"Oct. 20, 2012 -- Babies conceived with the help of high-tech fertility treatments such as in vitro fertilization (IVF) have an increased risk for birth defects, a new study shows.
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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
DOSAGE AND ADMINISTRATION
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).
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].
- Do not administer daily doses of MENOPUR® or MENOPUR® in combination with BRAVELLE® that exceed 450 International Units.
- Therapy should not exceed 20 days.
Dosage Forms And Strengths
Lyophilized powder for Injection containing 75 International Units FSH and 75 International Units of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q•Cap® vial adapters.
MENOPUR® (menotropins for injection) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet.
Each vial of MENOPUR® is accompanied by a vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride for Injection, USP:
75 International Units FSH and 75 International Units of LH activity, supplied as
NDC 55566-7501-1: Box of 5
vials + 5 vials diluent.
NDC 55566-7501-2: Box of 5 vials + 5 vials diluent + 5 Q•Cap® vial adapters
Storage And Handling
Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light. Use immediately after reconstitution. Discard unused material.
Manufactured For: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054. Rev 02/2014
Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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