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FertinexTM (urofollitropin for injection, purified) and hCG given in a sequential manner are indicated for the stimulation of follicular recruitment and development and the induction of ovulation in patients with polycystic ovary syndrome and infertility, who have failed to respond or conceive following adequate clomiphene citrate therapy. Fertinex (urofollitropin) TM and hCG may also be used to stimulate the development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization.
Selection of Patients
1. Before treatment with FertinexTM (urofollitropin for injection, purified) is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Fertinex (urofollitropin) TM only if enrolled in an in vitro fertilization program.
4. Patients in late reproductive life have a greater pre-disposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic examination should always be performed before starting Fertinex (urofollitropin) TM 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 AND ADMINISTRATION
The lowest dose consistent with the expectation of good results should be used. Over the course of treatment, doses of Fertinex (urofollitropin) TM may range between 75 IU to 300 IU per day depending on the individual patient response. Fertinex (urofollitropin) TM should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.
It is recommended that the initial dose of the first cycle be 75 IU of Fertinex (urofollitropin) TM per day, ADMINISTERED SUBCUTANEOUSLY. An adjustment in dose may be considered after 5 to 7 days. An additional dose adjustment may also be considered based on individual patient response. The dose should not be increased more than twice in any cycle or by more than one ampule (75 IU) per adjustment. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, hCG, 5,000 U to 10,000 U, should be given 1 day after the last dose of Fertinex (urofollitropin) TM. Human chorionic gonadotropin should be withheld if the serum estradiol is greater than 2,000 pg/mL. If the ovaries are abnormally enlarged or abdominal pain occurs, Fertinex (urofollitropin) TM treatment should be discontinued, hCG should not be administered, and the patient should be advised not to have intercourse; this will reduce the chance of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chance of multiple gestation. A follow-up visit should be conducted in the luteal phase.
The initial dose administered in the subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses larger than 300 IU of FSH per day are not routinely recommended. As in the initial cycle, 5,000 U to 10,000 U of hCG must be given 1 day after the last dose of Fertinex (urofollitropin) TM to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of development of the Ovarian Hyperstimulation Syndrome.
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. Care should be taken to ensure insemination. In light of the 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 Fertinex (urofollitropin) TM.
Assisted Reproductive Technologies: As in the treatment of patients with polycystic ovary syndrome, the dose of Fertinex (urofollitropin) TM to stimulate development of the follicle must be individualized for each patient. For Assisted Reproductive Technologies, therapy with Fertinex (urofollitropin) TM should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day, until sufficient follicular development is attained. In most cases, therapy should not exceed ten days.
Dissolve the contents of one or more ampules of Fertinex (urofollitropin) TM in one-half one mL of sterile saline (concentration should not exceed 225 IU/0.5 mL) and ADMINISTER SUBCUTANEOUSLY 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.
FertinexTM (urofollitropin for injection, purified) is supplied in a sterile, lyophilized form as a white to off-white powder or pellet in ampules containing 75 IU or 150 IU FSH activity. The following package combinations are available:
- ampule 75 IU Fertinex (urofollitropin) TM and 1 ampule 2 mL Sodium Chloride Injection (USP),
- 1 ampule 150 IU Fertinex (urofollitropin) TM and 1 ampule 2 mL Sodium Chloride Injection (USP),
- 10 ampules 75 IU Fertinex (urofollitropin) TM and 10 ampules 2 mL Sodium Chloride Injection (USP),
- 100 ampules 75 IU Fertinex (urofollitropin) TM and 100 ampules 2 mL Sodium Chloride Injection (USP),
Lyophilized powder may be stored refrigerated or at room temperature (3°-25°C/37°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.
Caution : Federal law prohibits dispensing without prescription.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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