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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 HAS AN ESTABLISHED SAFETY PROFILE2

The majority of adverse reactions were mild or moderate2

Adverse reactions occurring in ≥5% of patients treated with TARPEYO + RASi and ≥2% higher than patients treated with RASi alone2‡

Adverse reaction TARPEYO + RASi
(n=195), n (%)		 RASi alone
(n=194), n (%)
Peripheral edema 33 (17) 10 (5)
Hypertension 23 (12) 6 (3)
Muscle spasms 23 (12) 8 (4)
Acne 22 (11) 2 (1)
Headache 19 (10) 14 (7)
Upper respiratory tract infection 16 (8) 12 (6)
Face edema 15 (8) 1 (0.5)
Weight increased 13 (7) 6 (3)
Dyspepsia 13 (7) 4 (2)
Dermatitis 12 (6) 2 (1)
Arthralgia 12 (6) 4 (2)
White blood cell count increased 11 (6) 1 (0.5)

Low discontinuation rate due to adverse reactions3

  • <10% of patients treated with TARPEYO + RASi discontinued due to TEAEs (9% vs 2%)3‡
  • Most adverse reactions occurring at a greater incidence in the TARPEYO + RASi group were consistent with hypercortisolism and resolved within 3 months after discontinuation2
  • Incidence of TESAEs with TARPEYO + RASi vs RASi alone was 9% vs 5%3‡
  • Common steroid-specific TEAEs developed at a mean of 4 months following treatment initiation, and generally resolved following treatment cessation3

*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.
‡Safety updated based on NefIgArd Safety Analysis Set, which included data from all patients who received ≥1 dose of study drug. In the global study, an additional 29 patients were enrolled in China for regulatory requirements after global recruitment had ended. ADRs or ARs were reported in the placebo-controlled 9-month treatment period until 14 days after completion of the tapering period.3

CLINICAL EVENTS TYPICALLY SEEN WITH SYSTEMIC CORTICOSTEROIDS WERE GENERALLY LIMITED2,3

Median weight gain did not exceed 2.2 lbs

TARPEYO + RASi median change in body weight
Median change in body weight from baseline did not exceed 2.2 lbs and returned to baseline within 3 months after the end of treatment3

Changes in blood pressure or HbA1c during treatment generally resolved after the end of treatment

  • Median changes in systolic and diastolic blood pressure were small and resolved to baseline levels within 3 months after the end of treatment. Median changes in systolic and diastolic blood pressure were small with no clinically relevant differences (<6 mmHg)3
  • HbA1c was generally unchanged throughout treatment. Increases in HbA1c observed during treatment generally resolved after the end of treatment3*

Incidence of infections was comparable between treatment groups

  • Incidence of infections was comparable between treatment groups: TARPEYO + RASi (37.4%); RASi alone (33.5%)3
  • Low rates of severe infections requiring hospitalization: 3 (1.5%) TARPEYO + RASi vs 1 (0.5%) RASi alone3,4

*Increases occurred in a few TARPEYO-treated patients with a diabetes diagnosis pre-enrollment or with baseline values indicative of prediabetes per ADA-defined thresholds (HbA1c 5.7% or FBG 100 mg/dL).3

DISCOVER MOD & MOA

ADA=American Diabetes Association; ADR=adverse drug reaction; AR=adverse reaction; HbA1c=hemoglobin A1c; RASi=renin-angiotensin system inhibitor; REMS=Risk Evaluation and Mitigation Strategy; TEAE=treatment-emergent adverse event; TESAE=treatment-emergent serious adverse event.

REFERENCES: 1. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2024 clinical practice guideline for the management of immunoglobulin A nephropathy (lgAN) and immunoglobulin A vasculitis (lgAV). 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. Lafayette R, Kristensen J, Stone A, et al. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial. Lancet. 2023;402(10405):825-936. http://doi.org/10.1016/S0140-6736(23)01554-4

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.

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All rights reserved.  06/25 US-TAR-2400170 v4.0

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