Ilaris Side Effects

Generic Name: canakinumab

Please note - some side effects for Ilaris 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 Ilaris - for the Consumer

Ilaris

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 Ilaris:

Cold or flu symptoms; diarrhea; dizziness; headache; mild pain, redness, or swelling at the injection site; mild sore throat; nausea; sinus inflammation; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Ilaris:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; open sore that does not heal; persistent cough; persistent pain, swelling, or redness at the injection site; severe or persistent headache or dizziness; signs of infection (eg, fever, chills, or sore throat; warm, red, or painful skin; increased or painful urination); unusual bruising; unusual lumps; unusual tiredness or weakness.

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.

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Ilaris Side Effects - for the Professional

Ilaris

The data described herein reflect exposure to Ilaris in 104 adult and pediatric CAPS patients, (including 20 FCAS, 72 MWS, 10 MWS/NOMID (Neonatal Onset Multisystem Inflammatory Disorder) overlap, 1 non-FCAS non-MWS, and 1 mis-diagnosed in placebo-controlled (35 patients) and uncontrolled trials. Sixty-two patients were exposed to Ilaris for at least 6 months, 56 for at least 1 year and 4 for at least 3 years. A total of 9 serious adverse reactions were reported for CAPS patients. Among these were vertigo (2 patients), infections (3 patients), including intra-abdominal abscess following appendectomy (1 patient). The most commonly reported adverse reactions associated with Ilaris treatment in the CAPS patients were nasopharyngitis, diarrhea, influenza, headache, and nausea. No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment. One patient discontinued treatment due to potential infection.

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 practice.

Clinical Trial Experience 

Approximately 833 subjects have been treated with Ilaris in blinded and open-label clinical trials in CAPS and other diseases, and healthy volunteers. A total of 15 patients reported serious adverse reactions during the clinical program.

Study 1 investigated the safety of Ilaris in an 8-week, open-label period (Part 1), followed by a 24-week, randomized withdrawal period (Part 2), followed by a 16-week, open-label period (Part 3). All patients were treated with Ilaris 150 mg subcutaneously or 2 mg/kg if body weight was greater than or equal to 15 kg and less than or equal to 40 kg.

Since all CAPS patients received Ilaris in Part 1, there are no controlled data on adverse events (AEs). Data in Table 1 are for all AEs for all CAPS patients receiving canakinumab. In study 1, no pattern was observed for any type or frequency of adverse events throughout the three study periods.

Table 1 Number (%) of Patients with AEs by Preferred Terms, in > 10% of Patients in Parts 1 to 3 of the Phase 3 Trial for CAPS Patients

Preferred Term	Ilaris N=35 n (%)
n % of Patients with Adverse Events	35 (100)
Nasopharyngitis	12 (34)
Diarrhea	7 (20)
Influenza	6 (17)
Rhinitis	6 (17)
Nausea	5 (14)
Headache	5 (14)
Bronchitis	4 (11)
Gastroenteritis	4 (11)
Pharyngitis	4 (11)
Weight increased	4 (11)
Musculoskeletal pain	4(11)
Vertigo	4(11)

Vertigo

Vertigo has been reported in 9 to 14% of patients in CAPS studies, exclusively in MWS patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with Ilaris.

Hypersensitivity

Hypersensitivity reactions have been reported with Ilaris therapy. No anaphylactic reactions have been reported. Ilaris should not be administered to any patients with known clinical hypersensitivity to Ilaris [see Contraindications (4) and Warnings and Precautions (5.3)].

Injection Site Reactions

In Study 1, subcutaneous injection site reactions were observed in 9% of patients in Part 1 with mild tolerability reactions; in Part 2, one patient each (7%) had a mild or a moderate tolerability reaction and, in Part 3, one patient had a mild local tolerability reaction. No severe injection-site reactions were reported and none led to discontinuation of treatment.

Immunogenicity

A specific biosensor binding assay was used to detect antibodies directed against canakinumab in patients who received Ilaris. None of the 60 CAPS patients who had received Ilaris tested positive for treatment-emergent binding antibodies at the time points tested. Thirty-one of 60 CAPS patients had a duration of exposure to canakinumab >48 weeks. The data obtained in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, underlying disease, and the number of patients tested. For these reasons, comparison of the incidence of antibodies to canakinumab with the incidence of antibodies to other products may be misleading.

Laboratory Findings

Hematology

During clinical trials with Ilaris, mean values decreased for white blood cells, neutrophils and platelets.

Hepatic transaminases

Elevations of transaminases have been observed in patients treated with Ilaris.

Bilirubin

Asymptomatic and mild elevations of serum bilirubin have been observed in patients treated with Ilaris without concomitant elevations of transaminases.

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Side Effects by Body System - for Healthcare Professionals

Respiratory

Respiratory side effects including nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), and pharyngitis (11%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (20%), nausea (14%), and gastroenteritis (11%) have been reported.

Other

Other side effects including influenza (17%) and increased weight (11%) have been reported.

Nervous system

Vertigo has been reported in 9% to 14% of patients in CAPS studies, exclusively in Muckle-Wells Syndrome (MWS) patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with canakinumab.

Nervous system side effects including headache (14%) and vertigo (11%) have been reported.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain (11%) have been reported.

Local

Local side effects including subcutaneous injection site reactions have been reported.

No severe injection site reactions were reported and none led to discontinuation of treatment.

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