Kabiven

2.1 Administration KABIVEN® is for intravenous infusion only into a central vein [see Warnings and Precautions (5.8)].  Use a 1.2 micron in-line filter. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Use a dedicated line without any connections.  Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as KABIVEN® via a Y-site due to precipitation.  However, ceftriaxone and KABIVEN® may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.9)]. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP).  Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer. 2.2 Important Preparation Instructions Inspect the bag prior to activation.  Discard the bag in the following situations: Evidence of damage to the bag More than one chamber is white Solution is yellow Any seal is already broken Activate the bag [see Dosage and Administration (2.3)]. Once the bag is activated, ensure the vertical seals between chambers are broken at least from the bend in the seals and down to the ports.  The upper sections of the vertical seals above the bend and the horizontal seal may remain closed. It is recommended to mix the contents thoroughly by inverting the bag upside down to ensure a homogenous admixture. Ensure the vertical seals between chambers are broken and the contents of all three chambers are mixed together prior to infusion [see Dosage and Administration (2.3)]. For total parenteral nutrition add multivitamins and trace elements via the additive port.   Any other additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi USA, LLC Vigilance and Medical Affairs. When introducing additives, it is recommended to use 18 to 23 gauge needles with a maximum length of 1.5 inches (40 mm) and to mix thoroughly after each addition,  use aseptic technique and add after the vertical seals have been broken (i.e. bag has been activated) and the three components are mixed [see Dosage and Administration (2.3)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect KABIVEN® to ensure: Precipitates have not formed during the mixing or addition of additives. The emulsion has not separated.  Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion.

           Discard the admixture if any of the above are observed.

KABIVEN® should be used immediately after mixing and the introduction of additives.  If not used immediately, the storage time and conditions prior to use should not be longer than 24 hours at 2° to 8°C (36° to 46°F).  After removal from storage at 2° to 8°C (36° to 46°F), the admixture should be infused within 24 hours.  Any mixture remaining must be discarded. 2.3 Instructions for Use

       2.4 Dosing Considerations

The dosage of KABIVEN® should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids, dextrose and lipids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient.

KABIVEN® is a combination of amino acids, electrolytes, dextrose, and lipids in a fixed volume and concentration.  The dosage selection is based upon fluid requirements which can be used in conjunction with the nutritional requirements to determine final dosage [See Table 1]. KABIVEN® meets the total nutritional requirements for protein, dextrose, and lipids in stable patients, and can be individualized to meet specific needs with the addition of nutrients.  The maximum infusion rate is based upon the dextrose component. Prior to administration of KABIVEN®, correct severe fluid electrolyte and acid-base disorders.  Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. Recommended Adult Dosage The recommended dosage of KABIVEN® in adults is 19 to 38 mL/kg/day. The recommended daily nutritional requirements for protein, dextrose and lipids compared to the amount of nutrition provided by KABIVEN® are shown in Table 1. The maximum daily dosage of KABIVEN® in adults should not exceed 40 mL/kg/day. In patients with serum triglyceride concentrations above 400 mg/dL, stop the KABIVEN® infusion and monitor serum triglyceride levels. Once the triglycerides are <400 mg/dL, restart KABIVEN® at a lower infusion rate and advance rate  in smaller increments towards target dosage, checking the triglyceride levels prior to each adjustment [see Contraindications (4) and Warnings and Precautions (5.12)]. Table 1:  Nutritional Comparison Nutrition Provided by KABIVEN®   recommended dosage Recommended Nutritional Requirements1 Stable Patients Critically Ill Patients* Fluid mL/kg/day 19 to 38 30 to 40 Minimum needed to deliver adequate macronutrients Protein** g/kg/day Nitrogen g/kg/day 0.6 to 1.3 0.1 to 0.2 0.8 to 1.0 0.13 to 0.16 1.5 to 2 0.24 to 0.3 Dextrose g/kg/day 1.9 to 3.7 ≤10 ≤5.8 Lipids g/kg/day 0.7 to 1.5 1 ≤1 Total Energy Requirement kcal/kg/day 16 to 32 20 to 30 25 to 30 * Do not use in patients with conditions that are contraindicated [see Contraindications (4)]. ** Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. Treatment with KABIVEN® may be continued for as long as is required by the patient’s condition. Dosing in Renal Impairment In patients with renal impairment, the dosage of KABIVEN® should be the recommended adult dosage (see above). Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of KABIVEN® administered as required [see Warnings and Precautions (5.11)]. Renal patients not needing dialysis require 0.6 to 0.8 g of protein/kg/day.  Serum electrolyte levels should be closely monitored. Patients on hemodialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses2. The KABIVEN® dosage can be adjusted based on the treatment for the renal impairment, supplementing protein as indicated. If required, additional amino acids may be added to the KABIVEN® bag or infused separately.  Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Fresenius Kabi USA, LLC Vigilance and Medical Affairs. Infusion Duration and Rate The recommended duration of infusion for KABIVEN® is between 12 and 24 hours, depending on the clinical situation. The maximum infusion rate of KABIVEN® is 2.6 mL/kg/hour.  This corresponds to 0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose (the rate limiting factor) and 0.1 g/kg/hour of lipids. Dosing Instructions Determine the fluid requirements (19 to 38 mL/kg/day) and the patient’s nutritional requirements (see Table 1) to be delivered, and then select the corresponding KABIVEN® bag. Determine the preferred duration of infusion (12 to 24 hours). Ensure that the rate of infusion (KABIVEN® dosage in mL/kg/day divided by the preferred duration of infusion (hours) does not exceed the maximum infusion rate for the patient (i.e., 2.6 mL/kg/hour).  The infusion rate may need to be reduced and duration of infusion increased in order not to exceed the maximum infusion rate. Once the infusion rate in mL/kg/hour has selected, calculate the infusion rate (mL/hour) using the patient’s weight. Compare the patient’s nutrient requirements with the amount supplied by KABIVEN®. Discuss with a pharmacist any additions that may be required. 2.1 Administration KABIVEN® is for intravenous infusion only into a central vein [see Warnings and Precautions (5.8)].  Use a 1.2 micron in-line filter. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Use a dedicated line without any connections.  Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as KABIVEN® via a Y-site due to precipitation.  However, ceftriaxone and KABIVEN® may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.9)]. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP).  Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer. 2.2 Important Preparation Instructions Inspect the bag prior to activation.  Discard the bag in the following situations: Evidence of damage to the bag More than one chamber is white Solution is yellow Any seal is already broken Activate the bag [see Dosage and Administration (2.3)]. Once the bag is activated, ensure the vertical seals between chambers are broken at least from the bend in the seals and down to the ports.  The upper sections of the vertical seals above the bend and the horizontal seal may remain closed. It is recommended to mix the contents thoroughly by inverting the bag upside down to ensure a homogenous admixture. Ensure the vertical seals between chambers are broken and the contents of all three chambers are mixed together prior to infusion [see Dosage and Administration (2.3)]. For total parenteral nutrition add multivitamins and trace elements via the additive port.   Any other additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi USA, LLC Vigilance and Medical Affairs. When introducing additives, it is recommended to use 18 to 23 gauge needles with a maximum length of 1.5 inches (40 mm) and to mix thoroughly after each addition,  use aseptic technique and add after the vertical seals have been broken (i.e. bag has been activated) and the three components are mixed [see Dosage and Administration (2.3)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect KABIVEN® to ensure: Precipitates have not formed during the mixing or addition of additives. The emulsion has not separated.  Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion.

           Discard the admixture if any of the above are observed.

KABIVEN® should be used immediately after mixing and the introduction of additives.  If not used immediately, the storage time and conditions prior to use should not be longer than 24 hours at 2° to 8°C (36° to 46°F).  After removal from storage at 2° to 8°C (36° to 46°F), the admixture should be infused within 24 hours.  Any mixture remaining must be discarded. 2.3 Instructions for Use

       2.4 Dosing Considerations

The dosage of KABIVEN® should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids, dextrose and lipids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient.

KABIVEN® is a combination of amino acids, electrolytes, dextrose, and lipids in a fixed volume and concentration.  The dosage selection is based upon fluid requirements which can be used in conjunction with the nutritional requirements to determine final dosage [See Table 1]. KABIVEN® meets the total nutritional requirements for protein, dextrose, and lipids in stable patients, and can be individualized to meet specific needs with the addition of nutrients.  The maximum infusion rate is based upon the dextrose component. Prior to administration of KABIVEN®, correct severe fluid electrolyte and acid-base disorders.  Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. Recommended Adult Dosage The recommended dosage of KABIVEN® in adults is 19 to 38 mL/kg/day. The recommended daily nutritional requirements for protein, dextrose and lipids compared to the amount of nutrition provided by KABIVEN® are shown in Table 1. The maximum daily dosage of KABIVEN® in adults should not exceed 40 mL/kg/day. In patients with serum triglyceride concentrations above 400 mg/dL, stop the KABIVEN® infusion and monitor serum triglyceride levels. Once the triglycerides are <400 mg/dL, restart KABIVEN® at a lower infusion rate and advance rate  in smaller increments towards target dosage, checking the triglyceride levels prior to each adjustment [see Contraindications (4) and Warnings and Precautions (5.12)]. Table 1:  Nutritional Comparison Nutrition Provided by KABIVEN®   recommended dosage Recommended Nutritional Requirements1 Stable Patients Critically Ill Patients* Fluid mL/kg/day 19 to 38 30 to 40 Minimum needed to deliver adequate macronutrients Protein** g/kg/day Nitrogen g/kg/day 0.6 to 1.3 0.1 to 0.2 0.8 to 1.0 0.13 to 0.16 1.5 to 2 0.24 to 0.3 Dextrose g/kg/day 1.9 to 3.7 ≤10 ≤5.8 Lipids g/kg/day 0.7 to 1.5 1 ≤1 Total Energy Requirement kcal/kg/day 16 to 32 20 to 30 25 to 30 * Do not use in patients with conditions that are contraindicated [see Contraindications (4)]. ** Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. Treatment with KABIVEN® may be continued for as long as is required by the patient’s condition. Dosing in Renal Impairment In patients with renal impairment, the dosage of KABIVEN® should be the recommended adult dosage (see above). Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of KABIVEN® administered as required [see Warnings and Precautions (5.11)]. Renal patients not needing dialysis require 0.6 to 0.8 g of protein/kg/day.  Serum electrolyte levels should be closely monitored. Patients on hemodialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses2. The KABIVEN® dosage can be adjusted based on the treatment for the renal impairment, supplementing protein as indicated. If required, additional amino acids may be added to the KABIVEN® bag or infused separately.  Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Fresenius Kabi USA, LLC Vigilance and Medical Affairs. Infusion Duration and Rate The recommended duration of infusion for KABIVEN® is between 12 and 24 hours, depending on the clinical situation. The maximum infusion rate of KABIVEN® is 2.6 mL/kg/hour.  This corresponds to 0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose (the rate limiting factor) and 0.1 g/kg/hour of lipids. Dosing Instructions Determine the fluid requirements (19 to 38 mL/kg/day) and the patient’s nutritional requirements (see Table 1) to be delivered, and then select the corresponding KABIVEN® bag. Determine the preferred duration of infusion (12 to 24 hours). Ensure that the rate of infusion (KABIVEN® dosage in mL/kg/day divided by the preferred duration of infusion (hours) does not exceed the maximum infusion rate for the patient (i.e., 2.6 mL/kg/hour).  The infusion rate may need to be reduced and duration of infusion increased in order not to exceed the maximum infusion rate. Once the infusion rate in mL/kg/hour has selected, calculate the infusion rate (mL/hour) using the patient’s weight. Compare the patient’s nutrient requirements with the amount supplied by KABIVEN®. Discuss with a pharmacist any additions that may be required.