Human Genome Sciences, Inc.

Human Genome Sciences, Inc. Drugs

• Raxibacumab
  

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  Raxibacumab

  

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  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.

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• Benlysta
  

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  Benlysta

  

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  2.1 Dosage Schedule

  BENLYSTA is for intravenous infusion only and must be reconstituted and diluted prior to administration [see Dosage and Administration (2.3)]. Do not administer as an intravenous push or bolus.

  The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute, and administer as an intravenous infusion only, over a period of 1 hour. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.4)].

  2.2 Premedication Recommendations

  Prior to dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions [see Warnings and Precautions (5.4, 5.5), Adverse Reactions (6.1)].

  2.3 Preparation of Solutions

  BENLYSTA is provided as a lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows:

  Reconstitution Instructions

  • Remove BENLYSTA from the refrigerator and allow to stand 10 to 15 minutes for the vial to reach room temperature. • Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab. • Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP. • Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP. • The stream of sterile water should be directed toward the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight. • If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, it should not exceed 500 rpm and the vial swirled for no longer than 30 minutes. • Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.

  Dilution Instructions

  • Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP. Dilute the reconstituted product to 250 mL in 0.9% Sodium Chloride Injection, USP (normal saline) for intravenous infusion. From a 250-mL infusion bag or bottle of normal saline, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient’s dose. Then add the required volume of the reconstituted solution of BENLYSTA into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed. • The reconstituted solution of BENLYSTA, if not used immediately, should be stored protected from direct sunlight and refrigerated at 2° to 8°C (36° to 46°F). Solutions of BENLYSTA diluted in normal saline may be stored at 2° to 8°C (36° to 46°F) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours. • No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.

  2.4 Administration Instructions

  • BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis [see Warnings and Precautions (5.4)]. • BENLYSTA should not be infused concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of BENLYSTA with other agents. • The reconstituted solution of BENLYSTA, if not used immediately, should be stored protected from direct sunlight and refrigerated at 2° to 8°C (36° to 46°F). Solutions of BENLYSTA diluted in normal saline may be stored at 2° to 8°C (36° to 46°F) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.

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