Plenaxis

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

Severe allergic reactions have occurred immediately following doses of Plenaxis, 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. Plenaxis is only for use in men when other treatments have failed or are not appropriate and the patient has refused castration. In addition, Plenaxis 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 Plenaxis 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 Plenaxis.


Plenaxis is used for:

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

Plenaxis 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 Plenaxis if:

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

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Plenaxis:

Some medical conditions may interact with Plenaxis. 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 Plenaxis. 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 Plenaxis 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 Plenaxis:

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

  • Plenaxis comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Plenaxis refilled.
  • Plenaxis is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Plenaxis at home, carefully follow the injection procedures taught to you by your health care provider.
  • If Plenaxis 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.
  • Plenaxis 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 Plenaxis, contact your doctor immediately.

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

Important safety information:

  • Plenaxis may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Plenaxis. Using Plenaxis 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.
  • Plenaxis is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Plenaxis if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Plenaxis is excreted in breast milk. Do not breast feed while taking Plenaxis.

Possible side effects of Plenaxis:

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 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 Plenaxis:

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. Plenaxis 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 Plenaxis out of the reach of children and away from pets.

General information:

  • If you have any questions about Plenaxis, please talk with your doctor, pharmacist, or other health care provider.
  • Plenaxis 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 Plenaxis. 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: July 2, 2014
Database Edition 14.3.1.001
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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