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Cladribine Novaplus 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 Cladribine Novaplus.

For the Consumer

Applies to cladribine: intravenous solution

Along with its needed effects, cladribine (the active ingredient contained in Cladribine Novaplus) 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

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

Less Common

For Healthcare Professionals

Applies to cladribine: intravenous solution

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Leustatin (cladribine)." Ortho Biotech Inc, Raritan, NJ.

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

More about Cladribine Novaplus (cladribine)

Consumer resources

Other brands: Leustatin

Professional resources

Related treatment guides

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