Cladribine injection, USP must be diluted with the designated diluent prior to administration. Since the drug product does not contain any antimicrobial preservative or bacteriostatic agent,  aseptic technique and proper environmental precautions must be observed in preparation of cladribine injection solutions.

### To prepare a single daily dose

Cladribine injection, USP should be passed through a sterile 0.22µm disposable hydrophilic syringe filter prior to introduction into the infusion bag, prior to each daily infusion. Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of cladribine injection, USP through the sterile filter to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP. Infuse continuously over 24 hours. Repeat daily for a total of 7 consecutive days.  The use of 5% dextrose as a diluent is not recommended because of increased degradation of cladribine. Admixtures of cladribine injection, USP are chemically and physically stable for at least 24 hours at room temperature under normal room fluorescent light in Baxter Viaflex ® PVC infusion containers.  Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised.

### To prepare a 7-day infusion

The 7-day infusion solution should only be prepared with Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved). In order to minimize the risk of microbial contamination, both cladribine injection, USP and the diluent should be passed through a sterile 0.22 µm disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of cladribine injection, USP (7 days × 0.09 mg/kg or mL/kg) to the infusion reservoir through the sterile filter. 

Then add a calculated amount of Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved) also through the filter to bring the total volume of the solution to 100 mL. After completing solution preparation, clamp off the line, disconnect and discard the filter. Aseptically aspirate air bubbles from the reservoir as necessary using the syringe and a dry second sterile filter or a sterile vent filter assembly. Reclamp the line and discard the syringe and filter assembly. Infuse continuously over 7 days. Solutions prepared with Bacteriostatic Sodium Chloride Injection for individuals weighing more than 85 kg may have reduced preservative effectiveness due to greater dilution of the benzyl alcohol preservative. Admixtures for the 7-day infusion have demonstrated acceptable chemical and physical stability for at least 7 days in the SIMS Deltec MEDICATION CASSETTE™ Reservoir.

Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing cladribine injection, USP should not be mixed with other intravenous drugs or additives or infused simultaneously via a common intravenous line, since compatibility testing has not been performed. Preparations containing benzyl alcohol should not be used in neonates (see  WARNINGS). 

Care must be taken to assure the sterility of prepared solutions. Once diluted, solutions of cladribine injection, USP should be administered promptly or stored in the refrigerator (2° to 8° C) for no more than 8 hours prior to start of administration. Vials of cladribine injection, USP are for single-use only. Any unused portion should be discarded in an appropriate manner (see  Handling and Disposal). 

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A precipitate may occur during the exposure of cladribine injection, USP to low temperatures; it may be resolubilized by allowing the solution to warm naturally to room temperature and by shaking vigorously.  DO NOT HEAT OR MICROWAVE.