Urofollitropin

A to Z Drug Facts

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

 Indications

Bravelle: In conjunction with human chorionic gonadotropin (hCG) for ovulation induction in patients who previously received pituitary suppression.

Fertinex: In conjunction with hCG for stimulation of follicular recruitment and development and the induction of ovulation in patients with polycystic ovary syndrome and infertility who have failed to respond or conceive following adequate clomiphene citrate therapy; in conjunction with hCG to stimulate development of multiple follicles in ovulatory patients undergoing assisted reproductive technologies (eg, in vitro fertilization).

 Contraindications Women who have high follicle stimulating hormone (FSH) level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; organic intracranial lesion (eg, pituitary tumor); presence of any cause of infertility other than anovulation unless patient is candidate for in vitro fertilization; abnormal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; pregnancy; prior hypersensitivity to urofollitropin.

 Route/Dosage

Infertility

ADULTS: SC/IM Bravelle: In patients who have received gonadotropin-releasing hormone (GnRH) agonist or antagonist pituitary suppression, start with 150 IU/day for 5 days, then based on patient response, adjust dose. Do not make adjustments more frequently than once q 2 days and do not exceed 75 to 150 IU per adjustment (max, 450 IU/day). In most cases, do not dose beyond 12 days. If response is appropriate, give hCG 5000 to 10,000 U 1 day following the last dose of urofollitropin. Withhold hCG if serum estradiol is greater than 2000 pg/mL.

Polycystic Ovary Syndrome and Infertility

ADULTS: SC Fertinex: Start with 75 IU/day for first cycle; then adjust dose after 5 to 7 days based on patient response. Do not increase dose more than twice in any cycle or by more than 75 IU per adjustment. To complete follicular development and effect ovulation in absence of an endogenous luteinizing hormone (LH) surge, give 5000 to 10,000 U hCG 1 day after the last dose of urofollitropin. Withhold hCG if serum estradiol is greater than 2000 pg/mL. Individualize dose in subsequent cycles based on patient response in the preceding cycle. Doses larger than 300 IU/day of FSH are not routinely recommended. As in initial cycle, 5000 to 10,000 U of hCG must be given 1 day after last dose of urofollitropin to complete follicular development and induce ovulation.

Follicle Stimulation

ADULTS: SC Fertinex: For assisted reproductive technologies, start in the early follicular phase (cycle day 2 or 3) with 150 IU/day, until sufficient follicular development is attained. Usually, therapy should not exceed 10 days.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Vascular complications (eg, stroke). CNS: Headache. GI: Nausea; enlarged abdomen; abdominal pain. GU: Ovarian hyperstimulation syndrome/vaginal hemorrhage; ovarian disorder (eg, pain, cyst); ectopic pregnancy; premature labor; congenital abnormalities; mild to moderate ovarian enlargement; ovarian neoplasm (benign and malignant). RESP: Respiratory disorder; pulmonary complications (eg, thrombolic events). OTHER: Hot flashes; spontaneous abortion; postpartum fever; adnexal torsion; hemoperitoneum.

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Safety and efficacy not established. Multiple births: Multiple pregnancies have occurred. Health care provider use: Urofollitropin should only be used by health care providers thoroughly familiar with infertility problems and their management. Ovarian enlargement: Mild to moderate uncomplicated ovarian enlargement may occur in approximately 20% of women treated with follitropin and hCG and generally regresses without treatment within 2 to 3 wk. 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 or Pellet for Injection. Administer prescribed dose immediately after reconstitution.
• Do not administer if particulate matter or discoloration noted.
• Administer Bravelle only by IM or SC injection. Not for ID or IV administration.
• Administer Fertinex only by SC injection. Not for ID, IM, or 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 (37° to 77°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 urofollitropin (eg, previous allergic reaction to urofollitropin, 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 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 be sure to keep appointments.

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