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Cladribine Novaplus Side Effects

Generic name: cladribine

Medically reviewed by Drugs.com. Last updated on Aug 6, 2023.

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

Applies to cladribine: intravenous solution. Other dosage forms:

Warning

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

Serious side effects of Cladribine Novaplus

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

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

More common

Less common

This medicine may also cause the following side effects that your doctor will watch out for:

More common

Other side effects of Cladribine Novaplus

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, 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]

Frequently asked questions

References

1. Product Information. Leustatin (cladribine). Ortho Biotech Inc. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. 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.