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Indication

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

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 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. Chickenpox 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 (e.g., chickenpox, 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 or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

Adverse reactions: 

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).

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

Resources

VIDEO LIBRARY

video

Watch how TARPEYO is thought to work

DOWNLOADABLE RESOURCES

Tarpeyo Touchpoints HCP Brochure cover

TARPEYO TouchpointsTM HCP Brochure

Information about services, assistance, and resources that can help patients easily access treatment

DOWNLOAD
Tarpeyo Touchpoints enrollment form PDF cover

TARPEYO TouchpointsTM Enrollment Form

Complete and submit this form when you prescribe TARPEYO to help your patients access treatment

DOWNLOAD
Tarpeyo Touchpoints Chinese-language enrollment form PDF cover

TARPEYO TouchpointsTM Enrollment Form (Chinese)

A translated version of the enrollment form in Chinese

DOWNLOAD
Tarpeyo Touchpoints Spanish-language enrollment form PDF cover

TARPEYO TouchpointsTM Enrollment Form (Spanish)

A translated version of the enrollment form in Spanish

DOWNLOAD
IgA Nephropathy Foundation logo

IGA NEPHROPATHY FOUNDATION Dedicated to finding a cure.

Empower your patients to learn what it is like to live with IgA Nephropathy by pointing them to credible information and support. The IgA Nephropathy Foundation is led by patients for patients

FIND SUPPORT

IgAN INSIGHTS QUIZ

Test the depth of your knowledge of IgA Nephropathy by taking this IgAN Insights Quiz

Question 1.

In what demographic group is IgAN seen in the largest percentage?13

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Next Question SUBMIT ANSWER

Question 2.

What type of tissue is responsible for producing the bulk of IgA in the body?2

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Next Question SUBMIT ANSWER

Question 3.

IgA-producing lymphocytes in the gut make up approximately __% of all immunoglobulin-producing cells in the body.2

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Next Question SUBMIT ANSWER

Question 4.

GALT stands for ________________.2

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Next Question SUBMIT ANSWER

Question 5.

Peyerʼs patches, which consist of lymphoid follicles, are found in high concentrations in the ___________.2

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Next Question SUBMIT ANSWER

Question 6.

__________ is the most widely recognized risk factor for progression to end-stage renal disease in patients with IgAN and is used as an outcome in clinical trials.4,14-16

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Next Question SUBMIT ANSWER

Question 7.

In patients with IgAN, IgA-containing complexes form in the ________ before trafficking to the kidney.17

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Next Question SUBMIT ANSWER

Question 8.

The IgA that is found in the kidney in patients with IgAN is ___________.17,18

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Next Question SUBMIT ANSWER

Question 9.

A majority of the B cells that produce IgA are found in the ___________.2

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Next Question SUBMIT ANSWER

Question 10.

IgA Nephropathy was first described by the Parisian pathologist Jean Berger over _____ years ago.2

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Next Question SUBMIT ANSWER
close X

Congratulations!

You have successfully completed the IgAN Insights Quiz

Indication

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

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 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. Chickenpox 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 (e.g., chickenpox, 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 or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

Adverse reactions: 

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).

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