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 significant adverse reactions are described elsewhere in the labeling.
Serious Infections [see Warnings and Precautions (5.1) ] Risk of Malignancy [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Lipid Profile Changes [see Warnings and Precautions (5.4) ] The most common adverse reactions reported by patients with CAPS and RP treated with ARCALYST are injection-site reactions and upper respiratory tract infections.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Kiniksa at 1-833-KINIKSA (1-833-546-4572) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial Experience Clinical trials are conducted under widely varying conditions and, as such, adverse reaction rates observed cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described herein reflect exposure to ARCALYST in over 2,000 patients who received at least one dose, including approximately 1700 exposed to 160 mg or more, of whom 151 patients were exposed for at least 6 months and 111 patients for at least one year.
These included patients with CAPS and RP, patients with other diseases, and healthy volunteers.
CAPS Approximately 60 patients with CAPS were treated weekly with 160 mg of ARCALYST.
The pivotal trial population included 47 patients with CAPS.
These patients were between the ages of 22 and 78 years (average 51 years).
Thirty-one patients were female and 16 were male.
5 WARNINGS AND PRECAUTIONS Serious Infections : Serious, life-threatening infections have been reported in patients taking ARCALYST.
Do not initiate treatment with ARCALYST in patients with active or chronic infections.
Discontinue treatment if a patient develops a serious infection.
( 5.1 ) Hypersensitivity Reactions : If a hypersensitivity reaction occurs, discontinue administration of ARCALYST and initiate appropriate therapy.
( 5.3 ) Immunizations : Avoid live vaccines.
Like all medications, Arcalyst 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: