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HOW SHOULD I TAKE TARPEYO?

It is important to 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.

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

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Take TARPEYO in the morning, at least 1 hour before your morning meal

A crushed pill, crossed out within a larger circle

Don’t crush, chew, or open TARPEYO. Don’t eat grapefruit, or drink grapefruit juice, while on TARPEYO treatment

ONCE-DAILY DOSING

The recommended course of therapy based on the clinical study is 9 months at 16 mg (4 capsules per day). When your doctor decides that you no longer need to take TARPEYO, you should take 8 mg (2 capsules) per day for 2 weeks.

WHEN DID PATIENTS START TO SEE RESULTS IN THE STUDY?

The TARPEYO study results are based on 9 months of treatment

  • Protein levels began to decrease after 3 months
  • Protein levels decreased by 34% at month 9
  • Protein levels continued to decrease to 53% for 3 months after treatment (months 9-12)

Chart demonstrating results of Tarpeyo study where patients received nine months of treatment
Chart demonstrating results of Tarpeyo study where patients received nine months of treatment

Data presented prior to or beyond the first 9 months should be interpreted with caution.

*Patients did not receive treatment during the 3-month follow-up phase.

FREQUENTLY ASKED QUESTIONS

WHAT IS TARPEYO?

TARPEYO is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with IgA Nephropathy (IgAN) who are at high risk of disease progression. TARPEYO was specifically designed for IgAN.

WHEN WAS TARPEYO APPROVED?

TARPEYO was FDA-approved in December 2021, and is available by prescription. This approval is based on reduction in proteinuria. Confirmatory clinical trial results are needed to verify the clinical benefit of slowing kidney function decline.

HOW IS TARPEYO THOUGHT TO WORK?

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 thought to be responsible for the production of IgA1. These types of IgA1 can build up in the kidneys and cause IgAN. TARPEYO can reduce the amount of this antibody.†

HOW IS TARPEYO DIFFERENT FROM OTHER STEROIDS IʼVE BEEN PRESCRIBED FOR IgAN?

TARPEYO is the first FDA-approved treatment to reduce protein levels in the urine of patients with IgAN and was designed for delivery to the area where the disease is thought to come from. Other steroids have not established efficacy or safety and are not FDA approved for IgAN.

WHAT DID TARPEYO CLINICAL STUDIES SHOW?

In a clinical study at 9 months, there was a significant 34% reduction in the level of protein in urine seen in the TARPEYO-treated group compared with a 5% reduction in the placebo plus blood pressure medication group.†

The most common side effects (occurring in ≥10% of patients treated with TARPEYO at a higher incidence than blood pressure medication alone) were: high blood pressure; swelling of the lower legs, ankles, and feet; muscle cramp; and acne.

HOW OFTEN WILL I NEED TO MONITOR MY LAB VALUES WHILE TAKING TARPEYO?

You will need to have your labs measured to determine how well you are responding to treatment. Your doctor will decide which lab values and how often they will monitor them. With TARPEYO, there is no FDA-required monthly lab monitoring, as seen with other products.

IS THERE A PROGRAM THAT CAN HELP PROVIDE FINANCIAL ASSISTANCE FOR TARPEYO?

Yes, TARPEYO TouchpointsTM is a program that was developed to help support your treatment journey. A Care Navigator can help with financial support options you may be eligible for. They can also connect you with nurses and resources, and help track your prescription shipment each month.

*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.

ASK YOUR HEALTHCARE PROVIDER ABOUT TARPEYO

Here are some questions you may want to ask your doctor to determine if TARPEYO is right for you.

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ADVOCATE FOR YOURSELF

  • Can we discuss a disease-specific treatment option like TARPEYO?
  • Based on my recent lab results, could TARPEYO be an option for me?
  • What makes TARPEYO different from other treatments that you may prescribe to treat IgAN?
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DISCUSS BENEFITS AND RISKS

  • What are the potential benefits and risks of taking TARPEYO to treat my IgAN?
  • What results might I expect once Iʼm on TARPEYO?
Medical pill with the number four

STARTING TARPEYO

  • How do I take TARPEYO?
  • Do I take TARPEYO along with another medication?
  • How long will I need to take TARPEYO?
Magnifying glass with a bar chart inside

TRACKING RESULTS

  • When can I expect to see results?
  • How often should I schedule my follow-up appointments?
  • What should I do if I experience any side effects while taking TARPEYO?
  

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