May 25, 2017
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Ilaris

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Ilaris




Indications
Dosage
How Supplied

INDICATIONS

Periodic Fever Syndromes

ILARIS® (canakinumab) is an interleukin-1β (IL-1 β) blocker indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes:

Cryopyrin-Associated Periodic Syndromes (CAPS)

ILARIS is 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)
Tumor Necrosis Factor Receptor (TNF) Associated Periodic Syndrome (TRAPS)

ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)

ILARIS is indicated for the treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.

Familial Mediterranean Fever (FMF)

ILARIS is indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients.

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.

DOSAGE AND ADMINISTRATION

General Dosing Information

INJECTION FOR SUBCUTANEOUS USE ONLY.

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.

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), And Familial Mediterranean Fever (FMF)

The recommended dose of ILARIS for TRAPS, HIDS/MKD, and FMF patients is based on body weight.

For patients with body weight less than or equal to 40 kg, the recommended dose is 2 mg/kg administered every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate.

For patients with body weight greater than 40 kg, the recommended dose is 150 mg administered every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate.

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 4 mg/kg (with a maximum of 300 mg) administered every 4 weeks.

Preparation And Administration Of ILARIS Lyophilized Powder

STEP 1: Using aseptic technique, reconstitute each vial of ILARIS lyophilized powder by slowly injecting 1 mL of 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. 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 clear to opalescent, colorless to a slightly brownish yellow tint, and essentially free from particulates. If the solution has a distinctly brown discoloration, do not use. Slight foaming of the product upon reconstitution is not unusual.

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.

STEP 4: Using a sterile 1-mL syringe and needle, carefully withdraw the required volume depending on the dose to be administered 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.

Discard any unused product or waste material in accordance with local requirements.

Administration Of ILARIS Solution

STEP 1: ILARIS solution has a concentration of 150 mg/mL. Do not shake. The solution should be essentially free from particulates, clear to opalescent, colorless to slightly brownish-yellow tint. If the solution has a distinctly brown discoloration, is highly opalescent or contains visible particles, do not use.

STEP 2: Using a sterile 1-mL syringe and 18-gauge x 2” needle, carefully withdraw the required volume depending on the dose to be administered 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.

Discard unused product or waste material in accordance with the local requirements.

HOW SUPPLIED

Dosage Forms And Strengths

  • For injection: 150 mg lyophilized powder in single-dose vials for reconstitution.
  • Injection: 150 mg/mL solution in single-dose vials. The solution is a clear to slightly opalescent, colorless to a slightly brownish yellow tint.

Storage And Handling

ILARIS for Injection (Lyophilized Powder)

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

Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.

ILARIS Injection (Solution)

Carton of 1 vial............NDC 0078-0734-61

Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.

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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.

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

Manufactured by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 US License Number 1244 Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 © Novartis For more information about ILARIS, call 1-877-452-7471 or visit www.ILARIS.com. Revised: Dec 2016

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

Last reviewed on RxList: 1/3/2017

Indications
Dosage
How Supplied

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