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.

Image of capsules

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

Time for taking Tarpeyo

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

Instructions to take Tarpeyo

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

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 who are at high risk of disease progression. TARPEYO was specifically designed for IgA Nephropathy.

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 IgA Nephropathy. 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 IgA Nephropathy. TARPEYO can reduce the amount of this antibody.*

HOW IS TARPEYO DIFFERENT FROM OTHER STEROIDS I’VE BEEN PRESCRIBED FOR IgA NEPHROPATHY?

TARPEYO is the first FDA-approved treatment to reduce protein levels in the urine of patients with IgA Nephropathy 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 IgA Nephropathy.

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.

WHAT DOES A URINE ANALYSIS MEAN IN IgA NEPHROPATHY?

A routine urine test may be the first sign of IgAN if high levels of protein are seen. Large amounts of protein in the urine is called proteinuria. This helps measure kidney function in IgAN. Proteinuria was studied in the TARPEYO clinical trial.

*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 that can help you start the conversation.

What makes TARPEYO unique for people with IgA Nephropathy?

How does TARPEYO work?

What results might I expect?

What tests will you do to monitor if TARPEYO is working?

How do I take TARPEYO?

Is there anything I should avoid while taking TARPEYO?

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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.