NEOGENTIN is indicated in conjunction with human chorionic gonadotropin (hCG) for multiple follicular development (controlled ovarian stimulation) and ovulation induction in those who have received previous pituitary suppression.

NEOGENTIN must be advocated in late reproductive life period since there is a greater predilection for endometrial carcinoma, as well as a higher incidence of anovulatory disorders.

NEOGENTIN must be advocated in the lowest possible dose so as to minimize the chances of producing abnormal ovarian enlargement. If the ovaries are enlarged on the last day of NEOGENTIN therapy, hCG should not be administered in this course of therapy so as to reduce chances of development of Ovarian Hyper Stimulation Syndrome (OHSS). Occurrence of OHSS is an indication for stopping treatment with NEOGENTIN and hospitalizing the patient.

Multiple pregnancies have been reported following usage of menotropins (NEOGENTIN). Before instituting therapy with NEOGENTIN, evaluation of the spouse's fertility potential must be evaluated.

The combination of estradiol levels estimation and ultrasonography is useful for monitoring the growth and development of follicles, timing of hCG administration as well as minimizing the risk of precipitating OHSS, and multiple pregnancies.

Safety and efficacy of menotropins (NEOGENTIN) during lactation and in children have not been established.

Urofollitropin (NEOGENTIN) administration can cause hypersensitivity reactions including flu-like symptoms, pulmonary and vascular complications, OHSS, hemoperitoneum, adnexal torsion, mild-to-moderate ovarian enlargement, Ovarian cysts, vaginal / cervical disorders, breast tenderness, abdominal pain and other gastrointestinal complaints, dizziness, headache, pain, hot flushes, emotional lability, depression, tachycardia, hypertension, dyspnea, tachypnea as well as local reaction at injection site (pain, rash, swelling, irritation).

Subsequent to pregnancy resulting from NEOGENTIN, urofollitropin usage has been associated with spontaneous labor, ectopic pregnancy, premature labor, postpartum fever and congenital abnormalities; however, the incidence of the latter does not exceed that found in general population

INFERTILITY WITH OLIGO-ANOVULATION

Patients having received gonadotropin releasing hormone (GnRH) agonist or antagonist pituitary suppression: 150 IU NEOGENTIN daily subcutaneous (SC) (lower abdomen alternating sites) or intramuscularly (IM) daily for the first 5 days. Subsequent dosing must be determined by the patient's response and must be made no more frequently than once every 2 days and should not increase more than 75 to 150 IU NEOGENTIN SC / IM per adjustment.

The maximum dose of NEOGENTIN should not exceed 450 IU SC / IM and dosing beyond 12 days is not recommended.

If response to menotropins is appropriate, hCG 5000-10000 units IM is to be given 1 day following the last dose of NEOGENTIN. The hCG must be withheld if the serum estradiol level is greater than 2000 pg/ml, or if the ovaries are enlarged or if abdominal pain occurs. Follow up must be closely chosen for at least 2 weeks after hCG administration. If there is inadequate follicular development or ovulation without subsequent pregnancy, the course of NEOGENTIN must be repeated. The couple must be encouraged to have intercourse daily, beginning the day prior to the administration of hCG until ovulation becomes apparent.