Tarpeyo (budesonide) belongs to a class of medications called corticosteroids. Budesonide works by decreasing inflammation (swelling) in the kidney of people with nephropathy.

Tarpeyo is a prescription medicine used to decrease protein in the urine (proteinuria) in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation).

It is not known if Tarpeyo is safe and effective in children.

Use Tarpeyo only as directed. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine, erythromycin, ketoconazole, indinavir, itraconazole, ritonavir, and saquinavir.

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with budesonide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on the above list.

Take Tarpeyo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Tarpeyo delayed release capsules should be swallowed whole in the morning, at least 1 hour before a meal. Do not crush, break, or dissolve a Tarpeyo capsule. Swallow the capsule whole.

You should not stop using Tarpeyo suddenly. Follow your doctor's instructions about tapering your dose.

Do not stop using Tarpeyo without your doctor's advice. Tell your doctor if your medicine seems to stop working.

Your dosage needs may change if you have surgery, are ill, or are under stress. Do not change your doses or medication schedule without advice from your doctor.

If you take this medicine long-term, you may need frequent medical tests.

Call your doctor if your symptoms do not improve, or if they get worse.

Store tightly closed at room temperature, away from moisture and heat.

The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy.

You should not use Tarpeyo if you are allergic to budesonide or any of the ingredients in Tarpeyo delayed release capsules.

To make sure Tarpeyo is safe for you, tell your doctor if you have ever had:

• tuberculosis;

• any type of infection caused by bacteria, virus, fungus, or parasites especially chickenpox or measles;

• high blood pressure;

• a weak immune system (caused by disease or by using certain medicines);

• osteoporosis or low bone mineral density;

• a stomach ulcer;

• eczema;

• plan to have a surgery;

• any allergies;

• diabetes, cataracts, or glaucoma (in you or a family member); or

• liver disease.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed.

Do not use Tarpeyo in a child to treat any condition that has not been checked by your doctor.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Tarpeyo.

Get emergency medical help if you have signs of an allergic reaction to Tarpeyo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tarpeyo may cause serious side effects. Call your doctor at once if you have:

• increased adrenal gland hormones - hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes;

• decreased adrenal gland hormones - nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods; or

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Budesonide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Tarpeyo side effects may include:

• headache, dizziness;

• indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation;

• feeling tired;

• high blood pressure;

• back pain, muscle cramps, joint pain;

• swelling of the face, lower legs, ankles, and feet;

• pain and burning when you urinate;

• acne;

• thicker or increased hair on your body and face;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• decreased adrenal gland hormones.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Ask a doctor or pharmacist before using Tarpeyo with any other medicines, especially:

• stomach acid reducers.

This list is not complete. Other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.