July 28, 2016


How Supplied


Cryopyrin-Associated Periodic Syndromes (CAPS)

ILARIS (canakinumab) is an interleukin-1β blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including:

  • Familial Cold Autoinflammatory Syndrome (FCAS)
  • Muckle-Wells Syndrome (MWS)

Systemic Juvenile Idiopathic Arthritis (SJIA)

ILARIS is indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.


General Dosing Information


Cryopyrin-Associated Periodic Syndromes (CAPS)

The recommended dose of ILARIS is 150 mg for CAPS patients with body weight greater than 40 kg. For CAPS patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg, the recommended dose is 2 mg/kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg.

ILARIS is administered every eight weeks as a single dose via subcutaneous injection.

Systemic Juvenile Idiopathic Arthritis (SJIA)

The recommended dose of ILARIS for SJIA patients with a body weight greater than or equal to 7.5 kg is 4mg/kg (with a maximum of 300 mg) administered every four weeks via subcutaneous injection.

Four Steps For Preparation And Administration

STEP 1: Using aseptic technique, reconstitute each vial of ILARIS by slowly injecting 1 mL of preservative-free Sterile Water for Injection with a 1 mL syringe and an 18 gauge x 2” needle.

STEP 2: Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for 5 minutes. Do not shake. Then gently turn the vial upside down and back again ten times. Avoid touching the rubber stopper with your fingers.

STEP 3: Allow to stand for about 15 minutes at room temperature to obtain a clear solution. The reconstituted solution has a final concentration of 150 mg/mL. Do not shake. Do not use if particulate matter is present in the solution. Tap the side of the vial to remove any residual liquid from the stopper. The reconstituted solution should be essentially free from particulates, and clear to opalescent. The solution should be colorless or may have a slight brownish-yellow tint. If the solution has a distinctly brown discoloration it should not be used. If not used within 60 minutes of reconstitution, the solution should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) and used within 4 hours. Slight foaming of the product upon reconstitution is not unusual.

STEP 4: Using a sterile syringe and needle carefully withdraw the required volume depending on the dose to be administered (0.2 mL to 1 mL) and subcutaneously inject using a 27 gauge x 0.5” needle.

Injection into scar tissue should be avoided as this may result in insufficient exposure to ILARIS.

ILARIS 180 mg powder for solution for injection is supplied in a single-use vial. Any unused product or waste material should be disposed of in accordance with local requirements.


Dosage Forms And Strengths

ILARIS is supplied as a 180 mg white lyophilized powder for solution for subcutaneous injection. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug, resulting in a total volume of 1.2 mL reconstituted solution. The reconstituted ILARIS is a clear to slightly opalescent, colorless to a slight brownish yellow tint, essentially free from particulates, 150 mg/mL solution.

Storage And Handling

Carton of 1 vial…………………….NDC 0078-0582-61

Each single-use vial of ILARIS contains a sterile, preservative free, white lyophilized powder containing 180 mg of canakinumab. Each vial is to be reconstituted with 1 mL of preservative-free Sterile Water for Injection resulting in a final concentration of 150 mg/mL.

Special Precautions For Storage

The unopened vial must be stored refrigerated at 2°C to 8°C (36°F to 46° F). Do not freeze. Store in the original carton to protect from light. Do not use beyond the date stamped on the label. After reconstitution, ILARIS should be kept from light, and can be kept at room temperature if used within 60 minutes of reconstitution. Otherwise, it should be refrigerated at 2°C to 8°C (36°F to 46°F) and used within 4 hours of reconstitution. ILARIS does not contain preservatives. Unused portions of ILARIS should be discarded.

Keep this and all drugs out of the reach of children.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: October 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/3/2014

How Supplied

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