. Use Follistim AQ exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much Follistim AQ to use, how to inject it, and how often it should be injected. Do not inject Follistim AQ at home until your healthcare provider has taught you the right way.
  • Do not mix Follistim AQ with any other medicines in the same vial or in the same syringe. Do not change your dose of Follistim AQ unless your healthcare provider tells you to.
  • Call your healthcare provider immediately if you use too much Follistim AQ.
  • If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
  • Your healthcare provider will do blood and urine hormone tests while you are taking Follistim AQ. 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 Follistim AQ. Make sure you follow-up with your healthcare provider to give a semen sample for testing.

What are the Possible Side Effects of Follistim AQ

Follistim AQ 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 you 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. Follistim AQ can cause you to have fluid in your lungs (atelectasis) and trouble breathing (acute respiratory distress syndrome).
  • Blood clots. Follistim AQ 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. Follistim AQ 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 Follistim AQ Include

In women

  • cyst in the ovary
  • stomach pain

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 Follistim AQ. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider immediately if you get worsening or strong abdominal pain. 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 FDA at 1-800-FDA-1088.

How should I Store Follistim AQ

  • Store Follistim AQ in the refrigerator between 2° - 8°C (36° - 46°F) until the expiration date.
  • Follistim AQ can be stored at or below 25°C (77°F) for 3 months or until the expiration date, whichever comes first.
  • Keep Follistim AQ away from light. Do not freeze.
  • Keep Follistim AQ and all medicines out of the reach of children.

General Information About Follistim AQ

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Follistim AQ for a condition for which it was not prescribed. Do not give Follistim AQ to other people, even if they have the same condition that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Follistim AQ. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Follistim AQ that is written for healthcare professionals.

For more information, go to www.follistim.com or call 1-866-836-5633.

What are the Ingredients in Follistim AQ

Active ingredient: follitropin beta

Inactive ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide.

Manufactured By

N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html