Rx Item-Leustatin 10Mg 10Ml Vial 10Ml By J O M Pharma

LEUSTATIN- cladribine injection, solution
Janssen Products, L.P.

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.

DESCRIPTION

LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2?-deoxy- ? -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-?-D-erythropento-furanosyl) purine. CLINICAL PHARMACOLOGY

Cellular Resistance and Sensitivity
The selective toxicity of 2-chloro-2?-deoxy-?-D-adenosine towards certain normal and malignant lymphocyte and monocyte populations is based on the relative activities of deoxycytidine kinase and deoxynucleotidase. Cladribine passively crosses the cell membrane. In cells with a high ratio of deoxycytidine kinase to deoxynucleotidase, it is phosphorylated by deoxycytidine kinase to 2-chloro-2?-deoxy- ? -D-adenosine monophosphate (2-CdAMP). Since 2-chloro-2?-deoxy- ? -D-adenosine is resistant to deamination by adenosine deaminase and there is little deoxynucleotide deaminase in lymphocytes and monocytes, 2-CdAMP accumulates intracellularly and is subsequently converted into the active triphosphate deoxynucleotide, 2-chloro-2?-deoxy- ? -D-adenosine triphosphate (2-CdATP). It is postulated that cells with high deoxycytidine kinase and low deoxynucleotidase activities will be selectively killed by 2-chloro-2?-deoxy- ? -D-adenosine as toxic deoxynucleotides accumulate intracellularly.

RX ITEM-Leustatin 10Mg 10Ml Vial 10Ml By
NDC 59676-0201-01 UPC/GTIN No.3-59676-20101-4 Mfg.Part No.20101

Leustatin 10Mg 10Ml Vial 10Ml By J O M P
BRAND: LEUSTATIN NDC: 59676-0201-01,59676020101 UPC: 3-59676-20101-4,359676201014 J/O/M Pharma Services

CLADRIBINE INTRAVEN VIAL
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