Menopur label

Menopur

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Uses

Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle

Prior to initiation of treatment with MENOPUR®:

  • Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
  • Exclude the possibility of pregnancy
  • Evaluate the fertility status of the male partner
  • Exclude a diagnosis of primary ovarian failure
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History

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Other Information

MENOPUR® is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification.

MENOPUR® is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR® contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).

The biological activity of MENOPUR® is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR®.

MENOPUR® has been mixed in vitro with Bravelle® with no evidence of aggregation.

Therapeutic class: Infertility

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Menopur Manufacturers

  • Ferring Pharmaceuticals Inc.
    Menopur | Ferring Pharmaceuticals Inc.
    No Recall

    Menopur | Ferring Pharmaceuticals Inc.

    Menopur | Ferring Pharmaceuticals Inc.
    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® (urofollitropin for injection, purified) 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 [see Warnings and Precautions (5.1, 5.2, 5.10)]. Do not administer daily doses of MENOPUR® or MENOPUR® in combination with BRAVELLE® that exceed 450 International Units. Therapy should not exceed 20 days.
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