Cladribine
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Questions & Answers
Side Effects & Adverse Reactions
Severe bone marrow suppression, including neutropenia, anemia and thrombocytopenia, has been commonly observed in patients treated with Cladribine, especially at high doses. At initiation of treatment, most patients in the clinical studies had hematologic impairment as a manifestation of active Hairy Cell Leukemia. Following treatment with Cladribine, further hematologic impairment occurred before recovery of peripheral blood counts began. During the first two weeks after treatment initiation, mean Platelet Count, ANC, and Hemoglobin concentration declined and subsequently increased with normalization of mean counts by Day 12, Week 5 and Week 8, respectively. The myelosuppressive effects of Cladribine were most notable during the first month following treatment. Forty-four percent (44%) of patients received transfusions with RBCs and 14% received transfusions with platelets during Month 1. Careful hematologic monitoring, especially during the first 4 to 8 weeks after treatment with Cladribine Injection, is recommended (see PRECAUTIONS).
Fever (T ≥ 100°F) was associated with the use of Cladribine in approximately two-thirds of patients (131/196) in the first month of therapy. Virtually all of these patients were treated empirically with parenteral antibiotics. Overall, 47% (93/196) of all patients had fever in the setting of neutropenia (ANC ≤ 1000), including 62 patients (32%) with severe neutropenia (i.e., ANC ≤ 500).
In a Phase I investigational study using Cladribine in high doses (4 to 9 times the recommended dose for Hairy Cell Leukemia) as part of a bone marrow transplant conditioning regimen, which also included high dose cyclophosphamide and total body irradiation, acute nephrotoxicity and delayed onset neurotoxicity were observed. Thirty one (31) poor-risk patients with drug-resistant acute leukemia in relapse (29 cases) or non-Hodgkins Lymphoma (2 cases) received Cladribine for 7 to 14 days prior to bone marrow transplantation. During infusion, 8 patients experienced gastrointestinal symptoms. While the bone marrow was initially cleared of all hematopoietic elements, including tumor cells, leukemia eventually recurred in all treated patients. Within 7 to 13 days after starting treatment with Cladribine, 6 patients (19%) developed manifestations of renal dysfunction (e.g., acidosis, anuria, elevated serum creatinine, etc.) and 5 required dialysis. Several of these patients were also being treated with other medications having known nephrotoxic potential. Renal dysfunction was reversible in 2 of these patients. In the 4 patients whose renal function had not recovered at the time of death, autopsies were performed; in 2 of these, evidence of tubular damage was noted. Eleven (11) patients (35%) experienced delayed onset neurologic toxicity. In the majority, this was characterized by progressive irreversible motor weakness (paraparesis/quadriparesis) of the upper and/or lower extremities, first noted 35 to 84 days after starting high dose therapy with Cladribine. Non-invasive testing (electromyography and nerve conduction studies) was consistent with demyelinating disease. Severe neurologic toxicity has also been noted with high doses of another drug in this class.
Axonal peripheral polyneuropathy was observed in a dose escalation study at the highest dose levels (approximately 4 times the recommended dose for Hairy Cell Leukemia) in patients not receiving cyclophosphamide or total body irradiation.
Severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.
In patients with Hairy Cell Leukemia treated with the recommended treatment regimen (0.09 mg/kg/day for 7 consecutive days), there have been no reports of nephrologic toxicities.
Of the 196 Hairy Cell Leukemia patients entered in the two trials, there were 8 deaths following treatment. Of these, 6 were of infectious etiology, including 3 pneumonias, and 2 occurred in the first month following Cladribine therapy. Of the 8 deaths, 6 occurred in previously treated patients who were refractory to α interferon.
Benzyl alcohol is a constituent of the recommended diluent for the 7-day infusion solution. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. (see DOSAGE AND ADMINISTRATION)
Cladribine Injection should not be given during pregnancy.
Cladribine is teratogenic in mice and rabbits and consequently has the potential to cause fetal harm when administered to a pregnant woman. A significant increase in fetal variations was observed in mice receiving 1.5 mg/kg/day (4.5 mg/m2) and increased resorptions, reduced litter size and increased fetal malformations were observed when mice received 3.0 mg/kg/day (9 mg/m2). Fetal death and malformations were observed in rabbits that received 3.0 mg/kg/day (33.0 mg/m2). No fetal effects were seen in mice at 0.5 mg/kg/day (1.5 mg/m2) or in rabbits at 1.0 mg/kg/day (11.0 mg/m2).
Although there is no evidence of teratogenicity in humans due to Cladribine, other drugs which inhibit DNA synthesis (e.g., methotrexate and aminopterin) have been reported to be teratogenic in humans. Cladribine has been shown to be embryotoxic in mice when given at doses equivalent to the recommended dose.
There are no adequate and well controlled studies in pregnant women. If Cladribine is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing age should be advised to avoid becoming pregnant.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cladribine Injection is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
History
There is currently no drug history available for this drug.
Other Information
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. Cladribine Injection is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each milliliter 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-β-D-erythropento-furanosyl) purine and the structure is represented below:
cladribine MW 285.7
Sources
Cladribine Manufacturers
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Onco Therapies Limited
![Cladribine Injection [Onco Therapies Limited ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cladribine | Onco Therapies Limited
Usual Dose:The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial 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:Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection 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 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.
Dose of
Recommended
Quantity of Diluent
Cladribine Injection
Diluent
24-hour infusion
1(day) x 0.09 mg/kg
0.9% Sodium Chloride
500 mL
method
Injection, USP
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 and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 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‡.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
7-day infusion method
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium
q.s. to 100 mL
(use sterile 0.22μ filter
Chloride Injection, USP
when preparing infusion
(0.9% benzyl alcohol)
solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection 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 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 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 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.
Chemical Stability of Vials:When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
-
Pfizer Laboratories Div Pfizer Inc.
Cladribine | Pfizer Laboratories Div Pfizer Inc.
Usual Dose:The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial 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:Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection 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 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.
Dose of
Recommended
Quantity of Diluent
Cladribine Injection
Diluent
24-hour infusion
1(day) x 0.09 mg/kg
0.9% Sodium Chloride
500 mL
method
Injection, USP
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 and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 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‡.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
7-day infusion method
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium
q.s. to 100 mL
(use sterile 0.22μ filter
Chloride Injection, USP
when preparing infusion
(0.9% benzyl alcohol)
solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection 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 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 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 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.
Chemical Stability of Vials:When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
-
Pfizer Laboratories Div Pfizer Inc.
Cladribine | Pfizer Laboratories Div Pfizer Inc.
Usual Dose:The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial 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:Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection 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 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.
Dose of
Recommended
Quantity of Diluent
Cladribine Injection
Diluent
24-hour infusion
1(day) x 0.09 mg/kg
0.9% Sodium Chloride
500 mL
method
Injection, USP
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 and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 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‡.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
7-day infusion method
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium
q.s. to 100 mL
(use sterile 0.22μ filter
Chloride Injection, USP
when preparing infusion
(0.9% benzyl alcohol)
solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection 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 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 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 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.
Chemical Stability of Vials:When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
-
Fresenius Kabi Usa, Llc
Cladribine | Fresenius Kabi Usa, Llc
Usual DosageThe recommended dose and schedule of cladribine injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for seven consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of cladribine injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from cladribine injection have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous SolutionsCladribine injection 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 should be passed through a sterile 0.22 μm 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 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 seven consecutive days.The use of 5% dextrose as a diluent is not recommended because of increased degradation of cladribine. Admixtures of cladribine injection 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.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
24-hour
infusion
method
1 (day) x 0.09 mg/kg
0.9% Sodium
Chloride
Injection, USP
500 mL
To prepare a 7-day infusion
The seven-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 and the diluent should be passed through a sterile 0.22μm disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of cladribine injection (7 days x 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 seven 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 seven-day infusion have demonstrated acceptable chemical and physical stability for at least seven days in the SIMS Deltec MEDICATION CASSETTE™ Reservoir.
Dose of Cladribine Injection
Recommended Diluent
Quantity of Diluent
7-day infusion method (use sterile 0.22μm filter when preparing infusion solution
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol)
q.s. to 100 mL
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing cladribine injection 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 should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than eight hours prior to start of administration. Vials of cladribine injection 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 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.
Chemical Stability of VialsWhen stored in refrigerated conditions between 2° to 8°C (36° to 46°F) and protected from light, unopened vials of cladribine injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of cladribine injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing cladribine injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and DisposalThe potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering cladribine injection. The use of disposable gloves and protective garments is recommended. If cladribine injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution’s guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
Usual DosageThe recommended dose and schedule of cladribine injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for seven consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of cladribine injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from cladribine injection have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous SolutionsCladribine injection 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 should be passed through a sterile 0.22 μm 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 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 seven consecutive days.The use of 5% dextrose as a diluent is not recommended because of increased degradation of cladribine. Admixtures of cladribine injection 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.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
24-hour
infusion
method
1 (day) x 0.09 mg/kg
0.9% Sodium
Chloride
Injection, USP
500 mL
To prepare a 7-day infusion
The seven-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 and the diluent should be passed through a sterile 0.22μm disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of cladribine injection (7 days x 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 seven 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 seven-day infusion have demonstrated acceptable chemical and physical stability for at least seven days in the SIMS Deltec MEDICATION CASSETTE™ Reservoir.
Dose of Cladribine Injection
Recommended Diluent
Quantity of Diluent
7-day infusion method (use sterile 0.22μm filter when preparing infusion solution
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol)
q.s. to 100 mL
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing cladribine injection 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 should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than eight hours prior to start of administration. Vials of cladribine injection 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 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.
Chemical Stability of VialsWhen stored in refrigerated conditions between 2° to 8°C (36° to 46°F) and protected from light, unopened vials of cladribine injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of cladribine injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing cladribine injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and DisposalThe potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering cladribine injection. The use of disposable gloves and protective garments is recommended. If cladribine injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution’s guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
-
Mylan Institutional Llc
Cladribine | Mylan Institutional Llc
Usual Dose:The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial 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:Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection 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 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.
Dose of
Recommended
Quantity of Diluent
Cladribine Injection
Diluent
24-hour infusion
1(day) x 0.09 mg/kg
0.9% Sodium Chloride
500 mL
method
Injection, USP
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 and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 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‡.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
7-day infusion method
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium
q.s. to 100 mL
(use sterile 0.22μ filter
Chloride Injection, USP
when preparing infusion
(0.9% benzyl alcohol)
solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection 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 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 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 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.
Chemical Stability of Vials:When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
-
Mylan Institutional Llc
Cladribine | Mylan Institutional Llc
Usual Dose:The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial 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:Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection 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 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.
Dose of
Recommended
Quantity of Diluent
Cladribine Injection
Diluent
24-hour infusion
1(day) x 0.09 mg/kg
0.9% Sodium Chloride
500 mL
method
Injection, USP
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 and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 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‡.
Dose of
Cladribine Injection
Recommended
Diluent
Quantity of
Diluent
7-day infusion method
7 (days) x 0.09 mg/kg
Bacteriostatic 0.9% Sodium
q.s. to 100 mL
(use sterile 0.22μ filter
Chloride Injection, USP
when preparing infusion
(0.9% benzyl alcohol)
solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection 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 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 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 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.
Chemical Stability of Vials:When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
![Cladribine Injection [Pfizer Laboratories Div Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1c241013-defb-4766-9f87-58b9075c9524&name=cladribineinjpfizer-figure-02.jpg)
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