Repronex®, in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.

Selection of Patients

1. Before treatment with Repronex® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an in vitro fertilization program, this should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive menotropins only if enrolled in an in vitro fertilization program.

2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.

3. Careful examination should be made to rule out the presence of an early pregnancy.

4. Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Repronex therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.

5. Evaluation of the husband's fertility potential should be included in the workup.

Dosage

Infertile patients with oligo-anovulation: The dose of Repronex® to stimulate development of ovarian follicles must be individualized for each patient. The lowest dose consistent with achieving good results based on clinical experience and reported clinical data should be used.

The recommended initial dose of Repronex® for patients who have received GnRH agonist or antagonist pituitary suppression is 150 IU daily for the first 5 days of treatment. 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 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Repronex® should not exceed 450 IU and dosing beyond 12 days is not recommended.

If patient response to Repronex® is appropriate, hCG (5000 to 10,000 USP units) should be given 1 day following the last dose of Repronex. The hCG should be withheld if the serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally enlarged or if abdominal pain occurs, and the patient should be advised to refrain from intercourse. These precautions may reduce the risk of Ovarian Hyperstimulation Syndrome and multiple gestation. Patients should be followed closely for at least 2 weeks after hCG administration. If there is inadequate follicle development or ovulation without subsequent pregnancy, the course of treatment with Repronex® may be repeated. The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. In the light of the foregoing indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not use Repronex®.

Assisted Reproductive Technologies: The recommended initial dose of Repronex® for patients who have received GnRH agonist or antagonist 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 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Repronex® given should not exceed 450 IU and dosing beyond 12 days is not recommended.

Once adequate follicular development is evident, hCG (5000 - 10,000 USP units) 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.

Administration

Dissolve the contents of one to 6 vials of Repronex® in one to two mL of sterile saline and ADMINISTER SUBCUTANEOUSLY OR INTRAMUSCULARLY immediately. Any unused reconstituted material should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The lower abdomen (alternating sides) should be used for subcutaneous administration.

Repronex® (menotropins for injection, USP) is available in vials as a sterile, lyophilized, white to off-white powder or pellet.

Each vial is available with an accompanying 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:

150 IU FSH and 150 IU of LH activity, supplied as:

NDC 55566-7125-1 -Box of 1 vial + 1 vial diluent.

By biological assay, one IU of LH for the Second International Reference Preparation (2nd-IRP) for hMG is biologically equivalent to approximately 0.5 U of hCG.

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.

Rx only

Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP manufactured for Ferring Pharmaceuticals Inc

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