Clofarabine, Injection

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KEY POINTS

• This medicine is given by IV to treat acute lymphoblastic leukemia.
• Your child may get infections more easily when taking this medicine.
• Keep all appointments for tests to see how this medicine affects your child.
• This medicine may cause serious bleeding or other unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: clofarabine, injection; Clolar

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat children 1 to 21 years old with relapsed acute lymphoblastic leukemia (fast-growing cancer of the blood and bone marrow).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if your child has ever had:

• An allergic reaction to any medicine
• A blood disorder or bleeding problems
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Liver or kidney disease

Males should use effective birth control. This medicine may affect sperm and lead to birth defects.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine is given by a healthcare provider. The infusion is usually given over 2 hours daily for 5 days in a row. Treatment cycles are usually repeated every 2 to 6 weeks. Your child will be monitored closely while receiving this medicine. Keep all appointments for treatments and tests.

What should I watch out for?

Your child will need to have blood tests regularly. Keep all appointments for these tests.

Your child may get infections more easily when receiving this medicine. Stay away from people with colds, flu, or other infections. Also, your child should not have any vaccines without getting your healthcare provider's approval first.

Your child may bleed more easily when receiving this medicine. The bleeding may be serious. Report any unusual bruising or bleeding, dizziness, lightheadedness, fainting spells, or decreased urine output to your healthcare provider.

This medicine can harm the liver or kidneys. The risk of this may be increased when your child also takes other medicines harmful to the liver or kidneys. Your child may need to avoid using certain medicines while receiving this medicine, including some nonprescription medicines or natural remedies. Talk with your healthcare provider about this. Tell your healthcare provider about all the medicines your child takes.

This medicine may make your child's mouth sore. Use a soft bristle brush or mouth swab to brush teeth.

This medicine may cause the fast breakdown of certain types of cancer cells. Your child’s healthcare provider may do blood tests to check for this and will treat him or her if needed. Call your healthcare provider right away if your child has a fast heartbeat or heartbeat that does not feel normal, trouble passing urine, muscle weakness or cramps, severe vomiting or diarrhea, or feels sluggish.

It is important that your child drinks plenty of fluids while taking this medicine.

If your child needs emergency care, surgery, or dental work, tell the healthcare provider or dentist your child is receiving this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reactions (hives, itching, rash, tightness in your chest, trouble breathing); sudden weakness, numbness, or tingling, especially on one side of the body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe nausea, vomiting, or diarrhea; inflammation or sores near the mouth, eyes, or rectum; sore, red eyes; unusual bruising or bleeding; fever; chills; cough; sore throat; dizziness; lightheadedness; fainting spells; decreased urine output; swelling of the hands, ankles, feet, legs or any unexplained swelling; blisters or red skin on the palms of the hands and the soles of the feet; unusual tiredness or weakness; fast or irregular heartbeat; fast or trouble breathing; chest pain; yellowing of skin or eyes; dark urine; light-colored bowel movements.

Other: Loss of appetite, mild diarrhea or vomiting, irritation where the shot was given, headache, stomach cramps, nervousness, flushing, itching, tiredness, drowsiness, muscle pain, back pain, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), and terazosin
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Clozapine (Clozaril, FazaClo)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, lepirudin (Refludan), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Natural remedies such as cat's claw, dong quai, echinacea, evening primrose, fenugreek, feverfew, fish oil, garlic, ginger, ginkgo biloba, ginseng, green tea, horse chestnut, red clover, and turmeric
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.