Obiltoxaximab
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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 and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs [see Indications and Usage ( 1.2 ), Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )].
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning. Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion ( 5.1 ) ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis ( 1.2 , 2.4 , 5.1 ) Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs ( 2.4 , 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 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 [see Description] . Do not shake the vial. [See table below.] 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 lunused product.
Administration Administer ANTHIM in appropriately monitored settings which are equipped to manage anaphylaxis [see Warnings and Precautions] . Dilute ANTHIM injection [see Dosage and Administration] 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 [see Dosage and Administration] .
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 [see Warnings and Precautions] . Stop the infusion immediately and treat appropriately, if hypersensitivity or anaphylaxis occurs [see Warnings and Precautions] .
Flush the line with 0.9% Sodium Chloride Injection, USP at the end of the intravenous infusion.
| 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 |
Drug interactions
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- Obiltoxaximab
Label text (2 paragraphs)
7 DRUG INTERACTIONS
7.1 Ciprofloxacin Co-administration of 16 mg/kg ANTHIM intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or obiltoxaximab [see Clinical Pharmacology ( 12.3 )] .
Contraindications
None. None ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for obiltoxaximab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data on the use of ANTHIM in pregnant women to inform on drug-associated risk. There are adverse effects on maternal and fetal outcomes associated with anthrax in pregnancy (see Clinical Considerations ). In pregnant rabbits, intravenous administration of obiltoxaximab during organogenesis was not associated with adverse developmental outcomes at up to 0.62 times the human systemic exposure at the maximum recommended adult dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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 obiltoxaximab at dose levels of 16 or 32 mg/kg during organogenesis on Gestation Days 6, 10, 13 and 17.
No maternal toxicity or adverse developmental outcomes were observed at the highest tested dose, 32 mg/kg. In those rabbits, mean maternal maximum plasma concentration (C max = 1180 mcg/mL) and mean maternal AUC inf (3220 mcg•day/mL) were approximately 3 times and 0.62 times the respective values for C max and AUC reported in clinical trial subjects at the maximum recommended adult dose of 16 mg/kg.
Breastfeeding (LactMed)
No information is available on the clinical use of obiltoxaximab during breastfeeding. Because obiltoxaximab is a large protein molecule with a molecular weight of 148,000, 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, obiltoxaximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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