Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone.
Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of CAPS, including:
Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA, CAPS and Still’s disease, respectively.
The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day.
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.
The recommended dose for patients weighing 50 kg or more is 100 mg/day by subcutaneousinjection. Patients weighing less than 50 kg should be dosed by body weight with a starting dose of 1-2 mg/kg/day.
Response to treatment should be evaluated after 1 month: In case of persistent systemic manifestations dose may be adjusted in children or continued treatment with Kineret should be reconsidered by the treating physician.
No dose adjustment is required. Posology and administration are the same as for adults 18 to 64 years of age.
Data in elderly patients are limited. No dose adjustments are expected to be required.
Data in elderly patients are limited. No dose adjustment are expected to be required.
No data are available in children under the age of 8 months.
The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
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.
Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day. In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B). Kineret should be used with caution in patients with severe hepatic impairment.
No dose adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/min). Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 59 ml/min). In patients with severe renal impairment (CLcr <30 ml/min) or end stage renal disease, including dialysis, administration of the prescribed dose of Kineret every other day should be considered.
Kineret is administered by subcutaneous injection.
Kineret is supplied ready for use in a graduated 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 to room temperature, use of cold packs (before and after the injection), and use of topical glucocorticoids and antihistamines after the injection can alleviate the signs and symptoms of injection site reactions.
No dose-limiting toxicities were observed during clinical studies.
In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/kg/hour i.v. (~35 times the recommended dose in RA) over a 72 hour treatment period. The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original container in order to protect from light.
For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at temperature not above 25°C, without exceeding the expiry date. At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle. The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover. None of the syringe or needle shield components are made with natural rubber latex.
Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Not all pack sizes may be marketed.
Kineret is a sterile unpreserved solution. For single use only.
Do not shake. Allow the pre-filled syringe to reach room temperature before injecting.
Before administration, visually inspect the solution for particulate matter and discolouration. Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
The presence of these particles does not affect the quality of the product.
The pre-filled syringe is for single use only. Discard any unused medicinal product. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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