Tarpeyo

What is Tarpeyo?

• Tarpeyo (Budesonide) is a corticosteroid used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN).

Budesonide

Budesonide

Budesonide ball-and-stick

What are the uses of this medicine?

• Tarpeyo (Budesonide) 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.

Limitations of use:

• This indication is approved under accelerated approval based on a reduction in proteinuria.
• It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN.

How does this medicine work?

• Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
• Mucosal B-cells present in the ileum, including the Peyer's patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy.
• The anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, corticosteroids can modulate B-cell numbers and activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to budesonide or any of the ingredients in Tarpeyo.

What drug interactions can this medicine cause?

• 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, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine

• Avoid ingestion of grapefruit juice with Tarpeyo.

Is this medicine FDA approved?

Budesonide was initially patented in 1973.

• Commercial use as an asthma medication began in 1981.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is 16 mg administered orally once daily, in the morning at least 1 hour before a meal.
• When discontinuing, reduce dosage to 8 mg once daily for the last two weeks.

Administration:

• Budesonide comes as a capsule to take by mouth.
• It is usually taken once a day in the morning.
• Take budesonide at around the same time every day.
• Budesonide (Tarpeyo) should be taken at least one hour before a meal.
• Swallow the capsules whole; do not split, chew, or crush them.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed release capsules: 4 mg

This medicine is available in fallowing brand namesː

• Tarpeyo

What side effects can this medication cause?

The most common side effects of this medicine 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

Tarpeyo may cause serious side effects, including:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism)
• Adrenal suppression
• Risk of immunosuppression

What special precautions should I follow?

• 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.
• Tarpeyo may cause hypercorticism and adrenal axis suppression and to follow a taper schedule, as instructed by their healthcare provider if discontinuing therapy.
• Tarpeyo causes immunosuppression. Advise patients to avoid exposure to people with chicken pox or measles and, if exposed, to consult their healthcare provider immediately. There is an increased risk of developing a variety of infections, including worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex, and to contact their healthcare provider if they develop any symptoms of infection. Provide advice regarding vaccination schedules for immunocompromised patients.
• Tarpeyo delayed release capsules should be swallowed whole and not chewed, crushed or broken and to take Tarpeyo in the morning, at least 1 hour before a meal.
• Tarpeyo is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Reports of acute toxicity and/or death following overdosage of corticoids are rare.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of acute overdosage, no specific antidote is available.
• Treatment consists of supportive and symptomatic therapy.

Can this medicine be used in pregnancy?

• The available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and efficacy of Tarpeyo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: budesonide
• Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.
• The capsules contain: hypromellose and titanium oxide (E171).
• The printing ink on the capsules contain: shellac, propylene glycol and black iron oxide (E172).
• The enteric coating on the capsules contain: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who manufactures and distributes this medicine?

Manufactured for and distributed by:

• Calliditas Therapeutics AB, Stockholm, Sweden
• Tarpeyo is a trademark of Calliditas Therapeutics AB, or its affiliates.

What should I know about storage and disposal of this medication?

• Store Tarpeyo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Tarpeyo in a tightly closed container.
• Protect from moisture.

• Dailymed label info on Tarpeyo
• FDA Tarpeyo

Tarpeyo Resources
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