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Kinpeygo is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is 16 mg once daily in the morning, at least one hour before a meal, for an initial duration of 9 months. When treatment is to be discontinued, the dose should be reduced to 8 mg once daily for 2 weeks of therapy; the dose may be reduced to 4 mg once daily for an additional 2 weeks, at the discretion of the treating physician.
1). If the patient forgets to take Kinpeygo, the patient should take Kinpeygo the next day, in the morning as usual. The patient should not double the daily dose to make up for a missed dose. Special populations Elderly Experience of the use of Kinpeygo in the elderly is limited.
However, from the clinical data available, the efficacy and safety of Kinpeygo are expected to be similar to that of other age groups studied. 3 Hepatic impairment The safety and efficacy of Kinpeygo capsules in patients with hepatic impairment have not been studied.
Kinpeygo is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C). 2. Renal impairment The pharmacokinetics of budesonide are not expected to be altered in patients with renal impairment. Paediatric population The safety and efficacy of Kinpeygo capsules in children and adolescents below 18 years of age have not yet been established.
No data are available. Method of administration Kinpeygo is for oral use. 2). The capsules must not be opened, crushed or chewed, as it could affect the release profile.
Summary of the safety profile In the Kinpeygo phase 3 clinical study the most commonly reported adverse drug reactions were acne reported in approximately 10% of patients, peripheral oedema, face oedema, weight increased and white blood cell count increased, each occurring in approximately 5% of patients; these were mainly of mild or moderate severity and reversible, reflecting the low systemic exposure to budesonide after oral administration.
7 Data for re-treatment of patients who were re-treated as part of an open-label extension study to the previous phase 3 study suggested a safety profile for re-treatment consistent with that observed in the phase 3 clinical study.
Tabulated list of adverse reactions Adverse drug reactions reported in the pivotal phase 3 clinical study and from post-marketing data with Kinpeygo are presented in Table 1.
Adverse reactions reported are listed according to the following frequency:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 7% or FBG≥100 mg/dL). , cushingoid features, increased blood pressure, increased risk of infection, delayed wound healing, reduced glucose tolerance, sodium retention with oedema formation, muscle weakness, osteoporosis, glaucoma, mental disorders, peptic ulcer, increased risk of thrombosis).
These adverse drug reactions are dependent on dose, treatment time, concomitant and previous glucocorticosteroid intake, and individual sensitivity. Not all of these adverse reactions were observed in the clinical study program of Kinpeygo.
Paediatric population No data available. 8 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Hypercorticism and adrenal axis suppression When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress.
In situations where patients are subject to surgery or other stress situations, supplementation with a systemic glucocorticosteroid is recommended. Since Kinpeygo contains a glucocorticosteroid, general warnings concerning glucocorticosteroids, as given below, should be followed.
Hepatic impairment Patients with moderate or severe hepatic impairment (Child-Pugh Class B or C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide.
Patients with moderate hepatic impairment (Child-Pugh Class B) should be monitored for increased signs and/or symptoms of hypercorticism. Symptoms of steroid withdrawal in patients transferred from systemic corticosteroids Patients who are transferred from glucocorticosteroid treatment with high systemic availability to glucocorticosteroids with lower systemic availability, such as budesonide, should be monitored since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop.
Adrenocortical function monitoring may be required in these patients and the dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously. , rhinitis and eczema), which were previously controlled by the systemic medicinal product.
Infections Patients who are on medicinal products that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids.
1. Patients with severe hepatic impairment (Child-Pugh Class C).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of glucocorticosteroid administration affect the risk of developing a disseminated infection is not known.
The contribution of the underlying disease and/or prior glucocorticosteroid treatment to the risk is also not known. If exposed to chickenpox, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. ) If chickenpox develops, treatment with antiviral agents may be considered. Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
Caution with special diseases Patients with infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where use of glucocorticosteroids may be associated with an increased risk of adverse effects, should be monitored.
Visual disturbance Visual disturbance may be reported with systemic and topical glucocorticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical glucocorticosteroids.
Concomitant treatment with potent CYP3A4 inhibitors Concomitant treatment with potent CYP3A4 inhibitors, including ketoconazole and cobicistat-containing products, is expected to increase the risk of systemic side effects attributable to budesonide.
The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticosteroid side effects. 5). After extensive intake of grapefruit juice (which inhibits CYP3A4 activity predominantly in the intestinal mucosa), the systemic exposure to budesonide after oral administration increased approximately two-fold.
As with other medicinal products primarily metabolised through CYP3A4, regular ingestion of grapefruit or its juice should be avoided in connection with Kinpeygo administration (other juices such as orange juice or apple juice do not inhibit CYP3A4).
5. 5 ACTH stimulation test Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicinal product.