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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).

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.

Please see Full Prescribing Information.

References: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; May 2024. 2. 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 randomised phase 3 trial. Lancet. 2023. https://doi.org/10.1016/S0140-6736(23)01554-4 3. Pitcher D, Braddon F, Hendry B, et al. Long-term outcomes in IgA nephropathy. CGASN. 2023;18. 4. KDIGO Clinical Practice Guideline for Glomerulonephritis. 2021. 5. 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 6. Lafayette R, Kelepouris E. Immunoglobulin A Nephropathy: advances in understanding of pathogenesis and treatment. Am J Nephrol. 2018. doi:10.1159/000481636 7. Data on file Part B. Calliditas Therapeutics AB. 8. Wimbury D, Muto M, Bhachu J, et al. Targeted-release budesonide modifies key pathogenic biomarkers in immunoglobulin A nephropathy: insights from the NEFIGAN trial. Kid Int. 2023. https://doi.org/ 10.1016/j.kint.2023.11.003 9. 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 10. 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. 11. Dressman J, Philipson R, Barratt J. Comparison of the dissolution profile of Nefecon with three other commercially available oral formulations of budesonide: implications for interchangeability. Abstract presented at IIgANN Congress; September 28-30, 2023. 12. Data on file. Calliditas Therapeutics AB.

TARPEYO was designed to address the pathophysiology of IgAN2,7

TARPEYO modulates B cells and is designed to deliver treatment to an area of ileum where Peyer's patches are located to downregulate production of Gd-IgA1, a key pathogenic biomarker1,2,8

Mechanism of action graphic demonstrating Tarpeyo's impact

The 4-HIT hypothesis is a widely accepted model for understanding the pathogenesis of IgAN 9

  • Through anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, TARPEYO can modulate B-cell numbers and activity1,10
  • In the NefIgArd trial, TARPEYO significantly reduced levels of circulating Gd-IgA1 and IgG complexes from baseline at 3, 6, and 9 months vs RASi alone10

Data are exploratory. Clinical significance has not been established.

Targeting the disease where it is thought to originate and modulating a key pathogenic biomarker supports a potential disease-modifying approach to IgAN2,10

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

Gd-IgA1=galactose-deficient IgA1.

Designed with targeted-release technology to deliver an immunomodulating agent to where IgAN is thought to originate

The chart describes the delayed-release technology of Tarpeyo and their coats

Budesonide was specifically selected for use with the targeted-release technology of TARPEYO7

  • Budesonide is a highly potent, locally acting glucocorticoid widely used in products where it can be locally applied to a mucosal surface7
  • Budesonide has not been developed for systemic treatment due to its extensive metabolism by the liver, limiting systemic exposure7
  • Budesonide was developed for inhaled treatment of bronchial asthma and later formulated for enteric use for the treatment of inflammatory bowel disease7

Targeted, delayed delivery

  • The once-daily oral capsules are designed to dissolve when they encounter the right pH level in the ileum7
  • Once the capsules are dissolved, the triple-coated beads control the rate of release of the active immunomodulating ingredient7
  • A dissolution study confirmed that the release pattern of TARPEYO differs from other formulations of budesonide11

TARPEYO is the only formulation of budesonide designed to target the
Peyerʼs patches of the ileum11

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).

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.

Please see Full Prescribing Information.

References: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; May 2024. 2. 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 randomised phase 3 trial. Lancet. 2023. https://doi.org/10.1016/S0140-6736(23)01554-4 3. Pitcher D, Braddon F, Hendry B, et al. Long-term outcomes in IgA nephropathy. CGASN. 2023;18. 4. KDIGO Clinical Practice Guideline for Glomerulonephritis. 2021. 5. 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 6. Lafayette R, Kelepouris E. Immunoglobulin A Nephropathy: advances in understanding of pathogenesis and treatment. Am J Nephrol. 2018. doi:10.1159/000481636 7. Data on file Part B. Calliditas Therapeutics AB. 8. Wimbury D, Muto M, Bhachu J, et al. Targeted-release budesonide modifies key pathogenic biomarkers in immunoglobulin A nephropathy: insights from the NEFIGAN trial. Kid Int. 2023. https://doi.org/ 10.1016/j.kint.2023.11.003 9. 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 10. 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. 11. Dressman J, Philipson R, Barratt J. Comparison of the dissolution profile of Nefecon with three other commercially available oral formulations of budesonide: implications for interchangeability. Abstract presented at IIgANN Congress; September 28-30, 2023. 12. Data on file. Calliditas Therapeutics AB.