1 Dosing Considerations Pre-medicate with diphenhydramine prior to administering ANTHIM [see WARNINGS AND PRECAUTIONS]. 9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dilution]. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis [see WARNINGS AND PRECAUTIONS].
Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration [see WARNINGS AND PRECAUTIONS]. 2 Recommended Dose and Dosage Adjustment Adults The recommended dosage of ANTHIM in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes) [see DOSAGE AND ADMINISTRATION].
Pediatrics (< 18 yrs) The recommended dose for pediatric patients is based on weight as shown in Table 1 below. Serious Warnings and Precautions Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM.
Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration.
Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs [see Administration]. EUND Anthim™ Product Monograph Page 6 of 24 Table 1 Recommended Pediatric Dose of ANTHIM (weight-based dosing) Body Weight Dose Greater than 40 kg 16 mg/kg Greater than 15 kg up to 40 kg 24 mg/kg Less than or equal to 15 kg 32 mg/kg Administer the recommended dose of ANTHIM intravenously over 90 minutes (1 hour and 30 minutes) [see DOSAGE AND ADMINISTRATION].
There have been no studies of the safety or PK of ANTHIM conducted in the pediatric population. The dosing recommendations in Table 1 are derived from simulations using a population PK approach designed to match the observed adult exposure to ANTHIM at a 16 mg/kg dose [see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations].
3 Dilution Important Preparation Instructions: Keep vials in their cartons prior to preparation of an infusion solution to protect ANTHIM from light. ANTHIM vials contain no preservative. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard the vial if the solution is discolored or contains extraneous particles other than a few translucent-to-white, proteinaceous particles [see DESCRIPTION]. Do not shake the vial. Preparation and Dilution in Bag for Infusion 1.
Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms. 2. Calculate the required volume in milliliters of ANTHIM injection and number of vials needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL.
Each single vial allows for delivery of 6 mL of ANTHIM. 3. 9% Sodium Chloride Injection, USP. Withdraw a volume of solution from the bag equal to the calculated volume in milliliters of ANTHIM in step 2 above. Discard the solution that was withdrawn from the bag.
4. Withdraw the required volume of ANTHIM injection (calculated from step 2) from the ANTHIM vial(s). Discard any unused portion remaining in the ANTHIM vial(s) [see SPECIAL HANDLING INSTRUCTIONS]. 5. Transfer the required volume of ANTHIM injection to the selected infusion bag.
6. Gently invert the bag to mix the solution. Do not shake. 7. The prepared solution is stable for 8 hours stored at room temperature 20°C to 25°C or 8 hours stored in the refrigerator at 2°C to 8°C [see STORAGE, STABILITY AND DISPOSAL].
Preparation and Dilution in Syringe for Infusion 1. Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms. 2. Calculate the required volume in milliliters of ANTHIM injection and number of vials Anthim™ Product Monograph Page 7 of 24 needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL.
Each single vial allows delivery of 6 mL of ANTHIM. 3. Select an appropriate size syringe for the total volume of infusion to be administered. 4. Using the selected syringe, withdraw the required volume of ANTHIM injection (calculated from step 2).
Discard any unused portion remaining in the ANTHIM vial(s) [see SPECIAL HANDLING INSTRUCTIONS]. 5. 9% Sodium Chloride Injection, USP to prepare the total infusion volume specified in Table 2. 6. Gently mix the solution. Do not shake. 7. Once a diluted solution of ANTHIM has been prepared, administer immediately according to the infusion rate in Table 2.
Do not store solution in syringe [see STORAGE, STABILITY AND DISPOSAL]. Discard unused product [see SPECIAL HANDLING INSTRUCTIONS]. 4 Administration Administer ANTHIM in appropriately monitored settings which are equipped to manage anaphylaxis [see WARNINGS AND PRECAUTIONS].
Dilute ANTHIM injection before administering ANTHIM intravenously using the bag or syringe for infusion [see Dilution]. 22 micron inline filter with the infusion rate described in Table 2 [see Administration]. There are no known incompatibilities between ANTHIM and polyvinyl chloride (PVC) or polyolefin infusion bags, PVC or polyethylene-lined administration sets.
In the absence of compatibility studies, ANTHIM should not be mixed with other medicinal products. Do not add or simultaneously infuse other drug substances through the same intravenous line. Table 2 ANTHIM […]