Clofarabine injection for infusion

What is this medicine?

CLOFARABINE (kloe FAR a been) is a chemotherapy drug. It reduces the growth of cancer cells and can suppress the immune system. It is used for treating leukemia.

How should I use this medicine?

This drug is given as an infusion into a vein. It is given in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast heartbeat

• low blood counts - This drug may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, nosebleeds

• signs of decreased red blood cells - breathing problems, fainting spells, lightheadedness

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; yellowing of the eyes or skin

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• headache

• loss of appetite

• nausea, vomiting

• pain or redness at the injection site

What may interact with this medicine?

This medicine may interact with the following medications:

• acetaminophen

• amiodarone

• aspirin and aspirin-like medicines

• cisplatin

• cyclosporine

• diuretics

• isoniazid

• lomitapide mesylate

• medicines for blood pressure, heart disease, irregular heart beat

• medicines for cholesterol like atorvastatin and simvastatin

• medicines for fungal infections like amphotericin B, fluconazole, and ketoconazole

• medicines for infection like acyclovir, adefovir, amoxicillin, bacitracin, cidofovir, erythromycin, foscarnet, ganciclovir, gentamicin, minocycline, pentamidine, sulfamethoxazole/trimethoprim, telithromycin, tetracycline, vancomycin

• medicines for seizures like carbamazepine, phenytoin, valproic acid/divalproex sodium

• methotrexate

• methyldopa

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• pamidronate

• rifampin

• zoledronic acid

What if I miss a dose?

It is important not to miss a dose. Call your doctor or health care professional if you are unable to keep an appointment.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

• bleeding problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• liver disease

• low blood counts

• an unusual or allergic reaction to clofarabine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You may need blood work done while you are taking this medicine.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 6 months after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine or for at least 3 months after the last dose. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 2 weeks after the last dose.

This medicine may make it more difficult to get pregnant or to father a child. Talk to your health care provider if you are concerned about your fertility.