Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
The recommended dose is 16 mg once daily in the morning, at least one hour before a meal, for 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.
Re-treatment may be considered at the discretion of the treating physician. Safety and efficacy of treatment with subsequent courses of Kinpeygo have not been established.
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.
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.
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). See section 4.3, 4.4 and 5.2.
The pharmacokinetics of budesonide are not expected to be altered in patients with renal impairment.
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.
Kinpeygo is for oral use. The modified-release hard capsules should be swallowed whole with water in the morning, at least 1 hour before a meal (see section 5.2). The capsules must not be opened, crushed or chewed, as it could affect the release profile.
Reports of acute toxicity or death following overdose of glucocorticosteroids are rare. Acute overdose, even in excessive doses, is not expected to lead to clinically significant consequences. In the event of acute overdose, no specific antidote is available. Treatment consists supportive and symptomatic therapy.
3 years.
This medicinal product does not require any special storage conditions.
White high density polyethylene (HDPE) bottle with a white polypropylene (PP) child-resistant closure with an induction seal.
Pack sizes: 1 bottle containing 120 modified-release hard capsules and multipacks containing 360 (3 packs of 120) modified-release hard capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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