Tarpeyo

— THERAPEUTIC CATEGORIES —
  • Miscellaneous urogenital disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tarpeyo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Budesonide 4mg; del-rel caps.

    Pharmacological Class

    Glucocorticoid.

    How Supplied

    Caps—120

    Manufacturer

    Calliditas Therapeutics AB

    Generic Availability

    NO

    Mechanism of Action

    Budesonide has potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. Mucosal B-cells present in the ileum, including the Peyer’s patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. Through their anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, corticosteroids can modulate B-cell numbers and activity.

    Tarpeyo Indications

    Indications

    To reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

    Tarpeyo Dosage and Administration

    Adult

    Swallow whole. Take in the AM at least 1hr before a meal. 16mg once daily. Treat for 9 months. When discontinuing treatment, reduce dose to 8mg once daily for the last 2 weeks. Safety and efficacy of treatment with subsequent courses: not established.

    Children

    Not established.

    Tarpeyo Contraindications

    Not Applicable

    Tarpeyo Boxed Warnings

    Not Applicable

    Tarpeyo Warnings/Precautions

    Warnings/Precautions

    Avoid in active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Supplement with systemic corticosteroids in surgery or other stress situations. Monitor for adrenal axis suppression when discontinuing therapy or switching between corticosteroids. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Moderate hepatic impairment: monitor for hypercorticism. Severe hepatic impairment: avoid. Elderly. Pregnancy: monitor infants for hypoadrenalism. Nursing mothers.

    Tarpeyo Pharmacokinetics

    Absorption

    Average geometric mean Cmax : 4.4 ng/mL (58.3). AUC0-24 (CV%): 24.1 h*ng/mL (49.7). Median Tlag (min, max): 3.1 h (0, 6); median Tmax (min, max): 5.1 h (4.5, 10). 

    Distribution

    Volume of distribution: 3 to 4 L/kg. ~85–90% plasma protein bound.

    Metabolism

    Hepatic (CYP3A4). 

    Elimination

    Renal (~60%), fecal. Half-life: 5–6.8 hours.

    Tarpeyo Interactions

    Interactions

    Avoid grapefruit juice. May be potentiated by potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine); avoid. May decrease immune response to some vaccines.

    Tarpeyo Adverse Reactions

    Adverse Reactions

    Peripheral edema, hypertension, muscle spasms, acne, headache, upper respiratory tract infection, face edema, weight increase, dyspepsia, dermatitis, arthralgia, WBC count increase; hypercorticism.

    Tarpeyo Clinical Trials

    See Literature

    Tarpeyo Note

    Not Applicable

    Tarpeyo Patient Counseling

    See Literature

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