Raxibacumab

RAXIBACUMAB- raxibacumab injection
Emergent Manufacturing Operations Baltimore LLC

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS

Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions (5.1)].
Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available [see Warnings and Precautions (2.3, 5.1)].

1 INDICATIONS AND USAGE

1.1 Inhalational Anthrax

Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. Raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

1.2 Limitations of Use

The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. It is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax [see Clinical Studies (14.1)].

Safety and pharmacokinetics (PK) of raxibacumab have been studied in adult healthy volunteers. There have been no trials of safety or PK of raxibacumab in the pediatric population. An extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults [see Use in Specific Populations (8.4)].

Raxibacumab binds to the protective antigen (PA) of B. anthracis ; it does not have direct antibacterial activity. Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs.

2 DOSAGE AND ADMINISTRATION

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 the raxibacumab infusion to reduce the risk of occurrence and/or the severity of an infusion reaction. Diphenhydramine route of administration (oral or intravenous) should be based on the temporal proximity to the start of the 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 40 kg

40 mg/kg

Greater than 10 kg to 40 kg

60 mg/kg

10 kg or less

80 mg/kg

Premedicate with diphenhydramine within 1 hour prior to the raxibacumab infusion to reduce the risk of occurrence and/or the severity of an infusion reaction. Diphenhydramine route of administration (oral or intravenous) should be based on the temporal proximity to the start of the 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 and Administration of Raxibacumab

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 in adults 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 Volumes, and Rates by Body Weight
a For patients requiring maximal fluid restriction, dilution factors can be adjusted at the discretion of the physician to a maximal concentration of 32 mg/mL.

Preparation

Administration

Body Weight

Dose

Total

Infusion

Volumea

Type of Diluent

Infusion Rate

Infusion Rate

First 20 Minutes

Remaining Infusion

Adults

40 mg/kg

250 mL

0.9% Sodium Chloride Injection

15 mL/hour

125 mL/hour

Pediatric Patients (Younger than 18 Years)

Less than 1 kg

80 mg/kg

7 mL

0.45% Sodium Chloride Injection

or

0.9% Sodium Chloride Injection

0.5 mL/hour

3.5 mL/hour

1 kg to less than 2 kg

15 mL

1 mL/hour

7 mL/hour

2 kg to less than 3 kg

20 mL

1.2 mL/hour

10 mL/hour

3 kg to less than 5 kg

25 mL

1.5 mL/hour

12 mL/hour

5 kg to 10 kg

40 mL

3 mL/hour

20 mL/hour

Greater than 10 kg to less than 15 kg

60 mg/kg

50 mL

0.9% Sodium Chloride Injection

6 mL/hour

25 mL/hour

15 kg to less than 30 kg

100 mL

6 mL/hour

50 mL/hour

30 kg to 40 kg

125 mL

15 mL/hour

62.5 mL/hour

Greater than 40 kg

40 mg/kg

150 mL

15 mL/hour

75 mL/hour

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 Step 2 above. 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 raxibacumab in monitored settings appropriately equipped to manage hypersensitivity, anaphylaxis, and shock [see Warnings and Precautions (5.1)].
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.

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