Clofarabine Side Effects

Brand Names: Clolar

Please note - some side effects for Clofarabine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Clofarabine - for the Consumer

Clofarabine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clofarabine:

Back pain; constipation; cough; decreased weight; diarrhea; dizziness; drowsiness; dry or irritated skin; flushing; gum bleeding; headache; itching; joint or muscle pain or weakness; loss of appetite; minor pain, swelling, or redness at the injection site; nausea; stomach pain; swelling or soreness of the mouth; tiredness or weakness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or severe swelling or pain at the injection site; blood in the urine; cloudy or dark urine; decreased urination; fainting; fast breathing; fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes; nosebleed; persistent cough; pneumonia; red, swollen, blistered, or peeling skin; severe dizziness or lightheadedness; severe or persistent tiredness or weakness; severe or persistent vomiting or diarrhea; shaking; shortness of breath; small red spots under the skin; swelling of arms or legs; tingling, pain, redness, or swelling of the palms of the hands or soles of the feet; unusual bleeding or easy bruising; unusual tiredness or weakness; unusually pale skin; white patches in the mouth; yellowing of the skin or eyes.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including vomiting (83%), nausea (75%), diarrhea (53%), abdominal pain (36%), anorexia (31%), constipation (21%), gingival bleeding (15%), sore throat (14%), and decreased appetite (11%) have been reported.

Other

Other side effects have included infections and infestations such as sepsis (15%), staphylococcal infection (13%), oral candidiasis (13%), herpes simplex (11%), cellulitis (11%), bacteremia (10%), and pneumonia (10%).

Several cases of capillary leak syndrome have been reported. (Signs and symptoms of cytokine release have included tachypnea, tachycardia, hypotension, and pulmonary edema.) Several patients developed rapid onset of respiratory distress, hypotension, capillary leak (pleural and pericardial effusions), and multi-organ failure.

A total of 85% of patients experienced at least one infection after clofarabine treatment, including fungal, viral, and bacterial infections.

Hematologic

Hematologic side effects including febrile neutropenia (57%), neutropenia (10%), transfusion reactions (10%) and bone marrow failure have been reported.

Dermatologic

Dermatologic side effects including pruritus (47%), dermatitis (41%), petechiae (29%), erythema (18%), palmar-plantar erythrodysesthesia syndrome (13%), contusion (11%), and dry skin (10%) have been reported. Occurrences of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients who were receiving or had recently been treated with clofarabine and other medications (e.g. allopurinol or antibiotics) known to cause these syndromes.

Nervous system

Nervous system side effects including headache (46%), dizziness (16%), somnolence (10%), and tremor (10%) have been reported.

Hepatic

Veno-occlusive disease has been reported in patients that received conditioning regimens that included busulfan, melphalan, and/or the combination of cyclophosphamide and total body irradiation.

Elevations of AST and ALT were transient and typically of less that 2 weeks duration.

Hepatic side effects including jaundice (15%), hepatomegaly (15%), and veno-occlusive disease have been reported. Grade 3 or 4 elevated ALT (44%), grade 3 or 4 elevated AST (38%), and grade 3 or 4 elevated bilirubin (15%) have also been reported.

General

General side effects including pyrexia (41%), rigors (38%), fatigue (36%), edema (20%), pain (19%), mucosal inflammation (18%), lethargy (11%), decreased weight (10%) and systemic inflammatory response syndrome (SIRS) have been reported.

Cardiovascular

Cardiovascular side effects including pericardial effusion (35%), tachycardia (34%), left ventricular systolic dysfunction (27%), hypertension (3%), flushing (2%), and hypotension (1%) have been reported.

Respiratory

Respiratory side effects including epistaxis (31%), cough (19%), respiratory distress (14%), dyspnea (13%), and pleural effusion (10%) have been reported.

Musculoskeletal

Musculoskeletal side effects including pain in limb (29%), myalgia (14%), back pain (13%), and arthralgia (11%) have been reported.

Psychiatric

Psychiatric side effects have been reported including anxiety (22%), depression (11%), and irritability (11%).

Genitourinary

Genitourinary side effects including hematuria (17%) have been reported.

Local

Local side effects including injection site pain (14%) have been reported.

Renal

Renal side effects including grade 3 or 4 elevated creatinine (6%) have been reported.

Oncologic

Oncologic side effects have included clastogenic activity in the in vitro mammalian cell chromosome aberration assay (CHO cells) and in the in vivo rat micronucleus assay.

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