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
- 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
- Skin rash
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
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
- Headache
- loss of appetite
- nausea
- unusual tiredness
- vomiting
Less common
- 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
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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More about Cladribine Novaplus (cladribine)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: antimetabolites
- Breastfeeding
Patient resources
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Professional resources
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Related treatment guides
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.