CLADRIBINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Leustatin

In Canada?

• Leustatin

Other commonly used names are 2-chlorodeoxyadenosine and 2-CdA.

Category

• Antineoplastic

Description

Cladribine (KLAD-ri-been) belongs to the group of medicines called antimetabolites.It is used to treat hairy cell leukemia, a cancer of the blood and bone marrow.It is also sometimes used to treat other kinds of cancer, as determined byyour doctor.

Cladribine interferes with the growth of cancer cells, which are eventuallydestroyed. Since the growth of normal body cells may also be affected by cladribine,other effects will also occur. Some of these may be serious and must be reportedto your doctor. Other effects may not be serious but may cause concern. Someeffects may not occur for months or years after the medicine is used.

Before you begin treatment with cladribine, you and your doctor shouldtalk about the good this medicine will do as well as the risks of using it.

Cladribine is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and 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 cladribine, thefollowing should be considered:

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

Pregnancy?There is a chance that this medicine may cause birthdefects if either the male or female is taking it at the time of conceptionor if it is taken during pregnancy. Cladribine has been shown to cause birthdefects in mice and rabbits. In addition, many cancer medicines may causesterility which could be permanent. Although sterility has not been reportedwith this medicine, fertility problems do occur in male monkeys and the possibilityshould be kept in mind.

Be sure that you have discussed this with your doctor before receivingthis medicine. It is best to use some kind of birth control while you arereceiving cladribine. Tell your doctor right away if you think you have becomepregnant while receiving cladribine.

Breast-feeding?It is not known whether cladribine passes intobreast milk. However, because this medicine may cause serious side effects,breast-feeding is generally not recommended while you are receiving it.

Children?There is no specific information comparing use ofcladribine in children with use in other age groups. However, cladribine hasbeen reported to be tested in children with certain types of cancers of theblood.

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. Although there is no specific informationcomparing use of cladribine in the elderly with use in other age groups, itis not expected to cause different side effects or problems in older peoplethan it does 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 receivingcladribine it is especially important that your health care professional knowif you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines?Cladribinemay increase the effects of these medicines or radiation therapy on the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Cladribine may raise the amountof uric acid in the blood. Since these medicines are used to lower uric acidlevels, they may not be as effective in patients receiving cladribine

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

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• Gout (history of) or
• Kidney stones (history of)?Cladribine may increase levels ofuric acid in the body, which can cause gout or kidney stones

• Infection?Cladribine may decrease your body's ability to fightinfection

Proper Use of This Medicine

This medicinemay cause mild nausea and may also cause vomiting. However, it is very importantthat you continue to receive the medicine even if you begin to feel ill. Askyour health care professional for ways to lessen these effects.

Dosing?The dose of cladribine 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 weight, and whetheror not other medicines are also being taken. If you arereceiving cladribine at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of cladribine,ask your doctor.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check forunwanted effects.

While you are being treated with cladribine, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Cladribine may lower your body's resistanceand 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 the sameroom with them for very long. If you cannot take these precautions, you shouldconsider wearing a protective face mask that covers the nose and mouth.

Cladribine 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, colds, or flu. Check with your doctor immediately if you think you are getting aninfection or if you get a fever or chills, cough or hoarseness, lower backor 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.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Some side effects will have signs or symptoms that you can see or feel. Yourdoctor may watch for others by doing certain tests.

Also, because of the way cancer medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These delayed effects may include certaintypes of cancer. Discuss these possible effects with your doctor.

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

More common

Black, tarry stools; blood in urine; cough or hoarseness, accompanied by fever or chills; fever; lower back or sidepain, accompanied by fever or chills; painful ordifficult urination, accompanied by fever or chills; pinpoint red spots on skin; unusual bleeding or bruising

Check with your health care professional as soon as possible if any ofthe following side effects occur:

More common

Skin rash

Less common

Pain or redness at place of injection; shortness of breath; stomach pain; swelling of feet or lower legs; unusually fast heartbeat

This medicine may also cause the following side effects that your doctorwill watch out for:

More common

Anemia; low white cell counts in blood

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. Also, your health care professional may be able to tell youabout ways to prevent or reduce some of these side effects. Check with yourhealth care professional if any of the following side effects continue orare bothersome or if you have any questions about them:

More common

Headache; loss of appetite; nausea; unusual tiredness; vomiting

Less common

Constipation; diarrhea; dizziness; general feeling of discomfortor illness; itching; muscleor joint pain; sweating; trouble in sleeping; weakness

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, cladribine is used in certain patients with the following conditions:

• Cancer of the blood and lymph system
• Waldenstr?m's macroglobulinemia (a certain type of cancer ofthe blood)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.