Kinpeygo®▼ 4mg (modified-release hard capsules budesonide) Prescribing Information
Please refer to the Summary of Product Characteristics before prescribing Kinpeygo.
Presentation: Each modified-release hard capsule contains budesonide 4 mg.
Indication: 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).
Dosage and administration: Adults – 16 mg once daily in the morning, at least one hour before a meal, for an initial duration of 9 months. For discontinuation, 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. Retreatment may be considered. Safety and efficacy of treatment with subsequent courses have not been established. Method of administration – For oral use. Must not be opened, crushed or chewed.
Contraindications: Hypersensitivity to the active substance or any of the excipients. Patients with severe hepatic impairment (Child-Pugh Class C).
Warnings and Precautions: 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 axis to stress. During surgery or other stress situations, supplement with a systemic glucocorticosteroid. 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 increased systemic exposure to oral budesonide. Monitor for increased signs and/or symptoms of hypercorticism in moderate hepatic impairment (Child-Pugh Class B). Steroid withdrawal in patients transferred from high to low systemic corticosteroids – Monitor for symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension. Adrenocortical function monitoring may be required. The dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic glucocorticosteroids with budesonide may unmask allergies previously controlled by the systemic medicinal product. Infections – Patients on immune system suppressants are more susceptible to infection e.g. chickenpox and measles, can have a more serious or even fatal course. Patients who have not had these diseases, should avoid exposure. See SmPC for treatment options. 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. 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 disturbances – May be reported with systemic and topical glucocorticosteroid use. Concomitant treatment – CYP3A4 inhibitors, including ketoconazole and cobicistat products should be avoided. Grapefruit or its juice should be avoided as it inhibits CYP3A4 activity. ACTH stimulation test – False results may present as adrenal function may be suppressed. Contains sucrose – Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take Kinpeygo.
Fertility, pregnancy and lactation: Pregnancy – Administration should be avoided unless there are compelling reasons for therapy with Kinpeygo. Breast-feeding – Budesonide is excreted in breast milk. Risk to the breastfed infant cannot be excluded. Fertility – Effect is unknown.
Undesirable effects: Serious common side effects: White blood cell count increased, cushingoid, diabetes mellitus. Very common side effects: Hypokalaemia, skin reactions (acne, dermatitis). Other common side effects: Neutrophil count increased, hypertension, dyspepsia, muscle spasms face oedema, oedema peripheral, weight increase.
For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: 120 modified-release hard capsules – £4,681.24. 28 modified-release hard capsules – £1092.29.
MA Number: PLGB 17225/0027
MA Holder: Genus Pharmaceuticals Holdings Limited (trading as ‘STADA’), Linthwaite, Huddersfield, HD7 5QH, UK
Date of preparation: July 2025
Unique ID number: UK-KINPE-41(3)
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-KINPE-41(3)b | September 2025