Frequently Asked Questions
Before You Start Taking NOVAREL®
What is NOVAREL®?
What is NOVAREL® used for?
Who should prescribe NOVAREL® and monitor my care?
Taking and Storing NOVAREL®
How is NOVAREL® supplied?
How do I take NOVAREL®?
When should I take NOVAREL®?
How should I store NOVAREL®?
More About NOVAREL®—
Side Effects and Effectiveness
Are there side effects?
Have clinical studies been conducted to demonstrate the effectiveness of NOVAREL®?
Click here to print the NOVAREL® FAQ page
NOVAREL® is human chorionic gonadotropin (hCG) and is used to stimulate egg release (ovulation).
NOVAREL® is used to stimulate egg release (ovulation) after gonadotropin stimulation with BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) or REPRONEX® (menotropins for injection, USP).
Who should prescribe NOVAREL® and monitor my care?
NOVAREL® should be used in conjunction with gonadotropins only by physicians who are experienced with infertility treatment and have adequate monitoring facilities. A reproductive endocrinologist, who is most knowledgeable about fertility treatment, should be managing your care to ensure the best outcome. For a referral to a recognized reproductive endocrinologist, contact the American Society for Reproductive Medicine at 205-978-5000 or online at www.asrm.org.
NOVAREL® comes in a vial as a sterile powder, along with the accompanying sterile diluent.
One vial of NOVAREL® must be dissolved with the accompanying diluent according to your physician's instructions and then injected intramuscularly. The administration of NOVAREL® generally requires a partner for ease of injection.
NOVAREL® should be taken after gonadotropin stimulation at the time and dose specified by your doctor.
Store NOVAREL® at room temperature (59°-86°F) until it is dissolved in the sterile diluent. After it is dissolved, it should be stored in the refrigerator and may be stored for up to 30 days.
What are possible side effects?
NOVAREL®, like all gonadotropins, may produce side effects. The potential side effects for NOVAREL® are headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, and pain at the site of injection.
Have clinical studies been conducted to demonstrate the effectiveness of NOVAREL®?
Yes. Please see Full Prescribing Information.
NOVAREL® is indicated for induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with urofollitropins or human menotropins.
Important Safety Information
NOVAREL® should be used in conjunction with urofollitropin or human menopausal gonadotropins only by physicians thoroughly experienced with infertility treatment. Principal serious adverse reactions are: OHSS; enlargement or rupture of ovarian cysts with resultant hemoperitoneum; multiple births; and arterial thromboembolism. NOVAREL® is contraindicated in women with precocious puberty, androgen-dependent neoplasm, and prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare’s serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.
Click here to see Full Prescribing Information for NOVAREL®.
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