Take the next step on your journey with NOVAREL® (chorionic gonadotropin for injection, USP)

Prescribing Information

NOVAREL is one of the first hCGs approved for use in OI. NOVAREL is injected intramuscularly (into the muscle) according to the directions provided by your doctor.

NOVAREL is used to stimulate egg release (ovulation) in women who are not ovulating and in whom ovarian failure is not the cause of infertility. Before using NOVAREL, patients should be appropriately pretreated with human menotropins, such as MENOPUR® (menotropins for injection).

NOVAREL is designed for intramuscular (into the muscle) injection.

5,000 USP units

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10,000 USP units

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What is NOVAREL?

NOVAREL is an hCG used to stimulate egg release (ovulation).

What is NOVAREL used for?

NOVAREL is used to stimulate egg release (ovulation) after gonadotropin stimulation.

Who should prescribe NOVAREL and monitor my care?

NOVAREL should be prescribed 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, visit the Find a Reproductive Health Specialist page, or contact the American Society for Reproductive Medicine at 1-205-978-5000 or online at ASRM.org.

How is NOVAREL supplied?

NOVAREL comes in a vial as a sterile powder.

When should I take NOVAREL?

NOVAREL should be taken after gonadotropin stimulation at the time and dose specified by your doctor.

How should I store NOVAREL?

Store NOVAREL at room temperature 68°F to 77°F (20°C-25°C) 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 the most common 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here to review Important Safety Information and also full Prescribing Information, including Patient Information.

IMPORTANT SAFETY INFORMATION
Please see Full Prescribing Information
Please see
Important Safety Information
and full Prescribing Information
IMPORTANT SAFETY INFORMATION

NOVAREL® (chorionic gonadotropin for injection, USP)

NOVAREL® (chorionic gonadotropin for injection, USP) is a prescription medicine that contains a hormone to help stimulate healthy ovaries to make eggs. NOVAREL is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

Important Safety Information

Do not use NOVAREL if you have begun puberty at an unusually early age, have prostate cancer, or have had a prior allergic reaction to this hormone. This hormone may cause harm to an unborn baby when given to a pregnant woman.

NOVAREL may cause serious side effects. It sometimes stimulates the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. NOVAREL can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination. NOVAREL may cause you to be pregnant with twins or more than two babies at the same time.

Other side effects of NOVAREL include headache, irritability, restlessness, depression, fatigue, swelling, and pain at the site of injection.

Anaphylaxis has been reported with urinary-derived hCG products.

These are not all the side effects with NOVAREL. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.