ANTHRASIL Solution for infusion (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Emergent BioSolutions Canada Inc.

Λέξεις κλειδιά

60492-0249

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WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS AND THROMBOSIS

Maltose in immune globulin products, including ANTHRASIL, may give falsely high blood glucose levels with some blood point-of-care glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase ...

1. Indications and Usage

ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The ...

2. Dosage and Administration

For intravenous use only. 2.1 Dose Table 1. ANTHRASIL Dosing Guide and Intravenous Infusion Rate: Patient Group Dosea Starting Infusion Rate (first 30 minutes) Incremental Infusion ...

3. Dosage Forms and Strengths

Each vial of ANTHRASIL contains a minimum potency of ≥60 units per vial.

4. Contraindications

ANTHRASIL is contraindicated in individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. ...

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Hypersensitivity reactions may occur with ANTHRASIL. Administer ANTHRASIL in a setting where appropriate equipment, medication (including epinephrine) and personnel trained ...

6. Adverse Reactions

The most common adverse reactions to ANTHRASIL observed in >5% of subjects in the healthy volunteer clinical trial were headache, infusion site pain, nausea, infusion site swelling, and back pain. The ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Ciprofloxacin and Levofloxacin Based on animal studies, ANTHRASIL did not interfere with antibiotic therapy. Concomitant administration of ANTHRASIL with levofloxacin or ciprofloxacin in exposed rabbits ...

8. Use in Specific Populations

8.7 Use in Obese Populations Safety and effectiveness of ANTHRASIL in the obese population have not been studied.

8.1. Pregnancy

Risk Summary There are no human data to establish the presence or absence of ANTHRASIL associated risk.

8.2. Lactation

Risk Summary There are no data to assess the presence or absence of ANTHRASIL in human milk, the effects on the breastfed child or the effects on milk production/excretion.

8.4. Pediatric Use

Safety and effectiveness of ANTHRASIL in the pediatric population (≤16 yrs of age) have not been studied. Allometric scaling was used to derive dosing regimens to provide pediatric patients with exposure ...

8.5. Geriatric Use

Safety and effectiveness of ANTHRASIL in the geriatric population (>65 yrs of age) have not been studied.

8.6. Renal Impairment

Use ANTHRASIL with caution in patients with any degree of pre-existing renal insufficiency and in patients at risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, ...

11. Description

ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component ...

12.1. Mechanism of Action

The polyclonal immune globulin G in ANTHRASIL is a passive immunizing agent that neutralizes anthrax toxin. ANTHRASIL binds to protective antigen (PA) to prevent PA mediated cellular entry of anthrax edema ...

12.3. Pharmacokinetics

The mean TNA activities for three doses of ANTHRASIL (210, 420 and 840 units TNA) in the clinical trial in healthy volunteers [See 14 CLINICAL STUDIES] are plotted on a semi-log scale in Figure ...

13. Nonclinical Toxicology

Immune globulins are normal constituents of the human body. Toxicology studies have not been performed with ANTHRASIL or its components. The evaluation of new treatment options for anthrax using placebo-controlled ...

13.2. Animal Toxicology and/or Pharmacology

Anthrax infected New Zealand white rabbits and cynomolgus macaques administered an intravenous injection of ANTHRASIL (15 units TNA per kg) that did not survive their infection showed an increase in the ...

14. Clinical Studies

Because it is not ethical or feasible to conduct placebo-controlled clinical trials in humans with inhalational anthrax, the effectiveness of ANTHRASIL is based on efficacy studies demonstrating a survival ...

15. References

1. Kahwaji J, Barker E, Pepkowitz S, Klapper E, Villicana R, Peng A, et al. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol. ...

16.1. How Supplied

NDC 60492-0249-1 for single vial NDC 60492-0249-2 for shelf carton containing seven vials ANTHRASIL is supplied as a 50 mL single dose vial seated with a butyl rubber stopper and an aluminum seal with ...

16.2. Storage and Handling

Store frozen at or below ≤-15°C (≤5°F) until required for use. Do not use after expiration date. Once punctured, use the vial contents to prepare the infusion bag and infuse as soon as possible. ANTHRASIL ...

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information). Discuss the risks and benefits of this product with the patient or their legally authorized representative before administering it to the patient. ...