Leustatin Side Effects

Generic name: cladribine

Medically reviewed by Drugs.com. Last updated on Dec 23, 2024.

Note: This document provides detailed information about Leustatin Side Effects associated with cladribine. Some dosage forms listed on this page may not apply specifically to the brand name Leustatin.

Applies to cladribine: intravenous solution.

Other dosage forms:

• oral tablet

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Cladribine injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.

Suppression of bone marrow function should be anticipated.

This is usually reversible and appears to be dose dependent.

Serious neurological toxicity (including irreversible paraparesis and quadriparesis) has been reported in patients who received cladribine injection by continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukemia).

Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Acute nephrotoxicity has been observed with high doses of cladribine (4 to 9 times the recommended dose for hairy cell leukemia), especially when given concomitantly with other nephrotoxic agents/therapies

Precautions

It is very important that your doctor check 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 (the active ingredient contained in Leustatin) 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 persons 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 persons 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 the 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.

Serious side effects of Leustatin

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

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

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

More common side effects

• black, tarry stools
• blood in urine
• cough or hoarseness, accompanied by fever or chills
• fever
• lower back or side pain, accompanied by fever or chills
• painful or difficult urination, accompanied by fever or chills
• pinpoint red spots on skin
• unusual bleeding or bruising
• skin rash
• anemia
• low white cell counts in blood

Check with your doctor as soon as possible if any of the following side effects occur while taking cladribine:

Less common side effects

• pain or redness at place of injection
• 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 watch out for:

Other side effects of Leustatin

Some side effects of cladribine 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 health care professional may be able to tell you about ways 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 side effects

• headache
• loss of appetite
• nausea
• unusual tiredness
• vomiting

Less common side effects

• constipation
• diarrhea
• dizziness
• general feeling of discomfort or illness
• itching
• muscle or joint pain
• sweating
• trouble in sleeping
• weakness

For healthcare professionals

Applies to cladribine: intravenous solution, oral tablet.

Hematologic adverse events

• Very common (10% or more): Neutropenia, thrombocytopenia, anemia, purpura
• Common (1% to 10%): Febrile neutropenia
• Uncommon (0.1% to 1%): Bone marrow suppression with prolonged pancytopenia, aplastic anemia, hypereosinophilia, myelodysplastic syndrome
• Postmarketing reports: Hemolytic anemia, febrile neutropenia^[Ref]

Renal

• Common (1% to 10%): Renal impairment, renal failure

Gastrointestinal

• Very common (10% or more): Nausea (28%), anorexia (17%), vomiting (13%), diarrhea (10%)
• Common (1% to 10%): Constipation, abdominal pain, flatulence
• Uncommon (0.1% to 1%): Mucositis^[Ref]

Dermatologic

• Very common (10% or more): Rash (28%), diaphoresis, pruritus
• Common (1% to 10%): Hyperhidrosis, petechiae, ecchymosis, urticaria
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic skin eruption, toxic epidermal necrolysis
• Rare (less than 0.1%): Alopecia^[Ref]

Nervous system

• Very common (10% or more): Headache
• Common (1% to 10%): Dizziness, somnolence
• Uncommon (0.1% to 1%): Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis)^[Ref]

Local

• Very common (10% or more): Administration site reaction^[Ref]

Metabolic

• Common (1% to 10%): Weight loss
• Uncommon (0.1% to 1%): Tumor lysis syndrome, metabolic acidosis^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, tachycardia, myocardial ischemia, peripheral edema
• Rare (less than 0.1%): Heart failure, arrhythmia, heart murmur, hypotension, thrombosis^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia
• Uncommon (0.1% to 1%): Muscular weakness, paraparesis^[Ref]

Respiratory

• Very common (10% or more): Cough
• Common (1% to 10%): Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis), abnormal breath sounds, abnormal chest sounds, dyspnea, rales^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increases in bilirubin, increases in transaminases, jaundice^[Ref]

Immunologic

• Very common (10% or more): Infection (unspecified) (up to 28%)
• Common (1% to 10%): Bacteremia, cellulitis, localized infection, pneumonia, septic shock, serious infection, opportunistic infection^[Ref]

Ocular

• Postmarketing reports: Conjunctivitis^[Ref]

Other

• Very common (10% or more): Fatigue, pyrexia, pain
• Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills^[Ref]

Oncologic

• Postmarketing reports: Secondary malignancies^[Ref]

Psychiatric

• Common (1% to 10%): Confusion, anxiety, insomnia^[Ref]

See also:

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Further information

Leustatin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer