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Follistim Aq Cartridge Generic Name & Formulations
Legal Class
Rx
General Description
Follitropin beta (recombinant follicle-stimulating hormone) 300 IU, 600 IU, 900 IU; per pre-filled cartridge; soln for SC inj.
How Supplied
Cartridge (w. needles)—1; Follistim Pen (w. needles)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Follicle-stimulating hormone (FSH) 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 men with hypogonadotropic hypogonadism, Follistim administered with hCG stimulates spermatogenesis. FSH is the pituitary hormone responsible for spermatogenesis.
Follistim Aq Cartridge Indications
Indications
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.
Follistim Aq Cartridge Dosage and Administration
Adult
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
Not applicable.
Follistim Aq Cartridge Contraindications
Contraindications
Primary gonadal failure. Uncontrolled thyroid, adrenal, or pituitary disorders. Tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland. Streptomycin or neomycin allergy. Pregnancy. Undiagnosed abnormal vaginal bleeding. Ovarian cysts or enlargement.
Follistim Aq Cartridge Boxed Warnings
Not Applicable
Follistim Aq Cartridge Warnings/Precautions
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.
Follistim Aq Cartridge Pharmacokinetics
Absorption
Cmax in healthy, pituitary-suppressed, women: 5.41 ± 0.72 international units/L (for SC administration); 6.86 ± 2.90 international units/L (for IM administration).
Apparent dose absorbed: 77.8% (for SC administration); 76.4% (for IM administration).
Distribution
Volume of distribution in healthy, pituitary-suppressed, women following IV administration of a 300 international units dose: ~8 L.
Elimination
Renal.
Half-life: 33.4 hours.
Clearance: 0.01 L/h/kg.
Follistim Aq Cartridge Interactions
Not Applicable
Follistim Aq Cartridge Adverse Reactions
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.
Follistim Aq Cartridge Clinical Trials
See Literature
Follistim Aq Cartridge Note
Not Applicable
Follistim Aq Cartridge Patient Counseling
See Literature
