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 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 clinical practice.
Rheumatoid Arthritis (RA) Most common adverse reactions (incidence ≥ 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu like-symptoms, and abdominal pain ( 6.1 ) NOMID The most common AEs during the first 6 months of treatment (incidence > 10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis ( 6.2 ) DIRA The most common AEs are upper respiratory tract infections, rash, pyrexia, influenza like illness, and gastroenteritis ( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-547-0644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Experience in RA The most serious adverse reactions were: Serious Infections – [see Warnings and Precautions ( 5.1 )] Neutropenia, particularly when used in combination with TNF blocking agents The most common adverse reaction with KINERET is injection-site reactions.
These reactions were the most common reason for withdrawing from studies.
The data described herein reflect exposure to KINERET in 3025 patients, including 2124 exposed for at least 6 months and 884 exposed for at least one year.
Studies 1 and 4 used the recommended dose of 100 mg per day.
The patients studied were representative of the general population of patients with rheumatoid arthritis.
Injection-site Reactions The most common and consistently reported treatment-related adverse event associated with KINERET is injection-site reaction (ISR).
In Studies 1 and 4, 71% of patients developed an ISR, which was typically reported within the first 4 weeks of therapy.
The majority of ISRs were reported as mild (72.6% mild, 24.1% moderate and 3.2% severe).
5 WARNINGS AND PRECAUTIONS In RA, discontinue use if serious infection develops.
In KINERET-treated NOMID or DIRA patients, the risk of a disease flare when discontinuing KINERET treatment should be weighed against the potential risk of continued treatment.
Do not initiate KINERET in patients with active infections.
( 5.1 ) Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended ( 5.2 ) Hypersensitivity reactions, including anaphylactic reactions and angioedema, and serious cutaneous reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur;
discontinue KINERET, treat promptly, and monitor until reaction resolves.
Like all medications, Kineret 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: