WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT FOLLICLE STIMULATING HORMONE?
Treatment with Gonal F increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.
WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE USING FOLLICLE STIMULATING HORMONE?
Follicle stimulating hormone in Gonal F will not induce ovulation if the ovaries are not capable of producing an egg. Also, follicle stimulating hormone will not induce the production of sperm if the testes are not capable of producing sperm.
Before using Gonal F, tell your doctor if you
- might be pregnant;
- have a thyroid problem;
- have adrenal dysfunction;
- have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
- have undiagnosed abnormal vaginal bleeding; or
- have ovarian cysts or enlargement not due to polycystic ovary disease (PCOD).
You may not be able to use follicle stimulating hormone, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.
Treatment with Gonal F increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.
Tell your doctor if you are allergic to neomycin or streptomycin. The Follistim AQ Cartridge may contain traces of these antibiotics and may cause allergic reactions.
Do not use this medication if you are pregnant. Follicle stimulating hormone is in the FDA pregnancy category X. This means that Gonal F’s follicle stimulating hormone is known to cause birth defects in an unborn baby (when used beyond the period of ovulation). It is not known whether follicle stimulating hormone passes into breast milk. Do not use follicle stimulating hormone without first talking to your doctor if you are breastfeeding a baby.
HOW SHOULD I USE FOLLICLE STIMULATING HORMONE?
Use follicle stimulating hormone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.
Gonal F and Follistim AQ should only be administered subcutaneously. Follistim may be administered as a subcutaneous injection (injection under the skin) or intramuscular injection (injection into the muscle). If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give the injection. Do not inject
Gonal F if you are not sure how.
Do not shake the vial, but gently swirl until the solution is clear. Do not inject any medication that is discolored or that has particles in it.
Gonal F ampules and Follistim should be used immediately after mixing.
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.
Follistim AQ should only be used with the Follistim Pen.
Store unmixed vials of follicle stimulating hormone at room temperature or in the refrigerator away from light, moisture, and heat.
Store the Follistim AQ cartridges in the refrigerator until the expiration date is printed on the cartridge. Alternatively, the cartridges can be stored at room temperature for up to 3 months or until the expiration date, whichever comes first. Once the rubber stopper on the cartridge has been pierced by a needle, the product must be used within 28 days.
Store mixed multi-dose vials of Gonal F in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius), protected from light. Throw away any unused medication 28 days after mixing.
WHAT HAPPENS IF I MISS A DOSE?
Contact your doctor if you miss a dose of follicle stimulating hormone.
WHAT HAPPENS IF I OVERDOSE?
An overdose of follicle stimulating hormone is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose of Gonal F is suspected.
Symptoms of a follicle stimulating hormone overdose are not known.
WHAT SHOULD I AVOID WHILE USING FOLLICLE STIMULATING HORMONE?
There are no restrictions on food, beverages, or activity during treatment with follicle stimulating hormone unless otherwise directed by your doctor.
FOLLICLE STIMULATING HORMONE SIDE EFFECTS
Stop using Gonal F and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
- confusion, severe dizziness, severe headache; or
- difficulty breathing.
Approximately 5% of patients treated with follicle stimulating hormone develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms on using Gonal F.
Other side effects may also occur. Notify your doctor if you experience
- ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
- nausea, vomiting, diarrhea, or flatulence (gas);
- fever or chills;
- headache;
- dizziness;
- rapid pulse or heart rate;
- muscle or joint weakness or aching;
- breast tenderness;
- spotting or menstrual changes;
- pain, swelling, or irritation at the injection site; or
- dry skin, a rash, or hair loss
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
