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Indication

TARPEYO® (budesonide) delayed release capsules 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. Kiryluk K, Novak J. The genetics and
immunobiology of IgA nephropathy. J Clin Invest. 2014;124(6):2325-2332.
doi:10.1172/JCI74475 6. Wehbi B, Oblet C, Boyer F, et al. Mesangial deposition
can strongly involve innate-like IgA molecules lacking affinity maturation. J Am
Soc Nephrol. 2019;30(7):1238-1249. doi:10.1681/ASN.2018111089 7. Cheung CK,
Barratt J. Pathogenesis of IgA nephropathy. UpToDate. Accessed April 5, 2022.
https://www.uptodate.com/contents/pathogenesis-of-iga-nephropathy. 8. Bhachu JS,
Scionti K, Muto M, Molyneux K, Barratt J. Targeted release-budesonide (Nefecon)
modifies circulating IgA-IgGimmune complex levels and levels of poorly
O-galactosylated IgA in IgAN [abstract 0038]. Kidney Dis. 2018;4(3):121-122. 9.
KDIGO Clinical Practice Guideline for Glomerulonephritis. June 2012. Accessed
April 5, 2022.
https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2012-GN-Guideline-English.pdf.
10. 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 11. Trachtman H, Nelson P, Adler S, et al; for DUET
Study Group. DUET: a phase 2 study evaluating the efficacy and safety of
sparsentan in patients with FSGS. J Am Soc Nephrol. 2018;29(11):2745-2754. doi:
10.1681/ASN.2018010091 12. 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. 13. 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 14. 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 15. de Sousa-Pereira P,
Woof JM. IgA: structure, function, and developability. Antibodies (Basel).
2019;8(4):57. doi:10.3390/antib8040057


FOR ADULTS AT RISK OF RAPID DISEASE PROGRESSION,


FIRST TREATMENT FDA APPROVED TO REDUCE PROTEINURIA IN IGA NEPHROPATHY1

TARPEYO is designed to deliver treatment to an area of the ileum to target
mucosal B cells, which are responsible for the production of galactose-deficient
IgA1 antibodies, causing IgAN.1,2,4

It has not been established to what extent the efficacy of TARPEYO is mediated
via local effects in the ileum vs systemic effects.1

*Drug release is initiated in the ileum by the 
pH-dependent disintegration of the enteric coat.1,3



Navigate the pathogenesis of IgAN and treatment with TARPEYO
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Indication

TARPEYO® (budesonide) delayed release capsules 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. Kiryluk K, Novak J. The genetics and
immunobiology of IgA nephropathy. J Clin Invest. 2014;124(6):2325-2332.
doi:10.1172/JCI74475 6. Wehbi B, Oblet C, Boyer F, et al. Mesangial deposition
can strongly involve innate-like IgA molecules lacking affinity maturation. J Am
Soc Nephrol. 2019;30(7):1238-1249. doi:10.1681/ASN.2018111089 7. Cheung CK,
Barratt J. Pathogenesis of IgA nephropathy. UpToDate. Accessed April 5, 2022.
https://www.uptodate.com/contents/pathogenesis-of-iga-nephropathy. 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.
KDIGO Clinical Practice Guideline for Glomerulonephritis. June 2012. Accessed
April 5, 2022.
https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2012-GN-Guideline-English.pdf.
10. 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 11. Trachtman H, Nelson P, Adler S, et al; for DUET
Study Group. DUET: a phase 2 study evaluating the efficacy and safety of
sparsentan in patients with FSGS. J Am Soc Nephrol. 2018;29(11):2745-2754. doi:
10.1681/ASN.2018010091 12. 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. 13. 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 14. 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 15. de Sousa-Pereira P,
Woof JM. IgA: structure, function, and developability. Antibodies (Basel).
2019;8(4):57. doi:10.3390/antib8040057


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