Summary

Commonly reported side effects of clofarabine include: febrile neutropenia, herpes simplex infection, infection, oral candidiasis, pericardial effusion, pleural effusion, pneumonia, respiratory distress, sepsis, staphylococcal infection, abdominal pain, anxiety, arthralgia, back pain, cellulitis, confusion, constipation, cough, depression, dermatitis, diarrhea, dizziness, drowsiness, dyspnea, edema, epistaxis, erythrodysesthesia syndrome, fatigue, fever, gingival hemorrhage, headache, hematuria, hepatomegaly, hypertension, hypotension, jaundice, lethargy, limb pain, mucositis, myalgia, nausea, neutropenia, pain, petechia, pruritus, rigors, sore throat, tachycardia, transfusion reaction, tremor, vomiting, weight loss, anorexia, bacteremia, decreased appetite, erythema of skin, flushing, irritability, pain at injection site, and xeroderma. Other side effects include: increased serum creatinine. Continue reading for a comprehensive list of adverse effects.

Applies to clofarabine: intravenous solution.

Serious side effects of Clofarabine

Along with its needed effects, clofarabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking clofarabine:

More common

• Abdominal or stomach pain or tenderness
• area rash
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• bloody nose
• blurred vision
• burning or stinging of the skin
• chest pain
• chills
• clay-colored stools
• cold or flu-like symptoms
• confusion
• cough or hoarseness
• dark urine
• decreased urine output
• diarrhea
• difficult or labored breathing
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• facial swelling
• fainting
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• flushing, redness of the skin
• headache
• irregular breathing
• itching in the genital area
• itching or skin rash
• joint pain, stiffness, or swelling
• lightheadedness
• loss of appetite
• lower back or side pain
• nausea
• nervousness
• pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid, shallow breathing
• redness of the face, neck, arms, and occasionally, upper chest
• redness, swelling, or skin pain
• scaling of the skin on the hands and feet
• severe abdominal or stomach cramps with pain
• slow or fast heartbeat
• small red or purple spots on the skin
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swelling of the ankles, feet, or lower legs
• swelling or inflammation of the mouth
• swollen glands
• tenderness
• tightness in the chest
• tingling of the hands and feet
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusually warm skin
• vomiting
• vomiting of blood
• warmth on the skin
• watery and severe diarrhea, which may also be bloody
• weight gain
• yellow eyes or skin

Less common

• Agitation
• bloating
• blue lips and fingernails
• chest pain or discomfort
• cloudy urine
• constipation
• coughing that sometimes produces a pink frothy sputum
• darkened urine
• decrease or increase in the amount of urine
• decreased level of consciousness
• depression
• difficult, fast, or noisy breathing
• dry mouth
• general feeling of discomfort or illness
• hives
• hostility
• hyperventilation
• increased sweating
• indigestion
• irritability
• muscle aches and pains
• muscle twitching
• pain or tenderness around the eyes and cheekbones
• pains in the stomach, side, or abdomen, possibly radiating to the back
• rapid weight gain
• restlessness
• seizures
• shaking
• shivering
• stuffy or runny nose
• swelling of the eyelids, face, lips, or hands
• trouble sleeping

Incidence not known

• Blistering, peeling, or loosening of the skin
• red irritated eyes
• red skin lesions, often with a purple center

Other side effects of Clofarabine

Some side effects of clofarabine 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

• Back pain
• bone pain
• bruises on the skin
• cracked lips
• difficulty with moving
• difficulty with swallowing
• discouragement
• dry skin
• fear
• feeling sad or empty
• feeling unusually cold
• injection site pain
• itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
• lack or loss of strength
• loss of interest or pleasure
• muscle pain or stiffness
• pain in the limbs
• pain in the rectum
• right upper stomach pain and fullness
• skin discoloration
• sore mouth or tongue
• swollen joints
• tiredness
• trouble concentrating
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually warm skin
• weight loss
• white patches with diaper rash

For Healthcare Professionals

Applies to clofarabine: intravenous solution.

Gastrointestinal

Very common (10% or more): Vomiting (78%), nausea (73%), diarrhea (56%), abdominal pain (35%), gingival or mouth bleeding (17%), mucosal inflammation (16%)

Common (1% to 10%): Upper abdominal pain, oral mucosal petechiae, proctalgia, stomatitis, cecitis, pancreatitis

Postmarketing reports: GI hemorrhage (including fatalities)^[Ref]

Other

Very common (10% or more): Pyrexia (39%), chills (34%), fatigue (34%), pain (15%), edema (12%), asthenia (10%)^[Ref]

Hematologic

Very common (10% or more): Leukopenia (88%), anemia (83%), lymphopenia (82%), thrombocytopenia (81%), neutropenia (64%), febrile neutropenia (55%), nonfebrile neutropenia (10%)^[Ref]

Dermatologic

Very common (10% or more): Pruritus (43%), rash (38%), petechiae (26%), palmar-plantar erythrodysesthesia syndrome (16%), erythema (11%)

Common (1% to 10%): Rash pruritic

Postmarketing reports: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) (including fatal cases)^[Ref]

Nervous system

Very common (10% or more): Headache (43%), anxiety (21%), lethargy (10%), somnolence (10%)

Common (1% to 10%): Agitation^[Ref]

Hepatic

Very common (10% or more): SGPT elevated (81%), SGOT elevated (74%), bilirubin elevated (45%)

Common (1% to 10%): Jaundice, hyperbilirubinemia^[Ref]

Cardiovascular

Very common (10% or more): Tachycardia (35%), hypotension (29%), flushing (19%), hypertension (13%)

Common (1% to 10%): Pericardial effusion^[Ref]

Respiratory

Very common (10% or more): Epistaxis (27%), dyspnea (13%), pleural effusion (12%), pneumonia (10%), respiratory distress (10%), respiratory syncytial virus infection, sinusitis

Common (1% to 10%): Upper respiratory tract infection, tachypnea, pulmonary edema^[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (34%), myalgia (16%), back pain (12%), bone pain (11%)

Common (1% to 10%): Arthralgia^[Ref]

Psychiatric

Very common (10% or more): Irritability (11%)

Common (1% to 10%): Mental status change^[Ref]

Genitourinary

Very common (10% or more): Hematuria (13%)^[Ref]

Renal

Very common (10% or more): Creatinine elevated (50%)^[Ref]

Oncologic

Common (1% to 10%): Tumor lysis syndrome^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Immunologic

Very common (10% or more): Sepsis, including septic shock (17%), catheter related infection (12%), herpes simplex (10%)

Common (1% to 10%): Clostridium colitis, bacteremia, staphylococcal bacteremia, staphylococcal sepsis, candidiasis, cellulitis, herpes zoster, oral candidiasis, bacterial infection, enterococcal bacteremia, escherichia bacteremia, escherichia sepsis, fungal infection, fungal sepsis, gastroenteritis adenovirus, infection, influenza, parainfluenza virus infection, pneumonia fungal, pneumonia primary atypical, staphylococcal infection^[Ref]

Metabolic

Very common (10% or more): Anorexia (30%)

Postmarketing reports: Hyponatremia^[Ref]