Follitropin Beta

A to Z Drug Facts

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

 Indications For development of multiple follicles in ovulatory patients participating in assisted reproductive technology program; for induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by primary ovarian failure.

 Contraindications Prior hypersensitivity to recombinant human follicle-stimulating hormone products; high circulating FSH level (indicating primary ovarian failure); uncontrolled thyroid or adrenal dysfunction; tumor of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome.

 Route/Dosage

Follicle Stimulation (Assisted Reproductive Technologies [ART])

ADULTS: IM/SC 150 to 225 IU/day for first 4 days of treatment, then adjust dose upon patient's ovarian response. Daily maintenance dosages ranging from 75 to 300 IU for 6 to 12 days is usually sufficient; although longer treatment may be necessary. However, in low or poor responders, maintenance doses of 375 to 600 IU have been administered (max dose, 600 IU/day). The final maturation of the follicles is induced by administering human chorionic gonadotropin (hCG) at a dose of 5000 to 10,000 IU.

Ovulation Induction

ADULTS: IM/SC There are various treatment protocols. In studies using a gradually increasing dosing scheme, treatment was initiated with 75 IU/day for up to 14 days, then the dose was increased 37.5 IU at weekly intervals until follicular growth or serum estradiol levels indicate an adequate response (max, 300 IU). Continue treatment until ultrasonic visualization or serum estradiol determinations indicate pre-ovulatory conditions at least those of normal individuals followed by hCG, 5000 to 10,000 IU. If the ovaries are abnormally enlarged on the last day, hCG must be withheld during this course of treatment.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Vascular complications (eg, venous thrombosis, cerebral vascular accident, arterial occlusion); tachycardia. DERM: Dry skin; rash; hair loss; hives. GU: Miscarriage; ovarian hyperstimulation syndrome; ovarian cyst; ectopic pregnancy; vaginal hemorrhage; breast tenderness; ovarian neoplasm (benign and malignant). RESP: Pulmonary complication (eg, atelectasis, acute respiratory distress syndrome); dyspnea; tachypnea. CNS: Dizziness. GI: Abdominal discomfort; lower abdominal pain; abdominal pain. OTHER: Injection site pain; hemoperitoneum; adnexal torsion; febrile reactions; flu-like symptoms (eg, fever, chills, musculoskeletal aches, joint pain, nausea, headache, malaise).

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Safety and efficacy in subjects 65 yr and older not established. Physician use: Product should only be used by physicians experienced in infertility treatment. Multiple births: In clinical trials, multiple gestation rates were 31% in follicle stimulation (ie, ART) and 8% ovulation induction. Ovarian enlargement: To minimize hazards associated with abnormal ovarian enlargement, use the lowest effective dose. Ovarian hyperstimulation syndrome: Warning signs include pelvic pain, nausea, vomiting, distention, 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 (may result in pulmonary infarct) or extremities (which may cause loss of limbs).

 Administration/Storage

• Follow manufacturer's instructions for reconstituting the Powder for Injection. Administer prescribed dose immediately after reconstitution.
• Do not administer if particulate matter or discoloration noted.
• Administer only by IM or SC injection. Not for IV administration.
• With patient lying down or sitting, administer drug by SC or IM injection. Rotate injection sites.
• To minimize bleeding do not rub site after injection.
• Discard any unused reconstituted material.
• Store vials in refrigerator or at controlled room temperature (59° to 86°F). 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 beta (previous allergic reaction to other recombinant hFSH products, high levels of FSH, uncontrolled thyroid or adrenal dysfunction, intracranial lesion, sex hormone dependent tumors, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, pregnancy).
• Ensure that patient has had a thorough gynecological and endocrinologic 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. Review the treatment regimen including duration and monitoring that will be required.
• If patient will be administering at home, teach 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