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ANTHIM(obiltoxaximab) injection

2016-04-27 12:04:12 来源: 作者: 【大中小】浏览:373次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM.
ANTHIM® (obiltoxaximab) injection, for intravenous use
Initial U.S. Approval: 2016
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)

INDICATIONS AND USAGE

ANTHIM® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. (1.1)

Limitations of Use

ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. (1.2, 5.1)
The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. (1.2, 14)
There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. (1.2, 8.4)
ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. (1.2)
ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. (1.2)

DOSAGE AND ADMINISTRATION

Pre-medicate with diphenhydramine. (2.1, 5.1)
Recommended Dosage of ANTHIM:
- Adult Patients: 16 mg/kg. (2.1)
- Pediatric Patients: (2.2)
  
  ➢
  
  Greater than 40 kg: 16 mg/kg
  
  ➢
  
  Greater than 15 kg to 40 kg: 24 mg/kg
  
  ➢
  
  Less than or equal to 15 kg: 32 mg/kg
Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous (IV) infusion over 1 hour and 30 minutes. (2.3)
Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. (2.4, 5.1)
See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection. (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/6 mL (100 mg/mL) solution in single-dose vial. (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Hypersensitivity reactions, including anaphylaxis (Boxed Warning, 1.2, 2.1, 2.4, 5.1)

ADVERSE REACTIONS

Most frequently reported adverse reactions in healthy adult subjects (≥1.5%) were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, nasal congestion, infusion site pain, urticaria and pain in extremity. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Elusys Therapeutics, Inc. at 1-844-808-0222 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. (1.2, 8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS

1 INDICATIONS AND USAGE

1.1 Inhalational Anthrax

1.2 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Adult Patients

2.2 Dosage for Pediatric Patients

2.3 Preparation and Dilution for Administration

2.4 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity and Anaphylaxis

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Immunogenicity

7 DRUG INTERACTIONS

7.1 Ciprofloxacin

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

1.1 Inhalational Anthrax

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs.

ANTHIM is indicated for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate [see Indications and Usage (1.2)].

1.2 Limitations of Use

ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis [see Warnings and Precautions (5.1)].

The effectiveness of ANTHIM 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)].

Safety and PK of ANTHIM have been studied in adult healthy volunteers. There have been no studies of safety or PK of ANTHIM in the pediatric population. A population PK approach was used to derive intravenous infusion 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)].

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

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Adult Patients

Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions (5.1)].
Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration (2.3)].
The recommended dosage of ANTHIM in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes) [see Dosage and Administration (2.4)].
For adult patients weighing less than 40 kg, see Table 1 below.

2.2 Dosage for Pediatric Patients

Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions (5.1)].
Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration (2.3)].
The recommended dose for pediatric patients is based on weight as shown in Table 1 below.

Table 1. Recommended Pediatric Dose of ANTHIM (weight-based dosing)
Body Weight	Dose
Greater than 40 kg	16 mg/kg
Greater than 15 kg to 40 kg	24 mg/kg
Less than or equal to 15 kg	32 mg/kg

Administer the recommended dose of ANTHIM intravenously over 90 minutes (1 hour and 30 minutes) [see Dosage and Administration (2.4)].

There have been no studies of the safety or PK of ANTHIM conducted in the pediatric population. The dosing recommendations in Table 1 are derived from simulations using a population PK approach designed to match the observed adult exposure to ANTHIM at a 16 mg/kg dose [see Use in Specific Populations (8.4)].

2.3 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 (11)].
Do not shake the vial.

Table 2. ANTHIM Dose, Total Infusion Volume and Infusion Rate by Body Weight
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

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