Indication

TARPEYO^® is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.

This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Important Safety Information

Contraindications:

TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.

Warnings and Precautions

Hypercorticism and adrenal axis suppression:

When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy [see Dosing and Administration] or switching between corticosteroids, monitor for signs of adrenal axis suppression.

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

Risks of immunosuppression:

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on 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 transmitted infections (eg, chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

Other corticosteroid effects:

TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, a family history of diabetes or glaucoma, or with any other condition in which corticosteroids may have unwanted effects.

Adverse reactions:

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO patients and ≥2% higher than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase (7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).

Drug interactions:

Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.

Use in specific populations

Pregnancy:

The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.

Please see Full Prescribing Information.

References: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; 2021. 2. Barratt J, Rovin BH, Cattran D, et al. Why target the gut to treat IgA nephropathy? Kidney Int Rep. 2020;5(10):1620-1624. doi:10.1016/j.ekir.2020.08.009 3. Data on file. Calliditas Therapeutics AB. 4. Fellström BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017;389(10084):2117-2127. doi:10.1016/S0140-6736(17)30550-0 5. Chang S, Li X-K. The role of immune modulation in pathogenesis of IgA nephropathy. Front Med (Lausanne). 2020;7:92. doi:10.3389/fmed.2020.00092 6. Canetta PA, Kiryluk K, Appel GB. Glomerular diseases: emerging tests and therapies for IgA nephropathy. Clin J Am Soc Nephrol. 2014;9(3):617-625. doi:10.2215/CJN.07260713 7. Kiryluk K, Novak J. The genetics and immunobiology of IgA nephropathy. J Clin Invest. 2014;124(6):2325-2332. doi:10.1172/JCI74475 8. Bhachu JS, Scionti K, Muto M, Molyneux K, Barratt J. Targeted release- budesonide (Nefecon) modifies circulating IgA-IgG immune complex levels and levels of poorly O-galactosylated IgA in IgAN [abstract 0038]. Kidney Dis. 2018;4(3):121-122. 9. Suzuki H, Kiryluk K, Novak J, et al. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011;22(10):1795-1803. doi:10.1681/ASN.2011050464 10. Del Vecchio L, Rimoldi C, Pozzi C. Nefecon (targeted-release formulation-budesonide) for the treatment of IgA nephropathy. Future Rare Dis. 2021;1(4). doi.org/10.2217/frd-2021-0013 11. Barratt J, Lafayette R, Kristensen J, et al; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023;103:391-402. https://doi.org/10.1016/j.kint.2022.09.017 12. KDIGO Clinical Practice Guideline for Glomerulonephritis. June 2012. Accessed June 22, 2023. https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2012-GN-Guideline-English.pdf 13. Hall YN, Fuentes EF, Chertow GM, Olson JL. Race/ethnicity and disease severity in IgA nephropathy. BMC Nephrol. 2004;5:10. doi:10.1186/1471-2369-5-10 14. Trachtman H, Nelson P, Adler S, et al. DUET: A phase 2 study evaluating the efficacy and safety of sparsentan in patients with FSGS [published correction appears in J Am Soc Nephrol. 2019;30(3):518]. J Am Soc Nephrol. 2018;29(11):2745-2754. doi:10.1681/ASN.2018010091 15. Barratt J, Tumlin JA, Suzuki Y, et al. 24-week interim analysis of a randomized, double-blind, placebo-controlled phase 2 study of atacicept in patients with IgA nephropathy and persistent proteinuria. Abstract presented at: American Society of Nephrology Kidney Week; October 20-25, 2020; Denver, CO. 16. Thompson A, Carroll K, Inker LA, et al. Proteinuria reduction as a surrogate end point in trials of IgA nephropathy. Clin J Am Soc Nephrol. 2019;14(3):469-481. doi:10.2215/CJN.08600718 17. Barratt J, Feehally J. Primary IgA nephropathy: new insights into pathogenesis. Semin Nephrol. 2011;31(4):349-360. doi:10.1016/j.semnephrol.2011.06.006 18. DeSousa- Pereira P, Woof JM. IgA: structure, function, and developability. Antibodies (Basel). 2019;8(4):57. doi:10.3390/antib8040057

Terms of use

The contents on this site are owned and/or controlled by Calliditas Therapeutics AB, PO Box 70351, SE-107 24 Stockholm, Sweden. By using this site you agree to be bound by these terms, which are governed by the laws of the State of New York, USA. Check these terms of use regularly, as they may be changed at any time, with changes effective when posted.

Do not access, browse or use this site if you do not agree with these terms of use. We reserve the right to terminate your access to this site if you breach these terms of use.

Your access to and use of this website is also subject to our Privacy Policy, a link to which can be found in the site menu and which is incorporated by reference in these terms of use.

This site is only intended for access by licensed health care professionals and is for informational purposes only. If you are not a licensed health care professional, do not access, browse or use this website.

We or our licensors own the content of this website, which is protected by United States and foreign intellectual property laws. Unauthorized use of this content may result in violation of copyright, trademark, and other laws. Unless explicitly authorized by us you may not alter, copy, disable, frame, link, modify (including by removing any copyright and other proprietary notices), post, reproduce, republish, sell, transfer, transmit, translate, upload, or create derivative versions of any material from this site, in particular for any commercial purpose. We and our licensors retain all rights with respect to logos, service marks and trademarks used and displayed on this site.

You agree not to: (a) take any action that imposes an unreasonable load on this site’s infrastructure, (b) interfere or attempt to interfere with the proper working of this site or any activity conducted on the site, or (c) attempt to decipher, decompile, disassemble or reverse engineer any of the software comprising or making up this site.

Any links to third-party websites on this site are provided solely as a convenience to you and not as an endorsement by us of the content on such websites, the content of which is developed and provided by others. We are not responsible for the content of any linked websites and, if you access any linked websites, you do so at your own risk.

The content on this site includes health-related information or material; this health-related information or material only describes general principles of health care that should not be construed as specific instructions or advice for individual patients. This site is intended for educational purposes only and is not a substitute for actual medical care. Persons requiring diagnosis or treatment, or who have specific questions related to their condition or care, should not access or use this site and are urged to contact their health care provider.

CALLIDITAS THERAPEUTICS AB IS NEITHER RESPONSIBLE NOR LIABLE FOR ANY ACTION, INACTION, SERVICES, ADVICE, ANALYSIS OR INFORMATION BY OR OF ANY HEALTH CARE PROVIDER WHO ACCESSES OR USES THIS SITE.

ALL CONTENTS ON THIS SITE ARE PROVIDED “AS IS.” IN PARTICULAR, WE DO NOT MAKE ANY REPRESENTATIONS OR WARRANTIES REGARDING THE USE OR THE RESULTS OF THE USE OF THIS SITE NOR MATERIALS ON THIS SITE AND, TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, DISCLAIM ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. WE SHALL NOT BE RESPONSIBLE FOR ANY LOSS, DAMAGE, LIABILITY OR EXPENSE THAT MAY RESULT FROM YOUR USE OF THE SITE.