2.1 Dose and Schedule for Adults
Administer raxibacumab as a single dose of 40 mg/kg intravenously over 2 hours and 15 minutes after dilution in 0.9% Sodium Chloride Injection, USP (normal saline) to a final volume of 250 mL. Administer 25 to 50 mg diphenhydramine within 1 hour prior to raxibacumab infusion to reduce the risk of infusion reactions. Diphenhydramine route of administration (oral or IV) should be based on the temporal proximity to the start of raxibacumab infusion. [See Warnings and Precautions (5.1), Adverse Reactions (6.1).]
2.2 Dose and Schedule for Pediatric Patients
The recommended dose for pediatric patients is based on weight as shown in Table 1.
Table 1. Recommended Pediatric Dose
Pediatric Body Weight
Pediatric Dose
Greater than 50 kg
40 mg/kg
Greater than 15 kg to 50 kg
60 mg/kg
15 kg or less
80 mg/kg
Premedicate with diphenhydramine within 1 hour prior to raxibacumab infusion. Diphenhydramine route of administration (oral or IV) should be based on the temporal proximity to the start of raxibacumab infusion. Infuse raxibacumab over 2 hours and 15 minutes. No pediatric patients were studied during the development of raxibacumab. The dosing recommendations in Table 1 are derived from simulations designed to match the observed adult exposure to raxibacumab at a 40 mg/kg dose. [See Use in Specific Populations (8.4).]
2.3 Preparation for Administration
The recommended dose of raxibacumab is weight-based, given as an intravenous infusion after dilution in a compatible solution to a final volume of 250 mL (adults and children 50 kg or heavier) or to a volume indicated based on the child’s weight (Table 2). Dilute raxibacumab using one of the following compatible solutions:
•
0.9% Sodium Chloride Injection, USP
•
0.45% Sodium Chloride Injection, USP
Keep vials in their cartons prior to preparation of an infusion solution to protect raxibacumab from light. Raxibacumab vials contain no preservative.
Table 2. Raxibacumab Dose, Diluents, Infusion Volume and Rate by Body Weight
Body Weight
(kg)
Preparation
Administration
Dose
(mg/kg)
Total Infusion Volume (mL)
Type of Diluent
Infusion Rate (mL/h)
Infusion Rate (mL/h)
First 20 Minutes
Remaining Infusion
1 or less
80
7
0.45% or 0.9% NaCl
0.5
3.5
1.1 to 2
15
1
7
2.1 to 3
20
1.2
10
3.1 to 4.9
25
1.5
12
5 to 10
50
3
25
11 to 15
100
0.9% NaCl
6
50
16 to 30
60
100
6
50
31 to 40
250
15
125
41 to 50
250
15
125
Greater than 50 or adult
40
250
15
125
Preparation: Follow the steps below to prepare the raxibacumab intravenous infusion solution.
1.
Calculate the milligrams of raxibacumab injection by multiplying the recommended mg/kg dose in
Table 2 by patient weight in kilograms.
2.
Calculate the required volume in milliliters of raxibacumab injection needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 50 mg/mL. Each single-use vial allows delivery of 34 mL raxibacumab.
Based on the total infusion volume selected in Table 2, prepare either a syringe or infusion bag as appropriate following the steps below.
Syringe Preparation
3.
Select an appropriate size syringe for the total volume of infusion to be administered, as described in
Table 2.
4.
Using the selected syringe, withdraw the volume of raxibacumab as calculated in step 2.
5.
Withdraw an appropriate amount of compatible solution to prepare a total volume infusion syringe as specified in
Table 2.
6.
Gently mix the solution. Do not shake.
7.
Discard any unused portion remaining in the raxibacumab vial(s).
8.
The prepared solution is stable for 8 hours stored at room temperature.
Infusion Bag Preparation
3. Select appropriate size bag of compatible solution (see compatible solutions listed in Table 2), withdraw a volume of solution from the bag equal to the calculated volume in milliliters of raxibacumab in Table 2. Discard the solution that was withdrawn from the bag.
4. Withdraw the required volume of raxibacumab injection from the raxibacumab vial(s).
5. Transfer the required volume of raxibacumab injection to the selected infusion bag (step 3). Gently invert the bag to mix the solution. Do not shake.
6. Discard any unused portion remaining in the raxibacumab vial(s).
7. The prepared solution is stable for 8 hours stored at room temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if particulate matter is present or color is abnormal. [See Description (11).]
Administration: Administer the infusion solution as described in Table 2. The rate of infusion may be slowed or interrupted if the patient develops any signs of adverse reactions, including infusion-associated symptoms.
