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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.

HCP Resources

Filter:

An image of the TAPPEYO enrollment form, used to help healthcare providers start their patients on TAPPEYO.

Enrollment Form

An enrollment form to help you start your patients on TARPEYO.

The CoverMyMeds logo, representing an electronic enrollment form service to help healthcare providers start patients on TAPPEYO.

CoverMyMeds Form

An electronic enrollment form through CoverMyMeds to help start your patients on TARPEYO.

A guide image titled "Getting Patients Started" to help healthcare providers establish a patient on TAPPEYO.

Getting Patients Started

A tool to guide you through establishing a patient on TARPEYO.

Dosing guide for healthcare providers on how to administer TAPPEYO to their patients.

Dosing Guide

Instructions on administering TARPEYO to your patients.

A document image for the CJASN publication on Long-Term Outcomes in IgA Nephropathy, titled "RaDaR Reprint."

RaDaR Reprint

CJASN publication: Long-Term Outcomes in IgA Nephropathy.

The KDIGO logo, representing a comprehensive overview of the most up-to-date guidelines for healthcare providers.

KDIGO Guidelines

A comprehensive overview of the most up-to-date KDIGO Guidelines.

A video thumbnail titled "MOA Video," providing a concise, informative video on TAPPEYO’s mechanism of action.

MOA Video

A concise, informative video illustrating the unique mechanism of action of TARPEYO.

WATCH VIDEO
A video thumbnail titled "TAPPEYO: Reducing Kidney Function Loss," providing a video on kidney function loss in IgA Nephropathy.

TARPEYO: Reducing Kidney Function Loss in IgAN Video

An overview of IgAN and its potential long-term clinical impact, along with an examination of the Phase 3 NefIgArd trial and outcomes.

WATCH VIDEO
A circular icon featuring connected shapes, representing the management and treatment of IgA nephropathy (IgAN).

Managing and treating
IgAN

LEARN MORE
A circular icon with a central shape, representing a kidney and TAPPEYO, an FDA-approved treatment for IgA nephropathy aimed at reducing the loss of kidney function.

Discovering TARPEYO,
an FDA-approved treatment for IgAN to reduce
the loss of kidney function

LEARN MORE

Patient Resources

Filter:

Image of a brochure with a cover featuring a smiling woman, offering essential details about IgAN and TARPEYO.

Patient Brochure

An informative brochure offering essential details about IgAN and TARPEYO.

Image of a brochure with a cover featuring a person golfing, outlining next steps to help patients navigate their TARPEYO treatment journey.

Patient Next Steps

A brochure outlining next steps to help your patients navigate their TARPEYO treatment journey.

Thumbnail image for a video, featuring a play button icon, which explores how TARPEYO may help preserve kidney function for people living with IgAN.

Help Take Control of IgAN with TARPEYO Video

This webinar explores IgAN as well as how TARPEYO may help preserve the kidney function of people living with IgAN.

WATCH VIDEO
Image of a guide for patients to prepare for discussions with their doctor about how TARPEYO can address their IgAN.

Doctor Discussion Guide

A guide to help patients prepare for informed discussions with their doctor about TARPEYO and how it can address their IgAN.

Image of a brochure featuring TARPEYO Patients, sharing resilient stories about their experience with TARPEYO and their treatment adherence.

Patient Ambassador Adherence Brochure

Resilient stories from real people who took charge with TARPEYO.

Logo of the IgA Nephropathy Foundation, an organization dedicated to supporting patients and caregivers affected by IgAN.

IgA Nephropathy Foundation

A patient-centric organization for patients and caregivers focused on finding a cure for IgAN.

Engage with us directly.

Request tailored information and guidance from a Calliditas Representative.

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.