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Clofarabine

 
Drug Info: Clofarabine

Brand names: Clolar™



Clofarabine injection

What is Clofarabine injection?

CLOFARABINE (Clolar™) is a chemotherapy agent used for treating leukemia which has relapsed or not responded to at least two previous treatments. Clofarabine inhibits the growth of rapidly growing cancer cells and can suppress the immune system. Generic clofarabine injection is not available.

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

• bleeding problems or blood disorders
• dental disease
• infection (especially virus infection such as chickenpox or cold sores)
• kidney disease
• liver disease
• an unusual or allergic reaction to clofarabine, other chemotherapy, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Clofarabine is for infusion into a vein, and usually infused over 2 hours. It is administered in a hospital or clinic setting by a specially trained health care professional. Clofarabine is typically given as a 5 day course that is repeated every 2—6 weeks.

What if I miss a dose?

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

What drug(s) may interact with Clofarabine?

• agents that treat or prevent blood clots
digoxin
• vaccines

Talk to your prescriber or health care professional before taking any of these medicines:
acetaminophen
• aspirin
• blood pressure medications
ibuprofen
naproxen
ketoprofen

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Clofarabine?

Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood checks. The side effects of clofarabine can continue after you finish your treatment; report side effects promptly.

Clofarabine may make you feel generally unwell. This is not uncommon because clofarabine affects good cells as well as cancer cells. Report any side effects as above, but continue your course of medicine even though you feel ill, unless your prescriber or health care professional tells you to stop.

Clofarabine decreases your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Clofarabine may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise, or injure yourself because you may get an infection and bleed more than usual. Be careful brushing and flossing your teeth or using a toothpick while receiving clofarabine because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are taking or have taken clofarabine.

Clofarabine quickly kills leukemia cells which may result in a syndrome called 'tumor lysis syndrome'. If you experience symptoms such as fast breathing, fast heartbeat, dizziness, and difficulty breathing, notify your healthcare professional immediately.

Clofarabine can cause vomiting and diarrhea which may lead to dehydration. Signs and symptoms of dehydration include dizziness, lightheadedness, fainting spells, or decreased urination. If you experience any of these symptoms, notify your healthcare professional immediately.

Unless instructed to by your prescriber or health care professional, avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), naproxen (Aleve®), or ketoprofen (Orudis® KT) products or products containing these agents, as these drugs may hide a fever or other signs of an infection.

Clofarabine can harm your unborn child if taken during pregnancy. Women who are able to have children should avoid becoming pregnant while taking clofarabine.

If you are going to have surgery, tell your prescriber or health care professional that you are receiving or have recently received clofarabine.

What side effects may I notice from receiving Clofarabine?

The side effects you may experience with clofarabine therapy depend upon the dose, other types of chemotherapy or radiation therapy given, and the disease being treated. Not all of these effects occur in all patients. Discuss any concerns or questions with your prescriber or health care professional.

Side effects that you should report to your prescriber or health care professional as soon as possible:
• low blood counts - clofarabine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• 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 - unusual weakness or tiredness, fainting spells, lightheadedness
• confusion, agitation
• dizziness, lightheadedness
• difficulty breathing, shortness of breath, rapid heartbeat
• mouth sores
• skin rash

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• constipation
• diarrhea
• headache
• loss of appetite
• nausea, vomiting
• sweating
• water retention
• weakness

Where can I keep my medicine?

This does not apply. You will only receive this medicine in a clinic or hospital setting.

Last updated: 12/1/2004 9:34:00 PM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Wikipedia: Clofarabine
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Clofarabine
Systematic (IUPAC) name
5-(6-amino-2-chloro-purin-9-yl) -4-fluoro-2- (hydroxymethyl)oxolan-3-ol
Identifiers
CAS number 123318-82-1
ATC code L01BB06
PubChem 119182
DrugBank APRD00878
Chemical data
Formula C10HClFN5O3 
Mol. mass 303.677 g/mol
Pharmacokinetic data
Bioavailability  ?
Metabolism  ?
Half life  ?
Excretion  ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes  ?

Clofarabine is a purine nucleoside antimetabolite marketed in the U.S. and Canada as Clolar. In Europe and Australia/New Zealand the product is marketed under the name Evoltra. It is FDA-approved for treating a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL) in children, after at least two other types of treatment have failed. It is not known if it extends life expectancy. Some investigations of effectiveness in cases of acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) have been carried out. Ongoing trials are assessing its efficacy, if any, for managing other cancers.

Contents

Side effects

  • Tumor lysis syndrome (TLS). Clofarabine quickly kills leukaemia cells in the blood. The body may react to this. Symptoms include fast breathing, fast heartbeat, low blood pressure, and fluid in the lungs. TLS is very serious and can lead to death if it is not treated right away.
  • Bone marrow problems (suppression). Clofarabine can stop the bone marrow from making enough red blood cells, white blood cells, and platelets. Serious side effects that can happen because of bone marrow suppression include severe infection (sepsis), bleeding, and anemia.
  • Effects on pregnancy and breastfeeding. Girls and women should not become pregnant or breastfeed during treatment which harm the baby.
  • Dehydration and low blood pressure. Clofarabine can cause vomiting and diarrhea which may lead to low body fluid (dehydration). Signs and symptoms of dehydration include dizziness, lightheadedness, fainting spells, or decreased urination.
  • Other side effects. The most common side effects are stomach problems (including vomiting, diarrhea, and nausea), and effects on blood cells (including low red blood cells count, low white blood cell count, low platelet count, fever, and infection. Clofarabine can also cause tachycardia and can affect the liver and kidneys.

Contraindications

  • pregnancy or planned pregnancy
  • breast-feeding
  • liver problems
  • kidney problems

Drug interactions

  • nephrotoxic drugs
  • hepatotoxic drugs

Delivery

  • By intravenous infusion.
  • Dosage is a 2 hour infusion (52 mg/m²) every day for five days. The cycle is repeated every 2 to 6 weeks.
  • Regular blood tests to monitor his or her blood cells, kidney function, and liver function.

Results of clinical trials

Efficacy and safety were demonstrated in a single multi-center trial that enrolled 40 patients aged 2-19. The patients were suffering with relapsed or refractory acute lymphoblastic leukaemia (ALL) (An additional 9 patients suffering with acute myelogenous leukaemia (AML) had similar pharmacokinetics but are not included in the figure below.) Most patients had received 2 to 4 prior regimens and 15/49 (31%) had undergone at least one transplant. The median age was 12 years. Clofarabine was given at a dose of 52 mg/m2, intravenously, over 2 hours daily x 5 repeated every 2 to 6 weeks following recovery or return to baseline organ function. The study endpoints were the rate of complete response (CR) and the rate of complete response without platelet recovery (CRp). The former was defined as no evidence of circulating blasts or extramedullary disease, an M1 bone marrow, and recovery of peripheral platelet and absolute neutrophil counts; the latter was defined as meeting all criteria for CR except for platelet count recovery. Response rates were determined by an Independent Response Review Panel (IRRP).

Six patients (12%) achieved a CR and 4 patients (8%) achieved a CRp, and 5 patients (10%) achieved a PR. Of the 15 responding patients, 6 had post-clofarabine bone marrow transplantation. Hence, response durations could not be determined. In the patients who were not transplanted, the response durations for CR were 43, 50, 82, 93+, and 160+ days; for CRp the response duration was 32 days.

The principal clofarabine toxicities were nausea, vomiting, hematologic toxicity, febrile neutropenia, hepatobiliary toxicity, infections and renal toxicity. Clofarabine can produce systemic inflammatory response syndrome/capillary leak syndrome (SIRS), manifested by the rapid development of tachypnea, tachycardia, hypotension, shock, and multi-organ failure. Cardiac toxicity was characterized as left ventricular systolic dysfunction; tachycardia may also occur.

Approval

Clolar was Food and Drug Administration (FDA) Approved 28 December 2004. (Under accelerated approval regulations requiring further clinical studies.)

Patents

External links


 
 
Learn More
Clofarabine injection
Genzyme Corporation
Antileukemic drug

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