For U.S. Residents Only
Clolar clofarabine injection

Text Size:

A A A

Important Safety Information
Clolar causes myelosuppression which may be severe and prolonged. Bone marrow function usually recovers when Clolar treatment is stopped. Your doctor will monitor your blood counts for signs of myelosuppression. Continue below.

A path to response in pediatric patients ages 1-21 with relapsed or refractory acute lymphoblastic leukemia (ALL) after at least two prior regimens.

Young patient in a hospital bed.

Patients and Caregivers

Learn about pediatric acute lymphoblastic leukemia (ALL) and treatment with Clolar.

Learn More

Young patient being examined by a doctor.

Healthcare Professionals

Find information on Clolar, including response rate data, clinical trial information, and safety profile.

Learn More

Indication

Acute Lymphoblastic Leukemia (ALL)

Clolar is indicated for the treatment of patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) who have had at least 2 treatment regimens and whose ALL has recurred or resisted treatment.

This indication is based upon the percentage of patients whose ALL responded to Clolar treatment. There are no trials showing whether or not disease-related symptoms or survival improved with Clolar.

For more information, please consult the full Prescribing Information.

Patient Assistance with Sanofi Patient Connection

For more information about Sanofi Patient Connection, call to speak with one of our counselors:

  • 1-888-847-4877
  • Monday - Friday, 9:00 a.m. – 8:00 p.m. Eastern Time

or click here to visit our site

Multi-lingual assistance is available.

Prescribing Information

Prescribing Information
Clolar prescribing information

Indication

Clolar is indicated for the treatment of patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) who have had at least 2 treatment regimens and whose ALL has recurred or resisted treatment. This indication is based upon the percentage of patients whose ALL responded to Clolar treatment. There are no trials showing whether or not disease-related symptoms or survival improved with Clolar.

Important Safety Information for Clolar (clofarabine injection)

Clolar can cause serious side effects:

  • Myelosuppression (impaired bone marrow function). Clolar causes myelosuppression which may be severe and prolonged. Bone marrow function usually recovers when Clolar treatment is stopped. If you experience symptoms such as feeling weak or tired, paleness, shortness of breath, easy bruising, tiny spots on your skin, or fever, report this to your doctor. Your doctor will monitor your blood counts for signs of myelosuppression.
  • Infections. Clolar increases the risk of infection, including severe and fatal internal infections. If you have a fever or experience other signs and symptoms of infection, report this to your doctor immediately. Your doctor will monitor your blood counts for signs of infection.
  • Hyperuricemia (high uric acid levels). Treatment with Clolar may result in high uric acid levels due to the break-down products from leukemia cell death. Your doctor will monitor you for signs of hyperuricemia and may give you treatments to prevent hyperuricemia.
  • Cytokine reactions.Treatment with Clolar can cause the release of proteins called cytokines that may lead to symptoms such as rapid breathing, rapid heart rate, low blood pressure, and fluid build-up in the lungs. Cytokine reactions may also lead to organ impairment which may be fatal. Your doctor will monitor you for these symptoms.
  • Blocked veins in the liver (hepatic veno-occlusive disease, or VOD). If you have had a hematopoietic stem cell transplant (HSCT) and were treated with etoposide and cyclophosphamide, you have a higher risk of developing blocked veins in the liver, which can result in liver damage.
  • Hepatotoxicity (liver damage). Severe and fatal liver damage has occurred with the use of Clolar. Let your doctor know if you notice signs and symptoms of abnormal liver function, such as yellowing of your skin or eyes. During the 5 days of Clolar administration it is important to avoid other medications that may cause liver damage, so tell your doctor about all medications you are taking, including over-the-counter and herbal medications. Your doctor will monitor your liver enzyme levels.
  • Renal toxicity (kidney damage). Kidney damage and kidney failure has occurred with the use of Clolar. During the 5 days of Clolar administration it is important to avoid other medications that may cause kidney damage, so tell your doctor about all medications you are taking, including over-the-counter and herbal medications. Your doctor will monitor your kidney function.
  • Embryo-fetal Toxicity. Clolar may harm your unborn baby. You should not become pregnant while receiving Clolar. Use highly effective contraception. Tell your doctor right away if you become pregnant or are concerned that you have become pregnant while receiving Clolar.
  • Nursing Mothers. It is not known if Clolar passes into your breast milk. You should not breastfeed while receiving Clolar.

The most common side effects of Clolar include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Low white blood cell count with fever
  • Headache
  • Rash
  • Itchiness
  • Fever
  • Feeling tired and weak
  • Swelling and skin peeling oon the hands and feet
  • Anxiety
  • Warm, red skin
  • Swelling or irritation of the mucus membranes

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Clolar. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

For more information, please consult the full Prescribing Information