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DISCOVER TARPEYO

The first FDA-approved treatment to reduce proteinuria in adults with IgA Nephropathy (IgAN) at risk of rapid disease progression

Two inflamed human kidneys

Specifically designed for and studied in IgAN

TARPEYO is the first FDA-approved therapy that was specifically designed for IgAN

Graphic of a target

Targets a source of IgAN in the gut

Designed to deliver treatment to an area of the gut thought to play a role in IgAN*

Foamy urine in collection sample cup

Significantly reduced protein in urine

34% reduction seen in the TARPEYO-treated group vs 5% reduction in the placebo plus blood pressure medication group†

Medical pill with the number four

Once-daily oral medicine

4 capsules of TARPEYO should be taken once a day and swallowed whole

Please see information for how to take TARPEYO and what to avoid while taking TARPEYO here

.

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

†In Part A of the TARPEYO clinical study, 97 patients received TARPEYO plus blood pressure medication, and 102 patients received placebo plus blood pressure medication.

HOW IS TARPEYO THOUGHT TO WORK?

Human intestines
Human intestines

TARPEYO is designed to deliver treatment to an area of the gut thought to play a role in IgAN.
Types of cells in the gut are responsible for the production of an antibody called IgA1, which can build up in the kidneys, causing IgAN. TARPEYO can reduce the amount of this antibody.‡

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

WHAT IS UNIQUE ABOUT TARPEYO?

The TARPEYO capsule was designed with targeted-release technology to dissolve once it reaches a specific area of the gut thought to play a role in IgAN

Tarpeyo pill with a line indicating where in human intestines it impacts
CLICK TO SEE A VIDEO ABOUT HOW TARPEYO WORKS

HOW WAS TARPEYO STUDIED?

TARPEYO was specifically studied in a large trial of patients with IgAN

Part A of the clinical study of TARPEYO was the pivotal placebo-controlled efficacy and safety trial that served as the basis for the FDA accelerated approval

97

patients received TARPEYO plus blood pressure medication

102

patients received placebo plus blood pressure medication

  • Primary objective: See how TARPEYO reduced high levels of protein in the urine (proteinuria) after 9 months of treatment, as measured by urine protein-to-creatinine ratio (UPCR)
  • Estimated glomerular filtration rate (eGFR) was a selected secondary objective in this part of the study
  • Part B of the clinical study is a follow-up study for full approval that will assess eGFR over 2 years for patients who were treated with TARPEYO or placebo in Part A

TARPEYO STUDY RESULTS

Proven to lower urine protein levels at 9 months (primary objective of study)§

Tarpeyo study results showcasing significantly lowered levels of protein in urine in 9 months
Tarpeyo study results showcasing significantly lowered levels of protein in urine in 9 months

§At 9 months, 97 patients received treatment with TARPEYO plus blood pressure medication and 102 patients received placebo plus blood pressure medication.

Change in eGFR at 9 months (secondary objective of the study)

Part B of Tarpeyo study
Part B of Tarpeyo study

As kidney function worsens, the eGFR number goes down.

It has not yet been established whether TARPEYO has demonstrated a benefit in slowing kidney function decline in patients with IgAN.

||At the start of study, the average eGFR was 54.9 mL/min/1.73 m2 in the TARPEYO group and 55.5 mL/min/1.73 m2 in the placebo group.

The overall impact on slowing kidney function decline as measured by eGFR is the focus of Part B of the study.

TARPEYO SAFETY PROFILE

TARPEYO may cause serious side effects, including:

TARPEYO may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism), adrenal suppression, and risk of immunosuppression
  • Please see detailed Important Safety Information

THE MOST COMMON SIDE EFFECTS REPORTED BY PATIENTS IN THE CLINICAL STUDY OF TARPEYO

Table containing the most common side effects reported by patients in clinical study of Tarpeyo
Table containing the most common side effects reported by patients in clinical study of Tarpeyo

TARPEYO may cause serious side effects, including effects of having too much corticosteroid medicine in your blood (hypercorticism), adrenal suppression, and risk of immunosuppression.

Approximately 90% of patients in the clinical study stayed on TARPEYO during the 9-month treatment period

Heart and heart rate line

Blood pressure: Increases in blood pressure were small and resolved to baseline levels by the end of the 9-month treatment period

Weight scale

Weight gain: Increases in body weight were minor and did not exceed 2.2 lbs. Patients returned to pre-treatment weight within 3 months of ending treatment

Unlike with other products, there are no FDA-mandated tests for TARPEYO; however, your doctor will likely order lab tests to determine how well you are responding to treatment.

The TARPEYO Patient Brochure provides helpful information about TARPEYO.

Cover page of the Tarpeyo Patient Brochure PDF file DOWNLOAD
  

Indication

What is TARPEYO?

  • TARPEYO® is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at high risk of disease progression. It is not known if TARPEYO is safe and effective in children
  • This approval is based on reduction in proteinuria. Confirmatory clinical trial results are needed to verify the clinical benefit of slowing kidney function decline

Important Safety Information

Who should not take TARPEYO?

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 chicken pox or measles or have recently been near anyone with chicken pox 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
  • Take 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 chicken pox or measles, during treatment with TARPEYO. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox 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:

  • high blood pressure
  • swelling of the lower legs, ankles, and feet
  • muscle cramp
  • acne
  • irritation or inflammation of the skin
  • weight increase
  • shortness of breath
  • swelling of the face
  • indigestion
  • tiredness
  • thicker or more hair on your body and face

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

What is TARPEYO?

  • TARPEYO® is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at high risk of disease progression. It is not known if TARPEYO is safe and effective in children
  • This approval is based on reduction in proteinuria. Confirmatory clinical trial results are needed to verify the clinical benefit of slowing kidney function decline

Important Safety Information

Who should not take TARPEYO?

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 chicken pox or measles or have recently been near anyone with chicken pox 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
  • Take 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 chicken pox or measles, during treatment with TARPEYO. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox 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:

  • high blood pressure
  • swelling of the lower legs, ankles, and feet
  • muscle cramp
  • acne
  • irritation or inflammation of the skin
  • weight increase
  • shortness of breath
  • swelling of the face
  • indigestion
  • tiredness
  • thicker or more hair on your body and face

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.

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This site is intended only for US residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider. TARPEYO is a registered trademark of Calliditas Therapeutics AB, or its affiliates.
© Calliditas Therapeutics AB All rights reserved. 07/23 US-TAR-2300110