Cladribine Novaplus Side Effects

Generic name: cladribine

Medically reviewed by Drugs.com. Last updated on Aug 27, 2024.

Note: This document provides detailed information about Cladribine Novaplus Side Effects associated with cladribine. Some dosage forms listed on this page may not apply specifically to the brand name Cladribine Novaplus.

Applies to cladribine: intravenous solution.

Other dosage forms:

• oral tablet

Important warnings This medicine can cause some serious health issues

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 side effects

• 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
• skin rash
• anemia
• low white cell counts in blood

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

Less common side effects

• 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:

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 side effects

• headache
• loss of appetite
• nausea
• unusual tiredness
• vomiting

Less common side effects

• 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, oral tablet.

Hematologic adverse events

• 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]

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Further information

Cladribine Novaplus side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer