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CLADRIBINE is a brand name for Cladribine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions 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. Significant and prolonged lymphopenia has been noted. Serious neurological toxicity (including irreversible paraparesis and quadriparesis) has been reported in patients who received cladribine 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.
General Cladribine Injection is a potent antineoplastic agent with potentially significant toxic side effects. It should be administered only under the supervision of a physician experienced with the use of cancer chemotherapeutic agents.
Patients undergoing therapy should be closely observed for signs of hematologic and non-hematologic toxicity. , infection or bleeding). Since fever is a frequently observed side effect during the first month on therapy, patients should be kept well hydrated.
As with other potent chemotherapeutic agents, monitoring of renal and hepatic function is also recommended, especially in patients with underlying kidney or liver dysfunction. ) Tumor Lysis Syndrome: Rare cases of Tumor Lysis Syndrome have been reported in patients treated with cladribine with other hematologic malignancies having a high tumor burden.
Administration of Cladribine Injection:
Cladribine Injection must be diluted in designated intravenous solutions prior to administration. ) Benzyl Alcohol as a Diluent: 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.
) Carcinogenesis and Mutagenesis As expected for compounds in this class, the actions of cladribine yield DNA damage. 0 Page 5 of 32 Hematologic Bone Marrow Suppression: Severe bone marrow suppression, including neutropenia, anemia and thrombocytopenia, has been commonly observed in patients treated with cladribine, especially at high doses.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 (assessment of peripheral blood counts), particularly during the first 4 to 8 weeks post-treatment, is recommended. Most patients in the clinical studies had hematologic impairment as a manifestation of active Hairy Cell Leukemia.
Consequently, care should be taken to distinguish disease-related bone marrow suppression from that which may result following treatment with Cladribine Injection. ] Proceed carefully in patients with severe bone marrow impairment of any etiology since further suppression of bone marrow function should be anticipated.
Hepatic/Biliary/Pancreatic There are inadequate data on dosing of patients with hepatic insufficiency. Therefore, caution is advised when administering Cladribine Injection to patients with known or suspected hepatic insufficiency. 8 °C or 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 x 106/L), including 62 patients (32%) with severe neutropenia (ANC ≤ 500 x 106/L).
) Opportunistic infections have occurred in the acute phase of treatment due to the immunosuppression mediated by cladribine. Neurologic Neurotoxicity was observed in patients undergoing bone marrow transplantation for acute leukemia.
High doses (4 to 9 times the recommended dose for Hairy Cell Leukemia), in conjunction with cyclophosphamide and total body irradiation as preparation for bone marrow transplantation, have been associated with severe, irreversible, neurologic toxicity (paraparesis/quadriparesis) and/or acute renal insufficiency.
These toxicities occurred in 45% of patients treated for 7 - 14 days. 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. 0 Page 6 of 32 Renal Acute renal insufficiency has developed in some patients receiving high doses of cladribine. In one study, following a one-hour infusion, the recovery of […]