Clolar Side Effects

Generic name: clofarabine

Note: This document contains side effect information about clofarabine. Some of the dosage forms listed on this page may not apply to the brand name Clolar.

Some side effects of Clolar 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 clofarabine: intravenous solution

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

Call your doctor at once if you have:

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

• runny or stuffy nose, cough, rapid heart rate, trouble breathing, swelling and pain in any part of your body;

• lower back pain, blood in your urine, little or no urinating;

• numbness or tingly feeling around your mouth;

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

• pain, redness, numbness, and peeling skin on your hands or feet;

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

• numbness or redness on the palms of your hands or the soles of your feet;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• jaundice (yellowing of the skin or eyes); or

• signs of infection such as fever, chills, sore throat, flu symptoms, pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, mouth sores, unusual weakness.

Common side effects may include:

• nausea, vomiting, diarrhea;

• headache, feeling tired or anxious;

• mild itching or skin rash; or

• warmth, redness, or tingly feeling under your skin.

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 clofarabine: intravenous solution

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. Postmarketing reports have included gastrointestinal hemorrhage some with fatalities.

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 (the active ingredient contained in Clolar) 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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