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Cladribine Novaplus Side Effects

Generic Name: cladribine

Note: This page contains information about the side effects of cladribine. Some of the dosage forms included on this document 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.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Severity: Moderate

If any of the following side effects occur while taking cladribine, check with your doctor or nurse as soon as possible:

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

Minor Side Effects

Some of the side effects that can occur with cladribine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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, anemia, febrile neutropenia[Ref]

Renal

Common (1% to 10%): Renal failure (including renal failure acute, renal impairment)

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, petechiae
Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic skin eruption, toxic epidermal necrolysis
Rare (less than 0.1%): Alopecia
Very rare (less than 0.01%): Epidermal necrolysis
Postmarketing reports: Hypereosinophilia[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

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, pain
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
Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills, weight loss[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. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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

Not all side effects for Cladribine Novaplus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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