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Important Safety Information
Warning and Precautions
- Interleukin-1 (IL-1) blockade may interfere with the immune response to infections. Treatment with another medication that works through inhibition of IL-1 has been associated with an increased risk of serious infections, and serious infections have been reported in patients taking ARCALYST. ARCALYST is not recommended for use with tumor necrosis factor (TNF) inhibitors because this may increase risk of serious infections. ARCALYST should be discontinued if a patient develops a serious infection. Treatment with ARCALYST should not be initiated in patients with an active or chronic infection.
- It is possible that taking drugs that block IL-1 increase the risk of tuberculosis (TB) or other atypical or opportunistic infections. Refer to current practice guidelines to evaluate and to treat possible latent TB infections before initiating therapy.
- The impact of ARCALYST on infections and the development of malignancies is not known. However, treatment with immunosuppressants may result in an increase in the risk of malignancies.
- Hypersensitivity reactions occurred in clinical trials. If a hypersensitivity reaction occurs, discontinue ARCALYST and initiate appropriate therapy.
- Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted.
- Since no data are available, avoid administration of live vaccines while patients are receiving ARCALYST. Because IL-1 blockade may interfere with immune response to infections, it is recommended that, prior to initiation of therapy with ARCALYST, patients receive all recommended vaccinations, as appropriate.
Adverse Reactions
- The most common adverse reactions (≥10%) include injection-site reactions, upper respiratory tract infections, arthralgia, and myalgia.
Drug Interactions
- Concomitant administration of ARCALYST with TNF-blocking agents or other agents that block IL-1 or its receptor is not recommended, as this may increase the risk of serious infections.
- In patients being treated with CYP450 substrates with narrow therapeutic indices, therapeutic monitoring of the effect or drug concentration should be performed, and the individual dose of the medicinal product may need to be adjusted as needed.
Use in Specific Populations
- Pregnancy outcomes reported post marketing and during clinical trials were rare, therefore, the effect of using ARCALYST during pregnancy is not known.
- There is no information on the presence of ARCALYST in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
For more information about ARCALYST, see Full Prescribing Information.
Indication
ARCALYST® (rilonacept) is an interleukin-1 blocker indicated for:
- Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.
- Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older.
- Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more.