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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 About tarpeyo

The first FDA-approved medicine that targets a source of IgA Nephropathy.*

Kidney icon Kidney icon

Slowed kidney function loss†

Down arrow icon Down arrow icon

Significantly lowered proteinuria better than placebo + blood pressure medicine‡

9 months icon 9 months icon

9-month course of treatment that may fit into your life

No FDA-mandate tests, immunizations or birth control required icon No FDA-mandate tests, immunizations or birth control required icon

No FDA-mandated tests, immunizations, or birth control required§

Financial assistance icon Financial assistance icon

Support and financial assistance made easy with TARPEYO Touchpoints®

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

†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).

‡At 2 years, there was an average 34% reduction from baseline in UPCR in people who received TARPEYO + blood pressure medication vs 4% in those who received blood pressure medication alone.

§Your doctor will likely order lab tests to see how well you are responding to treatment.

eGFR=estimated glomerular filtration rate; UPCR=urine protein-to-creatinine ratio.

TARPEYO WAS DESIGNED TO

TREAT IgAN AT A SOURCE

TREAT IgAN

AT A SOURCE

Intestinal hot spot icon Intestinal hot spot icon

The TARPEYO capsule is designed to deliver treatment to a specific area of the gut thought to play an important role in IgAN.

IgA1 reduction icon IgA1 reduction icon

The goal of TARPEYO treatment is to reduce the amount of IgA1 that is produced.

Kidney icon Kidney icon

Reducing IgA1 can reduce the buildup of abnormal IgA1 clusters. These clusters have been shown to lead to kidney inflammation and damage.*

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

TARPEYO WAS

STUDIED IN A 2-YEAR TRIAL

STUDIED IN A

2-YEAR TRIAL

The trial was designed so researchers could study the effect of TARPEYO during the 9-month ON-TREATMENT period AND for 15 months OFF TARPEYO TREATMENT to see if there was a lasting effect.

9-month ON-TREATMENT period AND for 15-months OFF TARPEYO TREATMENT chart 9-month ON-TREATMENT period AND for 15-months OFF TARPEYO TREATMENT chart

Zoom in to see details

TARPEYO IS

PROVEN TO HELP PRESERVE

KIDNEY FUNCTION

PROVEN TO

HELP PRESERVE

KIDNEY FUNCTION

TARPEYO Reduced the Loss of Kidney Function by 50%*

TARPEYO vs PLACEBO chart TARPEYO vs PLACEBO chart

At 2 years, TARPEYO + blood pressure medicine was proven to help preserve more kidney function than blood pressure medicine alone.

As kidney function worsens, the eGFR number goes down.

TARPEYO Stabilized Kidney Function During 9-Month On-Treatment Period

eGFR during 2 year study graph eGFR during 2 year study graph

Zoom in to see details

TARPEYO + blood pressure medicine reduced the loss of kidney function by more than 50% compared to blood pressure medicine alone.*

*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).

†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.

What Does This Mean
Kidney icon showing EGFR 89-60

TARPEYO was proven to help preserve kidney function over 2 years, even after stopping treatment for 15 months, following a 9-month treatment course.

TARPEYO + BLOOD PRESSURE MEDICINE

SIGNIFICANTLY LOWERED

PROTEINURIA

SIGNIFICANTLY

LOWERED

PROTEINURIA

Change in proteinuria at 2 years chart Change in proteinuria at 2 years chart

At 12 Months, TARPEYO Reduced Proteinuria by 52%

On average, people started to see reductions in proteinuria after month 3. Reductions lasted through 2 years.

Change in proteinuria at 2 years chart Change in proteinuria at 2 years chart

Zoom in to see details
What Does This Mean
months

TARPEYO significantly lowered proteinuria over 2 years, even after stopping treatment for 15 months, following a 9-month treatment course.

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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.