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
Get emergency medical help if you have any of these signs of an allergic reaction while taking cladribine (the active ingredient contained in Leustatin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
numbness, tingling, weakness, or burning pain in your fingers or toes;
numbness or tingly feeling around your mouth;
a light-headed feeling, like you might pass out;
redness, swelling, or itching under your skin;
lower back pain, blood in your urine, urinating less than usual or not at all;
muscle weakness, tightness, or contraction, overactive reflexes;
fast or slow heart rate, weak pulse, feeling short of breath;
pale or yellowed skin, dark colored urine, fever, confusion;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
signs of infection such as fever, chills, sore throat, flu symptoms, cough with yellow or green mucus, loss of appetite, mouth sores, unusual weakness.
Common side effects may include:
headache, tired feeling;
nausea, diarrhea, constipation;
mild itching or skin rash;
pain, swelling, or irritation around the IV needle.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to cladribine: intravenous solution
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
Postmarketing reports: Acute renal failure, renal impairment
Very common (10% or more): Nausea (22%)
Common (1% to 10%): Vomiting (9%), diarrhea (7%), constipation (4%), abdominal pain (4%), flatulence (1%)
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
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.
Very common (10% or more): Administration site reaction (11%)
Postmarketing reports: Tumor lysis syndrome
Common (1% to 10%): Tachycardia (2%)
Common (1% to 10%): Myalgia (6%), pain (6%), arthralgia (6%), muscular weakness (1%)
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)
Postmarketing reports: Hypersensitivity
Postmarketing reports: Increased bilirubin, increased transaminases
Very common (10% or more): Infection (up to 28%)
Common (1% to 10%): Serious infection (up to 6%)
Postmarketing reports: Septic shock, opportunistic infections
Postmarketing reports: Conjunctivitis
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%)
More Leustatin resources
- Leustatin Prescribing Information (FDA)
- Leustatin MedFacts Consumer Leaflet (Wolters Kluwer)
- Leustatin Concise Consumer Information (Cerner Multum)
- Leustatin Monograph (AHFS DI)
- Leustatin Advanced Consumer (Micromedex) - Includes Dosage Information
- Cladribine Professional Patient Advice (Wolters Kluwer)
- Cladribine Prescribing Information (FDA)
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