ABARELIX (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
Description
Abarelix (a-ba-REL-iks) is a type of medicine called a gonadotropin-releasinghormone (GnRH) antagonist that lowers the male hormone testosterone in yourblood. Testosterone makes most prostate cancers grow. Other ways to treatyour prostate cancer are taking other hormone medicines to lower testosteroneor surgery to remove your testicles. Abarelix is used when these other waysto treat prostate cancer cannot be used or are refused.
Abarelix is to be given only under the supervision of your doctor. It isto be injected into your buttocks and is available in the following dosageform:
Parenteral- Injection (U.S.)
Before Using This Medicine
It is very important thatyou read the Patient Information for abarelix before you start getting injections.You will need to sign the last page if you agree with treatment with abarelix.If you have any questions about this ask your doctor.
In deciding to use a medicine, the risks of using the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For abarelix, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to abarelix or any of its ingredients. Also tell yourdoctor if you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Abarelix is not for use in women.
Children?Studies on this medicine have only been done inadult patients, and there is no specific information comparing the use ofabarelix in children with other age groups. Abarelix is not for use in children.
Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are usingabarelix, it is especially important that your doctor and pharmacist knowif you are taking any of the following:
- Antiarrhythmic medications (medicine for heart conditions), suchas
- Amiodarone (e.g., Cordarone)
- Procainamide (e.g., Procan SR, Pronestyl)
- Quinidine (e.g., Quinidex)
- Sotalol (e.g., Betapace)? using these medicines at the sametime as abarelix may cause your heart conditions to get worse
Other medical problems?The presence of other medicalproblems may affect the use of abarelix. Make sure you tell your doctor ifyou have any other medical problems, especially:
- Osteoporosis?May be worsened by this medicine.
- QT prolongation (rare heart condition)?May be worsened by abarelix
Proper Use of This Medicine
Abarelixis only prescribed by doctors who are part of Plenaxis PLUS Program (Plenaxis User Safety Program) that is run by the pharmaceutical(drug) company that makes the medicine.
Abarelix is given as an injection (shot) in your buttocks. Your doctoror nurse will give you the injection. It is important that you keep your appointmentwith your doctor's office when your injection is due. If you are unable tokeep your appointment, contact your doctor's office to be rescheduled as soonas possible. It is very important that you follow theschedule that your doctor planned for your treatment.
You must always wait in your doctor's office for atleast 30 minutes after getting each abarelix injection (shot). If aserious or life-threatening allergic reaction happens it is usually soon aftergetting an abarelix injection. Tell your doctor rightaway if you feel warm, faint or lightheaded or if you have chest tightness,shortness of breath, redness of your skin, or swelling of your face, eyelids,tongue, or throat. These could be signs of an allergic reaction.
Abarelix is only used for treating advanced symptomatic prostate cancerwhen a patient cannot have or refuses other treatments for prostate cancer
Dosing?The following information includes only theaverage doses of abarelix.
- For parenteral dosage form (injection):
- For advanced prostate cancer:
- Adults?100 milligrams (mg) in the muscle (buttock) on Day 1,15, 29 (week 4) and every 4 weeks thereafter.
Precautions While Using This Medicine
It is very important that your doctor check you at regular visits. Your doctor will also want to do regular blood tests about every 8weeks to check your testosterone level to see if abarelix is working for you.If you weigh more than 225 pounds there may be a greater chance that abarelixmay stop working. Your doctor may also want to do blood tests to check yourliver function before and during treatment with abarelix.
This medicine may cause loss in bone mineral density with extended treatment.Loss in bone mineral density can lead to the thinning of bones (osteoporosis).If you have any questions about this ask your doctor.
This medicine can cause a change in heart rhythm called prolongation ofthe QTc interval. This condition may change the way your heart beats and cancause fainting and serious side effects in some patients. Contact your doctor right away if you have any of these symptoms or any questionsabout this.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome.
More common
Back pain; bladder pain; breast enlargement; breast pain; bloating or swelling of face, arms, hands, lower legs, or feet; bloody or cloudy urine; body aches or pain; burning while urinating; chills; cough; decrease in frequency of urination; decrease in urinevolume; diarrhea; difficult,burning, or painful urination; difficulty havinga bowel movement (stool); difficulty in passing urine[dribbling]; dizziness; ear congestion; feeling of warmth; fever; frequent urge to urinate; headache; loss of voice; lower back or side pain; nasal congestion; nausea; pain; rapid weight gain; nipple enlargement; redness of the face, neck, arms and occasionally upper chest; runny nose; sneezing; sore throat; sweating; tingling of hands or feet; trouble inholding or releasing urine; trouble in sleeping; unusual tiredness or weakness; unusualweight gain or loss
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Developed: 03/15/2004
Revised: 02/01/2006
