Leustatin (Intravenous)

Cladribine is part of a group of medicines known as antimetabolites. It is used to treat hairy cell leukemia, which is a cancer affecting the blood and bone marrow. Your doctor may also use it to treat other types of cancer.

Cladribine works by interfering with the growth of cancer cells, which are then destroyed. It can also affect the growth of normal body cells, leading to additional effects. Some of these effects may be serious and should be reported to your doctor. Other effects might not be serious but could cause concern. Some effects may not appear for months or even years after using the medicine.

Before starting treatment with cladribine, you and your doctor should discuss the benefits of this medicine as well as the risks associated with its use.

Cladribine must be given only by or under the close supervision of your doctor.

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

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

Cladribine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count 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 an infection or 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 if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine 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 your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

In deciding to use a medicine, you need to consider the risks and benefits together with your doctor. For this medicine, keep the following in mind:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information on how cladribine works in children compared to other age groups. However, cladribine has been reported to be tested in children with certain types of blood cancers.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known if they work the same way as they do in younger adults. While there is no specific information comparing cladribine use in older people to other age groups, it is not expected to cause different side effects or problems in older adults than in younger adults.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In these cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it's especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

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

• Infection—Cladribine may lower your body's ability to fight infection

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

Also, because of how cancer medicines work in the body, there is a chance that they might cause other unwanted effects that may not happen until months or years after the medicine is used. These delayed effects may include certain types of cancer. Talk about these possible effects with your doctor.

Check with your doctor right away if any of the following side effects happen:

More common

• Black, tarry stools
• Blood in urine
• Cough or hoarseness, along with fever or chills
• Fever
• Lower back or side pain, along with fever or chills
• Painful or difficult urination, along with fever or chills
• Pinpoint red spots on skin
• Unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects happen:

More common

• Skin rash

Less common

• Pain or redness at the injection site
• 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 doctor will monitor:

More common

• Anemia
• Low white cell counts in blood

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are 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 discomfort or illness
• Itching
• Muscle or joint pain
• Sweating
• Trouble sleeping
• Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Leustatin

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Chemical Class: Purine Nucleoside Analog

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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