IMPORTANT SAFETY INFORMATION & INDICATION

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).

Immunosuppression and increased risk of infection:

Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed.

Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. 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.

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.

Please see Full Prescribing Information.

Draft 2024 KDIGO guideline includes TARPEYO for the treatment of IgA nephropathy (IgAN)¹*^†

TARPEYO is the only FDA-approved treatment shown to stabilize eGFR while on therapy in a Phase 3 IgAN trial^2-4

TARPEYO is the first FDA-approved treatment for IgA nephropathy (IgAN) to reduce the loss of kidney function¹

Image shows a stylized representation of two kidneys. Each kidney has the letters "eGFR" displayed within, with a glowing effect highlighting the importance of estimated glomerular filtration rate (eGFR) in kidney function. The background is purple, enhancing the focus on the kidneys and the eGFR lettering.

AT DIAGNOSIS,

TARPEYO^‡ TO TARGET OF THE DISEASE^2,3

The first FDA-approved potentially disease-modifying therapy demonstrated to reduce kidney function loss^2,3

Callout text 'eGFR STABILIZATION' indicating TARPEYO’s clinical effect on preserving kidney function in IgAN patients.

ON TREATMENT^§ & UPCR REDUCTION

>50% less kidney function loss was seen at 2 years (p<0.0001)^2,3§

Primary endpoint: time-weighted average of eGFR change demonstrated a difference of 5.05 mL/min/1.73 m² over 2 years^2¶

Durable UPCR reduction was achieved through 2 years²**

CLINICAL RESULTS

Callout text 'REDUCED Gd-IgA1' describing TARPEYO’s role in lowering pathogenic Gd-IgA1 and immune complex levels.

Levels of circulating Gd-IgA1 and IgA immune complexes were reduced from baseline at 3, 6, and 9 months vs RASi alone^3,5

Data are exploratory. Clinical significance has not been established. Small sample sizes of a specific patient group are limitations of these analyses.

Gd-IgA1 DATA

The most common adverse reactions occurring in ≥10% of patients treated with TARPEYO + RASi and at a higher incidence than RASi alone were: peripheral edema, hypertension, muscle spasms, acne, and headache²

SAFETY PROFILE

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

*Draft submitted for public comment and subject to change.
^†TARPEYO was studied under the name Nefecon, which was used in the draft 2024 KDIGO guideline.
^‡The effect of TARPEYO on proteinuria and kidney function was assessed in adults with biopsy-proven IgAN who were on a stable dose of maximally tolerated RAS inhibitor therapy.
^§Calculated as relative reduction (9.4% TARPEYO + RASi vs 20.3% RASi alone).^2,3
^¶The effect of TARPEYO on the long-term rate of decline in kidney function has not been established.²
**Based on the 9-month interim analysis, there was a 31% reduction in UPCR in patients treated with TARPEYO + RASi vs RASi alone (95% CI: 16% to 42% reduction; p=0.0001; n=199).²

ACEi=angiotensin-converting enzyme inhibitor; CI=confidence interval; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; Gd-IgA1=galactose-deficient IgA1; KDIGO=Kidney Disease: Improving Global Outcomes; LS=least squares; RASi=renin-angiotensin system inhibitor; UPCR=urine protein-to-creatinine ratio.

REFERENCES: 1. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) Public Review Draft; August 2024. Accessed June 10, 2025. https://kdigo.org/wpcontent/uploads/2024/08/KDIG0-2024-lgAN-lgAV-Guideline-Public-Review-Draft.pdf 2. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; June 2024. 3. Data on file. Calliditas Therapeutics AB. 4. Barratt J, Lafayette RA, Rovin BH, et al. Budesonide delayed-release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy. Expert Rev Clin Immunol. 2023;19(7):699-710. doi:10.1080/1744666X.2023.2206119 5. Cotton V, Nawaz N, Molyneux K, et al. Analysis of the NefIgArd Part A study population confirms Nefecon suppresses circulating levels of IgA-containing immune complexes in IgA nephropathy. Leicester IgAN research group. Poster presented at IIgANN Congress; September 28-30, 2023.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypercorticism and adrenal axis suppression:

Immunosuppression and increased risk of infection:

Other corticosteroid effects:

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy:

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 & INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypercorticism and adrenal axis suppression:

Immunosuppression and increased risk of infection:

Other corticosteroid effects:

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy:

INDICATION

Please see Full Prescribing Information.

For IgAN patients at risk of progression

AT DIAGNOSIS,

TARPEYO‡ TO TARGET OF THE DISEASE2,3

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypercorticism and adrenal axis suppression:

Immunosuppression and increased risk of infection:

Other corticosteroid effects:

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy:

INDICATION

Please see Full Prescribing Information.

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NOW INCLUDED in draft 2024 KDIGO guideline

Draft guideline supports treatment with TARPEYO for patients at risk of progressive kidney function loss (2B)1*†

TARPEYO^‡ TO TARGET OF THE DISEASE^2,3

NOW INCLUDED
in draft 2024 KDIGO guideline

Draft guideline supports treatment with TARPEYO for patients at risk of progressive kidney function loss (2B)¹*^†