Infertility:

Indications for: FOLLISTIM AQ CARTRIDGE

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.

Adult Dosage:

Individualize. Ovulation induction: initially 50 IU by SC daily for at least first 7 days; then adjust weekly based on response. IVF or ICSI: initially 200 IU by SC daily for at least first 7 days of treatment, then adjust based on response. Both: induce final maturation of follicles or ovulation with 5000–10000 IU of hCG; see full labeling. Spermatogenesis induction: pretreat with hCG first; see full labeling. After normal serum testosterone levels are reached, give Follistim 450 IU by SC weekly (as either 225 IU twice weekly or 150 IU 3 times weekly) in combination with the same hCG dose used to normalize testosterone levels. A lower dose of Follistim AQ Cartridge may be considered due to delivery of a higher dose of follitropin beta. Continue therapy for at least 3–4 months and based on response.

Children Dosage:

Not applicable.

FOLLISTIM AQ CARTRIDGE Contraindications:

Ovarian failure. Uncontrolled thyroid or adrenal disease. Undiagnosed abnormal vaginal bleeding. Ovarian cysts or enlargement. Tumor of pituitary, breast, ovary, or uterus. Streptomycin or neomycin allergy. Pregnancy (Cat.X).

FOLLISTIM AQ CARTRIDGE Warnings/Precautions:

Do complete gynecological and endocrinological exam first. Thromboembolic disorders. Do not give hCG if high estrogen levels or excessive numbers of ovarian follicles by ultrasound indicate a high risk of ovarian hyperstimulation syndrome (OHSS). Nursing mothers: not recommended.

See Also:

    Adverse Reactions:

    OHSS with pulmonary and vascular complications, ovarian enlargement or cysts, abdominal pain (discontinue if occurs), local reactions, risk of high order multiple births.

    Generic Drug Availability:

    NO

    How Supplied:

    Cartridge (w. needles)—1; Follistim Pen (w. needles)—1