Novarel

Novarel is part of the drug class:

• Gonadotropins

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Novarel including the following:

• Hyperstimulation and/or enlargement of the ovaries. Discontinue using Novarel and get medical attention immediately if you experience abnormal severe abdominal pain.
• Life-threatening allergic reactions. Discontinue using Novarel and get medical attention immediately if you experience facial, lip, tongue, throat swelling and/or difficulty breathing.
• Early-onset puberty. Discontinue using Novarel and get medical attention immediately if you or your child experiences symptoms of early-onset puberty including increased hair growth and thickening, deepening of the voice, acne, early breast development, and/or rapid height growth.
• Fluid in the lungs. Discontinue using Novarel and get medical attention immediately if you experience sudden difficultly breathing.

Do not take Novarel if you:

• Are allergic to Novarel or to any of its ingredients
• Have early-onset puberty
• Have other cancers that are stimulated by androgens
• Have prostate cancer

Take Novarel exactly as prescribed.

This medication is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional typically three times per week.

If you miss a dose, receive the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and receive your next dose at the regular time. Do not receive two doses of Novarel at the same time.

Keep this and all medicines out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working and to check for unwanted effects.

For women taking this medicine to become pregnant :

• Record your basal body temperature every day if told to do so by your doctor, so that you will know if you have begun to ovulate. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Bloating (mild)
• stomach or pelvic pain

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• swelling of feet or lower legs
• weight gain (rapid)

• Acne
• enlargement of penis and testes
• growth of pubic hair
• increase in height (rapid)

• difficult or labored breathing
• difficulty breathing
• flushing of skin
• hives or welts
• itching of skin
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• pain in chest, groin, or legs, especially the calves
• redness of skin
• severe, sudden headache
• skin rash
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in arm or leg
• sudden, unexplained shortness of breath
• tightness in chest
• unusually warm skin
• vision changes
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Discouragement
• enlargement of breasts
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• pain at place of injection
• trouble concentrating
• trouble sleeping
• tiredness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to help women get pregnant.
• It is used to help the body make more testosterone in some people.
• It is used to treat delays in a male's normal growth pattern.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take Novarel. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• Do not give Novarel to a newborn. It has benzyl alcohol.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion; (2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum; (3) Multiple births, and (4) Arterial thromboembolism.

The recommended diluent for reconstitution is Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

Anaphylaxis has been reported with urinary-derived HCG products.