Buy Tarpeyo (budesonide)

What is Tarpeyo (budesonide) for?

Tarpeyo (budesonide) is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) of at least 1.5g/g.^[1]

It is available in capsule form, each containing 4 mg budesonide.^[1]

How does Tarpeyo (budesonide) work?

IgAN, also known as Berger’s disease, is a rare progressive autoimmune disease of the kidneys. It develops when the antibody IgA accumulates in the kidneys, causing inflammation that damages the kidneys. These IgA deposits can lead to leakage of blood and protein from the kidneys into the urine. The cells that are responsible for the (over)production of IgA and thus the development of IgAN are the B cells of the immune system.^[2,3]

The active ingredient in Tarpeyo, budesonide, is a corticosteroid. It acts on B cells found in the small intestines. Tarpeyo works by inhibiting the growth and activity of B cells, thereby reducing the overproduction and accumulation of IgA and thereby the damage to the kidneys.^[2,3]

Where has Tarpeyo (budesonide) been approved?

Tarpeyo (budesonide) was approved for the treatment of adults with IgAN by:

• The Food and Drug Administration (FDA), USA on December 17, 2021.^[3]

Tarpeyo (budesonide) was approved under Accelerated Approval and was previously granted Orphan Drug designation by the FDA, which is given to promote development of drugs for rare diseases.^[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tarpeyo (budesonide) taken?

The standard dosage is:^[1]

• 16 mg (four capsules of 4 mg) administered orally once per day, in the morning at least 1 hour before a meal.

The recommended duration of therapy is 9 months. When discontinuing treatment, the dosage should be reduced to 8 mg (two capsules) once per day for the last two weeks.^[1]

The capsules should be swallowed whole. Do not open, crush or chew.^[1]

Complete information about Tarpeyo (budesonide) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Tarpeyo (budesonide)?

Common adverse reactions

The most common side effects (53% of patients) listed in the prescribing information include:^[1]

• High blood pressure (hypertension)
• Swelling of your lower legs or hands (peripheral edema)
• Muscle spasms
• Acne
• Skin irritation (dermatitis)
• Weight increase
• Shortness of breath (dyspnea)
• Face edema
• Indigestion (dyspepsia)
• Tiredness (fatigue)
• Thicker or more hair on your body and face (hirsutism)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Having too much cortisol in your body (hypercorticism)
• Not able to produce enough cortisol (adrenal suppression)
• Weakening of your immune system
• Serious hypersensitivity reactions

Use in a specific population

Data does not show that Tarpeyo (budesonide) can harm your unborn child. It is not known if Tarpeyo passes into your breast milk or if it will affect your baby. Talk to your treating doctor about the possible risks.^[1]

Patients with moderate to severe liver problems may be at increased risk of side effects. ^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Tarpeyo (budesonide) [PDF]
Calliditas Therapeutics, Dec 2021

2. Why Target the Gut to Treat IgA Nephropathy?
Barratt, J et al., Kidney Int Rep, Oct 2020

3. FDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease
FDA press release, Dec 2021