Generic name: follicle stimulating hormone beta polypeptide and lutropin alfa
Dosage form: injection
This dosage information does not include all the information needed to use Menopur safely and effectively. See full prescribing information for Menopur.
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Selection of Patients
A thorough gynecologic and endocrinologic evaluation, including an assessment of pelvic anatomy must be performed before treatment with MENOPUR. Patients with tubal obstruction should receive MENOPUR only if enrolled in an IVF program.
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Careful examination should be made to rule out the presence of an early pregnancy.
Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting MENOPUR therapy.
Evaluation of the partner's fertility potential should be included in the workup.
Assisted Reproductive Technologies
The recommended initial dose of MENOPUR for patients who have received a GnRH agonist for pituitary suppression is 225 IU. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than once every two days and should not exceed 150 IU per adjustment. The maximum daily dose of MENOPUR given should not exceed 450 IU and dosing beyond 20 days is not recommended.
Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.
Dissolve the contents of one to six vials of MENOPUR in one mL of sterile saline and ADMINISTER SUBCUTANEOUSLY immediately. Any unused reconstituted material should be discarded.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
The lower abdomen (alternating sides) should be used for subcutaneous administration.