Posology : מינונים

4.2       Posology and method of administration

Kineret 100 mg solution for injection treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Rheumatoid Arthritis, FMF and CAPS, respectively.
Posology
RA: Adults
The recommended dose of Kineret 100 mg solution for injection is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day.

CAPS: Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above.
Starting dose:
The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection. The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Maintenance dose in mild CAPS (FCAS, mild MWS):
Patients are usually well-controlled by maintaining the recommended starting dose (1-2 mg/kg/day).

Maintenance dose in severe CAPS (MWS and NOMID/CINCA):
Dose increases may become necessary within 1-2 months based on therapeutic response. The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.

In addition to the evaluation of clinical symptoms and inflammatory markers in severe CAPS, assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified. When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.

FMF - Adults, adolescents and children aged 2 years and older

The recommended dose for patients weighing 50 kg or more is 100 mg/day by subcutaneous injection. Patients weighing less than 50 kg should be dosed by body weight with a recommended dose of 1- 2 mg/kg/day.

Elderly population (≥ 65 years)
No dose adjustment is required in RA patients. Posology and administration are the same as for adults 18 to 64 years of age.

Data in elderly CAPS patients are limited. No dose adjustments are expected to be required.

Paediatric population (< 18 years)
RA: The efficacy of Kineret 100 mg solution for injection in children with RA (JIA) aged 0 to 18 years has not been established.

CAPS: Posology and administration in children and infants aged 8 months and older with a body weight of 10 kg or above are the same as for adult CAPS patients, based on body weight. No data are available in children under the age of 8 months.

FMF: No data are available in children under 2 years of age with FMF.
Hepatic impairment
No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B). Kineret 100 mg solution for injection should be used with caution in patients with severe hepatic impairment.

Renal impairment
No dosage adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/minute). In the absence of adequate data, Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 59 ml/minute). Kineret must not be used in patients with severe renal impairment (CLcr < 30 ml/minute).

Method of administration
Kineret 100 mg solution for injection is administered by subcutaneous injection.

Kineret 100 mg solution for injection is supplied ready for use in graduated a pre-filled syringe.
The graduated pre-filled syringe allows for doses between 20 and 100 mg. As the minimum dose is 20 mg the syringe is not suitable for paediatric patients with a body weight below 10 kg. The pre-filled syringe should not be shaken. The instructions for use and handling are given in section 6.6.

Alternating the injection site is recommended to avoid discomfort at the site of injection. Cooling of the injection site, warming the injection liquid, use of cold packs (before and after the injection), and use of topical corticosteroids and antihistamines after the injection can alleviate the signs and symptoms of injection site reactions.