cladribine (injection)

What is the most important information I should know about cladribine?

Very high doses of cladribine injection can cause nerve damage or paralysis that may not be reversible. However, this effect is rare when cladribine is given in recommended doses.

What is cladribine?

Cladribine is a cancer medicine that is used to treat hairy cell leukemia (a type of blood cancer).

Cladribine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving cladribine?

Tell your doctor if you have ever had:

• heart problems;
• liver or kidney disease; or
• weak immune system (caused by disease or by using certain medicine).

How is cladribine given?

Cladribine is given as an infusion into a vein. A healthcare provider will give you this injection.

Cladribine is usually given around the clock for 7 days in a row. Your doctor will determine how many 7- day treatments you will receive and how often.

Cladribine can increase your risk of bleeding or infection. You will need frequent medical tests, and your next dose may be delayed based on the results.

If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

What happens if I miss a dose?

Since this medication is given in a healthcare setting around the clock, you will not miss a dose.

What happens if I overdose?

Very high doses of cladribine injection can cause nerve damage. In some people, this has resulted in loss of movement (paralysis) that may not be reversible. However, such severe symptoms are rare when cladribine is given in recommended doses. Talk with your doctor if you have concerns about this risk.

What should I avoid while receiving cladribine?

Do not receive a "live" vaccine while using cladribine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of cladribine?

• numbness, tingling, weakness, or burning pain in your fingers or toes;
• loss of movement in any part of your body;
• redness, swelling, or itching under your skin;
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• signs of infection --fever, chills, cough, chest pain, mouth sores, skin sores, sore throat, trouble breathing; or
• signs of tumor cell breakdown --tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

• fever;
• nausea, vomiting, diarrhea;
• headache, tiredness;
• rash;
• cough; or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cladribine?

Cladribine can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect cladribine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about cladribine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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