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 Frequently Asked Questions Before You Start Taking BRAVELLE®
What is BRAVELLE®? Taking and Storing BRAVELLE®
How is BRAVELLE® supplied? More About BRAVELLE®—
Are there side effects? Click here to print the BRAVELLE® FAQ page BRAVELLE® is a highly purified, human follicle-stimulating hormone (FSH), one of the most important hormones for inducing the growth of the follicles that produce ova (eggs). As a human follicle-stimulating hormone, BRAVELLE® is classified as a "urofollitropin." Urofollitropins—injectable hormones that control the reproductive function—are one of the most widely used types of infertility medication. BRAVELLE® stimulates egg follicles to grow within the ovaries. Who should prescribe BRAVELLE® and monitor my care? BRAVELLE® should be used only by physicians who are thoroughly familiar with infertility treatment and have adequate monitoring facilities. A reproductive endocrinologist, who is most knowledgeable about infertility treatments, should be managing your care to ensure the best outcome. For a referral to a recognized reproductive endocrinologist, contact the American Society of Reproductive Medicine at 205-978-5000, or online at www.asrm.org. BRAVELLE® should not be used by women who are pregnant or have primary ovarian failure, uncontrolled thyroid and adrenal dysfunction, or an organic intracranial lesion such as a pituitary tumor. Also, women who have abnormal bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovary syndrome, or prior hypersensitivity to urofollitropins should not use this product. Women whose cause of infertility is other than anovulation should not use BRAVELLE®. BRAVELLE® comes in a vial as a sterile powder along with the accompanying sterile diluent. Your doctor may recommend using a specified volume of diluent to dissolve one or more vials of BRAVELLE®. BRAVELLE® is the only human-derived FSH approved for both subcutaneous (SC) and intramuscular (IM) injection. With SC administration, you can self-inject the medication just under the skin with much shorter needles than needles used for IM injections. IM administration generally requires a partner to help administer the injection. Based on your specific needs, your doctor may recommend either the SC or IM route of administration. After you and your partner undergo a thorough exam to determine the cause of infertility, your doctor will then recommend a course of action and may prescribe BRAVELLE®. Treatment usually begins a few days after your period and may continue daily for 7 to 12 days, depending on how long it takes your follicles to mature. Undissolved BRAVELLE®, in powder form, should be stored in the refrigerator or at room temperature and is good until the date printed on the vial. The product should be protected from light, so store it in its box if possible. Once BRAVELLE® has been dissolved, it should be used immediately and any unused BRAVELLE® should be discarded. BRAVELLE®, like all gonadotropins, may produce side effects. Among the most common are headache, vaginal bleeding, nausea, and hot flashes. A less common but potentially serious side effect associated with all gonadotropin therapy is ovarian hyperstimulation syndrome (OHSS). OHSS occurs in approximately 6% of patients who take BRAVELLE®. Please see Full Prescribing Information. Have clinical studies been conducted to demonstrate the effectiveness of BRAVELLE®? Yes. Please see full Prescribing Information.
BRAVELLE® administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. BRAVELLE® administered SC or IM, in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression. Click here to see Full Prescribing Information for BRAVELLE®.
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