TEPYLUTE THIOTEPA 塞替派

Tarpeyo is used to reduce the level of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at high risk of disease progression.

Budesonide (Tarpeyo in the U.S. and Kinpeygo in the EU and UK) reduces proteinuria in adults with primary IgA nephropathy (also known as Berger’s disease) who are at high risk of disease progression.

It is not known if this medicine is safe and effective in children.

Tarpeyo budesonide dosage and administration

The recommended duration of treatment is 9 months at a dose of 16 mg taken orally once daily. When stopping treatment, reduce the dose to 8 mg once daily during the last 2 weeks of treatment.

The delayed-release capsules should be swallowed in the morning, at least 1 hour before meals. Do not open, crush or chew.

If a dose is missed, take the prescribed dose at the next scheduled time. Do not double the next dose.

The safety and effectiveness of subsequent courses of Tarpeyo have not been established.

DOSE FORMULATIONS AND STRENGTHS
Extended-release capsules containing 4 mg of budesonide. White coated opaque capsules printed with “CAL10 4MG” in black ink.

CONTRAINDICATIONS
Tarpeyo is contraindicated in patients with hypersensitivity to budesonide or any of the components of Tarpeyo. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide preparations.

WARNINGS AND PRECAUTIONS
Hypercorticism and adrenal axis suppression

Systemic effects such as hypercorticism and adrenal suppression may occur when corticosteroids are used chronically. Corticosteroids can reduce the response of the hypothalamic-pituitary-adrenal (HPA) axis to stress. Supplemental systemic corticosteroids are recommended in patients undergoing surgery or other stressful situations. Monitor for signs of adrenal axis suppression when discontinuing treatment or switching between corticosteroids.

Patients with moderate to severe hepatic impairment (Child-Pugh class B and C, respectively) may be at increased risk for hypercorticism and adrenal axis suppression due to increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh class C). Monitor patients with moderate hepatic impairment for signs and/or symptoms of hypercorticism (Child-Pugh class B).

Risks of Immunosuppression

Patients taking medications that suppress the immune system are more susceptible to infections than healthy individuals. For example, varicella and measles may have a more severe or even fatal course in susceptible patients or in patients taking immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. Avoid exposure to active, easily transmissible infections (e.g., varicella, measles). Corticosteroid therapy may reduce the immune response to some vaccines.

It is unclear how the dose, route, and duration of corticosteroid administration affect the risk of developing disseminated infection. The contribution of underlying medical conditions and/or prior corticosteroid therapy to risk is also unclear. If exposed to varicella, consider treatment with varicella zoster immune globulin (VZIG) or intravenous immune globulin (IVIG). If exposed to measles, consider prophylaxis with mixed intramuscular immune globulin (IG). If varicella develops, consider treatment with antiviral agents.

Other Corticosteroid Effects

Tarpeyo is a systemically available corticosteroid and is expected to cause relevant adverse reactions. Monitor patients with hypertension, prediabetes, diabetes, osteoporosis, peptic ulcers, glaucoma, or cataracts, or patients with a family history of diabetes or glaucoma, or any other condition that corticosteroids may adversely affect.

Adverse Reactions
Common adverse reactions (≥5%) are hypertension, peripheral edema, muscle cramps, acne, dermatitis, weight gain, dyspnea, facial edema, dyspepsia, fatigue, and hirsutism.

The above information is for reference only, please consult your doctor for details. For more drug information, please contact our pharmacist customer service!