Raxibacumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Boxed warning
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 )] .
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion ( 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 ( 2.3 , 5.1 ).
Anthrax Protective Antigen-directed Antibody
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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. [See table below.] 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 1. Select an appropriate size syringe for the total volume of infusion to be administered, as described in Table 2 . 2. Using the selected syringe, withdraw the volume of raxibacumab as calculated in Step 2. 3. Withdraw an appropriate amount of compatible solution to prepare a total volume infusion syringe as specified in Table 2 . 4.
Gently mix the solution. Do not shake. 5. Discard any unused portion remaining in the raxibacumab vial(s). 6. The prepared solution is stable for 8 hours stored at room temperature. Infusion Bag Preparation 1. 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. 2. Withdraw the required volume of raxibacumab injection from the raxibacumab vial(s). 3. 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. 4. Discard any unused portion remaining in the raxibacumab vial(s). 5.
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] .
Administration
Administer raxibacumab in monitored settings appropriately equipped to manage hypersensitivity, anaphylaxis, and shock [see Warnings and Precautions] .
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.
| aFor 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 | TotalInfusionVolume a | 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 Injectionor0.9% 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 | |
Drug interactions
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- Raxibacumab
Label text (3 paragraphs)
7 DRUG INTERACTIONS
7.1 Ciprofloxacin Co-administration of 40 mg/kg raxibacumab intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or raxibacumab [see Clinical Pharmacology ( 12.3 )] .
7.2 Anthrax Vaccine Adsorbed (AVA) Co-administration of 40 mg/kg raxibacumab intravenously (Day 1) with a SC AVA regimen (Days 1, 15, and 29) did not affect the immunogenicity of AVA [see Clinical Pharmacology ( 12.3 )] .
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for raxibacumab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data on the use of raxibacumab in pregnant women to inform on drug-associated risk. In pregnant rabbits, intravenous administration of raxibacumab was not associated with teratogenicity or other adverse developmental outcomes at 3 times the human maximum plasma concentrations at the maximum recommended adult dose (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background rate of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment. Data Animal Data: A study was conducted in pregnant, healthy New Zealand White rabbits administered intravenous raxibacumab at dose levels of 40 or 120 mg/kg on Gestation Days 7 and 14. No teratogenicity or other adverse developmental outcomes were observed in pregnant rabbits at 3 times the human maximum plasma concentrations at the maximum recommended adult dose of 40 mg/kg.
Maternal toxicity was observed at both doses (reduced body weight gain late in gestation, but no difference in mean total weight gain).
Breastfeeding (LactMed)
No information is available on the clinical use of raxibacumab during breastfeeding. Because raxibacumab is a large protein molecule with a molecular weight of 146,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, raxibacumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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