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 adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness.
The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions Canada Inc.
at 1-800-768-2304 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.
In a safety/pharmacokinetics study, 60 healthy male and female volunteers received a single intravenous dose of either 6000 Units per kg or 9000 Units per kg VIGIV.
The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both males and females enrolled in an approximate 50:50 ratio.
In a pharmacodynamic study, 32 healthy male and female volunteers were randomized to receive vaccinia vaccination (n=10), VIGIV (9000 Units per kg) 4 days prior to vaccinia vaccination (n=10), or VIGIV (9000 Units per kg) concurrent with vaccinia vaccination (n=12).
The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both male and female enrolled in a 75:25 ratio.
The ethnic background of patients included those of Caucasian, African American, Asian and Hispanic descent, with the majority of them being Caucasian.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity to human immune globulin (acute anaphylaxis) ( 5.1 ) • Acute renal dysfunction/failure ( 5.2 ) • Thrombosis may occur with immune globulin products, including VIGIV.
For patients at risk of thrombosis, administer VIGIV at the minimum dose and infusion rate practicable.
Ensure adequate hydration in patients before administration.
Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity ( 5.4 ) • Hemolysis or hemolytic anemia ( 5.5 ) • Aseptic meningitis syndrome (AMS) ( 5.6 ) • Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] ( 5.7 ) • Transmission of infectious agents from human plasma ( 5.8 ) • Monitor renal function and urine output in patients at risk of renal failure;
check baseline blood viscosity in patients at risk of hyperviscosity;
Like all medications, Cnj-016 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: