clofarabine

What is the most important information I should know about clofarabine?

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

What is clofarabine?

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.

What should I discuss with my healthcare provider before receiving clofarabine?

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.

• 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.

How is clofarabine given?

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

This medicine 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.

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while receiving clofarabine?

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

What are the possible side effects of clofarabine?

• 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 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.

What other drugs will affect clofarabine?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about clofarabine.