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UNDERSTANDING THE GUT-KIDNEY CONNECTION IN IgA NEPHROPATHY (IgAN)

What is IgAN?

IgAN is a progressive autoimmune disease affecting the kidneys. In patients with IgAN, too much of an antibody known as IgA1 builds up in your kidneys, leading to inflammation and damage.

Increased levels of IgA in blood

IgAN is caused by increased levels of a type 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 IgAN?

Even though the kidneys are the end-organs damaged in IgAN disease, it is not the only organ thought to be involved. One of the main underlying causes of IgAN is thought to be the IgA1 antibody, which is most often produced in the gut.

What may cause IgAN
What may cause IgAN

WHAT ARE THE POTENTIAL SIGNS AND SYMPTOMS OF IgAN?

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

Vector graphic of a person's back with an orange lightning bolt in lower area, indicating pain in lower back.

Lower back pain

Urine collection sample cup and drop of blood

Blood in the urine

Foamy urine in collection sample cup

Foamy urine due to excess protein

Swollen human foot

Swelling in feet, ankles, or legs

These symptoms may be subtle, and you may not experience any of them. Excess protein in the urine, also known as proteinuria, or even blood in your urine may not be discovered until a routine urine test. A kidney biopsy by your doctor is needed to confirm a diagnosis.

HOW IS IgAN DIAGNOSED?

A diagnosis of IgAN is confirmed with a kidney biopsy

A diagnosis of IgAN is confirmed with a kidney biopsy
Magnifying glass
Magnifying glass
  • 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

HOW IS IgAN MONITORED?

Two important measures for people with IgAN are eGFR and UPCR.

Kidney

eGFR
Estimated glomerular filtration rate
is a measure of kidney function. The higher the number (the range is 0 to 120), the better your kidney function. This is considered a useful measure of overall kidney function.

Measuring Cup

UPCR
Urine protein-to-creatinine ratio
is a test to measure the amount of protein in the urine. High protein in your urine, or proteinuria, is considered a risk factor for disease worsening.

Some studies have shown a correlation between eGFR and UPCR. For example, higher UPCR may be associated with a higher risk of kidney failure and greater average loss in eGFR.

  

Indication

What is TARPEYO?

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

Important Safety Information

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
  • Swallow 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:

  • swelling of the lower legs, ankles, and feet
  • high blood pressure
  • muscle spasms
  • acne
  • headache
  • upper respiratory tract infection
  • swelling of the face
  • weight increase
  • indigestion
  • irritation or inflammation of the skin
  • joint pain
  • increased white blood cell count

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 the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if TARPEYO is safe and effective in children.

Important Safety Information

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
  • Swallow 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:

  • swelling of the lower legs, ankles, and feet
  • high blood pressure
  • muscle spasms
  • acne
  • headache
  • upper respiratory tract infection
  • swelling of the face
  • weight increase
  • indigestion
  • irritation or inflammation of the skin
  • joint pain
  • increased white blood cell count

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.

Calliditas Therapeutics Logo
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. 2/25 US-TAR-2400252v2

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