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Cladribine

 
Oncology Encyclopedia: Cladribine
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Key Terms: Anemia, Complete response, Chemotherapy, DNA, Food and Drug Administration, Intravenous.

Definition

Cladribine, also known by the brand name Leustatin, is a chemotherapy medicine used to treat certain types of cancer by destroying cancerous cells.

Purpose

Cladribine is approved by the Food and Drug Administration (FDA) to treat active hairy cell leukemia. It has also been used to treat other types of leukemias and lymphomas.

Description

A member of the group of chemotherapy drugs known as a purine nucleoside analog, cladribine may also be referred to as 2-CdA, chlorodeoxyadenosine, and 2-chlorodeoxyadenosine. The purine nucleosides interfere with the genetic material (DNA) inside the cancer cells, cause DNA strand breaks, and block RNA synthesis. These traits help prevent cancer cells from further dividing and growing and also may cause the cancer cells to die.

Recommended Dosage

Cladribine is a clear solution that is administered through a vein. The dose of cladribine is based on a patient's weight in kilograms. The approved dose for hairy cell leukemia is 0.09 mg per kilogram of body weight administered each day as a continuous intravenous infusion administered over 24 hours each day for seven continuous days. Some patients may receive this treatment in more than one cycle.

Other doses include 0.1 to 0.3 mg per kilogram of body weight per day for seven days administered as a continuous infusion. Patients may also receive cladribine as a two-hour infusion daily for five days in a row.

Precautions

Blood counts will be monitored regularly while on cladribine therapy. During a certain time period after receiving cladribine, there is an increased risk of getting infections. Caution should be taken to avoid unnecessary exposure to crowds and people with infection.

Patients with a known previous allergic reaction to chemotherapy drugs should tell their doctor.

Patients who may be pregnant or are trying to become pregnant should tell their doctors before receiving cladribine.

Although chemotherapy can cause men and women to be sterile (not able to have children), it is unknown if cladribine has this effect on humans.

Patients should check with their doctors before receiving live virus vaccines while on chemotherapy.

Side Effects

The most common side effect from taking cladribine is low blood counts, referred to as myelosuppression. When the white blood cell count is lower than normal, referred to as neutropenia, patients are at an increased risk of developing a fever and infections. The platelet blood count can also be decreased due to cladribine administration, but generally returns back to normal within two weeks after the end of the infusion. Platelets are blood cells in the body that cause clots to form these clots stop bleeding. When the platelet count is low, patients are at an increased risk for bruising and bleeding. Cladribine causes low red blood cell counts, which is referred to as anemia. Low red counts make people feel tired and dizzy.

Other common side effects of cladribine include skin rashes or reactions, pain, redness, or swelling at the injection site. Half of patients with hairy cell leukemia experience a rash.

Patients may experience infections, chills, and fever when being treated with cladribine. This may result in treatment with antibiotics.

Nausea, vomiting, loss of appetite, abdominal pain, constipation and diarrhea are mild side effects from cladribine. If nausea and vomiting are a problem, patients can be given medicines known as antiemetics before receiving cladribine to help prevent or decrease these side effects.

Damage to the kidneys and nervous system tissues is uncommon with cladribine, unless given in high doses for bone marrow transplant patients. At high doses, kidney problems and nerve damage have resulted in weakness of the arms and legs.

Less common side effects of cladribine are hair loss, itching, a fever from taking the drug, lung problems, cough, inability to sleep, headache, dizziness, fast heart rate, muscle and joint aches, and fatigue.

Interactions

Patients should notify their doctors of any medications they are taking. In the case of cladribine, medications to make special note of include antithyroid agents, azathioprine, chloramphenicol, flucytosine, ganciclovir, interferon, plicamycin, zidovudine, probenecid, sulfinpyrazone.

Patients should tell their doctors if they have a known allergic reaction to amifostine or any other medications or substances, such as foods and preservatives. Before taking any new medications, including nonprescription medications, vitamins, and herbal medications, the patients should notify their doctors.

—Nancy J. Beaulieu, RPh., BCOP

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Drug Info: Cladribine
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Home > Library > Health > Drug Info

Brand names: Leustatin®

Chemical formula:



Cladribine Solution for injection

What is this medicine?

CLADRIBINE is a chemotherapy drug. This medicine reduces the growth of cancer cells and can suppress the immune system. It is used for treating leukemias.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

They need to know if you have any of these conditions:
•bleeding problems
•infection (especially a virus infection such as chickenpox, cold sores, or herpes)
•kidney disease
•liver disease
•an unusual or allergic reaction to cladribine, benzyl alcohol, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered 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 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you use two or more doses per day, use the missed dose as soon as you remember. If it is nearly time for the next dose, skip the missed dose and resume your regular schedule with the next dose. Do not use double doses.

If you use one dose per day, use the missed dose as soon as you remember on the day the dose was due. If you do not remember until the next day, skip the missed dose and resume your regular schedule with the next dose. Do not use double doses.

What may interact with this medicine?

•vaccines

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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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 professional 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.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

If you are a man, you should not father a child while receiving treatment.

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
•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.
•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 - unusually weak or tired, fainting spells, lightheadedness
•abdominal pain
•breathing problems
•dizziness
•mouth sores
•trouble passing urine or change in the amount of urine

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
•weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

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

Last updated: 7/1/2002

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.

Wikipedia: Cladribine
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Home > Library > Miscellaneous > Wikipedia
Cladribine
Systematic (IUPAC) name
5-(6-amino-2-chloro-purin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
Identifiers
CAS number 4291-63-8
ATC code L01BB04
PubChem 20279
DrugBank APRD00260
ChemSpider 19105
Chemical data
Formula C10H12ClN5O3 
Mol. mass 285.687 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 100% (IV)
Protein binding 20%
Metabolism  ?
Half life 5.4 hours
Excretion  ?
Therapeutic considerations
Pregnancy cat.

D(US)
Legal status

℞-only(US)
Routes IV, oral
 Yes check.svgY(what is this?)  (verify)

Cladribine (Leustatin) is a drug used to treat hairy cell leukemia (leukemic reticuloendotheliosis) and multiple sclerosis. Its chemical name is 2-chlorodeoxyadenosine (2CDA).

As a purine analog, it is a synthetic anti-cancer agent that also suppresses the immune system. Chemically, it mimics the nucleoside adenosine and thus inhibits the enzyme adenosine deaminase, which interferes with the cell's ability to process DNA. It is easily destroyed by normal cells except for blood cells, with the result that it produces relatively few side effects and results in very little non-target cell loss.

Contents

Indications

Cladribine is indicated for the treatment of symptomatic hairy cell leukemia (HCL).[1]

It is under investigation for other B cell leukemias and lymphomas, such as mantle cell lymphoma,[2], and for use in the treatment of multiple sclerosis.

According to the Histiocytosis Association of America, cladribine is used to treat histiocytosis.[3]

Routes of administration

For hairy cell leukemia, cladribine can be given by IV infusion or subcutaneous ("sub-q" or SQ) injection.

For outpatient IV infusions, the delivery time (not including time to place the IV line) may range from one to four hours; two hours is most common. Continuous IV infusion may be chosen; this approach drips in the cladribine slowly, 24 hours a day using a portable pump and a central venous catheter or a PICC line. By contrast, SQ injections take less than ten seconds per day.

The same total doses are given by both routes. IV and SQ routes have the same overall outcomes, and the SQ route may be reduce the infections and other risks associated with venipuncture.[4]

An oral tablet form of cladribine has been successfully tested in patients with relapsing multiple sclerosis.[5]

Treatment schedule

Using either IV or SQ routes of administration, cladribine can be administered on a daily or a weekly schedule. Daily schedules involve one SQ injection or one IV infusion per day for five to seven consecutive days. Weekly schedules involve one injection or infusion each week, for five or six weeks. One cycle is normally sufficient to produce a complete response, but in the event of a partial response, cycles may safely be repeated one to three months after the end of the first cycle.

Actual doses are calculated according to the surface area of the patient's skin instead of by weight, and divided by the number of planned treatments.

All schedules produce the same benefits and disadvantages. Five-day and seven-day daily schedules give the same total amount of drug and have the same outcomes, including remissions and adverse effects.[6] Daily and weekly schedules give the same total amount of drug and have the same outcomes, including similar proportions of complete responses and similar proportions of patients hospitalized for fevers and opportunistic infections.[7]

Adverse effects

Existing studies estimate that from 18%[8] to 42%[9] of patients will experience a fever after cladribine infusion. This is usually a transient fever which can be treated with acetaminophen (paracetamol).[10] These fevers resolve in less than 48 hours,[11] have no evidence of being related to infection.

However, some patients have fevers that last longer and may be caused by an infection.[11][12] Very few infections have actually been documented,[9] but they do happen, and these infections are largely responsible for the 3% mortality rate associated with cladribine therapy in HCL.[13] Factors that increased the likelihood of a neutropenic fever (with or without concomitant infection) include: anemia, hypocholesterolemia, a high proportion of hairy cells in the bone marrow with a low proportion of myelopoietic cells, low albumin, and high C-reactive protein. These are all signs of an advanced case of HCL.

In patients with hairy cell leukemia, there is no benefit to using hormones such as filgrastim or Granulocyte macrophage colony-stimulating factor to raise white blood cell counts prophylactically.[9][13] The use of these expensive drugs does not reduce the number of patients who experience fevers, the number of days that the fevers last, or the number of patients admitted to the hospital for antibiotic treatments.[9] Therefore routine adjunctive use (that is, use when there are no signs of infection) is not recommended.[9]

In addition to fevers, cladribine increases the risk of herpes virus infections, particularly shingles.[8]

Some HCL patients will require blood transfusions of platelets or packed red blood cells.[6]

Patients are expected to experience a decline in blood cell counts during treatment. Several weeks after successful treatment, cell counts will begin to rebound, with platelet and neutrophil counts recovering before red blood cells and T cells. T4 cell counts may never reach pre-disease levels. Patients are usually advised to avoid sick people and large crowds of people as well as to wash their hands and keep their hands away from their eyes, nose, and mouth until their neutrophil counts have recovered.

Many patients experience fatigue, even in the absence of anemia, but since fatigue is a common feature of the disease, this may be caused by the disease instead of by the drug.

This drug does not cause hair loss, vomiting, or other side effects that are commonly associated with "old style" alkylating chemotherapy drugs. However, peripheral neuropathy has been reported occasionally after repeated doses of cladribine in the treatment of hairy cell leukemia. Overdose may cause kidney damage.

Response

According to the drug's FDA-approved prescribing information,[14] the median time to normalization of blood counts in patients with hairy cell leukemia is: two weeks for platelets, five weeks for absolute neutrophil counts, eight weeks for hemoglobin, and nine weeks for a patient to have all three parameters normalized. Weeks are counted from the first day of treatment, and all patients were on a seven-day daily treatment schedule for these studies.

References

  1. ^ Else M, Dearden CE, Matutes E, et al. (March 2009). "Long-term follow-up of 233 patients with hairy cell leukaemia, treated initially with pentostatin or cladribine, at a median of 16 years from diagnosis". Br. J. Haematol.. doi:10.1111/j.1365-2141.2009.07668.x. PMID 19344416. http://dx.doi.org/10.1111/j.1365-2141.2009.07668.x. 
  2. ^ Mantle Cell Lymphoma initiative
  3. ^ Histiocytosis Association of America
  4. ^ von Rohr A, Schmitz SF, Tichelli A, et al. (2002). "Treatment of hairy cell leukemia with cladribine (2-chlorodeoxyadenosine) by subcutaneous bolus injection: a phase II study". Ann. Oncol. 13 (10): 1641–9. doi:10.1093/annonc/mdf272. PMID 12377655. http://annonc.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=12377655. 
  5. ^ Cladribine Tablets for Multiple Sclerosis Significantly Reduced Relapse Rate in Two-Year Phase III Pivotal Trial
  6. ^ a b Aurer I, Mitrović Z, Kovacević-Metelko J, et al. (2007). "[Treatment of hairy cell leukemia with cladribine]" (in Croatian). Lijec Vjesn 129 (3-4): 80–3. PMID 17557550. 
  7. ^ Robak T, Jamroziak K, Gora-Tybor J, et al. (2007). "Cladribine in a weekly versus daily schedule for untreated active hairy cell leukemia: final report from the Polish Adult Leukemia Group (PALG) of a prospective, randomized, multicenter trial". Blood 109 (9): 3672–5. doi:10.1182/blood-2006-08-042929. PMID 17209059. http://www.bloodjournal.org/cgi/pmidlookup?view=long&pmid=17209059. 
  8. ^ a b Van Den Neste E, Delannoy A, Vandercam B, et al. (1996). "Infectious complications after 2-chlorodeoxyadenosine therapy". Eur. J. Haematol. 56 (4): 235–40. PMID 8641392. 
  9. ^ a b c d e Saven A, Burian C, Adusumalli J, Koziol JA (1999). "Filgrastim for cladribine-induced neutropenic fever in patients with hairy cell leukemia". Blood 93 (8): 2471–7. PMID 10194424. http://www.bloodjournal.org/cgi/pmidlookup?view=long&pmid=10194424. 
  10. ^ Nelson MC, Hogan DK (1995). "The role of cladribine in the treatment of lymphoid malignancies". Oncol Nurs Forum 22 (9): 1395–400. PMID 8539180. 
  11. ^ a b Lauria F, Benfenati D, Raspadori D, et al. (1994). "Retreatment with 2-CdA of progressed HCL patients". Leuk. Lymphoma 14 Suppl 1: 143–5. PMID 7820047. 
  12. ^ Lauria F, Benfenati D, Raspadori D, Rondelli D, Zinzani PL, Tura S (1993). "High complete remission rate in hairy cell leukemia treated with 2-chlorodeoxyadenosine". Leuk. Lymphoma 11 (5-6): 399–404. doi:10.3109/10428199309067932. PMID 7907247. 
  13. ^ a b Juliusson G, Lenkei R, Tjønnfjord G, Heldal D, Liliemark J (April 1995). "Neutropenic fever following cladribine therapy for symptomatic hairy-cell leukemia: predictive factors and effects of granulocyte-macrophage colony-stimulating factor". Ann. Oncol. 6 (4): 371–5. PMID 7619752. http://annonc.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=7619752. 
  14. ^ "Leustatin prescribing information" (PDF). Ortho Biotech Products, L.P. (a subsidiary of Johnson & Johnson. August 2007 revision. http://www.orthobiotech.com/orthobiotech/shared/OBI/PI/Leustatin_PI.pdf. 
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This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer)

 
 
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Oncology Encyclopedia. Gale Encyclopedia of Cancer. Copyright © 2006 by The Gale Group, Inc. All rights reserved.  Read more
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