Brand Name
Anthim
Generic Name
Obiltoxaximab
View Brand Information FDA approval date: March 18, 2016
Classification: Anthrax Protective Antigen-directed Antibody
Form: Solution
What is Anthim (Obiltoxaximab)?
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.
Approved To Treat
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Brand Information
Anthim (obiltoxaximab)
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 (
1DOSAGE FORMS AND STRENGTHS
Injection: 600 mg/6 mL (100 mg/mL) in a single-dose vial.
ANTHIM is a clear to opalescent, colorless to pale yellow to pale brownish-yellow solution and may contain few translucent-to-white proteinaceous particulates.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically important adverse reactions are described elsewhere in the labeling:
- Hypersensitivity and Anaphylaxis
3.1Clinical 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 drug and may not reflect the rates observed in practice. The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax.
The safety of ANTHIM was evaluated in 320 healthy subjects treated with one or more 16 mg/kg IV doses in three clinical studies. Study 1 was a placebo-controlled study evaluating a single dose of ANTHIM vs. placebo (210 subjects received ANTHIM, 70 received placebo). Study 2 was a repeat-dose study in which 70 subjects received the first dose, but 34 and 31 subjects received a second dose of ANTHIM in sequences A (2 weeks apart) and B (≥ 4 months apart), respectively. Study 3 was a drug interaction study of a single dose of ANTHIM with ciprofloxacin in 40 subjects (20 subjects received ANTHIM alone and 20 subjects received ANTHIM plus ciprofloxacin for 9 days).
Subjects were 18 to 79 years of age, 54% were male, 70% Caucasian, 26% Black/African American, 2% American Indian/Alaska Native, 1% Asian and 10% Hispanic.
3.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The development of anti-ANTHIM antibodies was evaluated in all subjects receiving single and double doses of ANTHIM in studies 1, 2 and 3. Eight subjects (2.5%) who received at least one dose of IV ANTHIM were positive for a treatment-emergent anti-therapeutic antibody (ATA) response. Quantitative titers were low ranging from 1:20 – 1:320. There was no evidence of altered PK or toxicity profile in subjects with ATA development.
The incidence of antibody formation is highly dependent on the sensitivity and specificity of the immunogenicity assay. Additionally, the observed incidence of any antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to obiltoxaximab with the incidence of antibodies to other products may be misleading.
4OVERDOSAGE
There is no clinical experience with overdosage of ANTHIM. In case of overdosage, monitor patients for any signs or symptoms of adverse effects.
5DESCRIPTION
Obiltoxaximab is a chimeric IgG1 kappa monoclonal antibody (mAb) that binds the PA component of
ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates. ANTHIM is supplied as 600 mg/6 mL in single-dose vials for intravenous infusion. Each mL contains 100 mg obiltoxaximab in L-histidine (6.2 mg), polysorbate 80 (0.1 mg), sorbitol (36 mg) with a pH of 5.5.
6HOW SUPPLIED/STORAGE AND HANDLING
ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates in single-dose vials containing 600 mg/6 mL (100 mg/mL) and is available in the following packaging configuration:
Carton: Contains one (1) single-dose vial of ANTHIM 600 mg/6 mL (NDC 69604-204-02).
Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
8PRINCIPAL DISPLAY PANEL - NDC: 69604-204-02 - 600 mg/6 mL Vial Label
9PRINCIPAL DISPLAY PANEL - NDC: 69604-204-02 - 600 mg/6 mL Carton Label
