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Novarel

Generic Name: chorionic gonadotropin (KORE-ee-ON-ik goe-NAD-oh-troe-pin)
Brand Name: Examples include Novarel and Pregnyl

Novarel is used for:

Treating fertility problems in certain women who have not gone through menopause. Treating certain testicular development problems and stimulating the development of secondary sexual characteristics in certain patients. It is also used to treat boys 4 to 9 years old who have testicles that have not moved into the scrotum.

Novarel is a hormone. Human chorionic gonadotropin (HCG) stimulates cells in the testicles to produce androgens and in the ovaries to produce progesterone. Androgens cause the development of male secondary sexual characteristics (eg, hair growth, deepening voice) and may cause the testicles to drop. HCG acts like luteinizing hormone (LH) by stimulating ovulation (release of an egg) in women.

Do NOT use Novarel if:

  • you are allergic to any ingredient in Novarel
  • you have androgen (male sex hormone)-dependent tumors, prostate cancer, an active blood clot, brain lesions, unexplained uterine or genital bleeding, an enlarged ovary or ovarian cysts, or an enlargement or tumor of the pituitary gland
  • you are experiencing abnormally early puberty
  • you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Novarel:

Some medical conditions may interact with Novarel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, uterine fibroids, heart or kidney problems, migraine headaches, polycystic ovarian syndrome, or epilepsy

Some MEDICINES MAY INTERACT with Novarel. However, no specific interactions with Novarel are known at this time.

Ask your health care provider if Novarel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novarel:

Use Novarel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Novarel is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Novarel at home, carefully follow the injection procedures taught to you by your health care provider.
  • If Novarel contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Using the technique described to you by your doctor, add the diluent to the vial that contains the medicine. Mix the solution by gently rotating the vial. DO NOT SHAKE. The solution should be clear and free of particles.
  • Wipe the rubber stopper of the vial with an alcohol swab. Insert the needle straight through the center circle of the rubber stopper. Draw up the solution for injection. After drawing up the solution, switch needles. Be sure all air bubbles are tapped out of the syringe.
  • Wipe the appropriate injection site (usually the upper thigh or buttocks) with an alcohol swab, then insert the syringe. To be sure that the needle is not in a vein, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (drugs, syringes, etc.).
  • After giving the injection, cover the injection site with a small bandage if necessary.
  • Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Novarel, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Novarel.

Important safety information:

  • Women need to have a thorough gynecological exam before beginning treatment with Novarel.
  • Men need to have a complete medical and hormone evaluation before starting therapy with Novarel.
  • Novarel may increase your chance of multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births.
  • Use of Novarel can increase your risk of serious blood clots and ruptured ovarian cysts. Discuss the risk of these effects with your doctor.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some women who use Novarel. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination.
  • Novarel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Novarel.
  • Lab tests, including hormone levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Novarel is not recommended for use in CHILDREN younger than 4 years; safety and effectiveness in these children have not been confirmed.
  • Novarel may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • PREGNANCY and BREAST-FEEDING: Do not use Novarel if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Novarel is found in breast milk. If you are or will be breast-feeding while you are using Novarel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Novarel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fatigue; headache; irritability; nausea; pain, swelling, bruising, or redness at the injection site; restlessness; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal breast development; bloating or swelling in the stomach or pelvic area; breast tenderness; depression; infrequent urination; persistent or severe nausea, vomiting, or diarrhea; stomach or pelvic pain; sudden shortness of breath; swelling of the hands, feet, or legs; symptoms of a serious blood clot (eg, calf or leg pain, swelling, redness, or tenderness; chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache; vision changes); unusual early onset of puberty; weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Novarel:

Before mixing, store Novarel at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Different products have different storage instructions after mixing. Check with your doctor or pharmacist about how to store Novarel and how long it is good for after mixing. Keep Novarel out of the reach of children and away from pets.

General information:

  • If you have any questions about Novarel, please talk with your doctor, pharmacist, or other health care provider.
  • Novarel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Novarel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Novarel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Novarel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Novarel.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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