Usual Adult Dose for Follicle Stimulation

Ovulation induction:
Initial dose: 150 international units per day for 5 days, subcutaneously (SC) or intramuscularly (IM)
Maximum dose: 450 international units per day
Duration of therapy: 12 days

Comments:

• When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
• Withhold hCG when monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of therapy.
• Encourage daily intercourse, beginning on the day prior to hCG and until ovulation becomes apparent.
• Discourage intercourse when the risk for OHSS is increased.

• If given with menotropin, the total combined dose should not exceed 225 international units (150 international units urofollitropin and 75 international units menotropin, or 75 international units urofollitropin and 150 international units menotropin).

• If given with menotropin, the total combined dose of urofollitropin and menotropin should not exceed 450 international units per day.

• Beginning on cycle day 2 or 3, administer daily until sufficient follicular development is attained, as determined by ultrasound and measurement of serum estradiol levels.
• Continue treatment until adequate follicular development is evident, and then administer hCG.
• Withhold hCG where monitoring suggests an increased risk of OHSS on the last day of therapy.

• Induction of ovulation in women who have previously received pituitary suppression - intramuscular and subcutaneous administration.
• Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Ovulation Induction

• The dosing scheme is stepwise and is individualized for each woman.
• For women who have received GnRH agonist or pituitary suppression, a starting dose is administered subcutaneously or intramuscularly for 5 days in the first cycle of treatment.
• In subsequent cycles the starting dose and dosage adjustments should be determined based on ovarian response.
• Dose adjustments based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) should be used to prevent multiple follicular growth and cycle cancellation.
• Do not adjust dose more frequently than once every 2 days and do not exceed 150 international units per adjustment.
• Use the lowest dose that will achieve desired results.
• In general, do not exceed 12 days of treatment.

• The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman.
• Adjust the dose after 5 days based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
• Do not adjust dose more frequently than once every 2 days and do not exceed 150 international units per adjustment.
• In most cases, therapy should not exceed 12 days.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Inspect for particulate matter and discoloration prior to administration.
• Alternate injection site daily.
• Administer subcutaneously in the abdomen or intramuscularly.
• If using intramuscularly, a healthcare provider should administer the product.

• Store refrigerated or at room temperature; protect from light.
• Use immediately after reconstitution. Discard unused material.

• Prior to beginning therapy, inform women about the time commitment and monitoring procedures necessary for treatment.
• Instruct women on the correct usage and dosing.
• If a dose is missed, the next dose should not be doubled. The patient should call her healthcare provider for further dosing instructions.
• Caution women not to change the dosage or the schedule of administration unless told to do so by her healthcare provider.