Tarpeyo

Pronunciation: tar-PAY-oh
Generic name: budesonide
Dosage form: Delayed-release oral capsule
Drug class: Glucocorticoids

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 7, 2024.

What is Tarpeyo?

Tarpeyo (budesonide) is an oral, delayed-release, corticosteroid capsule that may be used to reduce inflammation and the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

IgAN is a common disease of the kidneys with a high risk of progression to end-stage renal disease (ESRD), especially in certain ethnicities. Galactose deficient IgA1(Gd-IgA1), produced by the mucosal B-cells present in the ileum (the final portion of the small intestine) is critical for the development and progression of the condition. Tarpeyo (budesonide) has anti-inflammatory and immunosuppressive effects and works by modulating mucosal B-cell numbers and activity.

Tarpeyo was first FDA-approved on December 15, 2021, under the accelerated approval designation. It received full approval on December 20, 2023, and was the first treatment that significantly reduces the loss of kidney function in IgA nephropathy to be approved.

Warnings

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

Long-term, regular use of corticosteroids can cause hypercorticism and adrenal axis suppression, which reduces the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. During surgery, illness, or other stressful events, supplementation with additional corticosteroids may be required. Your healthcare provider will monitor you for HPA suppression when tapering Tarpeyo. People with moderate to severe liver disease may be more at risk; do not use in those with severe liver disease.

Tarpeyo can suppress the immune system and make you more vulnerable to infection and disease. Avoid using Tarpeyo in patients with active or latent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or herpes simplex of the eye. May affect the response to vaccines. Tell your doctor about any illness or infection you had within the past several weeks.

Tarpeyo can cause side effects that may worsen other pre-existing conditions, such as high blood pressure, diabetes, osteoporosis, glaucoma, or cataracts. Your healthcare provider will monitor you for any worsening of your condition.

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

Before taking

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

have liver problems
plan to have surgery
have chickenpox or measles or have recently been near anyone with chickenpox 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
have a weak immune system (caused by disease or by using certain medicines)
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

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.

Breastfeeding

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. Your healthcare provider should regularly monitor how fast your baby grows if you are taking Tarpeyo and breastfeeding.

How should I take Tarpeyo?

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

Swallow the capsules whole in the morning, at least 1 hour before a meal. Do not crush, break, or dissolve a Tarpeyo capsule.
Do not stop using Tarpeyo suddenly. Tell your doctor if your medicine seems to stop working. Follow your doctor's instructions about tapering your dose if your doctor advises you to stop taking it.
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.

Dosage

The recommended dosage is 16mg once a day, administered orally (by mouth).

The recommended duration of therapy is 9 months. When discontinuing therapy, your healthcare provider should reduce the dosage to 8 mg once daily for the last 2 weeks of therapy.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking Tarpeyo?

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.

What are the side effects of 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, including:

Symptoms of 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
thicker or more hair on your body and face
bruise easily
a fatty pad or hump between your shoulders (buffalo hump)
rounding of your face (moon face)
pink or purple stretch marks on the skin of your abdomen, ankle swelling thighs, breasts, or arms.

Adrenal suppression. When Tarpeyo is taken for a long period (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
nausea and vomiting
weakness
low blood pressure.
Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment.

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 chickenpox or measles, during treatment. Tell your healthcare provider right away if you come in contact with anyone who has chickenpox 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
aches
feeling tired
pain
chills
nausea and vomiting.

Common Tarpeyo side effects affecting 5% or more of the population include:

headache, dizziness
indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation
feeling tired
high blood pressure
back pain, muscle cramps or spasms, joint pain
swelling of the face, lower legs, ankles, and feet
increased weight
pain and burning when you urinate
acne or dermatitis
thicker or increased hair on your body and face
cold symptoms such as stuffy nose, sneezing, sore throat or
decreased adrenal gland hormones
an increase in white blood cells.

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 Calliditas Therapeutics at 1-844-IGA-0011 or the FDA at 1-800-FDA-1088.

What other drugs will affect Tarpeyo?

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:

ketoconazole
grapefruit juice
cyclosporine
erythromycin
ketoconazole
indinavir
itraconazole
ritonavir
saquinavir
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.

Storage

Store at room temperature 20-25°C (68 - 77°F). Excursions permitted to 15° to 30°C (59° to 86°F).

Keep the container tightly closed. Protect from moisture.

Ingredients

Active: budesonide 4mg

Inactive: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides, and oleic acid.

Delayed-release capsule shells: hypromellose and titanium oxide (E171).

Printing ink: shellac, propylene glycol, and black iron oxide (E172).

Enteric coating: methacrylic acid and methacrylate copolymer, talc, and dibutyl sebacate.