Follicledosage

Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment Do not administer doses greater than 450 International Units per day MENOPUR may be administered together with BRAVELLE ® (urofollitropin for injection, purified). Only the total starting dose of 225 International Units (150 International Units of MENOPUR and 75 International Units of BRAVELLE or 75 International Units of MENOPUR and 150 International Units of BRAVELLE) was studied in a clinical trial.

2.1 General

Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer MENOPUR subcutaneously in the abdomen as described in Instructions for Use. MENOPUR may be administered together with BRAVELLE ® (urofollitropin for injection, purified).

2.2 Recommended

Dosing for Assisted Reproductive Technology The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of MENOPUR for women who have received a GnRH agonist for pituitary suppression is 225 International Units. MENOPUR may be administered together with BRAVELLE and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of MENOPUR and 75 International Units of BRAVELLE or 75 International Units of MENOPUR and 150 International Units of BRAVELLE). Beginning on cycle day 2 or 3, a starting dose of 225 International Units of MENOPUR is administered subcutaneously daily. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 2 days or by more than 150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG. Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of MENOPUR therapy. Do not administer daily doses of MENOPUR or MENOPUR in combination with BRAVELLE that exceed 450 International Units. Therapy should not exceed 20 days.