AMSACRINE (Systemic)*

Some commonly used brand names are:

In Canada?

• AMSA P-D

Other commonly used names are acridinyl anisidide and m-AMSA.

* Not commercially available in the U.S.

Category

• Antineoplastic

Description

Amsacrine (AM-sah-kreen) belongs to the general group of medicinesknown as antineoplastics. It is used to treat acute adult leukemia.

Amsacrine interferes with the growth of cancer cells, which are then eventuallydestroyed by the body. Since the growth of normal body cells may also be affectedby amsacrine, other effects will also occur. Some of these may be seriousand must be reported to your doctor. Other effects, like hair loss, may notbe serious but may cause concern. Some effects may not occur until monthsor years after the medicine is used.

Before you begin treatment with amsacrine, you and your doctor should talkabout the good this medicine will do as well as the risks of using it.

Amsacrine is to be administered only by or under the supervision of yourdoctor. It is available in the following dosage form:

Parenteral
• Injection (Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For amsacrine, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to amsacrine.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Before receiving amsacrine make sure your doctor knows if you are pregnantor if you may become pregnant. It is best to use some kind of birth controlwhile you are receiving amsacrine. Tell your doctor right away if you thinkyou have become pregnant while receiving amsacrine.

Breast-feeding? Amsacrine is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of amsacrinein children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof amsacrine in the elderly with use in other age groups.

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 receivingamsacrine, it is especially important that your health care professionalknow if you are taking any of the following:

• Acyclovir (e.g., Zovirax) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine taken by mouth) or
• Anti-infectives by mouth or by injection (medicine for infection)or
• Antipsychotics (medicine for mental illness) or
• Captopril (e.g., Capoten) or
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Gold salts (medicine for arthritis) or
• Imipenem or
• Inflammation or pain medicine, except narcotics or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tiopronin (e.g., Thiola) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril)?Concurrent use of these agentswith amsacrine may cause blood disorders

• Alpha interferons (e.g., Intron A, Roferon-A) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g. Cytoxan) or
• Flucytosine (e.g. Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Zidovudine (e.g., AZT, Retrovir)?Concurrent use of these agentswith amsacrine increases the risk of infection

• If you have ever been treated with radiation or cancer medicines?Amsacrinemay increase the effects of these medicines or radiation therapy on the blood

Other medical problems?The presence of other medicalproblems may affect the use of amsacrine. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Bone marrow depression or
• Infection?There may be an increased risk of infections orworsening infections because of the body's reduced ability to fight them

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body
• Heart rhythm problems?Patients who have problems with heartrhythms may have increased problems while taking amsacrine
• Kidney disease or
• Liver disease?Effects of amsacrine may be increased becauseof its slower removal from the body

Proper Use of This Medicine

Amsacrineoften causes nausea and vomiting. However, it is very important that you continueto receive the medication, even if you begin to feel ill. Ask your healthcare professional for ways to lessen these effects.

Dosing?The dose of amsacrine will be different fordifferent patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's body size, andwhether or not other medicines are also being taken. If you are taking or receiving amsacrine at home, follow your doctor's ordersor the directions on the label.If you have any questions about theproper dose of amsacrine, ask your doctor.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

While you are being treated with amsacrine, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Amsacrine may lower your body's resistance,and there is a chance you might get the infection the immunization is meantto prevent. In addition, other persons living in your household should nottake oral polio vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them, and do not stay in thesame room with them for very long. If you cannot take these precautions, youshould consider wearing a protective face mask that covers the nose and mouth.

Amsacrine can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
• Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick.Your medical doctor, dentist, or nurse may recommend other ways to clean yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

If amsacrine accidentally leaks out of the vein into which it is injected,it may damage some tissues and cause scarring. Tell thedoctor or nurse right away if you notice redness, pain, or swelling at theplace of injection.

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.

Check with your doctoror nurse immediately if any of the following side effects occur:

More common

Accumulation of pus or swollen, red, tender area of infectionaround the rectum; Black tarry stools; blood in urine or stools; cough or hoarseness; fever or chills; lowerback or side pain; painful or difficult urination; pinpoint red spots on skin; sores, ulcers, or white spots on lips, tongue, or inside mouth; unusual bleeding or bruising; unusualtiredness or weakness

Less common

Abdominal pain or tenderness; blurredvision; confusion; darkurine; diarrhea; dizziness,faintness, or light-headedness ; fast, pounding,or irregular heartbeat or pulse; fever; itching; nausea; palpitations; convulsions (seizures); vomiting or vomiting of blood or material that looks like coffeegrounds; yellow eyes or skin

Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

More Common

Burning, crawling, numbness, prickling, ?pins and needles?,or tingling feelings; headache

Less common

This medicine often causes a temporaryloss of hair. After treatment with amsacrine has ended, normal hair growthshould return.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.