Clofarabine is used to treat acute lymphoblastic leukemia (a type of blood cancer) in children and young adults up to 21 years old.

Clofarabine is usually given after other treatments have failed.

Clofarabine may also be used for purposes not listed in this medication guide.

Seek medical attention right away if you have signs of inflammation in your body: fever, fast heartbeats, sudden swelling or shortness of breath, rapid breathing, or feeling light-headed.

clofarabine can cause life-threatening side effects including serious infections, bleeding, or harm to your liver or kidneys.

Call your doctor at once if you have: fever, chills, pale skin, trouble breathing, sudden numbness or weakness, problems with vision or speech, stomach pain or swelling, bruising, decreased urination, rapid weight gain, dark urine, yellowing of your skin or eyes, blood in your urine or stools, or if you cough up blood.

Clofarabine is given as an infusion into a vein. A healthcare provider will give you this injection.

clofarabine must be given slowly, and the infusion can take at least 2 hours to complete.

Clofarabine is usually given daily for 5 days in a row every 2 to 6 weeks. Your doctor will determine how many treatment cycles you will receive and how often.

You may receive other medications to help prevent certain side effects of clofarabine.

Clofarabine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney or liver function may also need to be tested. Your cancer treatments may be delayed based on the results of these tests.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

18 to less than 22 years:
52 mg/m2 IV over 2 hours daily for 5 consecutive days of a 28-day cycle; repeat every 2 to 6 weeks

Comments:
-Subsequent cycles should begin no sooner than 14 days from day 1 of the previous cycle.
-Subsequent cycles may be administered when the ANC is greater than or equal to 750/mm3.
-Provide supportive care, such as IV fluids, antihyperuricemics, and alkalinization of urine throughout therapy to reduce the risk of tumor lysis and other adverse events.
-Monitor renal, hepatic, and cardiac function during therapy.
-Monitor patients taking medications known to affect blood pressure.
-Discontinue therapy if hypotension develops during the 5 days of administration.

Use: For patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least 2 prior regimens

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

1 year and older:
52 mg/m2 IV over 2 hours daily for 5 consecutive days of a 28-day cycle; repeat every 2 to 6 weeks

Comments:
-Subsequent cycles should begin no sooner than 14 days from day 1 of the previous cycle.
-Subsequent cycles may be administered when the ANC is greater than or equal to 750/mm3.
-Provide supportive care, such as IV fluids, antihyperuricemics, and alkalinization of urine throughout therapy to reduce the risk of tumor lysis and other adverse events.
-Monitor renal, hepatic, and cardiac function during therapy.
-Monitor patients taking medications known to affect blood pressure.
-Discontinue therapy if hypotension develops during the 5 days of administration.

Use: For patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least 2 prior regimens

Tell your doctor if you have recently been sick with flu symptoms or diarrhea, or if you have ever had:

• liver disease;

• kidney disease; or

• a stem cell transplant.

You may need to have a negative pregnancy test before starting this treatment.

Clofarabine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use clofarabine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using clofarabine.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because clofarabine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your clofarabine injection.

Since clofarabine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical attention right away if you have signs of inflammation in your body: flu-like symptoms, fast heartbeats, sudden swelling or shortness of breath, rapid breathing, or feeling light-headed.

Clofarabine may cause serious side effects. Call your doctor at once if you have:

• trouble breathing while lying down;

• diarrhea that is watery or bloody;

• little or no urination;

• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;

• low blood pressure--a light-headed feeling, like you might pass out;

• signs of a liver problem--upper stomach pain, sudden swelling in your mid-section, dark urine, jaundice (yellowing of the skin or eyes);

• signs of infection--fever, chills, tiredness, mouth and throat ulcers, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, shallow breathing;

• signs of bleeding inside the body--sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech, chest pain, coughing up blood, blood in your urine, bloody or tarry stools; or

• signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects of clofarabine may include:

• fever, chills, or other signs of infection;

• stomach pain, nausea, vomiting, loss of appetite, diarrhea;

• fast heartbeats;

• nosebleeds, bruising;

• pain in your arms or legs;

• headache, feeling tired;

• itching or skin rash; or

• low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Clofarabine can harm your liver or kidneys, especially if you also use certain medicines for infections, tuberculosis, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, cancer, osteoporosis, organ transplant rejection, bowel disorders, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).

Other drugs may affect clofarabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.