- Powder for injection, lyophilized 75 units follicle stimulating hormone (FSH) activity
Stimulates ovarian follicular growth in women who do not have primary ovarian failure.
Subcutaneous administration T max occurs in about 20 h; 17 h in IM administration.
Mean elimination t ½ for subcutaneous and IM single dosing are approximately 32 and 37 h, respectively.
Indications and Usage
To be administered in conjunction with human chorionic gonadotropin (hCG) for ovulation induction in patients who have previously received pituitary suppression; in conjunction with hCG for multiple follicular development (controlled ovarian stimulation) during assisted reproductive technologies (ART) cycles in patients who have previously received pituitary suppression.
Women who have high FSH levels, indicating primary ovarian failure; uncontrolled thyroid and adrenal function impairment; organic intracranial lesion (eg, pituitary tumor); presence of any cause of infertility other than anovulation; abnormal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; pregnancy; prior hypersensitivity to urofollitropin.
Dosage and AdministrationInfertility
Subcutaneous / IM In patients who have received gonadotropin-releasing hormone (GnRH) agonist or antagonist pituitary suppression, start with 150 units/day for 5 days, then based on patient response, adjust dose. Do not make adjustments more frequently than once every 2 days and do not exceed 75 to 150 units per adjustment (max, 450 units/day). In most cases, do not dose beyond 12 days. If response is appropriate, give hCG 5,000 to 10,000 units 1 day following the last dose of urofollitropin. Withhold hCG if serum estradiol is greater than 2,000 pg/mL.ART
Subcutaneous 225 units/day for the first 5 days for patients undergoing in vitro fertilization and donor egg patients who have received GnRH agonist or antagonist pituitary suppression. Adjust subsequent dosing according to individual patient response based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results). Dosage adjustments should not be more frequent than once every 2 days and should not exceed 75 to 150 units/adjustment (max, 450 units/day). In most cases, dosing beyond 12 days is not recommended. Once adequate follicular development is evident, administer 5,000 to 10,000 units of hCG to induce final follicular maturation in preparation for oocyte retrieval. To reduce the chance of developing ovarian hyperstimulation syndrome (OHSS), withhold hCG administration in cases where ovaries are abnormally enlarged on the last day of therapy.
- For subcutaneous or IM administration only when used for ovulation induction. Not for intradermal, IV, or intra-arterial administration.
- For subcutaneous administration only when used for multifollicular development during ART. Not for intradermal, IM, IV, or intra-arterial administration.
- Reconstitute powder for injection by adding 1 mL sterile sodium chloride 0.9% injection and swirl gently until solution is clear. Do not shake vial during reconstitution.
- For patient requiring a single injection from multiple vials of urofollitropin, up to 6 vials can be reconstituted with 1 mL of sterile sodium chloride 0.9% injection. Reconstitute the first vial as described above, then draw the entire contents of the first vial into a syringe and inject the contents into the second vial of lyophilized urofollitropin. Gently swirl the second vial until solution is clear. Repeat this process with 4 additional vials for a total of up to 6 vials of lyophilized urofollitropin into 1 mL of diluent.
- Discard any unused solution. Do not save unused solution for later administration.
Store lyophilized powder in refrigerator or at room temperature (37° to 77°F). Protect from light.
None well documented.
Laboratory Test Interactions
None well documented.
Headache (13%); emotional lability, depression (3%).
Rash, acne, exfoliative dermatitis (3%).
Abdominal cramps (14%); nausea (9%); abdominal fullness/enlargement (7%); abdominal pain (5%); constipation (3%).
OHSS (11%); vaginal hemorrhage (9%); postretrieval pain (8%); pelvic pain (7%); hot flashes (6%); uterine spasms, vaginal bleeding, vaginal discharge, UTI, cervix disorder (3%); ovarian disorder, breast tenderness, fungal infections (2%).
Weight gain, dehydration (3%).
Respiratory disorder (6%); accidental injury (2%).
Pain (6%); injection site reaction (4%); neck pain, fever, accidental injury (3%); anaphylactic reactions.
Category X .
Safety and efficacy not established.
Safety and efficacy not established.
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.
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.
Warning signs include difficulty breathing, severe pelvic pain, nausea, vomiting, rapid weight gain, stomach pain or bloating, diarrhea, or infrequent urination. May progress within 24 h to several days to become a serious medical event. Treatment must be stopped and patient hospitalized.
Pulmonary and vascular complications
Intravascular thrombosis and embolism can reduce blood flow to critical organs (may result in pulmonary infarct) or extremities (may cause loss of limbs).
OHSS, multiple gestations.
- Explain risk of multiple births. Review the treatment regimen, including duration of treatment and monitoring that will be required.
- If patient will be self-administering at home, ensure the patient understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
- Caution patient not to change the dose or stop taking the medicine unless advised by health care provider.
- Caution patient that if a dose is missed not to double the dose to catch up. Advise patient to contact health care provider for further instructions.
- 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, diarrhea, rapid weight gain, stomach pain or bloating, infrequent urination.
- Advise patient to inform health care provider of any adverse reactions, symptoms, physical changes, or bothersome injection site reactions.
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