Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags 16.2 Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch.; 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags; PRINCIPAL DISPLAY PANEL - 500 mg/100 mL NDC 0143-9471-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Use Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 500 mg Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV100 Rev. March 2025 Outlet port NDC 0143-9471-01 Rx Only TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 500 mg Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV100 Rx Only Sterile NDC 0143-9471-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9471-01 Ready To Use TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) For Intravenous Use Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 500 mg NEW FORMULATION Rx Only Sterile NDC 0143-9471-12 Contains six (12) single-dose Flexible Bags of NDC 0143-9471-01 Ready To Use TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 500 mg NEW FORMULATION bag 500mg OW CTN 500mg CTN 12; PRINCIPAL DISPLAY PANEL - 750 mg/150 mL NDC 0143-9468-01 EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 750 mg Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV150 Rev. March 2025 Outlet port NDC 0143-9468-01 Rx Only TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 750 mg Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV150 Rx Only Sterile NDC 0143-9468-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9468-01 Ready To Use TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 750 mg NEW FORMULATION Rx Only Sterile NDC 0143-9468-12 Contains twelve (12) single-dose Flexible Bags of NDC 0143-9468-01 Ready To Use TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 750 mg NEW FORMULATION 750mg Bag Label 750mg OW 750mg-150mL CTN06; PRINCIPAL DISPLAY PANEL - 1g/200mL NDC 0143-9472-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV200 Rev. March 2025 Outlet port NDC 0143-9472-01 Rx Only TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma O130USTZV200 Rx Only Sterile NDC 0143-9472-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9472-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1 g NEW FORMULATION Rx Only Sterile NDC 0143-9472-12 Contains twelve (12) single-dose Flexible Bags of NDC 0143-9472-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1 g NEW FORMULATION 1g 200mL Bag Label 1g 200mL OW 1g 200mL CTN06 1g 200mL CTN12; PRINCIPAL DISPLAY PANEL - 1.25g/250mL NDC 0143-9466-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.25 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV250 Rev. March 2025 Outlet port NDC 0143-9466-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.25 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV250 Rx Only Sterile NDC 0143-9466-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9466-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.25 g NEW FORMULATION 1.25g Bag Label 1.25 250mL OW 1.25 250mL CTN; PRINCIPAL DISPLAY PANEL - 1.5g/300mL NDC 0143-9469-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.5 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV300 Rev. March 2025 Outlet port NDC 0143-9469-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.5 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV300 Rx Only Sterile NDC 0143-9469-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9469-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.5 g NEW FORMULATION 1.5g 300mL Bag 1.5g 300mL OW 1.5g 300mL CTN; PRINCIPAL DISPLAY PANEL - 1.75g/350mL NDC 0143-9467-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.75 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV350 Rev. March 2025 Outlet port NDC 0143-9467-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.75 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV350 Rx Only Sterile NDC 0143-9467-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9467-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.75 g NEW FORMULATION 1.75 350mL Bag 1.75g 350mL OW 1.75 350mL CTN; PRINCIPAL DISPLAY PANEL - 2 g/400mL NDC 0143-9470-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 2 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV400 Rev. March 2025 Outlet port NDC 0143-9470-01 Rx Only TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 2 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV400 Rx Only Sterile NDC 0143-9470-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9470-01 Ready To Use TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 2 g NEW FORMULATION 2g 400mL Bag 2g 400mL OW 2g 400mL CTN
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags 16.2 Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch.
- 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags
- PRINCIPAL DISPLAY PANEL - 500 mg/100 mL NDC 0143-9471-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Use Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 500 mg Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV100 Rev. March 2025 Outlet port NDC 0143-9471-01 Rx Only TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 500 mg Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV100 Rx Only Sterile NDC 0143-9471-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9471-01 Ready To Use TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) For Intravenous Use Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 500 mg NEW FORMULATION Rx Only Sterile NDC 0143-9471-12 Contains six (12) single-dose Flexible Bags of NDC 0143-9471-01 Ready To Use TYZAVAN (vancomycin injection, USP) 500 mg/100 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 500 mg NEW FORMULATION bag 500mg OW CTN 500mg CTN 12
- PRINCIPAL DISPLAY PANEL - 750 mg/150 mL NDC 0143-9468-01 EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 750 mg Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV150 Rev. March 2025 Outlet port NDC 0143-9468-01 Rx Only TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 750 mg Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV150 Rx Only Sterile NDC 0143-9468-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9468-01 Ready To Use TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 750 mg NEW FORMULATION Rx Only Sterile NDC 0143-9468-12 Contains twelve (12) single-dose Flexible Bags of NDC 0143-9468-01 Ready To Use TYZAVAN (vancomycin injection, USP) 750 mg/150 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 750 mg NEW FORMULATION 750mg Bag Label 750mg OW 750mg-150mL CTN06
- PRINCIPAL DISPLAY PANEL - 1g/200mL NDC 0143-9472-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV200 Rev. March 2025 Outlet port NDC 0143-9472-01 Rx Only TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma O130USTZV200 Rx Only Sterile NDC 0143-9472-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9472-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1 g NEW FORMULATION Rx Only Sterile NDC 0143-9472-12 Contains twelve (12) single-dose Flexible Bags of NDC 0143-9472-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1 g/200 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1 g NEW FORMULATION 1g 200mL Bag Label 1g 200mL OW 1g 200mL CTN06 1g 200mL CTN12
- PRINCIPAL DISPLAY PANEL - 1.25g/250mL NDC 0143-9466-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.25 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV250 Rev. March 2025 Outlet port NDC 0143-9466-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.25 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV250 Rx Only Sterile NDC 0143-9466-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9466-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.25 g/250 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.25 g NEW FORMULATION 1.25g Bag Label 1.25 250mL OW 1.25 250mL CTN
- PRINCIPAL DISPLAY PANEL - 1.5g/300mL NDC 0143-9469-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.5 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV300 Rev. March 2025 Outlet port NDC 0143-9469-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.5 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV300 Rx Only Sterile NDC 0143-9469-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9469-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.5 g/300 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.5 g NEW FORMULATION 1.5g 300mL Bag 1.5g 300mL OW 1.5g 300mL CTN
- PRINCIPAL DISPLAY PANEL - 1.75g/350mL NDC 0143-9467-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 1.75 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV350 Rev. March 2025 Outlet port NDC 0143-9467-01 Rx Only TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 1.75 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV350 Rx Only Sterile NDC 0143-9467-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9467-01 Ready To Use TYZAVAN (vancomycin injection, USP) 1.75 g/350 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 1.75 g NEW FORMULATION 1.75 350mL Bag 1.75g 350mL OW 1.75 350mL CTN
- PRINCIPAL DISPLAY PANEL - 2 g/400mL NDC 0143-9470-01 LOT EXP Rx Only NEW FORMULATION TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 2 g Ready To Use NEW FORMULATION Made in Switzerland BH130USTZV400 Rev. March 2025 Outlet port NDC 0143-9470-01 Rx Only TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) Single-Dose Flexible Bag Sterile, Nonpyrogenic NEW FORMULATION Ready To Use Dosage: See Prescribing Information. For Intravenous Infusion Only Infuse over at least 60 minutes. 2 g Cautions: Do not add supplementary medication or additives. Discard unused portion. Store at 15°C to 25°C (59°F to 77°F), in original package. Use within 28 days of removal from aluminum overpouch. Each 100 mL contains: Vancomycin hydrochloride equivalent to 500 mg vancomycin; 1.36 g N-acetyl-D-alanine and 1.26 g L-lysine hydrochloride in water for injection. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Manufactured for Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ 07922 Made in Switzerland Rev. March 2025 Hikma 0130USTZV400 Rx Only Sterile NDC 0143-9470-06 Contains six (6) single-dose Flexible Bags of NDC 0143-9470-01 Ready To Use TYZAVAN (vancomycin injection, USP) 2 g/400 mL (5 mg/mL) For Intravenous Infusion Only Store at 15°F to 25°C (59°F to 77°F), in original package. Discard unused portion. 2 g NEW FORMULATION 2g 400mL Bag 2g 400mL OW 2g 400mL CTN
Overview
TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). The chemical name is ( S a )-(3 S ,6 R ,7 R ,22 R ,23 S ,26 S ,36 R ,38a R )-44-{[2- O -(3-amino-2,3,6-trideoxy-3- C -methyl-α-L- lyxo -hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R )-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 Cl 2 N 9 O 24 •HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L. Structural formula
Indications & Usage
TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Septicemia TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.2 Infective Endocarditis TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use TYZAVAN in combination with an aminoglycoside. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside. 1.3 Skin and Skin Structure Infections TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of skin and skin structure infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.4 Bone Infections TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of bone infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.5 Lower Respiratory Tract Infections TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of lower respiratory tract infections due to: Susceptible isolates of MRSA Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage & Administration
If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. ( 2.1 ). For intravenous use only. Do not administer orally ( 2.1 ). Administer TYZAVAN by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions ( 2.1 ) Recommended Dosage in Adult Patients with Normal Renal Function: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours ( 2.2 ) Recommended Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function: 10 mg/kg per dose given every 6 hours ( 2.3 ) Recommended Dosage in Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment ( 2.4 ) See full prescribing information for further important preparation and administration instructions ( 2.1, 2.5 ) 2.1 Important Administration Instructions If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. TYZAVAN is intended for intravenous use only. TYZAVAN is not to be administered orally. To reduce the risk of infusion related adverse reactions, administer TYZAVAN by intravenous infusion over 60 minutes or greater [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . An infusion rate of 10 mg/min or less is associated with fewer infusion-related adverse reactions [see Warnings and Precautions (5.1) ] . Infusion related adverse reactions may occur, however, at any rate or concentration. Drug additives should not be made to this solution. TYZAVAN concentrations of no more than 5 mg/mL are recommended in adults and pediatric patients (1 month and older) [see Dosage and Administration (2.2) ] . See also age-specific recommendations [see Dosage and Administration (2.3) ] . Administer TYZAVAN by a secure intravenous route of administration to reduce the risk of local irritation and phlebitis reactions [see Warnings and Precautions (5.8) ] . Administer TYZAVAN prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage in Adult Patients with Normal Renal Function The usual daily intravenous dosage of TYZAVAN is 2 grams (g) divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. The initial daily dose should be no less than 15 mg/kg. 2.3 Recommended Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered [see Use in Specific Populations (8.4) ] . Pediatric Patients (Aged 1 Month and Older) The usual intravenous dosage of TYZAVAN is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients. 2.4 Recommended Dosage in Adult Patients with Renal Impairment Dosage adjustment must be made in adult patients with renal impairment. The initial dose of TYZAVAN should be no less than 15 mg/kg in patients with any degree of renal impairment. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measure trough vancomycin serum concentrations to guide therapy, especially in seriously ill patients with changing renal function. For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentration. A dose of 1.9 mg/kg/24 h should be given after the initial dose of 15 mg/kg. Measure vancomycin serum concentrations at 24 hours following the first dose to guide further intravenous therapy. 2.5 Administration and Preparation and Storage Instructions for TYZAVAN Administration Instructions TYZAVAN in transparent single-dose flexible bag is for intravenous administration only. Intermittent infusion is the recommended method of administration. TYZAVAN is a room temperature stable, ready-to-use drug product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Preparation for Intravenous Administration and Storage Instructions: 1. Remove the flexible bag from aluminum overpouch. 2. Check for minute leaks by squeezing the bag firmly. If leaks are detected, discard solution because sterility may be impaired. Leaks may be more readily detected by wrapping the bag with blotting paper or a tissue before squeezing. 3. Do not add supplemental medication. 4. Visually inspect the flexible bag. If the outlet port protector is damaged, detached, or not present, discard the flexible bag as solution path sterility may be impaired. If after visual inspection the solution is cloudy or if an insoluble precipitate is noted or if any seals are not intact, the flexible bag should be discarded. 5. The solution in the flexible bag remains chemically stable for 28 days at room temperature (15°C - 25°C (59°F – 77ºF)) after removal from the aluminum overpouch. Discard unused drug. 6. Suspend the flexible bag from eyelet support. 7. Remove protector from outlet port at bottom of flexible bag. 8. Attach administration set. Refer to complete directions accompanying set. 9. Use sterile equipment. Do not use flexible bags in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. 2.6 Incompatibilities for Intravenous Use Vancomycin solution has a low pH and may cause chemical or physical instability when it is mixed with other compounds. Mixtures of solutions of vancomycin and beta-lactam antibacterial drugs have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibacterial drugs.
Warnings & Precautions
Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and “vancomycin infusion reactions” which manifests as pruritus and erythema that involves the face, neck and upper body may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer TYZAVAN over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1, 5.1 ) Nephrotoxicity : Monitor renal function in all patients receiving TYZAVAN. ( 5.2 ) Ototoxicity : Serial tests of auditory function may be helpful. ( 5.3 ) Severe Dermatologic Reactions : Discontinue TYZAVAN at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. ( 5.4 ) Clostridioides difficile -Associated Diarrhea (CDAD) : Evaluate patients if diarrhea occurs. ( 5.5 ). Neutropenia : Periodically monitor leukocyte count. ( 5.7 ) Phlebitis and Other Administration Site Reactions : Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. ( 5.8 ) 5.1 Infusion Reactions Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria or pruritus, muscular and chest pain may occur with rapid TYZAVAN administration (e.g., over several minutes). The reactions may be more severe in pediatric patients (1 month and older) [see Use in Specific Populations (8.4) ] . Rapid intravenous administration of TYZAVAN may also be associated with “vancomycin infusion reactions” which manifests as pruritus and erythema that involves the face, neck and upper body or pain and muscle spasm of the chest and back. There have been reports that the frequency of of infusion-related reactions (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related adverse reactions are related to both the concentration and the rate of administration of TYZAVAN. Infusion-related adverse reactions may occur, however, at any rate or concentration. Administer TYZAVAN over a period of 60 minutes or greater to reduce the risk of infusion-related adverse reactions. In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related adverse reactions. Administer TYZAVAN as a 60-minute infusion prior to administration of intravenous anesthetic agents when feasible to minimize infusion-related adverse reactions. Stop the infusion if a reaction occurs because this usually results in prompt cessation of these reactions. 5.2 Nephrotoxicity TYZAVAN can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions (7.2) ] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment. Monitor serum vancomycin concentrations and renal function in all patients receiving TYZAVAN. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels. If acute kidney injury occurs, discontinue TYZAVAN or reduce the dose [see Dosage and Administration (2.4) ] . 5.3 Ototoxicity Ototoxicity has occurred in patients receiving vancomycin. It may be reversible or permanent. Ototoxicity manifests as tinnitus, hearing loss, dizziness or vertigo. The risk is higher in older patients, patients who are receiving higher doses, who have an underlying hearing loss, who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside or who have underlying renal impairment. Monitor for signs and symptoms of ototoxicity during therapy. Monitor serum vancomycin concentrations and renal function in all patients receiving parenteral vancomycin. Discontinue TYZAVAN if ototoxicity occurs. Dosage of TYZAVAN must be adjusted for patients with renal impairment [see Dosage and Administration (2.3) ] . Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity . 5.4 Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes (including exfoliative dermatitis), mucosal lesions, and blisters. Discontinue TYZAVAN at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. 5.5 Clostridioides Difficile -Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including vancomycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Prolonged use of TYZAVAN may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin. 5.6 Hemorrhagic Occlusive Retinal Vasculitis (HORV) Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for the prophylaxis of endophthalmitis. 5.7 Neutropenia Reversible neutropenia has been reported in patients receiving vancomycin [see Adverse Reactions (6.1) ] . Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count. Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm 3 ) has been reported. 5.8 Phlebitis and Other Administration Site Reactions Inflammation at the injection site has been reported. Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Thrombophlebitis may occur, the frequency and severity of which can be minimized by slow infusion of the drug and by rotation of venous access sites. Administration of TYZAVAN by intramuscular (IM), intraperitoneal, intrathecal (intralumbar or intraventricular), or intravitreal routes has not been approved and is not recommended. The safety and efficacy of vancomycin administered by these routes of administration have not been established by adequate and well controlled trials. Pain, tenderness, and necrosis occur with intramuscular (IM) injection of vancomycin or with inadvertent extravasation. There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin of at least a 60-minute infusion prior to anesthetic induction. Administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has been reported to result in chemical peritonitis. Manifestations of this syndrome range from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be resolved after discontinuation of intraperitoneal vancomycin. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in 6 hours. Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials. 5.9 Development of Drug-Resistant Bacteria Prescribing TYZAVAN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Contraindications
TYZAVAN is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Nephrotoxicity [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] Severe Dermatologic Reactions [see Warnings and Precautions (5.4) ] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.6) ] Neutropenia [see Warnings and Precautions (5.7) ] Phlebitis and Other Administration Site Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions are anaphylaxis, “vancomycin infusion reactions”, acute kidney injury, hearing loss, neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions associated with the use of vancomycin were identified in clinical trials: Immune System Disorders: Anaphylaxis and “vancomycin infusion reaction” Renal and Urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus Skin and Subcutaneous Tissue Disorders: Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS) Gastrointestinal Disorders: Clostridioides difficile colitis, nausea Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia Cardiac Disorders: Cardiac arrest, chest pain General Disorders and Administration Site Conditions: General discomfort, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (TYZAVAN is not approved for intramuscular and intraperitoneal administration) Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and Connective Tissue Disorders: Muscle pain Nervous System Disorders: Dizziness Respiratory, Thoracic and Mediastinal Disorders: Wheezing, dyspnea Vascular Disorders: Hypotension, shock, vasculitis 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction. Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).
Drug Interactions
Anesthetic Agents : Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. ( 2.1 , 7.1 ) Piperacillin/Tazobactam : Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients. ( 7.2 ) 7.1 Anesthetic Agents Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . 7.2 Piperacillin-Tazobactam Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and TYZAVAN. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin. 7.3 Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs with TYZAVAN requires more frequent monitoring of renal function.
Storage & Handling
16.2 Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch.
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