Important Safety Information
Clolar® should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. View additional Important Safety Information.

Glossary

  • Acute lymphoblastic leukemia (ALL): A disease of the bone marrow and blood that starts from white blood cells in the bone marrow (called lymphoblasts). ALL usually moves quickly into the blood, and can spread into other parts of the body.
  • Alopecia: Loss of hair, either on the head or all over the body.
  • ANC: An abbreviation for absolute neutrophil count. This is the number of neutrophils (a type of white blood cell) found in the blood. The ANC is often low after chemotherapy.
  • Anemia: Low number of red blood cells.
  • Antiemetics: Medications that prevent or relieve nausea and vomiting.
  • B Cell: A type of lymphocyte (a specific type of white blood cell).
  • Blast cell (leukemic): An abnormal cell that does not develop into red blood cells, white blood cells, or platelets.
  • Blast cell (normal): Immature blood cells that become red blood cells, white blood cells, or platelets
  • Blood Cell: A general term describing the 3 cellular components of blood (white blood cells, red blood cells, and platelets), all of which are made in the bone marrow.
  • Blood Count: A routine test to determine the amount of white blood cells, red blood cells, and platelets in a sample of blood. Also called complete blood count (CBC).
  • Bone Marrow Suppression: A condition in which the number of blood cells the body produces is greatly reduced.
  • Bone Marrow Transplantation (BMT): The process of replacing damaged bone marrow with healthy bone marrow from the patient (autologous BMT) or from a suitable donor (allogeneic BMT) to help restore the patient's immune system after chemotherapy and radiation.
  • Capillary Leak Syndrome (CLS): A side effect of chemotherapy in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissues. This can cause dangerously low blood pressure.
  • Chemotherapy: Treatment with anticancer or antileukemic drugs. The type of drugs used are determined by the type of cancer and the treatment determined by the doctor.
  • Clinical Trial: Research conducted with volunteer patients, usually to evaluate a new treatment, under strictly controlled conditions. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease.
  • Combination Chemotherapy: The use of more than one drug to treat cancer.
  • Cytokine Release: A side effect of chemotherapy in which substances critical to the immune system are released and cause the body to respond as if it is battling a severe infection (see systemic inflammatory response syndrome [SIRS]).
  • Dehydration: A condition that occurs when a person loses more fluids that he or she takes in.
  • DNA: DNA or deoxyribonucleic acid is a molecule that is essential to the development and function of the cell, indeed of all known living organisms. It carries the genetic instructions used in the development and functioning of every living cell.
  • Drug Resistance: The failure of (cancer) cells to respond to drugs (chemotherapy).
  • Graft-Versus-Host Disease (GVHD): A complication that may develop after a bone marrow transplant in which the lymphocytes from the donated bone marrow react against the body's cells.
  • Hand-Foot Syndrome: Also known as palmar-plantar erythrodysesthesia syndrome; a side effect of chemotherapy that causes tingling, redness, dryness, and flaking of skin on the hands and/or feet.
  • Hematologist: A doctor who specializes in the treatment of blood diseases.
  • Hematology: Study of the development, diagnosis, treatment, and prevention of blood cell malignancies.
  • Hypotension: Low blood pressure.
  • Immune System: The system within the body that recognizes and fights foreign cells and disease.
  • Immunosuppression: Suppression of the immune response as a result of drugs (chemotherapy) or radiation.
  • Infusion: Administration of fluids or medications into the blood through the veins.
  • Intrathecal (I.T.): Into the spinal fluid.
  • Intravenous (I.V.): Within, or administered into, a vein.
  • Leukemia: A disease of the bone marrow and blood. Bone marrow is the soft, spongy tissue inside large bones.
  • Leukocyte: A white blood cell. There are 3 main types of leukocytes: monocytes, granulocytes or neutrophils, and lymphocytes.
  • Leukopenia: A low number of leukocytes or WBCs. Leukopenia decreases the body’s ability to fight disease and infections.
  • Lymphocytes/lymphoblasts: A type of white blood cell that fights infection and disease and are found in the bloodstream, the lymphatic system, and lymphoid organs.
  • Mitochondria: Membranes located outside the nucleus of the cell and the cell’s principal energy source.
  • Nausea: Feeling sick or wanting to vomit, possibly with dizziness or other symptoms. Some chemotherapy combinations can cause nausea for up to several days - this can be lessened by taking antiemetic drugs.
  • Neutropenia: A low number of neutrophils (a type of white blood cell); this condition may increase the risk of infection depending on how low the neutrophil count is and for how long it has been low.
  • Neutrophil: A type of white blood cell that fights bacterial infection (also called a granulocyte).
  • Platelet: A blood cell that helps to control bleeding by inducing clotting.
  • Pruritus: Itching.
  • Radiation Therapy: Treatment with high-energy radiation from X-rays or other sources of radiation.
  • Red Blood Cell: Blood cell that carries oxygen to the cells of the body and removes carbon dioxide. A low number of red blood cells is called anemia.
  • Refractory: Not responding to treatment.
  • Relapse: The return of symptoms and signs of a disease after a period of improvement.
  • Remission: The complete disappearance of cancer cells and symptoms. It does not always mean the individual has been cured.
  • Side Effect: Secondary effect caused by cancer treatment.
  • Stem Cell Transplant: The infusion of healthy stem cells into the body.
  • Systemic Inflammatory Response Syndrome (SIRS): A condition in which there is inflammation throughout the whole body. Patients with SIRS may experience fast heart rate, low blood pressure, low or high body temperature, and low or high white blood cell count.
  • T Cell: A type of lymphocyte that attacks any foreign substance in the body.
  • Thrombocytopenia: A low number of platelets in the blood. It can cause spontaneous bleeding of gums or nose and bleeding of other tissues. Unexplained bruising of the skin is also characteristic.
  • Tumor Lysis Syndrome: A complication that can occur after treatment of leukemia caused by the breakdown of leukemia cells.
  • White Blood Cell: A variety of cells that fight infection in the body and are part of the immune system. See leukocytes.
  • White Blood Cell Count: Measurement of the total number of white blood cells in a sample of blood.

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Prescribing Information

Prescribing Information 
Clolar prescribing information (.pdf)

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Indication

Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Important Safety Information

Warnings and Precautions:

Clolar® should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.

    Hematologic Toxicity

    • Monitor complete blood counts and platelet counts during and after Clolar therapy.
    • Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Severe bone marrow suppression, including neutropenia, anemia, and thrombocytopenia, has been observed in patients treated with Clolar. At initiation of treatment, most patients in the clinical studies had hematological impairment as a manifestation of leukemia.
    • Because of the pre-existing immunocompromised condition of these patients and prolonged neutropenia that can result from treatment with Clolar, patients are at increased risk for severe opportunistic infections.

    Infections

    The use of Clolar is likely to increase the risk of infection, including severe sepsis, as a result of bone marrow suppression. Monitor patients for signs and symptoms of infection and treat promptly.

      Hyperuricemia (Tumor Lysis)

      Administration of Clolar may result in a rapid reduction in peripheral leukemia cells. Evaluate and monitor patients undergoing treatment for signs and symptoms of tumor lysis syndrome. Provide intravenous infusion fluids throughout the five days of Clolar administration to reduce the effects of tumor lysis and other adverse events. Administer allopurinol if hyperuricemia (tumor lysis) is expected.

        Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome

        • Evaluate and monitor patients undergoing treatment with Clolar for signs and symptoms of cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS), capillary leak syndrome and organ dysfunction.
        • Discontinue Clolar immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome, either of which can be fatal, and consider use of steroids, diuretics, and albumin. Re-institute Clolar when the patient is stable, generally with a 25% dose reduction. The use of prophylactic steroids may be of benefit in preventing signs and symptoms of cytokine release.

        Hepatic Enzymes

        Hepato-biliary enzyme elevations were frequently observed in pediatric patients during treatment with Clolar. Some patients discontinued treatment due to hepatic enzyme abnormalities.

          Hepatic and Renal Impairment

          • Clolar has not been studied in patients with hepatic or renal dysfunction. Its use in such patients should be undertaken only with the greatest caution.
          • Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). Severe hepatotoxic events have been reported in an ongoing Phase 1/2 combination study of clofarabine in pediatric patients with relapsed or refractory acute leukemia.

          Use in Pregnancy

          Clolar can cause fetal harm when administered to a pregnant woman. Intravenous doses of clofarabine in rats and rabbits administered during organogenesis caused an increase in resorptions, malformations, and variations. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Clolar.

            Nursing Mothers

            Female patients should be advised to avoid breast-feeding during treatment with Clolar.

              Incidence of Treatment Emergent Laboratory Abnormalities (All Grades)

              ParameterAny gradeGrade 3 or higher
              Anemia 83% 75%
              Leukopenia 88% 88%
              Lymphopenia 82% 82%
              Neutropenia 64% 64%
              Thrombocytopenia 81% 80%
              Elevated creatinine 50% 8%
              Elevated SGOT 74% 36%
              Elevated SGPT 81% 43%
              Elevated total bilirubin 45% 13%

              Adverse Reactions:

              Most common adverse reactions with Clolar were nausea (73%), vomiting (78%), diarrhea (56%), febrile neutropenia (55%), headache (43%), rash (38%), pruritus (43%), pyrexia (39%), fatigue (34%), palmar-plantar erythrodysesthesia syndrome (16%), anxiety (21%), flushing (19%), and mucosal inflammation (16%).

              For more information, please consult the full Prescribing Information (PDF).