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.

Advocacy and Support Groups

Coping with a life-threatening illness like leukemia is not something anyone needs to do alone. There are support groups you can join (either “electronic” ones on the Web, or in your own community) that put you in touch with people going through the same situation as you. These can be extremely helpful. They can provide you with information and reassurance, as well as inspiration.

The following can also be of help:

  • Hospital social workers - Ask if your hospital has a pediatric social worker you and your family can speak with.
  • Clergy and religious community – Many people find strength in religion and benefit from speaking with a member of the clergy.
  • Professional counselors – Your physician or nurse may be able to recommend a mental health professional who can provide individual or family counseling.
  • Family and friends – Most people need the support and reassurance that friends and family can provide.

Useful Links

A growing number of organizations provide information on leukemia and clinical trials, as well as links to sources of support for patients and their families. The list below includes many of these groups.

American Cancer Society

A nationwide, community-based voluntary health organization committed to fighting cancer through balanced programs of research, education, patient service, advocacy, and rehabilitation.
http://www.cancer.org

CancerCare

A national non-profit organization that provides free professional support services to anyone affected by cancer.
http://www.cancercare.org

Childhood Leukemia Foundation

A national non-profit organization that offers a wide range of services at no charge to the child and family and is dedicated to enhancing the quality of life of children with cancer.
http://www.clf4kids.org

ClinicalTrials.gov

A Web site that provides regularly updated information about federally and privately supported clinical research in human volunteers.
http://www.clinicaltrials.gov

CureSearch

CureSearch unites the Children's Oncology Group (COG) and the National Childhood Cancer Foundation (NCCF) through a shared mission to cure and prevent childhood and adolescent cancer through scientific discovery and compassionate care.
http://www.curesearch.org

Ped-Onc Resource Center

Resources and information for parents of children with cancer, by parents of children with cancer.
http://www.acor.org/ped-onc/cfissues/maillist.html

The Leukemia and Lymphoma Society

A voluntary health organization dedicated to funding blood cancer research, education, and patient services.
http://www.leukemia-lymphoma.org

National Cancer Institute

A component of the National Institutes of Health (NIH) and part of the Department of Health and Human Services, the National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, treatment, and care of cancer.
http://www.cancer.gov

National Children’s Leukemia Foundation

A non-profit organization involved in the fight against leukemia and cancer for children and adults.
http://www.leukemiafoundation.org

National Marrow Donor Program

An organization dedicated to helping people who need a life-saving marrow or blood cell transplant by connecting patients, doctors, donors, and researchers to resources they need.
http://www.marrow.org

1.800.RX.CLOLAR is here to help

If you have any questions regarding Clolar including product and reimbursement information, 1.800.RX.CLOLAR may be able to help.

Call us at
1.800.RX.CLOLAR (800.792.5652)

Monday through Friday

  • Option 1:  Product Ordering 
    (9am - 8pm EST)

  • Option 2:  Medical Information and Adverse Event Reporting
    (8am - 6pm EST)

  • Option 3:  Reimbursement Assistance and Patient Assistance Program
    (9am - 7pm EST)

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).