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Pediatric acute lymphoblastic leukemia patient Clolar clofarabine for intravenous infusion
Treatment

What to Expect with Clolar


If your child is starting treatment with Clolar, you may have many questions about what to expect. Here are some answers.

How is Clolar given?

Clolar is given by intravenous (IV) infusion, meaning that it is injected directly into a vein over a period of time. Clolar will be given over a period of 2 hours for 5 consecutive days. This cycle may repeat every 2 to 6 weeks, depending on response. During this period, your child’s healthcare professional will do blood tests to monitor his or her blood cells, kidney function, and liver function.

Will Clolar treatment require a hospital stay?

During the first cycle of Clolar treatment, your child will likely be hospitalized so that any potential side effects can be monitored.

My child has not responded to several different kinds of treatments. How is Clolar different?

Clolar is only for use after at least two other treatment attempts for your child’s acute lymphoblastic leukemia (ALL) have failed. Clolar has allowed some patients who have not responded to, or have relapsed from, other therapies for ALL that allowed them to go into a remission and, in some cases, allowed them to proceed to a bone marrow transplant. At this time we do not know whether Clolar will help a child with ALL live longer or cure him or her of the cancer.

What are some of the most serious side effects of treatment with Clolar?

Systemic inflammatory response syndrome (SIRS) / capillary leak syndrome (CLS). Signs include fast breathing, fast heartbeat, low blood pressure, and fluid in the lungs. These signs should be reported to the physician right away, as CLS can be life-threatening if not treated right way.

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.

Liver and kidney function. Since Clolar may cause damage to the liver and kidneys, your child’s healthcare team will monitor your child’s liver and kidney function before and during treatment with Clolar.

What are some of the most common side effects of Clolar?

The most common side effects with Clolar are stomach problems (including vomiting, nausea, and diarrhea), and effects on blood counts (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.

What additional side effects might my child experience?

Anxiety – Some children experience restlessness, agitation, and anxiety during the Clolar infusion. If this occurs, your healthcare professional will immediately slow the infusion so that the drug is entering your child at a slower rate, which may help address the anxiety. As a precaution, your doctor may administer anti-anxiety medications to your child before the next cycle of Clolar.

Hand-foot syndrome – A skin condition called hand-foot syndrome may occur a few days after the start of Clolar therapy. This condition causes a tingling feeling at first, which progresses to redness, dryness, and possible flaking of skin on hands and/or feet. Your healthcare professional may recommend lightly applying moisturizers to minimize dryness and flaking. It is important not to rub the hands or feet vigorously if your child is experiencing this condition. Your doctor may prescribe steroids or antihistamines to help provide relief.

Dehydration and low blood pressure – Clolar can cause vomiting and diarrhea, which may lead to dehydration. Signs and symptoms of dehydration include dizziness, lightheadedness, fainting spells, or decreased urination.

Effects on pregnancy and breastfeeding – Females should not become pregnant or breastfeed during treatment with Clolar because Clolar may harm the baby.

Will my child lose her hair because of Clolar?

Clolar does not cause hair loss (alopecia). Your child may be taking other medications, however, that could cause hair loss.

What if I have more questions about what to expect with Clolar?

Your doctor and nurse are great resources for information about Clolar. Don’t be afraid to ask questions, or to ask them to explain something again if you do not understand.

Also, if you have more questions about Clolar, you can ask us.


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.

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