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Generic Name: Abarelix (ab-ah-REL-ix)
Brand Name: Plenaxis

Severe allergic reactions have occurred immediately following doses of Abarelix , including the first dose. The risk of allergic reaction appears to increase with additional doses. You will be monitored for any sign of an allergic reaction for at least 30 minutes following each dose of medicine. Abarelix is only for use in men when other treatments have failed or are not appropriate and the patient has refused castration. In addition, Abarelix is used when the cancer has spread to the bone, causing severe pain requiring regular doses of narcotics for pain-control, when the risk of neurological problems exists because of the cancer, or when urinary tract problems have resulted from the cancer. The effectiveness of Abarelix to suppress the level of testosterone in the blood decreases with continued use in some patients. Measurement of testosterone levels at certain times during treatment should be done to monitor the continued effectiveness of Abarelix .

Abarelix is used for:

Treating symptoms of advanced prostate cancer and certain conditions as determined by your doctor.

Abarelix is a gonadotropin releasing-hormone (GnRH) antagonist. It works by reducing the amount of a hormone called testosterone. Testosterone is involved in the growth of most prostate cancers.

Do NOT use Abarelix if:

  • you are allergic to any ingredient in Abarelix
  • you are a woman, pregnant, or a child

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

Before using Abarelix :

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

  • if you are 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 liver problems
  • if you have heart disease, including long QT syndrome, or have had any heartbeat problems

Some MEDICINES MAY INTERACT with Abarelix . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain antiarrhythmic medicines (eg, quinidine, procainamide, amiodarone, sotalol) because side effects, such as racing heartbeat, dizziness, fainting, or life-threatening irregular heartbeat may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abarelix 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 Abarelix :

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

  • Abarelix comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Abarelix refilled.
  • Abarelix is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Abarelix at home, carefully follow the injection procedures taught to you by your health care provider.
  • If Abarelix contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • You will be monitored for any sign of an allergic reaction for at least 30 minutes following each dose of medicine.
  • Abarelix is injected into a muscle.
  • 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, nurse, or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Abarelix , contact your doctor immediately.

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

Important safety information:

  • Abarelix may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Abarelix . Using Abarelix alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • LAB TESTS, including testosterone blood levels, prostate specific antigen (PSA), orliver function tests levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Abarelix is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Abarelix if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Abarelix is excreted in breast milk. Do not breast feed while taking Abarelix .

Possible side effects of Abarelix :

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:

Back pain; breast enlargement; breast or nipple pain or tenderness; constipation; diarrhea; dizziness; general pain; headache; hot flashes; nausea; pain, swelling, or redness at the injection site; sleep problems; tiredness; upper respiratory tract infection.

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; lightheadedness; fainting; warmth; redness; swelling of the mouth, face, eyelids, lips, tongue, or throat); change in heart rate; cough; dark urine; difficulty or pain when going to the bathroom; fainting; fever; frequently needing to go to the bathroom; pale stools; shortness of breath; stomach pain; swelling of the hands, legs, or feet; unusual tiredness; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Abarelix :

Store the unmixed medicine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Abarelix has no preservative and must be used within 1 hour of mixing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abarelix out of the reach of children and away from pets.

General information:

  • If you have any questions about Abarelix , please talk with your doctor, pharmacist, or other health care provider.
  • Abarelix 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.

This information is a summary only. It does not contain all information about Abarelix . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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