Monograph Details
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Ob/Gyn
> Infertility
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BRAVELLE |
| Manufacturer |
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Ferring Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Generic Name |
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Urofollitropin (follicle-stimulating hormone) 75 IU; per vial; pwd for SC or IM inj after reconstitution. |
| Indications |
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Induction of ovulation in patients with functional anovulatory infertility that is not due to ovarian failure, or stimulation of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) who have previously received pituitary suppression. |
| Children |
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Not applicable. |
| Adults |
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Individualize. Ovulation induction: Initially 150 IU SC or IM inj daily for 5 days. ART: Initially 225 IU SC inj daily for 5 days. Both: adjust dose based on response in increments of 75-150 IU at intervals of at least 2 days; max 450 daily; usual max 12 days. Induce final maturation of follicles with 5000-10000 Units of hCG (see Precautions) one day after last dose. |
| Contraindications |
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Primary ovarian failure. Uncontrolled thyroid or adrenal disease. Intracranial lesions. Undiagnosed abnormal vaginal bleeding. Ovarian cysts or enlargement. Tumor of pituitary, breast, ovary, or uterus. Pregnancy (Cat.X). |
| Precautions |
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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. |
| Adverse Reactions |
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OHSS with pulmonary and vascular complications, ovarian enlargement or cysts, abdominal pain (discontinue if occurs), local reactions, risk of high order multiple births. |
| How Supplied |
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Vials (w. diluent)—5, 100 |
| Additional Resources |
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• Related Prescribing Note |
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