Note: This document contains side effect information about cladribine. Some dosage forms listed on this page may not apply to the brand name Leustatin.
Applies to cladribine: oral tablet. Other dosage forms:
- intravenous solution
Warning
Oral route (Tablet)
MalignancyTreatment with cladribine may increase the risk of malignancy. Cladribine is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine on an individual patient basis. Follow standard cancer screening guidelines in patients treated with cladribine.Risk of TeratogenicityCladribine is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with cladribine in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course. Stop cladribine if the patient becomes pregnant.
Serious side effects of Leustatin
Along with its needed effects, cladribine (the active ingredient contained in Leustatin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cladribine:
More common
- Body aches or pain
- chills
- cough
- ear congestion
- fast heartbeat
- fever
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- loss of voice
- lower back or side pain
- painful or difficult urination
- redness of the skin
- runny or stuffy nose
- sneezing
- sore throat
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- unusual tiredness or weakness
Less common
- Blurred vision
- cough producing mucus
- discouragement
- dizziness
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- nervousness
- pounding in the ears
- slow heartbeat
- trouble concentrating
- trouble sleeping
Rare
- Burning or stinging of the skin
- confusion
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- seizures
- stiff neck
- vomiting
Incidence not known
- Blistering, peeling, loosening of the skin
- chest pain
- diarrhea
- muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
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
- Back pain
- difficulty in moving
- muscle stiffness
- trouble sleeping
Less common
- Thinning or loss of hair
For Healthcare Professionals
Applies to cladribine: intravenous solution, oral tablet.
Hematologic
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]
