Rilonacept Side Effects

Some side effects of rilonacept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rilonacept: subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking rilonacept: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with rilonacept. Call your doctor right away if you have any new signs of infection such as:

• fever, chills, sore throat, flu symptoms;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• nausea and vomiting, loss of appetite;

• mouth sores; or

• unusual weakness.

Call your doctor at once if you have any other serious side effect such as:

• bloody, black, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• wheezing, chest tightness, trouble breathing;

• pain or burning when you urinate; or

• headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Other common side effects may include:

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• nausea, stomach pain, diarrhea;

• numbness or tingly feeling; or

• pain, swelling, redness, itching, warmth, blistering, bleeding, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rilonacept: subcutaneous powder for injection

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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