Cladribine (injection)

Cladribine is a cancer medicine that treats hairy cell leukemia (a type of blood cancer).

Cladribine may also be used for reasons not mentioned in this medication guide.

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

Cladribine is usually given continuously for 7 days in a row. Your doctor will decide how many 7-day treatments you will have 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 cladribine accidentally gets on your skin, wash it thoroughly with soap and warm water.

Cladribine can raise your chances of bleeding or getting an infection. Contact your doctor if you notice unusual bruising or bleeding, or if you have new symptoms of infection (like fever, chills, cough, chest pain, mouth sores, skin sores, sore throat, or trouble breathing).

Taking very high doses of cladribine (injection) can lead to nerve damage or paralysis that might not be reversible. However, this is uncommon when cladribine is used at the recommended doses.

You should not use cladribine if you are allergic to it.

Tell your doctor if you have ever had:

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

Cladribine may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using cladribine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Cladribine may cause serious side effects. Call your doctor right away if you experience:

• 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 of cladribine 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.

Usual Adult Dose for Hairy Cell Leukemia:

0.09 mg/kg/day by continuous IV infusion for 7 daysAlternate dosing recommendation:-Subcutaneous bolus injection: 0.14 mg/kg/day subcutaneously for 5 consecutive days -IV infusion: 0.1 mg/kg/day IV for 7 consecutive days -Under certain hematological conditions (e.g., recovery of severe myelosuppression) a small number of patients may require a second cycle and occasionally a third cycle to achieve a stable and prolonged response.Comments:-Physicians should consider delaying or discontinuing therapy if neurotoxicity or renal toxicity occurs.-Consult the individual manufacturer product information for dosing recommendations.Use: For the primary or secondary treatment of patients with Hairy Cell Leukemia (HCL)

Since this medication is given in a healthcare setting 24 hours a day, you will not miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Very high doses of cladribine injection can cause nerve damage. In some people, this has led to 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.

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), 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.

Cladribine can damage your kidneys, particularly if you are taking other medications for infections, cancer, osteoporosis, preventing organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (such as Advil, Motrin, and Aleve).

Other drugs can also interact with cladribine, including both prescription and over-the-counter medications, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicines you begin or stop using.