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Clolar

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ALL is the most common type of pediatric "...

Clolar

Clolar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Clolar (clofarabine) is used to treat acute lymphoblastic leukemia (a type of blood cancer) in children and young adults up to 21 years old. It is usually given after other cancer medicines have been tried without successful treatment. It is a cancer (antineoplastic) medication. Common side effects include pain at the injection site, tiredness, flushing, headache, dizziness, lightheadedness, fainting, drowsiness, back pain, stomach pain, diarrhea, nausea/vomiting (may be severe), and loss of appetite.

The recommended pediatric dose of Clolar is 52 mg/m2 administered as an intravenous infusion over 2 hours daily for 5 consecutive days. Clolar may interact with blood pressure medications, auranofin, lithium, methotrexate, tuberculosis medications, birth control pills or hormone replacement therapy, antiviral medicines, ACE inhibitors, antibiotics, antifungal medications, cholesterol medications, HIV/AIDS medications, medicines used to prevent organ transplant rejection, medicines used to treat ulcerative colitis, pain or arthritis medicines, seizure medications, or other cancer medications. Tell your doctor all medications and supplements you use. Clolar is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Males and females must use 2 forms of birth control (e.g., condoms and birth control pills) during treatment with this drug; consult your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Clolar (clofarabine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Clolar in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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:

  • feeling like you might pass out;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • 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;
  • 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), purple or red pinpoint spots under your skin, loss of appetite, mouth sores, unusual weakness.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, rectal pain;
  • headache, muscle or joint pain;
  • mild itching or skin rash;
  • feeling tired, anxious, irritable; 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Clolar (Clofarabine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Clolar Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain at the injection site, tiredness, flushing, headache, dizziness, lightheadedness, fainting, drowsiness, back pain, stomach pain, diarrhea, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Treatment with clofarabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, taking long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of clofarabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor immediately.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, muscle/joint pain, swelling feet/ankles, mental/mood changes (e.g., anxiety, depression), dark urine, yellowing skin/eyes, fast/difficult breathing, fast heartbeat.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Clofarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Clolar (Clofarabine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clolar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Clolar in 115 pediatric patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) (70 patients) or Acute Myelogenous Leukemia (AML) (45 patients).

In total, 115 pediatric patients treated in clinical trials received the recommended dose of Clolar 52 mg/m² daily x 5. The median number of cycles was 2. The median cumulative amount of Clolar received by pediatric patients during all cycles was 540 mg.

The most common adverse reactions occurring in 10% or more of patients treated with Clolar are: nausea, vomiting, diarrhea, febrile neutropenia, headache, rash, pruritus, pyrexia, fatigue, palmar-plantar erythrodysesthesia syndrome, anxiety, flushing, and mucosal inflammation.

Table 1 lists adverse reactions by System Organ Class, including severe or lifethreatening (NCI CTC Grade 3 or Grade 4), reported in ≥ 5% of the 115 patients in the 52 mg/m²/day dose group (pooled analysis of pediatric patients with ALL and AML). More detailed information and follow-up of certain events is given below.

Table 1: Most Commonly Reported ( ≥ 5% Overall) Adverse Reactions by System Organ Class (N=115 pooled analysis)

System Organ Class1 Preferred Term1 ALL/AML (N=115) Worst NCI Common Terminology Criteria Grade1
3 4 5
N % N % N % N %
Blood and Lymphatic System Disorders Febrile neutropenia 63 54.8 59 51.3 3 2.6 . .
Neutropenia 11 9.6 3 2.6 8 7 . .
Cardiac Disorders Pericardial effusion 9 7.8 . . 1 0.9 . .
Tachycardia 40 34.8 6 5.2 . . . .
Gastrointestinal Disorders Abdominal pain 40 34.8 8 7 . . . .
Abdominal pain upper 9 7.8 1 0.9 . . . .
Diarrhea 64 55.7 14 12.2 . . . .
Gingival or mouth bleeding 20 17.4 8 7 1 0.9 . .
Nausea 84 73 16 13.9 1 0.9 . .
Oral mucosal petechiae 6 5.2 4 3.5 . . . .
Proctalgia 9 7.8 2 1.7 . . . .
Stomatitis 8 7 1 0.9 . . . .
Vomiting 90 78.3 9 7.8 1 0.9 . .
General Disorders and Administration Site Conditions Asthenia 12 10.4 1 0.9 1 0.9 . .
Chills 39 33.9 3 2.6 . . . .
Fatigue 39 33.9 3 2.6 2 1.7 . .
Irritability 11 9.6 1 0.9 . . . .
Mucosal inflammation 18 15.7 2 1.7 . . . .
Edema 14 12.2 2 1.7 . . . .
Pain 17 14.8 7 6.1 1 0.9 . .
Pyrexia 45 39.1 16 13.9 . . . .
Hepatobiliary Disorder Jaundice 9 7.8 2 1.7 . . . .
Infections and Infestations Bacteremia 10 8.7 10 8.7 . . . .
Candidiasis 8 7 1 0.9 . . . .
Catheter related infection 14 12.2 13 11.3 . . . .
Cellulitis 9 7.8 7 6.1 . . . .
Clostridium colitis 8 7 6 5.2 . . . .
Herpes simplex 11 9.6 6 5.2 . . . .
Herpes zoster 8 7 6 5.2 . . . .
Oral candidiasis 13 11.3 2 1.7 . . . .
Pneumonia 11 9.6 6 5.2 1 0.9 1 0.9
Infections and Infestations (continued) Sepsis, including septic shock 19 16.5 6 5.2 4 3.5 9 7.8
Staphylococcal bacteremia 7 6.1 5 4.4 1 0.9 . .
Staphylococcal sepsis 6 5.2 5 4.4 1 0.9 . .
Upper respiratory tract infection 6 5.2 1 0.9 . . . .
Metabolism and Nutrition Disorders Anorexia 34 29.6 6 5.2 8 7 . .
Musculoskeletal and Connective Tissue Disorders Arthralgia 10 8.7 3 2.6 . . . .
Back pain 12 10.4 3 2.6 . . . .
Bone pain 11 9.6 3 2.6 . . . .
Myalgia 16 13.9 . . . . . .
Pain in extremity 34 29.6 6 5.2 . . . .
Neoplasms Benign, Malignant and Unspecified (incl. cysts and polyps) Tumor lysis syndrome 7 6.1 7 6.1 . . . .
Nervous System Disorders Headache 49 42.6 6 5.2 . . . .
Lethargy 12 10.4 1 0.9 . . . .
Somnolence 11 9.6 1 0.9 . . . .
Psychiatric Disorders Agitation 6 5.2 1 0.9 . . . .
Anxiety 24 20.9 2 1.7 . . . .
Renal and Urinary Disorders Hematuria 15 13 2 1.7 . . . .
Respiratory, Thoracic and Mediastinal Disorders Dyspnea 15 13 6 5.2 2 1.7 . .
Epistaxis 31 27 15 13 . . . .
Pleural effusion 14 12.2 4 3.5 2 1.7 . .
Respiratory distress 12 10.4 5 4.4 4 3.5 1 0.9
Tachypnea 10 8.7 4 3.5 1 0.9 . .
Skin and Subcutaneous Tissue Disorders Erythema 13 11.3 . . . . . .
Palmar-plantar erythrodysesthesia syndrome 18 15.7 8 7 . . . .
Petechiae 30 26.1 7 6.1 . . . .
Pruritus 49 42.6 1 0.9 . . . .
Rash 44 38.3 8 7 . . . .
Rash pruritic 9 7.8 . . . . . .
Vascular Disorders Flushing 22 19.1 . . . . . .
Hypertension 15 13 6 5.2 . . . .
Hypotension 33 28.7 13 11.3 9 7.8 . .
1 Patients with more than one preferred term within a SOC are counted only once in the SOC totals. Patients with more than one occurrence of the same preferred term are counted only once within that term and at the highest severity grade.

The following less common adverse reactions have been reported in 1-4% of the 115 pediatric patients with ALL or AML:

Gastrointestinal Disorders: cecitis, pancreatitis

Hepatobiliary Disorders: hyperbilirubinemia

Immune System Disorders: hypersensitivity

Infections and Infestations: bacterial infection, Enterococcal bacteremia, Escherichia bacteremia, Escherichia sepsis, fungal infection, fungal sepsis, gastroenteritis adenovirus, infection, influenza, parainfluenza virus infection, pneumonia fungal, pneumonia primary atypical, Respiratory syncytial virus infection, sinusitis, staphylococcal infection

Investigations: blood creatinine increased

Psychiatric Disorders: mental status change

Respiratory, Thoracic and Mediastinal Disorder: pulmonary edema

Table 2 lists the incidence of treatment-emergent laboratory abnormalities after Clolar administration at 52 mg/m² among pediatric patients with ALL and AML (N=115).

Table 2: Incidence of Treatment-Emergent Laboratory Abnormalities after Clolar Administration

Parameter Any Grade Grade 3 or higher
Anemia (N=114) 95 (83.3%) 86 (75.4%)
Leukopenia (N=114) 100 (87.7%) 100 (87.7%)
Lymphopenia (N=113) 93 (82.3%) 93 (82.3%)
Neutropenia (N=113) 72 (63.7%) 72 (63.7%)
Thrombocytopenia (N=114) 92 (80.7%) 91 (79.8%)
Elevated Creatinine (N=115) 57 (49.5%) 9 (7.8%)
Elevated SGOT (N=100) 74 (74.0%) 36 (36.0%)
Elevated SGPT (N=113) 91 (80.5%) 49 (43.4%)
Elevated Total Bilirubin (N=114) 51 (44.7%) 15 (13.2%)

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Clolar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal connection to Clolar.

  • Gastrointestinal disorders: Gastrointestinal hemorrhage including fatalities.
  • Skin and subcutaneous tissue disorders: 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 Clolar and other medications (e.g., allopurinol or antibiotics) known to cause these syndromes. Other exfoliative conditions have also been reported.

Read the entire FDA prescribing information for Clolar (Clofarabine) »

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