RX ITEM-Cladribine 10Mg 10Ml Vial 10Ml By Mylan Institutional

CLADRIBINE- cladribine injection
Bedford Laboratories

Rx ONLY

For Intravenous Infusion Only

WARNING

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 cladribine 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 cladribine (4 to 9 times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.

DESCRIPTION

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. Cladribine Injection is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each mL of cladribine 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-erythro -pentofuranosyl)purine and the structure is represented below:

structure
Molecular Formula = C10 H12 ClN5 O3 Molecular Weight = 285.69

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.

Cells containing high concentrations of deoxynucleotides are unable to properly repair single-strand DNA breaks. The broken ends of DNA activate the enzyme poly (ADP-ribose) polymerase resulting in NAD and ATP depletion and disruption of cellular metabolism. There is evidence, also, that 2-CdATP is incorporated into the DNA of dividing cells, resulting in impairment of DNA synthesis. Thus, 2-chloro-2�-deoxy-�-D-adenosine can be distinguished from other chemotherapeutic agents affecting purine metabolism in that it is cytotoxic to both actively dividing and quiescent lymphocytes and monocytes, inhibiting both DNA synthesis and repair.

RX ITEM-Cladribine 10Mg 10Ml Vial 10Ml B
NDC 00069-0086-18 UPC/GTIN No.3-00690-08618-7 Mfg.Part No.8618

Cladribine 10Mg 10Ml Vial 10Ml By Mylan
BRAND: CLADRIBINE NDC: 00069-0086-18,69008618 UPC: 3-00690-08618-7,300690086187 Mylan Institutional/Gen

CLADRIBINE INTRAVEN VIAL
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