GONAL-F RFF PEN Rx
Generic Name and Formulations:
Follitropin alfa (recombinant follicle-stimulating hormone) 300 IU, 450 IU, 900 IU, per prefilled pen; liq for SC inj.
EMD Serono, Inc.
Indications for GONAL-F RFF PEN:
Development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technology (ART). Induction of ovulation and pregnancy in patients with functional anovulatory infertility without primary ovarian failure. Also, Gonal-F: Induction of spermatogenesis in men with hypogonadotropic hypogonadism without primary testicular failure.
Be fully familiar with infertility treatment and its complications before using this product. See Warnings/Precautions. Individualize. ART: initially 150 IU daily in early follicular phase; usual max 10 days. ART in women with suppressed endogenous gonadotropin levels: <35yrs: initially 150 IU daily; ≥35yrs: initially 225 IU daily. All: adjust dose after 5 days based on response, then by up to 75–150 IU every 3–5 days; max 450 IU/day. Give hCG 5000–10000 Units after follicular development. Induction of ovulation: initially 75 IU daily for 14 days in the first cycle; then determine subsequent doses based on response; if indicated, may increase after the initial 14 days, then every 7 days in increments of up to 37.5 IU; usual max 300 IU/day for up to 35 days. Give hCG 5000 Units one day after last dose. Men: 150 IU three times per week given with hCG 1000 Units three times per week; max 300 IU three times per week. Attain normal serum testosterone levels first by pretreating with hCG 1000–2250 Units 2–3 times per week.
Primary gonadal failure. Uncontrolled thyroid, adrenal, or pituitary disorders. Sex hormone-dependent tumors. Tumors of pituitary gland or hypothalamus. Undiagnosed abnormal uterine bleeding. Ovarian cysts or enlargement. Pregnancy (Cat.X).
Do complete gynecological and appropriate endocrinological exam first. Monitor appropriate lab values. Serious pulmonary conditions. Thromboembolic disorders. If ovaries are enlarged on last day of therapy, or other evidence of ovarian hyperstimulation syndrome (OHSS) occurs, do not give hCG. Discontinue if evidence of OHSS occurs (eg, excessive number of ovarian follicles seen by serum estradiol levels or ultrasound, abdominal pain). Increased risk of ovarian torsion, multi-fetal gestation and births, ectopic pregnancy, spontaneous abortion. Nursing mothers: not recommended.
Women: headache, abdominal pain, OHSS (with or without pulmonary and vascular complications; may be serious), ovarian enlargement or cysts, intermenstrual bleeding, local reactions; rare: ovarian neoplasms, congenital malformations. Men: Distension, acne, breast pain, fatigue, gynecomastia, varicocele, inj site reactions.
Multidose vials—1 (w. syringes); Single-dose vials—1, 10 (w. syringes); Pen—1 (w. needles); Redi-ject—1 (w. needles)
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