Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom
Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg, including:
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS.
After proper training in the correct injection technique, patients may self-inject Ilaris if their physician determines that it is appropriate and with medical follow-up as necessary.
The recommended dose of Ilaris is 150 mg for CAPS patients with body weight > 40 kg and 2 mg/kg for CAPS patients with body weight ≥ 15 kg and ≤ 40 kg. This is administered every eight weeks as a single dose via subcutaneous injection.
If a satisfactory clinical response (resolution of rash and other generalised inflammatory symptoms) has not been achieved 7 days after treatment start, a second dose of Ilaris at 150 mg or 2 mg/kg can be considered. If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg and 4 mg/kg should be maintained. No experience exists for doses > 600 mg every 8 weeks. Clinical experience with dosing at intervals of less than 4 weeks is limited.
Ilaris is not recommended for use in children below 4 years of age or with body weight below 15 kg due to a lack of clinical data.
Clinical experience in patients above 65 years is limited, therefore caution is recommended.
Ilaris has not been studied in patients with hepatic impairment.
No dose adjustment is needed in patients with renal impairment. However, clinical experience in such patients is limited.
For instructions on use and handling of the reconstituted solution, see section 6.6.
No case of overdose has been reported.
In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
36 months
After reconstitution, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3.
150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).
Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Not all pack sizes may be marketed.
Using aseptic technique, reconstitute each vial of Ilaris at room temperature by slowly injecting 1.0 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle. Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for about 5 minutes. Then gently turn the vial upside down and back again ten times. If possible, avoid touching the rubber stopper with your fingers. Allow to stand for about 15 minutes at room temperature to obtain a clear to opalescent solution. Do not shake. Do not use if particles are present in the solution.
Tap the side of the vial to remove any residual liquid from the stopper. The solution should be free of visible particles and clear to opalescent. The solution should be colourless or may have a slight brownish-yellow tint. If the solution has a distinctly brown discolouration it should not be used. If not used immediately after reconstitution, the solution should be kept at 2°C to 8°C and used within 24 hours.
Carefully withdraw the required volume depending on the dose to be administered (0.2 ml to 1.0 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.
The following are suitable injection sites: upper thigh, abdomen, upper arm or buttocks. Broken skin and areas which are bruised or covered by a rash should be avoided. Injection into scar-tissue should be avoided as this may result in insufficient exposure to Ilaris.
Ilaris vials are for single use only.
Patients or their caregivers should be instructed on the appropriate procedure for disposal of the vials, syringes and needles in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
