follitropin
follitropin is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Follistim AQ. Available dosage form: injection, solution.
Drug Details
- Generic Name
- follitropin
- Brand Names
- Follistim AQ
- Application Number
- BLA021211
- Sponsor
- Organon LLC
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- FOLLITROPIN
Indications and Usage
1 INDICATIONS AND USAGE FOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: 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 ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle ( 1.2 ) 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 ( 1.3 ) 1.1 Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Women should have a complete gynecologic and endocrinologic evaluation. Primary ovarian failure should be excluded. The possibility of pregnancy should be excluded. Tubal patency should be demonstrated. The fertility status of the male partner should be evaluated. 1.2 Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. The possibility of pregnancy should be excluded. The fertility status of the male partner should be evaluated. In Men for: 1.3 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 Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Men should have a complete medical and endocrinologic evaluation. Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. Serum testosterone levels should be normalized with human chorionic gonadotropin (hCG) treatment. The fertility status of the female partner should be evaluated.