Monograph Details
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Ob/Gyn
> Infertility
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GONAL-F RFF PEN |
| Manufacturer |
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EMD Serono, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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FSH. |
| Generic Name |
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Follitropin alfa (recombinant follicle-stimulating hormone) 300 IU, 450 IU, 900 IU, per prefilled pen; liq for SC inj. |
| Also |
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• GONAL-F
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| Indications |
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Development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technology (ART). Induction of ovulation in patients with functional anovulatory infertility without primary ovarian failure. Gonal-F only; not Gonal-F RFF pen: Induction of spermatogenesis in men with hypogonadotropic hypogonadism without primary testicular failure. |
| Children |
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Not applicable. |
| Adults |
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Be fully familiar with infertility treatment and its complications before using this product. See Precautions. ART: 150 IU daily in early follicular phase; usual max 10 days. ART with suppressed endogenous gonadotropin levels: 225 IU daily; may adjust after 5 days, then by up to 75–150 IU every 3–5 days; max 450 IU/day. Give hCG 5000–10000 Units after follicular development. To stimulate follicle development for anovulation: initially 75 IU daily; may increase after 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. |
| Contraindications |
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Undiagnosed abnormal vaginal bleeding. Ovarian cysts or enlargement. Primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone-dependent tumors. Intracranial lesions. Pregnancy (Cat.X). |
| Precautions |
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Do complete gynecological and appropriate endocrinological exam first. Monitor appropriate lab values. 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). Nursing mothers: not recommended. |
| Adverse Reactions |
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Women: headache, OHSS (with or without pulmonary and vascular complications; may be serious), ovarian enlargement or cysts, intermenstrual bleeding, local reactions, risk of high order multiple births. Men: Distention, acne, breast pain, fatigue, gynecomastia, varicocele, local reactions. |
| How Supplied |
Multidose vials—1 (w. syringes)
Pen—1 (w. needles) |
| Additional Resources |
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• Related Prescribing Note |
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