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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.

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

TARPEYO: established safety profile1

The majority of adverse reactions were mild or moderate1

Adverse reactions occurring in ≥5% of patients treated with TARPEYO + RASi and ≥2% higher than patients treated with RASi alone1*

Image of a table that lists the adverse reactions experienced by patients in two groups: TARPEYO + RASi (N=195) and RASi alone (N=196). The adverse reactions include:
Peripheral edema: 33 (17%) TARPEYO + RASi, 10 (5%) RASi alone
Hypertension: 22 (11%) TARPEYO + RASi, 6 (3%) RASi alone
Muscle spasms: 22 (11%) TARPEYO + RASi, 8 (4%) RASi alone
Acne: 19 (10%) TARPEYO + RASi, 1 (0.5%) RASi alone
Headache: 18 (9%) TARPEYO + RASi, 14 (7%) RASi alone
Upper respiratory tract infection: 16 (8%) TARPEYO + RASi, 12 (6%) RASi alone
Face edema: 15 (8%) TARPEYO + RASi, 2 (1%) RASi alone
Weight increased: 13 (7%) TARPEYO + RASi, 6 (3%) RASi alone
Dyspepsia: 13 (7%) TARPEYO + RASi, 4 (2%) RASi alone
Dermatitis: 12 (6%) TARPEYO + RASi, 8 (4%) RASi alone
Arthralgia: 12 (6%) TARPEYO + RASi, 4 (2%) RASi alone
White blood cell count increased: 11 (6%) TARPEYO + RASi, 1 (0.5%) RASi alone Image of a table that lists the adverse reactions experienced by patients in two groups: TARPEYO + RASi (N=195) and RASi alone (N=196). The adverse reactions include:
Peripheral edema: 33 (17%) TARPEYO + RASi, 10 (5%) RASi alone
Hypertension: 22 (11%) TARPEYO + RASi, 6 (3%) RASi alone
Muscle spasms: 22 (11%) TARPEYO + RASi, 8 (4%) RASi alone
Acne: 19 (10%) TARPEYO + RASi, 1 (0.5%) RASi alone
Headache: 18 (9%) TARPEYO + RASi, 14 (7%) RASi alone
Upper respiratory tract infection: 16 (8%) TARPEYO + RASi, 12 (6%) RASi alone
Face edema: 15 (8%) TARPEYO + RASi, 2 (1%) RASi alone
Weight increased: 13 (7%) TARPEYO + RASi, 6 (3%) RASi alone
Dyspepsia: 13 (7%) TARPEYO + RASi, 4 (2%) RASi alone
Dermatitis: 12 (6%) TARPEYO + RASi, 8 (4%) RASi alone
Arthralgia: 12 (6%) TARPEYO + RASi, 4 (2%) RASi alone
White blood cell count increased: 11 (6%) TARPEYO + RASi, 1 (0.5%) RASi alone
  • Incidence of TESAEs with TARPEYO + RASi vs RASi alone was (9% vs 5%)2*
    • 4 patients (2%) in both treatment groups had TESAEs considered treatment-related2*
  • <10% of patients treated with TARPEYO + RASi discontinued due to TEAEs (9% vs 2%)2*
  • High rate of study completion: 87% of patients treated with TARPEYO + RASi completed 9 months of treatment similar to 91% of patients on RASi alone3†
  • Low rate of severe infections requiring hospitalization2,3
    • 3 (1.5%) in TARPEYO + RASi treatment group vs 1 (0.5%) in RASi-alone group2*
  • Most adverse reactions occurring at a greater incidence in the TARPEYO + RASi group were consistent with hypercortisolism and resolved within 3 months after discontinuation1
  • Incidence of infections was comparable between treatment groups: TARPEYO + RASi (37.4%); RASi alone (33.5%)2

*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.2
Data based on FAS of 364 patients.1

ADR=adverse drug reaction; AR=adverse reaction; RASi=renin-angiotensin system inhibitor; TEAE=treatment-emergent adverse event; TESAE=treatment-emergent serious adverse event.

No clinically relevant differences between treatment groups in blood pressure, body weight, HbA1c, or creatinine excretion observed3

Icon representing blood pressure.

BLOOD PRESSURE2*

Median changes in systolic and diastolic blood pressure were small and resolved to baseline levels within 3 months after the end of treatment

Scale icon representing weight

WEIGHT2*

Median change in body weight from baseline did not exceed 2.2 lbs and returned to baseline within 3 months after the end of treatment

Icon representing HbA1c levels

HbA1c2,3†

Generally unchanged throughout treatment. Increases in HbA1c observed during treatment generally resolved after the end of treatment

Icon representing skeletal health

SKELETAL2‡

No new osteonecrosis events observed

Icon representing REMS (Risk Evaluation and Mitigation Strategies)

NO REMS1

TARPEYO is not subject to an FDA-required REMS program. No FDA-mandated drug monitoring beyond usual care

*Small increases from baseline in median systolic and diastolic blood pressure observed with TARPEYO compared with placebo were not clinically relevant, and resolved to levels similar to baseline within 3 months of the end of treatment. Similarly, small increases in median body weight were seen during TARPEYO treatment that were not clinically relevant and returned to baseline within 3 months of the end of treatment.2
A small numerical increase in median HbA1c levels was observed during TARPEYO treatment, with some outliers evident. Increases occurred in a few TARPEYO-treated patients with a diabetes diagnosis pre-enrollment or with baseline values indicative of pre-diabetes per ADA-defined thresholds (HbA1c 5.7% or FBG 100 mg/dL).2
During the 15-month observational follow-up, there were 3 confirmed fractures in the TARPEYO group and 2 confirmed fractures in the RASi-alone group that were considered not treatment related.2

FBG=fasting blood glucose; HbA1c=hemoglobin A1c; REMS=Risk Evaluation and Mitigation Strategy.

REFERENCES: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; June 2024. 2. Data on file. Part B. Calliditas Therapeutics AB. 3. 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.