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 serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.
The most common adverse reactions (≥ 2%) reported in all clinical trials were headache, nausea, and diarrhea.
The serious adverse reaction reported in clinical trials was anaphylactic reaction.
( 6 ) The common adverse reactions (≥ 2%) reported in clinical trials were headache, nausea, and diarrhea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharming Healthcare Inc.
at 1-800-930-5221 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, the 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 clinical practice.
The RUCONEST clinical development program evaluated a combined total of 940 administrations in 236 subjects (symptomatic and non-symptomatic).
In clinical studies, a total of 205 symptomatic HAE patients received treatment with RUCONEST for a combined total of 650 acute angioedema attacks.
Among these HAE patients, 83 were treated for a single HAE attack and 122 were treated for multiple attacks.
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis may occur.
Should symptoms occur, discontinue RUCONEST and administer appropriate treatment.
( 5.1 ) Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors.
Monitor patients with known risk factors for TE events during and after RUCONEST administration.
( 5.2 ) 5.1 Hypersensitivity Severe hypersensitivity reactions may occur .
Like all medications, Ruconest 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: