布地奈德缓释胶囊(Tarpeyo)的功效与作用

Budesonide extended-release capsules (Tarpeyo) received accelerated approval from the US FDA for the first time on December 15, 2021, and full approval on December 20, 2023. It is the first approved treatment method that can significantly reduce the loss of renal function in IgA nephropathy.

Efficacy and effects of budesonide extended-release capsules (Tarpeyo)

It is an oral, delayed-release corticosteroid capsule that can be used to reduce the inflammatory response and loss of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

IgAN is a common kidney disease associated with a high risk of progression to end-stage renal disease (ESRD), especially in certain ethnic groups. Galactose-deficient IgA1 (Gd-IgA1), produced by mucosal B cells in the ileum (the last part of the small intestine), is critical for the development and progression of the disease. Tarpeyo (budesonide) has anti-inflammatory and immunosuppressive effects by regulating the number and activity of mucosal B cells.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

How to take Budesonide extended-release capsules (Tarpeyo)

1. Dosage

The recommended dose is 16 mg orally once daily.

2. Course of treatment

The recommended course of treatment is 9 months. When stopping treatment, your healthcare provider should reduce the dose to 8 mg once daily for the last 2 weeks of treatment.

3. How to take the medicine

Please swallow the capsule whole in the morning, at least 1 hour before meals. Do not crush, break, or dissolve budesonide extended-release capsules.

4. Treatment of missed doses

If you accidentally miss a dose, you do not need to take the missed dose. You can just take the regular prescribed dose at the next prescribed medication time. Do not take a double dose at one time.

5. Treatment of drug withdrawal

Do not stop using budesonide extended-release capsules suddenly. If the drug stops working, please inform your doctor. If your doctor recommends stopping the medication, follow your doctor's instructions for gradually reducing your dose.

Precautions when using Budesonide extended-release capsules (Tarpeyo)

1. If you are allergic to budesonide or any ingredients in the delayed-release capsules, you should not use budesonide extended-release capsules.

2. Long-term and regular use of corticosteroids may lead to cortical hyperfunction and adrenal axis suppression, which will reduce the response ability of the hypothalamic-pituitary-adrenal (HPA) axis to stress.

Additional corticosteroids may be needed during surgery, illness, or other stressful events.

3. Budesonide sustained-release capsules can suppress the immune system and make you more susceptible to infections and diseases. Avoid use in patients with active or latent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infection, or ocular herpes simplex.

4. Budesonide extended-release capsules may cause side effects, thereby aggravating other existing disease conditions, such as hypertension, diabetes, osteoporosis, glaucoma or cataracts.