Rilonacept Side Effects

Brand Names: Arcalyst

Please note - some side effects for Rilonacept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Rilonacept - for the Consumer

Rilonacept

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rilonacept:

Mild pain, swelling, bruising, or redness at the injection site; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool or stomach pain; fever, chills, cough, or persistent sore throat; flu-like symptoms; increased, decreased, or painful urination; loss of sensation or unusual numbness; unusual lumps or skin growths; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Local

In patients with Cryopyrin-Associated Periodic Syndromes (CAPS), the most common and consistently reported adverse event associated with rilonacept was injection-site reaction (ISR). The ISRs included erythema, swelling, pruritis, mass, bruising, inflammation, pain, edema, dermatitis, discomfort, urticaria, vesicles, warmth, and hemorrhage. Most injection-site reactions lasted for one to two days. No ISRs were assessed as severe, and no patient discontinued study participation due to an ISR.

Local side effects including injection-site reactions (48%) have been reported.

Immunologic

Immunologic side effects including infections (34%) have been reported.

One subject receiving rilonacept for an unapproved indication developed an infection in his olecranon bursa with Mycobacterium intracellulare. The patient was on chronic glucocorticoid treatment. The infection occurred after an intraarticular glucocorticoid injection into the bursa with subsequent local exposure to a suspected source of mycobacteria. The patient recovered after the administration of the appropriate antimicrobial therapy.

A patient treated for another unapproved indication developed bronchitis/sinusitis, which resulted in hospitalization.

One patient died in an open-label study of CAPS from Streptococcus pneumoniae meningitis.

Respiratory

Respiratory side effects including upper respiratory tract infection (26%), sinusitis (9%), and cough (9%) have been reported.

Nervous system

Nervous system side effects including hypoesthesia (9%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (4%) diarrhea (4%) and stomach discomfort (4%) have been reported.

Hematologic

The patient did not experience any infection associated with the neutropenia.

Physicians should monitor the lipid profiles of their patients (for example after 2 to 3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines.

Hematologic side effects have been reported including one case of transient neutropenia (ANC less than 1 x 109/L) after receiving a large dose (2000 mg intravenously) of rilonacept. Patients with CAPS treated with rilonacept experienced increases in their mean total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The mean increases from baseline for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were 19 mg/dL, 2 mg/dL, 10 mg/dL, and 57 mg/dL respectively after 6 weeks of open-label therapy.

Genitourinary

Genitourinary side effects including urinary tract infection (4%) have been reported.

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