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Kineret is a brand name for Anakinra. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid Arthritis (RA) 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. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia…
Verbatim from this product's EMA label. Tap a section to expand.
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA, COVID-19, CAPS, FMF and Still’s disease, respectively. 1).
Posology RA:
Adults 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.
COVID-19:
Adults The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection for 10 days.
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 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.
4 Still’s disease 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 starting dose of 1-2 mg/kg/day.
8. 5 x 109/l). It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter. 5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
The safety and efficacy of Kineret in patients with neutropenia have not been evaluated. Pulmonary Events During post-marketing use events of interstitial lung disease, pulmonary alveolar proteinosis and pulmonary hypertension have been reported mainly in paediatric patients with Still’s disease treated with IL-6 and IL-1 inhibitors, including Kineret.
Patients with trisomy 21 seem to be overrepresented. In company-sponsored clinical studies in Still’s disease no such events were reported. In a non- interventional long-term safety study in 306 paediatric patients with Still’s disease one patient experienced a serious pulmonary event, an unspecified interstitial lung disease.
There was no patient with pulmonary alveolar proteinosis or pulmonary hypertension in the study. A causal relationship between Kineret and pulmonary events has not been established. Drug reaction with eosinophilia and systemic symptoms (DRESS) During post-marketing use, drug reaction with eosinophilia and systemic symptoms (DRESS) has rarely been reported in patients treated with Kineret, predominantly in paediatric patients with Still’s disease [systemic juvenile idiopathic arthritis (SJIA)].
Patients with DRESS may require hospitalization, as this condition may be fatal. If signs and symptoms of DRESS are present and an alternative aetiology cannot be established, Kineret should be discontinued and a different treatment considered.
8) isolated cases of systemic AIL1RAP (IL-1 receptor antagonist protein) amyloidosis have been reported during post-marketing use. 7 In patients with confirmed injection site amyloid deposits, observation for symptoms of systemic amyloidosis, including close monitoring for proteinuria, is recommended.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions Allergic reactions, including anaphylactic reactions and angioedema have been reported uncommonly.
The majority of these reactions were maculopapular or urticarial rashes. If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated. Hepatic Events In clinical studies transient elevations of liver enzymes have been seen.
These elevations have not been associated with signs or symptoms of hepatocellular damage, except for one patient with SJIA that developed a serious hepatitis in connection with a cytomegalovirus infection. During post-marketing use hepatic events, not affecting liver function, have been reported.
g. a history of transaminase elevations. In addition cases of non-infectious hepatitis, including occasional events of acute liver failure, have been reported in patients with Still’s disease during Kineret treatment. Hepatic events in patients with Still’s disease predominantly occur during the first month of Kineret treatment.
Routine testing of hepatic enzymes during the first month should be considered, especially if the patient has pre-disposing factors or develops symptoms indicating liver dysfunction. 5 x upper level of normal have not been evaluated.
8%) vs. 7%) in RA patients. 5%) vs. placebo-treated patients (0%), these infections were mainly related to the respiratory tract. The safety and efficacy of Kineret treatment in patients with chronic and serious infections have not been evaluated.
Kineret treatment should not be initiated in patients with active infections. Kineret treatment should be discontinued in RA patients if a serious infection develops. In Kineret treated CAPS or FMF patients, there is a risk for disease flares when discontinuing Kineret treatment.
1 or to E. coli derived proteins. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Elderly population (≥ 65 years) RA and COVID-19:
No dose adjustment is required. Posology and administration are the same as for adults 18 to 64 years of age.
CAPS:
Data in elderly patients are limited. No dose adjustments are expected to be required.
Still’s disease:
Data in elderly patients are limited. No dose adjustment are expected to be required. Paediatric population (< 18 years) No data are available in children under the age of 8 months. RA: The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
COVID-19:
The efficacy of Kineret in children with COVID-19 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.
FMF:
Children weighing less than 50 kg are dosed by body weight with a recommended 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.
The efficacy data of Kineret in children under 2 years of age with FMF are limited.
Still’s disease:
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.
Hepatic impairment 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. Renal 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.
Method of administration 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. 6. 5 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.
Immunosuppression The impact of treatment with Kineret on pre-existing malignancy has not been studied. Therefore the use of Kineret in patients with pre-existing malignancy is not recommended. Malignancies RA patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
In clinical studies, whilst patients treated with Kineret had a higher incidence of lymphoma than the expected rate in the general population, this rate is consistent with rates reported in general for RA patients. In clinical studies, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret. Vaccinations In a placebo-controlled clinical study (n = 126), no difference was detected in anti-tetanus antibody response between the Kineret and placebo treatment groups when a tetanus/diphtheria toxoid vaccine was administered concurrently with Kineret.
No data are available on the effects of vaccination with other inactivated antigens, or COVID-19 vaccines, in patients receiving Kineret. No data are available on either the effects of live vaccination or on the secondary transmission of infection by live vaccines in patients receiving Kineret.
Therefore, live vaccines should not be given concurrently with Kineret. Elderly population (≥ 65 years) A total of 752 RA patients ≥ 65 years of age, including 163 patients ≥ 75 years of age, and 173 COVID-19 patients ≥ 65 years of age were studied in clinical studies.
No overall differences in safety or effectiveness were observed between these patients and younger patients. There is limited experience in treating elderly CAPS, FMF and Still’s disease patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating elderly patients.
Concurrent Kineret and TNF-α antagonist treatment Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone in RA patients. This treatment combination has not demonstrated increased clinical benefit.
5). COVID-19 Patients The effect of treatment with Kineret has not been established in COVID-19 patients with suPAR < 6 ng/ml. Kineret treatment should not be initiated in patients requiring non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) as efficacy has not been established in these patient populations.
Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free’. 04 mg/ml. Polysorbates may cause allergic reactions. 5 Interaction with other medicinal products and other forms of interaction Interactions between Kineret and other medicinal products have not been investigated in formal studies.
In clinical studies, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed. Concurrent Kineret and TNF-α antagonist treatment In a clinical study with RA patients receiving background methotrexate, patients treated with Kineret and etanercept were observed to have a higher rate of serious infections […]
With careful monitoring, Kineret treatment can be continued also during a serious infection. Treatment with Kineret for COVID-19 can be continued despite (secondary) infections. 6 Physicians should exercise caution when administering Kineret to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
The safety of Kineret in individuals with latent tuberculosis is unknown. There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens. Patients should be screened for latent tuberculosis prior to initiating Kineret.
The available medical guidelines should also be taken into account. Other anti-rheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines also before starting therapy with Kineret.
Renal impairment Kineret is eliminated by glomerular filtration and subsequent tubular metabolism. Consequently plasma clearance of Kineret decreases with decreasing renal function. 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.
5 x 109/l) in placebo-controlled studies in RA and cases of neutropenia have been observed in patients with COVID-19, CAPS and Still’s disease. 8. 5 x 109/l). It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter.
5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued. The safety and efficacy of Kineret in patients with neutropenia have not been evaluated. Pulmonary Events During post-marketing use events of interstitial lung disease, pulmonary alveolar proteinosis and pulmonary hypertension have been reported mainly in paediatric patients with Still’s disease treated with IL-6 and IL-1 inhibitors, including Kineret.
Patients with trisomy 21 seem to be overrepresented. In company-sponsored clinical studies in Still’s disease no such events were reported. In a non- interventional long-term safety study in 306 paediatric patients with Still’s disease one patient experienced a serious pulmonary event, an unspecified interstitial lung disease.
There was no patient with pulmonary alveolar proteinosis or pulmonary hypertension in the study. A causal relationship between Kineret and pulmonary events has not been established. Drug reaction with eosinophilia and systemic symptoms (DRESS) During post-marketing use, drug reaction with eosinophilia and systemic symptoms (DRESS) has rarely been reported in patients treated with Kineret, predominantly in paediatric patients with Still’s disease [systemic juvenile idiopathic arthritis (SJIA)].
Patients with DRESS may require hospitalization, as this condition may be fatal. If signs and symptoms of DRESS are present and an alternative aetiology cannot be established, Kineret should be discontinued and a different treatment considered.
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