RILONACEPT REGENERON Powder and solvent for solution for injection Ref.[9671] Active ingredients: Rilonacept

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 Rilonacept Regeneron if their physician determines that it is appropriate and with medical follow-up as necessary.

Posology

Adults

Treatment in adults should be initiated with a loading dose of 320 mg. Dosing should be continued with a once-weekly injection of 160 mg. Rilonacept Regeneron should not be given more often than once weekly.

Paediatric population (12 to 17 years old)

Treatment should be initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg. Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg (see Table 1). Dosing in children must be adjusted as the child grows. The patient or care giver should be advised to speak to the treating physician before adjusting the dose. The experience in children is limited. In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months.

Paediatric population (up to 12 years old)

No data are available on the use of Rilonacept Regeneron in children with CAPS under 12 years of age, therefore it is not recommended in this paediatric age group.

Elderly (65 years old or older)

Available data indicate that dose modification is not required based on advanced age. However, clinical experience in patients above 65 years is limited, therefore caution is recommended (see section 5.1).

Renal impairment

No dose adjustment is required in patients with mild, moderate, or severe renal impairment, or end stage renal disease. However, clinical experience in such patients is limited.

Hepatic impairment

Rilonacept Regeneron has not been studied in patients with hepatic impairment.

Method of administration

Rilonacept Regeneron is for subcutaneous use only. It is not intended for intravenous or intramuscular use.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

The adult loading dose should be administered as two 2 ml subcutaneous injections (320 mg of rilonacept in total) given on the same day at different sites. The subsequent doses are administered as a 2 ml (160 mg of rilonacept) subcutaneous injection once a week.

For paediatric patients, the dose is delivered as one or two (for loading dose) subcutaneous injections with a maximum single-injection volume of 2 ml.

For convenience, the corresponding dose volume for weekly injection in paediatric patients is presented in Table 1 below.

Table 1. Rilonacept Regeneron dose volume (after reconstitution) by body weight for paediatric patients aged 12-17 years:

No case of overdose has been reported. The maximum amount of product that can be safely administered has not been determined.

Intravenous administration of Rilonacept Regeneron at doses of up to 2000 mg monthly in another patient population for up to six months was generally well-tolerated. One patient in a study of osteoarthritis developed transient neutropenia (absolute neutrophil count <1 × 10⁹/l) after receiving a very large dose (2000 mg). Maximum weekly doses of up to 320 mg have been administered subcutaneously for up to approximately 2 years or more in a small number of patients with CAPS and up to 6 months in patients with RA in clinical studies without evidence of dose-limiting toxicities.

In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.

Shelf life

Vial: 2 years.

Diluted solution: From a microbiological safety point of view, the product should be used as soon as possible but within 3 hours of reconstitution, because it does not contain a preservative. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.

Store in a refrigerator. Do not freeze.

Keep the vials in the outer carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Powder vial: 20 ml clear type I glass vial with rubber stopper and lacquered flip-off aluminium seal containing 220 mg rilonacept.

Solvent vial: LDPE vials containing 5 ml water for injections

Each pack contains:

4 vials of powder for solution for injection
4 vials of solvent
8 disposable 3 ml syringes
8 disposable 27 gauge, ½-inch needles

Instructions for reconstitution

Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml of solvent (water for injections) prior to administration.

The 2.3 ml of solvent should be withdrawn from the solvent vial attached directly to a 3 ml syringe and then injected into the powder vial for reconstitution using the 27 gauge, ½-inch needle (to obtain a final reconstitution volume of 2.75 ml). The needle and syringe used for reconstitution with solvent should then be discarded and should not be used for subcutaneous injections. After the addition of solvent, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute. The resulting 80 mg/ml solution is sufficient to allow a withdrawable volume of up to 2 ml for subcutaneous administration.

The reconstituted solution is viscous, clear and colourless to pale yellow. Prior to injection, the reconstituted solution should be carefully inspected for any discolouration or particulate matter. If there is discolouration or particulate matter in the solution, the product must not be used.

Instructions for administration

Using aseptic technique, the recommended dose volume, up to 2 ml (160 mg) of the solution, should be withdrawn with a new 27 gauge, ½-inch injection needle attached to a new 3 ml syringe for subcutaneous injection.

Sites for subcutaneous injection, such as the abdomen, thigh, or upper arm, should be rotated. Injections should never be made at sites that are bruised, red, tender, or hard.

The initial administration of Rilonacept Regeneron by a patient or caregiver should be under the guidance of a trained healthcare professional. For subsequent self-administration by patients, appropriate instruction in proper injection technique should be provided and ability to apply that technique ascertained.

Disposal

Each vial should be used for a single dose only. The vial should be discarded after withdrawal of the solution.

Patients or their caregivers should be instructed on the appropriate procedure for disposal of the vials, needles, and syringes.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.