Leustatin Side Effects

Generic Name: cladribine

Note: This document contains side effect information about cladribine. Some of the dosage forms listed on this page may not apply to the brand name Leustatin.

Some side effects of Leustatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cladribine: intravenous solution

Along with its needed effects, cladribine (the active ingredient contained in Leustatin) 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
  • 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

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

More common
  • Skin rash
Less common
  • 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:

More common
  • Anemia
  • low white cell counts in blood

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
  • 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 in sleeping
  • weakness

For Healthcare Professionals

Applies to cladribine: intravenous solution

Hematologic

Very common (10% or more): Neutropenia (up to 70%), anemia (up to 37%), thrombocytopenia (up to 12%)
Common (1% to 10%): Febrile neutropenia (8%)
Postmarketing reports: Bone marrow suppression with pancytopenia, aplastic anemia, hemolytic anemia, myelodysplastic syndrome

Renal

Postmarketing reports: Acute renal failure, renal impairment

Gastrointestinal

Very common (10% or more): Nausea (22%)
Common (1% to 10%): Vomiting (9%), diarrhea (7%), constipation (4%), abdominal pain (4%), flatulence (1%)

Dermatologic

Very common (10% or more): Rash (16%)
Common (1% to 10%): Hyperhidrosis (3%), petechiae (2%), pruritus (2%), ecchymosis (2%)
Postmarketing reports: Urticaria, hypereosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness (6%)
Postmarketing reports: Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy, polyneuropathy, paraparesis)

Profound (proximal > distal) extremity motor weakness has been described in some patients who received relatively large doses of 0.45 to 0.52 mg/kg per day. Some affected patients were unable to walk and experienced numbness, paresthesia, and hyperesthesia. Nerve conduction velocity studies in affected patients showed markedly decreased compound muscle action potential amplitude, absent or delayed F-wave and H-reflex responses, and (per EMG) polyphasic potentials without evidence of myopathic changes. Overall, the findings were consistent with a symmetric axonal peripheral polyneuropathy with prominent motor involvement.

Local

Very common (10% or more): Administration site reaction (11%)

Metabolic

Postmarketing reports: Tumor lysis syndrome

Cardiovascular

Common (1% to 10%): Tachycardia (2%)

Musculoskeletal

Common (1% to 10%): Myalgia (6%), pain (6%), arthralgia (6%), muscular weakness (1%)

Respiratory

Common (1% to 10%): Cough (7%), dyspnea (5%), abnormal breath sounds (4%), rales (1%)
Postmarketing reports: Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis)

Hypersensitivity

Postmarketing reports: Hypersensitivity

Hepatic

Postmarketing reports: Increased bilirubin, increased transaminases

Immunologic

Very common (10% or more): Infection (up to 28%)
Common (1% to 10%): Serious infection (up to 6%)
Postmarketing reports: Septic shock, opportunistic infections

Ocular

Postmarketing reports: Conjunctivitis

Other

Very common (10% or more): Pyrexia (33%), fatigue (31%),
Common (1% to 10%): Decreased appetite (8%), asthenia (6%), malaise (5%), chills (2%), peripheral edema (2%), contusion (1%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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