Clolar Facts

Clolar is the first cancer treatment approved specifically for children in more than a decade.

Here is a quick snapshot of additional information about Clolar.

• The US Food and Drug Administration approved Clolar in December, 2004. By January, many patients were already receiving treatment.
• Clolar is in a class of cancer medications called purine nucleoside analogs.
• Clolar is a medication to treat children, ages 1 to 21, with a type of leukemia called relapsed or refractory acute lymphoblastic leukemia (ALL), after at least 2 other treatment attempts have failed.
• Clolar can reduce the number of leukemia cells in the blood. 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.
• Clolar can cause serious side effects, including tumor lysis syndrome and bone marrow suppression, which are described in the Treatment section.
• Clolar can cause other side effects, including vomiting and diarrhea, which may lead to dehydration. That means people taking Clolar should be sure to drink plenty of fluids, and should tell their doctor or nurse if they experience the signs and symptoms of dehydration including dizziness, lightheadedness, fainting spells, or decreased urination. For more on the side effects, go to the Treatment section.
• Like many other cancer drugs, Clolar is given by intravenous (IV) infusion, meaning that the medication is given through a vein so it goes directly into the blood. For more on this, go to the Treatment section.
• Before it was approved by the FDA, Clolar was studied in a clinical trial that involved 49 children with ALL whose disease was not responsive to two or more prior therapies. For more on this, go to the Clolar in Detail section.

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How Clolar is Used

Clolar is a type of medication to treat children, ages 1 to 21 with a type of leukemia called relapsed or refractory acute lymphoblastic leukemia (ALL), after at least 2 other treatment attempts have failed. Clolar can reduce the number of leukemia cells in the blood. 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.

Important Safety Information for Patients

Serious side effects

Clolar can cause serious side effects that include:

• Systemic inflammatory response syndrome (SIRS)/capillary leak syndrome (CLS). Signs include fast breathing, fast heartbeat, low blood pressure, and difficulty breathing. These signs should be reported to the physician right away, as SIRS and CLS can be life-threatening if not treated right way. If your child experiences clinically significant signs of SIRS or CLS, your physician should stop Clolar immediately and consider giving your child steroids, diuretics, and albumin. When your child has stabilized, Clolar can be continued, usually at a lower dose.
• Bone marrow suppression and infection. Clolar can stop your child’s bone marrow from making enough red blood cells, white blood cells, and platelets. Serious side effects can result from this, and include severe infection (sepsis), bleeding, and anemia.
• Effects on pregnancy and breastfeeding. Females should not become pregnant or breastfeed during treatment with Clolar because Clolar may harm the baby.

Other side effects

The most common side effects with Clolar are stomach problems (including vomiting, diarrhea, and nausea), and effects on blood cells (including low red and white blood cells count, low platelet count, fever, and infection). A fast heartbeat has been noted in some patients taking Clolar. Clolar can also affect the liver and kidneys. For these reasons, your child’s healthcare professional will do blood tests to monitor his or her blood cells, kidney function, and liver function.

Treatment with Clolar quickly reduces the number of leukemia cells in your child’s blood. For this reason, your doctor should monitor your child for signs and symptoms of tumor lysis syndrome (TLS), as well as signs and symptoms of cytokine release, which can develop into SIRS, CLS, and organ problems. Your doctor is encouraged to give continuous IV fluids throughout the five days of Clolar treatment to reduce certain side effects. Your doctor may also prescribe allopurinol to reduce the build-up of uric acid that occurs with TLS. Your doctor should stop the Clolar treatment if your child develops low blood pressure for any reason during the five days of treatment.

Please speak with your healthcare professional if you have questions about Clolar. Also, please see full prescribing information.