Follitropin Alfa

A to Z Drug Facts

 Action Stimulates ovarian follicular growth in women who do not have primary ovarian failure.

 Indications Induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by primary ovarian failure; to stimulate development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Therapy (ART [eg, in vitro fertilization]); induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not primary testicular failure.

 Contraindications Women who exhibit the following: 1) prior hypersensitivity to recombinant follicle-stimulating hormone (FSH) preparations or one of their excipients; 2) high levels of FSH indicating primary ovarian failure; 3) uncontrolled thyroid or adrenal dysfunction; 4) an organic intracranial lesion such as a pituitary tumor; 5) abnormal uterine bleeding of undetermined origin; 6) ovarian cyst or enlargement of undetermined origin; 7) sex hormone dependent tumor of the reproductive tract and accessory organs; and 8) pregnancy.

 Route/Dosage

Ovulation Induction

ADULTS: SC Initial dose of first cycle is 75 IU/day; an incremental dosage adjustment of up to 37.5 IU may be considered after 14 days. Further dose increases of 37.5 IU may be made q 7 days if necessary. Treatment duration should not exceed 35 days unless serum estradiol increase indicates imminent follicular development. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, administer 5000 U human chorionic gonadotropin (hCG) 1 day after last dose of follitropin alfa. Withhold hCG if serum estradiol is over 2000 pg/mL. In subsequent cycles, individualize initial dose for each patient.

Follicle Stimulation

ADULTS: SC 150 IU/day started in early follicular phase (ie, cycle day 2 or 3), until sufficient follicular development is attained (in most cases therapy should not exceed 10 days). In patients undergoing ART, whose endogenous gonadotropin levels are suppressed, initiate follitropin alfa at a dose of 225 IU/day. Continue treatment until adequate follicular development is indicated as determined by ultrasound in combination with serum estradiol level measurements. Consider adjusting the dose after 5 days based on patients response; adjust subsequent dosages q 3 to 5 days and by no more than 75 to 150 IU additionally at each adjustment (max, 450 IU/day).

Spermatogenesis

ADULTS: Pretreat with hCG alone (1000 to 2250 U 2 to 3 times/wk). Continue hCG for a period sufficient to achieve serum testosterone levels within normal range, which may take 3 to 6 mo. It may be necessary to increase the hCG dose to achieve normal testosterone levels. After normal testosterone levels are reached, follitropin alfa may be administered. SC 150 IU follitropin alfa 3 times/wk and hCG 1000 U 3 times/wk. If azoospermia persists, the follitropin alfa dose may be increased to a maximum of 300 IU 3 times/wk. It may be necessary to administer therapy for up to 18 mo to achieve adequate spermatogenesis.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypotension; palpitation. CNS: Headache; dizziness; emotional lability; migraine; nervousness; somnolence; anxiety. DERM: Acne; pruritus. EENT: Sinusitis; pharyngitis; coughing; rhinitis. GI: Nausea; abdominal pain and enlargement; flatulence; diarrhea; vomiting; dyspepsia; anorexia. GU: Ovarian cyst; intermenstrual bleeding; breast pain; ovarian hyperstimulation; dysmenorrhea; ovarian disorder; cervix lesion; menstrual disorder; urinary tract infection; genital moniliasis; vaginal hemorrhage; dysmenorrhea; genital pruritus; leukorrhea. META: Weight increase. RESP: Upper respiratory tract infection; asthma; dyspnea; sinusitis; pharyngitis; coughing. OTHER: Pain; back pain; flu-like syndrome; fever; injection site pain; pelvic pain (female); fatigue; chest pain; myalgia; thirst.

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy not established. Health care provider use: Follitropin alfa should be used only by health care providers thoroughly familiar with infertility problems and their management. Ovarian enlargement: Mild to moderate uncomplicated ovarian enlargement may occur in about 20% of women treated and generally regresses without treatment within 2 to 3 wk. Ovarian hyperstimulation syndrome: Warning signs include pelvic pain, nausea, vomiting, distension, and weight gain. May progress within 24 hr to several days to become a serious medical event. Pulmonary and vascular complications: May occur, resulting in intravascular thrombosis and embolism, which reduce blood flow to critical organs (eg, pulmonary infarct, cerebral vascular occlusion) or the extremities, which may cause loss of limbs. Multiple births: In ovulation induction trials, 12.3% of live births were multiple births; in in vitro fertilization clinical trials, 44% of live births were multiple births.

 Administration/Storage

• Reconstitute by dissolving contents of 1 or more ampules in 0.5 to 1 mL of Sterile Water for Injection. Administer prescribed dose immediately after reconstitution.
• Do not administer if particulate matter or discoloration noted.
• Administer only by SC injection. Not for IM or IV administration.
• With patient lying down or sitting, administer drug by SC injection. Rotate injection sites.
• To minimize bleeding, do not rub site after injection.
• Discard any unused reconstituted material.
• Store ampules in refrigerator or at controlled room temperature. Protect from light.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review patient's health history for any condition that could contraindicate follitropin alfa (eg, previous allergic reaction to follitropin alfa, high levels of FSH, uncontrolled thyroid or adrenal dysfunction, intracranial lesion, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors, pregnancy).
• Ensure that patient has had a thorough gynecological and endocrinological evaluation before starting therapy.
• Monitor patient for signs of overstimulation of the ovary (eg, difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, infrequent urination) and report to health care provider immediately if noted.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug. If patient will be administering at home, teach patient how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
• Remind patient that drug is administered to promote follicular growth and egg production, and that hCG will need to be administered to induce ovulation.
• Encourage patient receiving drug for infertility to have intercourse daily, beginning on the day prior to administration of hCG until ovulation has become apparent.
• Warn patient that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, infrequent urination.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to keep appointments.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts