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Indication

What is TARPEYO?

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

ABOUT TARPEYO

TARPEYO IS DESIGNED TO

TARGET THE GUT

Developed specifically for people with IgA Nephropathy (IgAN), the TARPEYO capsule was designed intelligently to deliver the medicine budesonide directly in the gut where it is thought to work, and limit exposure in areas where it is not.*

Watch to learn more about how TARPEYO targets the gut.

Play the video Targeting a Source: The Gut Play the video Targeting a Source: The Gut

TARPEYO targets the gut to help lower Gd-IgA1,* thought to be an underlying cause of IgAN

*It has not been established to what extent the efficacy of TARPEYO is from local effects (in the gut) vs systemic effects (in circulation).

Woman seated with a small white dog, holding a to-go cup
Woman seated with a small white dog, holding a to-go cup

Cathrin, actual TARPEYO patient Cathrin was compensated for her time

REAL PEOPLE WHO TOOK CHARGE WITH TARPEYO

"My doctor explained how TARPEYO works differently to target a key source of my IgAN. After starting TARPEYO, my doctor and I are both pleased with the results." 
-Cathrin

HEAR PATIENT STORIES
TARPEYO WAS

PROVEN TO HELP PRESERVE KIDNEY FUNCTION

TARPEYO was studied in a 2-year trial of adults with IgAN. People took TARPEYO for 9 months, followed by 15 months off TARPEYO to see how it affected kidney function (eGFR).

How kidney function (eGFR) changed over 2 years†

Graphic showing how TARPEYO preserved kidney function over 2 years: average eGFR change was -5.3 with TARPEYO vs -11.2 with placebo.
Graphic showing how TARPEYO preserved kidney function over 2 years: average eGFR change was -5.3 with TARPEYO vs -11.2 with placebo.

TARPEYO helped people reach:

STABILIZED KIDNEY FUNCTION
during 9-month on-treatment period

HIGHER KIDNEY FUNCTION
over 2 years vs placebo

†At the start of the study, the average eGFR was approximately 58 mL/min/1.73 m2, with 60% of people having an eGFR <60 mL/min/1.73 m2.

‡At 2 years, there was a >50% difference in loss of kidney function as measured by eGFR in people who received TARPEYO plus blood pressure medicine vs those who received placebo plus blood pressure medicine. Calculated as relative reduction (9.4% TARPEYO plus blood pressure medicine vs 20.3% placebo plus blood pressure medicine).

TARPEYO

SIGNIFICANTLY LOWERED PROTEINURIA

Protein in your urine, or proteinuria, is considered a risk factor for IgAN getting worse. Higher proteinuria could mean more rapid loss of kidney function, so lowering proteinuria is another important goal for your treatment plan.

Average reduction in proteinuria at 2 years from start of study

Graphic showing how TARPEYO reduced proteinuria: average UPCR fell 34% with TARPEYO vs 4% with placebo; at 12 months, TARPEYO reduced proteinuria by 52%.
Graphic showing how TARPEYO reduced proteinuria: average UPCR fell 34% with TARPEYO vs 4% with placebo; at 12 months, TARPEYO reduced proteinuria by 52%.

Completing the full 9-month course of TARPEYO:

Provided ADDITIONAL REDUCTION in proteinuria
3 months after completing treatment

Kept proteinuria
LOWER OVER 2 YEARS§

UPCR=urine protein-to-creatinine ratio.

§Compared to reduction in proteinuria from baseline at 2 years in patients who received placebo. At 2 years, the average change in proteinuria from baseline, as measured by UPCR, was -34% in patients who received TARPEYO + blood pressure medicine vs -4% in patients who received placebo + blood pressure medicine.

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Indication

What is TARPEYO?

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

Important Safety Information

Do not take TARPEYO if you are allergic to budesonide or any of the ingredients in TARPEYO. See the end of the Patient Information for a complete list of ingredients in TARPEYO.

Before taking TARPEYO, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • plan to have surgery
  • have chickenpox or measles or have recently been near anyone with chickenpox or measles
  • have an infection
  • have high blood sugar levels (prediabetes or diabetes)
  • have glaucoma or cataracts
  • have a family history of diabetes or glaucoma
  • have or have had tuberculosis
  • have high blood pressure (hypertension)
  • have decreased bone mineral density (osteoporosis)
  • have stomach ulcers
  • are pregnant or plan to become pregnant. TARPEYO may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take TARPEYO when you are pregnant
  • are breastfeeding or plan to breastfeed. It is not known if TARPEYO passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with TARPEYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TARPEYO and other medicines may affect each other causing side effects.

How should I take TARPEYO?

  • Take TARPEYO exactly as your healthcare provider tells you
  • Your healthcare provider will decide how long you should take TARPEYO. Do not stop taking TARPEYO without first talking with your healthcare provider
  • Take your prescribed dose of TARPEYO 1 time each day in the morning, at least 1 hour before a meal
  • Swallow TARPEYO capsules whole. Do not open, chew, crush, or break TARPEYO capsules before swallowing
  • If you miss a dose of TARPEYO, take your prescribed dose at your next scheduled time. Do not take two doses of TARPEYO at the same time
  • If you take too much TARPEYO, call your healthcare provider right away or go to the nearest hospital emergency room

What should I avoid while taking TARPEYO?

Do not eat grapefruit or drink grapefruit juice during your treatment with TARPEYO. Eating grapefruit or drinking grapefruit juice can increase the level of TARPEYO in your blood.

What are the possible side effects of TARPEYO?

TARPEYO may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism): Long-time use of TARPEYO can cause you to have signs and symptoms of too much cortisol, a stress hormone in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, or arms
  • Adrenal suppression: When TARPEYO is taken for a long period of time (chronic use), adrenal suppression can happen. This is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal suppression include tiredness, weakness, nausea and vomiting, and low blood pressure. Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with TARPEYO
  • Risk of immunosuppression: TARPEYO weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases, such as chickenpox or measles, during treatment with TARPEYO. Tell your healthcare provider right away if you come in contact with anyone who has chickenpox or measles. Consult with your healthcare provider regarding appropriate vaccination scheduling
  • Tell your healthcare provider if you develop any symptoms of infection during treatment with TARPEYO, including fever, feeling tired, chills, aches, pain, and nausea and vomiting

The most common side effects of TARPEYO include:

  • swelling of the lower legs, ankles, and feet
  • high blood pressure
  • muscle spasms
  • acne
  • headache
  • upper respiratory tract infection
  • swelling of the face
  • weight increase
  • indigestion
  • irritation or inflammation of the skin
  • joint pain
  • increased white blood cell count

These are not all the possible side effects of TARPEYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information and Patient Information.

Indication and Important Safety Information

What is TARPEYO?

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

Important Safety Information

Do not take TARPEYO if you are allergic to budesonide or any of the ingredients in TARPEYO. See the end of the Patient Information for a complete list of ingredients in TARPEYO.

Before taking TARPEYO, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • plan to have surgery
  • have chickenpox or measles or have recently been near anyone with chickenpox or measles
  • have an infection
  • have high blood sugar levels (prediabetes or diabetes)
  • have glaucoma or cataracts
  • have a family history of diabetes or glaucoma
  • have or have had tuberculosis
  • have high blood pressure (hypertension)
  • have decreased bone mineral density (osteoporosis)
  • have stomach ulcers
  • are pregnant or plan to become pregnant. TARPEYO may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take TARPEYO when you are pregnant
  • are breastfeeding or plan to breastfeed. It is not known if TARPEYO passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with TARPEYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TARPEYO and other medicines may affect each other causing side effects.

How should I take TARPEYO?

  • Take TARPEYO exactly as your healthcare provider tells you
  • Your healthcare provider will decide how long you should take TARPEYO. Do not stop taking TARPEYO without first talking with your healthcare provider
  • Take your prescribed dose of TARPEYO 1 time each day in the morning, at least 1 hour before a meal
  • Swallow TARPEYO capsules whole. Do not open, chew, crush, or break TARPEYO capsules before swallowing
  • If you miss a dose of TARPEYO, take your prescribed dose at your next scheduled time. Do not take two doses of TARPEYO at the same time
  • If you take too much TARPEYO, call your healthcare provider right away or go to the nearest hospital emergency room

What should I avoid while taking TARPEYO?

Do not eat grapefruit or drink grapefruit juice during your treatment with TARPEYO. Eating grapefruit or drinking grapefruit juice can increase the level of TARPEYO in your blood.

What are the possible side effects of TARPEYO?

TARPEYO may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism): Long-time use of TARPEYO can cause you to have signs and symptoms of too much cortisol, a stress hormone in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, or arms
  • Adrenal suppression: When TARPEYO is taken for a long period of time (chronic use), adrenal suppression can happen. This is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal suppression include tiredness, weakness, nausea and vomiting, and low blood pressure. Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with TARPEYO
  • Risk of immunosuppression: TARPEYO weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases, such as chickenpox or measles, during treatment with TARPEYO. Tell your healthcare provider right away if you come in contact with anyone who has chickenpox or measles. Consult with your healthcare provider regarding appropriate vaccination scheduling
  • Tell your healthcare provider if you develop any symptoms of infection during treatment with TARPEYO, including fever, feeling tired, chills, aches, pain, and nausea and vomiting

The most common side effects of TARPEYO include:

  • swelling of the lower legs, ankles, and feet
  • high blood pressure
  • muscle spasms
  • acne
  • headache
  • upper respiratory tract infection
  • swelling of the face
  • weight increase
  • indigestion
  • irritation or inflammation of the skin
  • joint pain
  • increased white blood cell count

These are not all the possible side effects of TARPEYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information and Patient Information.