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WHAT IS IgA NEPHROPATHY?

IgA Nephropathy is an autoimmune disease, meaning a disease in which the body’s immune system attacks itself. The disease affects the kidneys and usually gets worse over time. In people with IgA Nephropathy, the body produces too much IgA1. Overproduction of IgA1 triggers the immune system to attack IgA1 and form clusters. These clusters build up in your kidneys, leading to inflammation and damage.

Increased levels of IgA in blood

IgA Nephropathy is caused by increased levels of IgA1 in the blood

antibodies

The body produces antibodies to IgA1

Cluster of autoimmune complexes

Clusters of these autoimmune complexes are deposited in the kidney

Inflammed kidneys

The kidneys become inflamed, and irreversible damage can occur

WHAT MAY CAUSE IgA NEPHROPATHY?

One of the main underlying causes of IgA Nephropathy is thought to be an IgA1 antibody, which is mostly produced in the gut.

Visual representation of IgA1 antibody produced in the gut causing IgA Nephropathy
Visual representation of IgA1 antibody produced in the gut causing IgA Nephropathy

HOW COMMON IS IgA NEPHROPATHY?

IgA Nephropathy is a rare disease. It is more common among certain groups and individuals

Distribution of population affected by IgAN across globe

Most common in Asian and Caucasian populations

Man rowing a boat

WHAT ARE THE POTENTIAL SIGNS AND SYMPTOMS OF IgA NEPHROPATHY?

Although IgA Nephropathy is often asymptomatic in early stages, you may experience the following:

Lower back pain logo

Lower back pain

Blood in the urine

Blood in the urine

Foamy urine due to excess protein

Foamy urine due to excess protein

Swelling in feet, ankles, or legs

Swelling in feet, ankles, or legs

These symptoms may be subtle, and you may not experience any of them. More protein than usual or even blood in your urine may not be noticed until a routine urine test.

HOW IS IgA NEPHROPATHY DIAGNOSED?

A diagnosis of IgA Nephropathy is confirmed with a kidney biopsy

Hospital logo
A diagnosis of IgA Nephropathy is confirmed with a kidney biopsy
Hospital logo
  • A kidney biopsy is a procedure that involves taking a small piece of kidney tissue for examination
  • A biopsy may reveal IgA deposits in the glomeruli
  • The biopsy can also show how much kidney damage has already occurred
  • The biopsy results can help you and your doctor determine the best course of treatment

DID YOU KNOW?

By the time IgA Nephropathy is diagnosed, some kidney damage may have already occurred.

HOW IS IgA NEPHROPATHY MONITORED?

IgA Nephropathy is a progressive disease—UPCR and eGFR are 2 important measures for patients with IgA Nephropathy.

Measuring Cup

UPCR (urine protein-to-creatinine ratio) is a measure of the amount of protein in the urine

Kidney

eGFR (estimated glomerular filtration rate) is a measure of kidney function

Your doctor may monitor UPCR and eGFR closely to track if your IgA Nephropathy is progressing.

WHAT YOU NEED TO KNOW

Use this guide to learn more about IgA Nephropathy, including common tests to check your kidney health and what to look for and expect at different stages. You’ll also find information on additional resources.

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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.

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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
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