Overview
11 DESCRIPTION Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta).
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Women: Follicle-stimulating hormone (FSH), the active component in FOLLISTIM AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. FOLLISTIM AQ Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with FOLLISTIM AQ Cartridge when patient monitoring indicates appropriate...
Indications
- 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.
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION See Dose Conversion Table 1 for FOLLISTIM AQ Cartridge with Pen Injector ( 2.1 ) In Anovulatory Women Undergoing Ovulation Induction ( 2.2 ): Starting daily dose of 50 international units of FOLLISTIM AQ 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.
Contraindications
- 4 CONTRAINDICATIONS FOLLISTIM AQ Cartridge is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant hFSH products or any component of FOLLISTIM AQ Cartridge. Reactions including anaphylaxis have been reported [see Adverse Reactions (6.2) ] High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1 , 1.2 , 1.3) ] Hypersensitivity reactions to streptomycin or neomycin.
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Atelectasis [see Warnings and Precautions (5.3) ] Thromboembolism [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5) ] Congenital Anomalies [see Warnings and Precautions (5.6) ] Ectopic Pregnancy [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS No drug-drug interaction studies have been performed.