bezlotoxumab- ZINPLAVA™ injection |
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Usual Diluents
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NS, D5W |
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Standard Dilutions [Amount of drug]
[Infusion volume] [Infusion rate]
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[10 mg/kg] [final concentration -1 mg/mL to 10 mg/mL ] [60 minutes]
Example 70 kg patient: [700 mg ] [100 - 500 mL] [60 minutes] Preparation of Diluted Solution
Administration
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WARNINGS
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See warnings and precautions below. |
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DESCRIPTION
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Description: Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa. ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0. |
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CLINICAL PHARMACOLOGY:
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Mechanism of Action: Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium dissociation constant (Kd) of <1×10-9M. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A. Activity In Vitro Bezlotoxumab binds to an epitope on toxin B that is conserved across reported strains of C. difficile, although amino acid sequence variation within the epitope does occur. In vitro studies in cell-based assays using Vero cells or Caco-2 cells, suggest that bezlotoxumab neutralizes the toxic effects of toxin B. |
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INDICATIONS AND
USAGE
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INDICATIONS AND USAGE: ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence. (1) Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. |
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CONTRAINDICATIONS
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Contraindications: None |
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PRECAUTIONS
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WARNINGS AND PRECAUTIONS:
Heart Failure |
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ADVERSE REACTIONS
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ADVERSE REACTIONS: Most common adverse
reactions (reported in >/=4% of patients) included nausea,
pyrexia, and headache. (6.1) See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
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DOSAGE AND ADMINISTRATION
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DOSAGE AND ADMINISTRATION:
Administration
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HOW SUPPLIED
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DOSAGE FORMS AND STRENGTHS: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. |
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Storage and Stability
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ZINPLAVA Injection: is a sterile, preservative-free, clear to
moderately opalescent, colorless to pale yellow solution and is
supplied in the following packaging configuration: Carton (NDC 0006-3025-00) containing one (1) single-dose vial of ZINPLAVA 1,000 mg/40 mL (25 mg/mL). SStore in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze. Do Not Shake. Storage of Diluted Solution
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Disclaimer |
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The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. |