Cladribine (Intravenous)

Cladribine is part of a group of medicines known as antimetabolites. It is used to treat hairy cell leukemia, a type of cancer affecting the blood and bone marrow. It may also be used for other types of cancer, based on your doctor's decision.

Cladribine works by interfering with the growth of cancer cells, which are eventually destroyed. Since it can also affect the growth of normal body cells, there may be additional effects. Some of these effects can be serious and need to be reported to your doctor. Other effects might not be serious but could still 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 its risks.

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

It is very important that your doctor checks your progress during regular visits to ensure that this medicine is working properly and to look for unwanted side effects.

While you are being treated with cladribine, and after you stop treatment with it, do not get any immunizations (vaccinations) without your doctor's approval. Cladribine may weaken your body's defense system, and there is a chance you could get the infection that the immunization is supposed to prevent. Also, people living with you should not receive the oral polio vaccine, as they could spread the polio virus to you. Additionally, stay away from anyone who has taken the oral polio vaccine in the last several months. Do not be close to them and do not stay in the same room with them for a long time. If you cannot follow these precautions, consider wearing a protective face mask that covers your nose and mouth.

Cladribine can temporarily reduce the number of white blood cells in your blood, which increases your risk of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this happens, there are some precautions you can take, especially when your blood count is low, to lower the risk of infection or bleeding:

• If you can, avoid people with infections, colds, or flu. Contact your doctor right away if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or tiny red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your 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 since then.
• Be careful not to cut yourself when using sharp objects like a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

There is no specific information comparing the use of cladribine in children with its use in other age groups. However, cladribine has been reported to have been tested in children with certain types of blood cancers.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Certain medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are 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 adjust the dose or frequency of use for 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

Certain medicines should not be used around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, 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 decrease your body's ability to fight infection

Along with its needed effects, this 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 they might cause other unwanted effects that may not happen until months or years after using the medicine. These delayed effects may include certain types of cancer. Talk about these possible effects with your doctor.

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

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 occur:

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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare 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 healthcare 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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