In Women for: ? Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ? Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle In Men for: ? Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure
Follitropin alfa stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of Follitropin Alfa, when monitoring of the patient indicates that sufficient follicular development is achieved. Follitropin Alfa stimulates spermatogenesis in men with hypogonadotropic hypogonadism when administered with hCG.
In Anovulatory Women Undergoing Ovulation Induction (2.2): ? Starting daily dose of 50 international units of it Cartridge is administered subcutaneously for at least the first 7 days. The dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. ? When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5,000 to 10,000 international units of human chorionic gonadotropin (hCG). ? The woman and her partner should have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent. In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle: ? Starting dose of 200 international units (actual cartridge doses) of it is administered subcutaneously for at least the first 7 days of treatment. Subsequent doses can be adjusted down or up based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Dosage reduction in high responders can be considered from the 6th day of treatment onward according to individual response. ? Final oocyte maturation is induced with a dose of 5,000- 10,000 international units of hCG. ? Oocyte (egg) retrieval is performed 34 to 36 hours later. Induction of Spermatogenesis in Men (2.4): ? Pretreatment with hCG alone (1,500 international units twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the dose may be increased to 3,000 international units twice a week. ? After normalization of serum testosterone levels, administer 450 international units per week (225 international units twice weekly or 150 international units three times weekly) of it.
Other ovulation stimulating agents (eg hCG, clomiphene citrate) may potentiate the follicular response, concurrent use of GnRH agonist-induced pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response.
Women and men who exhibit: ? Prior hypersensitivity to recombinant hFSH products ? High levels of FSH indicating primary gonadal failure ? Presence of uncontrolled non-gonadal endocrinopathies ? Hypersensitivity reactions related to streptomycin or neomycin ? Tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland Women who exhibit: ? Pregnancy ? Heavy or irregular vaginal bleeding of undetermined origin ? Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS)
ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant
Ovarian hyperstimulation syndrome (OHSS) and multiple gestations have been observed in
women with GONAL-F overdosage
Lyophilized Multi-Dose vials may be stored refrigerated or at room temperature (2°-25°C).
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