Anthim Dosage
Generic name: OBILTOXAXIMAB 100mg in 1mL
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Jun 7, 2023.
Dosage for Adult Patients
- Pre-medicate with diphenhydramine prior to administering ANTHIM.
- Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion.
- 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).
- For adult patients weighing less than 40 kg, see Table 1 below.
Dosage for Pediatric Patients
- Pre-medicate with diphenhydramine prior to administering ANTHIM.
- Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion.
- The recommended dose for pediatric patients is based on weight as shown in Table 1 below.
Body Weight | Dose |
Greater than 40 kg | 16 mg/kg |
Greater than 15 kg 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).
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.
Preparation and Dilution for Administration
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.
- Do not shake the vial.
Body Weight (weight-based dosing) | Total Infusion Volume | Infusion Rate |
Greater than 40 kg or adult (16 mg/kg) | ||
Greater than 40 kg | 250 mL | 167 mL/hr |
Greater than 15 kg to 40 kg (24 mg/kg) | ||
31 kg to 40 kg | 250 mL | 167 mL/hr |
16 kg to 30 kg | 100 mL | 67 mL/hr |
15 kg or less (32 mg/kg) | ||
11 kg to 15 kg | 100 mL | 67 mL/hr |
5 kg to 10 kg | 50 mL | 33.3 mL/hr |
3.1 kg to 4.9 kg | 25 mL | 17 mL/hr |
2.1 kg to 3 kg | 20 mL | 13.3 mL/hr |
1.1 kg to 2 kg | 15 mL | 10 mL/hr |
1 kg or less | 7 mL | 4.7 mL/hr |
Preparation and Dilution in Bag for Infusion
- Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms.
- 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 delivery of 6 mL of ANTHIM.
- Select an appropriate size bag of 0.9% 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.
- 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).
- Transfer the required volume of ANTHIM injection to the selected infusion bag.
- Gently invert the bag to mix the solution. Do not shake.
- The prepared solution is stable for 8 hours stored at room temperature 20°C to 25°C (68°F to 77°F) or 8 hours stored in the refrigerator at 2°C to 8°C (36°F to 46°F).
Preparation and Dilution in Syringe for Infusion
- Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms.
- 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 delivery of 6 mL of ANTHIM.
- Select an appropriate size syringe for the total volume of infusion to be administered.
- 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).
- Withdraw an appropriate amount of 0.9% Sodium Chloride Injection, USP to prepare the total infusion volume specified in Table 2.
- Gently mix the solution. Do not shake.
- Once a diluted solution of ANTHIM has been prepared, administer immediately. Do not store solution in syringe. Discard unused product.
Administration
- Administer ANTHIM in appropriately monitored settings which are equipped to manage anaphylaxis.
- Dilute ANTHIM injection before administering ANTHIM intravenously using the bag or syringe for infusion.
- After preparation of the bag or syringe for infusion administer the infusion solution using a 0.22 micron inline filter with the infusion rate described in Table 2.
- Administer diluted ANTHIM intravenous infusion over 1 hour and 30 minutes. Monitor patients closely for signs and symptoms of hypersensitivity throughout the infusion and for a period of time after administration.
- Stop the infusion immediately and treat appropriately, if hypersensitivity or anaphylaxis occurs.
- Flush the line with 0.9% Sodium Chloride Injection, USP at the end of the intravenous infusion.
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