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Leustatin

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Leustatin

LEUSTATIN ®
(cladribine) Injection For Intravenous Infusion Only

Leustatin

WARNING

LEUSTATIN (cladribine) Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTATIN Injection by continuous infusion at high doses (4 to 9 times the recommended dose for Hairy Cell Leukemia). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Acute nephrotoxicity has been observed with high doses of LEUSTATIN (4 to 9 times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.

DRUG DESCRIPTION

LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2'-deoxy- β -D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution. LEUSTATIN Injection is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each milliliter of LEUSTATIN Injection contains 1 mg of the active ingredient and 9 mg (0.15 mEq) of sodium chloride as an inactive ingredient. The solution has a pH range of 5.5 to 8.0. Phosphoric acid and/or dibasic sodium phosphate may have been added to adjust the pH to 6.3±0.3.

The chemical name for cladribine is 2-chloro-6-amino-9-(2-deoxy-β-D-erythropentofuranosyl) purine and the structure is represented below:

LEUSTATIN® (cladribine) Structural Formula Illustration

cladribine .......... MW 285.7

What are the possible side effects of cladribine (Cladribine Novaplus, Leustatin)?

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:

  • numbness, tingling, weakness, or burning pain in your fingers or toes;
  • numbness or tingly feeling around your mouth;
  • feeling like you might pass out;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • muscle weakness, tightness, or contraction, overactive...

Read All Potential Side Effects and See Pictures of Leustatin »

What are the precautions when taking cladribine injection for intravenous infusion only (Leustatin)?

Before using cladribine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, nerve/muscle disorder, blood/bone marrow disorder, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well...

Read All Potential Precautions of Leustatin »

Last reviewed on RxList: 8/9/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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