Active Ingredient: Anakinra
Anakinra 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:
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
1 - 8 mg per kg of body weight
From 1 To 8 mg per kg of body weight once every 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.
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