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.

Some side effects of Cladribine Novaplus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cladribine: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking cladribine (the active ingredient contained in Cladribine Novaplus) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• numbness, tingling, weakness, or burning pain in your fingers or toes;

• numbness or tingly feeling around your mouth;

• a light-headed feeling, like you might pass out;

• redness, swelling, or itching under your skin;

• lower back pain, blood in your urine, urinating less than usual or not at all;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, feeling short of breath;

• pale or yellowed skin, dark colored urine, fever, confusion;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

• signs of infection such as fever, chills, sore throat, flu symptoms, cough with yellow or green mucus, loss of appetite, mouth sores, unusual weakness.

Common side effects may include:

• headache, tired feeling;

• nausea, diarrhea, constipation;

• mild itching or skin rash;

• cough; or

• pain, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cladribine: intravenous solution

Hematologic

Very common (10% or more): Neutropenia (up to 70%), anemia (up to 37%), thrombocytopenia (up to 12%)
Common (1% to 10%): Febrile neutropenia (8%)
Postmarketing reports: Bone marrow suppression with pancytopenia, aplastic anemia, hemolytic anemia, myelodysplastic syndrome

Renal

Postmarketing reports: Acute renal failure, renal impairment

Gastrointestinal

Very common (10% or more): Nausea (22%)
Common (1% to 10%): Vomiting (9%), diarrhea (7%), constipation (4%), abdominal pain (4%), flatulence (1%)

Dermatologic

Very common (10% or more): Rash (16%)
Common (1% to 10%): Hyperhidrosis (3%), petechiae (2%), pruritus (2%), ecchymosis (2%)
Postmarketing reports: Urticaria, hypereosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness (6%)
Postmarketing reports: Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy, polyneuropathy, paraparesis)

Profound (proximal > distal) extremity motor weakness has been described in some patients who received relatively large doses of 0.45 to 0.52 mg/kg per day. Some affected patients were unable to walk and experienced numbness, paresthesia, and hyperesthesia. Nerve conduction velocity studies in affected patients showed markedly decreased compound muscle action potential amplitude, absent or delayed F-wave and H-reflex responses, and (per EMG) polyphasic potentials without evidence of myopathic changes. Overall, the findings were consistent with a symmetric axonal peripheral polyneuropathy with prominent motor involvement.

Local

Very common (10% or more): Administration site reaction (11%)

Metabolic

Postmarketing reports: Tumor lysis syndrome

Cardiovascular

Common (1% to 10%): Tachycardia (2%)

Musculoskeletal

Common (1% to 10%): Myalgia (6%), pain (6%), arthralgia (6%), muscular weakness (1%)

Respiratory

Common (1% to 10%): Cough (7%), dyspnea (5%), abnormal breath sounds (4%), rales (1%)
Postmarketing reports: Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis)

Hypersensitivity

Postmarketing reports: Hypersensitivity

Hepatic

Postmarketing reports: Increased bilirubin, increased transaminases

Immunologic

Very common (10% or more): Infection (up to 28%)
Common (1% to 10%): Serious infection (up to 6%)
Postmarketing reports: Septic shock, opportunistic infections

Ocular

Postmarketing reports: Conjunctivitis

Other

Very common (10% or more): Pyrexia (33%), fatigue (31%),
Common (1% to 10%): Decreased appetite (8%), asthenia (6%), malaise (5%), chills (2%), peripheral edema (2%), contusion (1%)

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