clofarabine

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

Do not use clofarabine if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are receiving clofarabine, whether you are a man or a woman. Clofarabine use by either parent may cause birth defects.

If you have liver or kidney disease, you may need a dose adjustment or special tests to safely receive clofarabine.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested often. Visit your doctor regularly.

Clofarabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor at once if you develop signs of infection.

Clofarabine can harm your liver or kidneys. This effect is increased when you also use other medicines harmful to the liver or kidneys. During your 5-day treatment with clofarabine, you may need to avoid using certain medications, including some over-the-counter medicines. Tell your doctor about all other medicines you use.

Tell your caregivers at once if you have a serious side effect such as rapid breathing and heart rate, trouble breathing, painful swelling, numbness or tingling, feeling like you might pass out, lower back pain, blood in your urine, urinating less than usual, or jaundice (yellowing of the skin or eyes).

What is clofarabine?

Clofarabine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

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 cancer medicines have been tried without successful treatment.

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

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

If you have liver or kidney disease, you may need a dose adjustment or special tests to safely receive clofarabine.

FDA pregnancy category D. Do not use clofarabine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving clofarabine, whether you are a man or a woman. Clofarabine use by either parent may cause birth defects.

It is not known whether clofarabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving clofarabine.

How is clofarabine given?

Clofarabine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Clofarabine must be given slowly, and the IV infusion can take at least 2 hours to complete.

Clofarabine is usually given daily for 5 days in a row during one or more treatment cycles. 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 the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To be sure your blood cells do not get too low, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), purple or red pinpoint spots under your skin, loss of appetite, mouth sores, or unusual weakness.

What happens if I miss a dose?

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

What happens if I overdose?

Since this medication 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?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• feeling like you might pass out;
• runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
• lower back pain, blood in your urine, urinating less than usual or not at all;
• numbness or tingly feeling around your mouth;
• muscle weakness, tightness, or contraction, overactive reflexes;
• fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;
• numbness or redness on the palms of your hands or the soles of your feet;
• jaundice (yellowing of the skin or eyes); or
• signs of infection such as fever, chills, sore throat, flu symptoms, pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), purple or red pinpoint spots under your skin, loss of appetite, mouth sores, unusual weakness.

Less serious side effects may include:

• nausea, vomiting, stomach pain;
• diarrhea, rectal pain;
• headache, muscle or joint pain;
• mild itching or skin rash;
• feeling tired, anxious, irritable; or
• warmth, redness, or tingly feeling under your skin.

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?

Tell your doctor about all other medications you use, especially blood pressure medications.

Clofarabine can harm your liver or kidneys. This effect is increased when you also use other medicines harmful to the liver or kidneys. During your 5-day treatment with clofarabine, you may need to avoid using certain medications. Many other drugs (including some over-the-counter medicines) can be harmful to the liver or kidneys, such as:

• auranofin (Ridaura);
• lithium (Lithobid);
• methotrexate (Rheumatrex, Trexall);
• tuberculosis medications;
• birth control pills or hormone replacement therapy;
• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
• an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;
• an antibiotic such as dapsone, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifater, Rifadin, Rifamate);
• antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
• cholesterol medications such as niacin (Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor), lovastatin (Mevacor, Altoprev, Advicor), rosuvastatin (Crestor), simvastatin (Zocor, Simcor, Vytorin) and others;
• HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);
• IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene);or
• other cancer medications.

This list is not complete and other drugs may interact with clofarabine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about clofarabine.