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TARPEYO WAS SPECIFICALLY
DESIGNED TO TREAT IgA NEPHROPATHY

TARPEYO is the first FDA-approved medicine to reduce proteinuria in adults with IgA Nephropathy who are at high risk of disease progression.

Image of Kidney

Specifically designed for and studied in IgA Nephropathy

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

Target logo

Targets a source of IgA Nephropathy in the gut

TARPEYO is designed to deliver treatment to an area of the gut thought to play a role in IgAN. TARPEYO can reduce the amount of IgA1 antibody.* IgA1 can build up in the kidneys, which can cause IgAN

reduced protein in urine

Significantly reduced protein in urine

TARPEYO reduced protein by 34% versus 5% in patients who received placebo with blood pressure medication†

Medicine

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.

WHAT IS UNIQUE ABOUT TARPEYO?

TARPEYO is made up of the active ingredient budesonide. The TARPEYO capsule was specifically designed with targeted-release technology to deliver treatment to an area of the gut thought to play a role in IgA Nephropathy.‡

Representation of Tarpeyo capsule getting into the area of gut for treatment 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).

HOW WAS TARPEYO STUDIED?

TARPEYO was specifically studied in a large trial of patients with IgA Nephropathy

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)
  • 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

TARPEYO significantly lowered levels of protein in urine at 9 months§

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

§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.

eGFR data at 9 months

Part B of Tarpeyo study
Part B of Tarpeyo study

The impact of TARPEYO on eGFR is being followed in Part B of the study. It has not been established whether TARPEYO has demonstrated a benefit in slowing kidney function decline in patients with IgA Nephropathy.

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

APPROXIMATELY 90% OF PATIENTS IN THE CLINICAL STUDY STAYED ON TARPEYO TREATMENT

The TARPEYO Patient Brochure provides helpful information about TARPEYO.

ARPEYOPatient Brochure DOWNLOAD
  

Indication

What is TARPEYO?

  • TARPEYO® (budesonide) delayed release capsules 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® (budesonide) delayed release capsules 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.
4/23 US-TAR-2200082v2.0