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|Plenaxis

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.

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.

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.

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.