Warnings:

This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as white cells, red cells, and platelets). This effect can weaken the immune system/increase the risk of infection, cause anemia, or cause your body to bruise or bleed easier. Tell your doctor right away if you develop any of the following: signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

When used in high doses, cladribine may cause very serious kidney or nerve problems. Nerve problems may also rarely occur in patients taking the normal dose of cladribine. Get medical help right away if you develop any of the following: change in the amount of urine, weakness/numbness/tingling in your hands/feet, or inability to move your arms/legs.

Cladribine may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking, seizures, or sudden vision changes. See also Side Effects section.

Warnings:

This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as white cells, red cells, and platelets). This effect can weaken the immune system/increase the risk of infection, cause anemia, or cause your body to bruise or bleed easier. Tell your doctor right away if you develop any of the following: signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

When used in high doses, cladribine may cause very serious kidney or nerve problems. Nerve problems may also rarely occur in patients taking the normal dose of cladribine. Get medical help right away if you develop any of the following: change in the amount of urine, weakness/numbness/tingling in your hands/feet, or inability to move your arms/legs.

Cladribine may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking, seizures, or sudden vision changes. See also Side Effects section.

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Uses

Cladribine is used to treat a certain type of cancer (hairy cell leukemia). It works by stopping the growth of cancer cells.

How to use Leustatin Solution

This medication is given by injection into a vein by a health care professional. Dosage is based on your weight and response to treatment. This medication is usually given continuously for 7 days in a row or as directed by your doctor.

Avoid getting the medication on the skin or in the eyes, mouth, or nose. If you do get the medication in those areas, flush with plenty of water and tell your doctor right away.

Side Effects

See also Warning section.

Nausea, vomiting, dizziness, headache, cough, diarrhea, joint/muscle pain, trouble sleeping, stomach/abdominal pain, constipation, or pain/swelling/redness at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: pain/swelling/redness of arms or legs, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Cladribine can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using cladribine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, nerve/muscle disorder, blood/bone marrow disorder, recent/current infections.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist that you are using this medication.

Tell your health care professional that you are using cladribine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as cyclosporine, natalizumab, rituximab, drugs to treat cancer like irinotecan), other drugs that worsen kidney problems (including NSAIDs such as ibuprofen).

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: weakness/numbness/tingling in your hands/feet, inability to move your arms/legs, change in the amount of urine, signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

Notes

Laboratory and/or medical tests (such as complete blood count, hemoglobin, platelets, kidney/liver function) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.