Follistim AQ

Follistim AQ is used to promote pregnancy and ovulation in women as part of certain fertility treatments and vitro fertilization and is also used in men to promote sperm production. 

Follistim AQ belongs to a group of medications called gonadotropins. These work to promote ovulation and pregnancy by effectively mimicking naturally-occurring hormones in the body, like follicle-stimulating hormone, that are critical to the development of the follicle and embryo implantation. Follistim AQ works to promote production of viable sperm in men by mimicking the effects of follicle-stimulating hormone, the primary hormone involved in sperm production. 

This medication is available as part of a pen-needle injection system with a medication cartridge. It is to be given directly under the skin, typically on a daily basis when used as part of fertility treatments in women, and typically two times per week when used to promote production of viable sperm in men.

Common side effects of Follistim AQ include pelvic pain, headache, and enlarged ovaries.

Follistim AQ can also cause drowsiness. Do not drive or operate heavy machinery until you know how Follistim AQ affects you.

Follistim AQ is used to promote ovulation and pregnancy in women as part of certain fertility treatments and vitro fertilization, in addition to other medications, and also in men to promote production of viable sperm. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck & Co., Inc.

Serious side effects have been reported with Follistim AQ. See the “Follistim AQ Precautions” section.

Common side effects of Follistim AQ include the following:

• pelvic pain and discomfort
• enlarged ovaries
• headache
• nausea
• fatigue
• acne
• fever

This is not a complete list of Follistim AQ side effects. Ask your doctor or pharmacist for more information.

Tell your doctor 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ganirelix
• follicle stimulating hormone 
• gonadorelin

 This is not a complete list of Follistim AQ drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Follistim AQ including the following:

• Ovarian Hyperstimulation Syndrome. Discontinue use of Follistim AQ and get medical attention immediately if you experience the following combination of symptoms:
  • severe pelvic pain
  • nausea
  • vomiting
  • weight gain
• Serious pulmonary complications. Asthma exacerbations and acute respiratory distress syndrome have been reported with use of Follistim AQ. Consult with your physician if you have asthma or lung problems before taking Follistim AQ.
• Blood clots. Consult with your physician if you have a history of heart disease and/or blood clots. Get medical attention immediately if you experience sudden difficulty breathing, persistent leg or other extremity pain and/or sudden severe headaches. 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.

Do not take Follistim AQ if you:

• are allergic to Follistim AQ  or to any of its ingredients
• have thyroid and/or adrenal gland disease
• have active cancer
• have heavy or irregular vaginal bleeding and the cause is not known
• have ovarian cysts
• are allergic to streptomycin or neomycin
• are pregnant or think you may be pregnant

Follistim AQ can also cause drowsiness. Do not drive or operate heavy machinery until you know how Follistim AQ affects you.

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 Follistim AQ, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Follistim AQ, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Follistim AQ or to any of its ingredients
• have heart disease
• have thyroid and/or adrenal gland disease
• have active cancer
• have polycystic ovary disease
• have ever had a blood clot (thrombosis), or anyone in your immediate family has ever had a blood clot (thrombosis)
• have an increased risk of blood clots (thrombosis)
• have asthma or lung diseases
• have abnormal vaginal bleeding
• have had stomach (abdominal) surgery
• have had twisting of your ovary (ovarian torsion)
• have ovarian cysts
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

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.

Follistim AQ falls into category X. It has been shown that women taking Follistim AQ during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Follistim AQ crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Follistim AQ.

Take Follistim AQ exactly as prescribed.

Follistim AQ is available as part of a pen-needle injection system with a medication cartridge. It is to be given directly under the skin, typically on a daily basis when used as part of fertility treatments in women, and typically two times per week when used to promote production of viable sperm in men.

Your healthcare provider will tell you how much Follistim AQ to use, how to inject it, and how often it should be injected. Be sure that you read, understand, and follow the "Patient Instructions for Use" that come included with Follistim AQ.

• Do not inject Follistim AQ 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.
• Use Follistim AQ 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 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 while you are taking Follistim AQ

Men:

• Your healthcare provider may test your semen while you are taking Follistim AQ.

If you miss or forget to take a dose, ask your healthcare provider for instructions. Do not take two doses of Follistim AQ at the same time.

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

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age
• your gender

The recommended dose range of Follistim AQ, when used as part of fertility treatments in women undergoing ovulation induction, is 50 international units (IU) to 250 IU administered under the skin daily.

The recommended dose range of Follistim AQ when used as part of fertility treatments in normally ovulating women undergoing controlled ovarian stimulation is 200 IU to 500 IU administered under the skin daily.

The recommended dose range of Follistim AQ, when used to promote production of viable sperm in men, is 150 IU injected subcutaneously three times per week to 225 IU injected subcutaneously two times per week.

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

• 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
• Once the rubber inlay of the Follistim AQ 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 Follistim AQ away from light
• Do not freeze
• Keep Follistim AQ and all medicines out of the reach of children