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(urofollitropin) for Injection, Purified
FOR SUBCUTANEOUS OR INTRAMUSCULAR INJECTION
BRAVELLE® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
BRAVELLE® is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of BRAVELLE® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 International Units of FSH. BRAVELLE® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in BRAVELLE®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
FSH is a glycoprotein that is acidic and water-soluble.
BRAVELLE® has been mixed in vitro with MENOPUR® with no evidence of aggregation.
Therapeutic class: Infertility
What are the possible side effects of urofollitropin (Bravelle)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition.
Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:
- severe pelvic pain;
- swelling of your...
What are the precautions when taking urofollitropin injection (Bravelle)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (e.g., primary ovarian failure), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (e.g., breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood clots, blood clotting...
Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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