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Gonal-f Rff Pen Generic Name & Formulations
Legal Class
Rx
General Description
Follitropin alfa (recombinant follicle-stimulating hormone) 300 IU, 450 IU, 900 IU, per prefilled pen; liq for SC inj.
Pharmacological Class
FSH.
How Supplied
Multidose vials—1 (w. syringes); Single-dose vials—1, 10 (w. syringes); Pen—1 (w. needles); Redi-ject—1 (w. needles)
Manufacturer
Gonal-f Rff Pen Indications
Indications
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.
Gonal-f Rff Pen Dosage and Administration
Adult
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. Prior to initiation, normalize serum testosterone levels first by pretreating with hCG 1000–2250 Units 2–3 times per week.
Children
Not established.
Gonal-f Rff Pen Contraindications
Contraindications
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.
Gonal-f Rff Pen Boxed Warnings
Not Applicable
Gonal-f Rff Pen Warnings/Precautions
Warnings/Precautions
Perform a complete gynecologic and endocrinologic evaluation prior to initiation. Discontinue and treat if anaphylaxis or other serious hypersensitivity reactions occur. 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). Avoid intercourse for women with significant ovarian enlargement after ovulation. Increased risk of ovarian torsion, multi-fetal gestation and births, ectopic pregnancy, spontaneous abortion. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.
Gonal-f Rff Pen Pharmacokinetics
See Literature
Gonal-f Rff Pen Interactions
Not Applicable
Gonal-f Rff Pen Adverse Reactions
Adverse Reactions
Women: headache, abdominal pain, OHSS (with or without pulmonary and vascular complications; may be serious), ovarian cysts, intermenstrual bleeding, nausea, flatulence, pelvic pain, local reactions; rare: ovarian neoplasms, congenital malformations. Men: acne, inj site pain, gynecomastia, seborrhea, fatigue.
Gonal-f Rff Pen Clinical Trials
See Literature
Gonal-f Rff Pen Note
Not Applicable
Gonal-f Rff Pen Patient Counseling
See Literature
