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.

FAQs

Quick answers to some commonly asked questions

What is acute lymphoblastic leukemia (ALL)?

ALL is a disease of the bone marrow and blood that starts from white blood cells in the bone marrow (called lymphoblasts). It usually moves quickly into the blood, and can spread into other parts of the body. ALL is the most common type of childhood leukemia, affecting about 80% of children with leukemia. Thanks to recent improvements in treatment, most children will respond to therapy (meaning that they will go into remission) and remain absent of disease progression. 

How can Clolar help?

About 20% of children with ALL do not respond to standard chemotherapy. They may either relapse after treatment (the leukemia comes back), or their bodies may not respond to treatment (they become refractory to treatment). Clolar can be an option for these children. Clolar was the first chemotherapy in more than a decade approved specifically for children with ALL.

What have clinical studies of Clolar shown?

Clolar has been shown to be effective in some patients from 1 to 21 years old who have not responded to other therapies for ALL, giving them a chance to go into remission. At this time, we do not know if Clolar will help a child with ALL live longer or cure him or her of the cancer. So all together, almost 1 of every 3 patients had a remission or partial response with Clolar in the clinical trial.*

The clinical relevance of a partial response (PR) is unknown.

How Is Clolar Given?

Your child will receive Clolar as an intravenous (I.V.) infusion every day for 5 days straight. Each infusion will usually last about 2 hours. Based on how your child responds to and recovers from the therapy, this treatment cycle will be repeated every 2 to 6 weeks.

Like many other chemotherapies, Clolar is given by I.V. infusion. Your child will likely be in the hospital for the first cycle of Clolar therapy.

How does Clolar work?

Clolar helps block the growth of new leukemia cells by interfering with the duplication of DNA. It also disrupts another important part of the leukemia cell, encouraging it to die.

What kinds of tests will my child need?

During treatment with Clolar, your child’s healthcare team will do blood tests to monitor his or her blood cells, kidney function, and liver function. The team will also monitor your child’s heart rate, breathing, and blood pressure, and watch for signs of infection.

What are the most common side effects of treatment?

The most common side effects with Clolar are stomach and intestinal problems (including vomiting, nausea, and diarrhea), and effects on blood counts (including low red blood cell and white blood cell and platelet counts, fever, and infection.  A fast heartbeat has been observed in some patients taking Clolar.

Clolar may also affect the liver and kidneys. For these reasons, your child’s healthcare team will do blood tests to monitor his or her blood cell counts and liver and kidney function.

Does Clolar cause hair loss?

Unlike some other chemotherapies, Clolar rarely causes hair loss.

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

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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).