"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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Menopur® (menotropins injection) administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.
Selection of Patients
- A thorough gynecologic and endocrinologic evaluation, including an assessment of pelvic anatomy must be performed before treatment with Menopur® (menotropins injection) . Patients with tubal obstruction should receive Menopur® (menotropins injection) 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® (menotropins injection) therapy.
- Evaluation of the partner's fertility potential should be included in the workup.
DOSAGE AND ADMINISTRATION
Assisted Reproductive Technologies
The recommended initial dose of Menopur® (menotropins injection) 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® (menotropins injection) 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® (menotropins injection) 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.
Menopur® (menotropins for injection, USP) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet.
Each vial of Menopur® (menotropins injection) is accompanied by a vial of sterile diluent containing 2 mL of 0.9 % Sodium Chloride Injection, USP:
75 IU FSH and 75 IU 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.
Lyophilized powder may be stored refrigerated or at room temperature (3° to 25°C/37° to 77°F). Protect from light. Use immediately after reconstitution. Discard unused material.
DIRECTIONS FOR USING MENOPUR® (menotropins injection)
- Wash hands thoroughly with soap and water.
- Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents.
- To prepare the Menopur® (menotropins injection) solution, inject 1 mL of Sterile Saline for Injection, USP into the vial of Menopur® (menotropins injection) . DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the Menopur® (menotropins injection) dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT.
- For patients requiring a single injection from multiple vials of Menopur® (menotropins injection) , up to 6 vials can be reconstituted with 1 mL of Sterile Saline for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Menopur® (menotropins injection) . Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized Menopur® (menotropins injection) into 1 mL of diluent.
- Draw the reconstituted Menopur® (menotropins injection) into an empty, sterile syringe.
- Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top; then squeeze the plunger gently until all the air has been expelled and only Menopur® (menotropins injection) solution is left in the syringe.
- Menopur® (menotropins injection) works if it is injected SC . The recommended sites for SC injection are either side of the lower abdomen alternating between left and right sides of the lower abdomen below the naval. SC injection of Menopur® (menotropins injection) into the thigh is not recommended unless the lower abdomen is not useable because of scarring, surgical deformity or other medical conditions.
- The injection site should be swabbed with alcohol. Clean about two inches around the point where the needle will go in and let the alcohol dry for at least one minute before proceeding.
- For SC injection, the needle should be inserted at a 90° angle to the skin surface.
- If the needle is incorrectly positioned, it will be difficult to draw back on the plunger. Any blood drawn into the syringe means the needle tip has penetrated a vein or artery. If this happens, the needle should be withdrawn, cover the injection site with a swab containing alcohol and apply pressure; the site should stop bleeding in a minute or two. After withdrawing the needle, replace with a sterile needle and administer the injection.
- Once the needle is properly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin or muscle tissue is not damaged.
- Withdraw the needle quickly and apply pressure to the site with a swab. If bleeding does not stop within a few minutes, place a clean piece of gauze and/or adhesive bandage over the site.
- Use the disposable syringe only once and dispose of it properly. Discard the used needle and syringe into your safety container. Do not reuse your injection materials.
Toll free number for providers and patients to call with questions: 1 -(888)-FERRING (1 -(888)-337-7464).
Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP manufactured for Ferring Pharmaceuticals Inc.
Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.
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