Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically important adverse reactions are described elsewhere in the labeling: Hypersensitivity and Anaphylaxis [see Warnings and Precautions ( 5.1 )].
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.
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 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).
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis ( Boxed Warning , 1.2 , 2.1 , 12.4 , 5.1 ) 5.1 Hypersensitivity and Anaphylaxis Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%).
Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion.
In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort.
ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis.
The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort.
Like all medications, Anthim can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: