tarpeyo
Tarpeyo (Budesonide) is a corticosteroid used to treat Perennial Allergic Rhinitis, Inflammatory Bowel Diseases.
Budesonide · by Calliditas
Key facts
- Active ingredient
- Budesonide
- Drug class
- Corticosteroid
- Form
- Capsule, delayed release
- Strength
- Budesonide 4MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Calliditas
- Half-life
- about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) (how long it stays in your system)
- What the pharmacy pays
- ~$0.75 per ml — not your price
- FDA application
- NDA215935
What is Tarpeyo?
From the FDA label:TARPEYO (budesonide) delayed release capsules, for oral administration, contain budesonide, a synthetic corticosteroid, as the active ingredient. Budesonide is designated chemically as 16α, 17α-[(1RS)-Butylidenebis(oxy)]-11β, 21-dihydroxypregna-1,4-diene-3,20-dione. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water, sparingly soluble in alcohol, and freely soluble in chloroform. The beads in each capsule contain the following inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid. The capsule shells contain hypromellose and titanium oxide (E171); and 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. Structural Formula
How to use
The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily [see Clinical Studies ( 14.1 )] . When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy [see Warnings and Precautions ( 5.1 )] . The delayed release capsules should be swallowed whole in the morning, at least 1 hour before a meal. Do not open, crush or chew. If a dose is missed, take the prescribed dose at the next scheduled time. Do not double the next dose. Safety and efficacy of treatment with subsequent courses of TARPEYO have not been established. The recommended dosage is 16 mg administered orally once daily, in the morning at least 1 hour before a meal. ( 2 ) Swallow whole. Do not open, crush or chew. ( 2 ) When discontinuing, reduce dosage to 8 mg once daily for the last two weeks. ( 2 , 5.1 )
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions ( 5.1 )] Risks of immunosuppression [see Warnings and Precautions ( 5.2 )] Other corticosteroid effects [see Warnings and Precautions ( 5.3 )] Most common adverse reactions ( ≥5%) are peripheral edema, hypertension, muscle spasms, acne, headache, upper respiratory tract infection, face edema, weight increased, dyspepsia, dermatitis, arthralgia, white blood cell count increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Calliditas Therapeutics at 1-844-IGA-0011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TARPEYO was evaluated in 389 patients in the randomized, double-blind, placebo-controlled study, NefIgArd (NCT: 03643965, Phase 3 clinical study in adults with primary IgAN). The data below reflect TARPEYO exposure in 195 patients with a median duration of 41 weeks, compared with comparable exposure to placebo in 194 patients. The most common adverse reactions, reported in greater than or…
Warnings
Important safety information
Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids, patients with hepatic impairment may be at increased risk. Taper upon discontinuation. ( 2 , 5.1 , 8.6 , 12.3 ) Immunosuppression and Increased Risk of Infection: Avoid use in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. May affect vaccine efficacy. ( 5.2 ) Other Corticosteroid Effects: Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus). ( 5.3 ) 5.1 Hypercorticism and Adrenal Axis Suppression When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy [see Dosing and Administration ( 2 )] or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . 5.2 Immunosuppression and Increased Risk of Infection Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider TARPEYO withdrawal as needed. Tuberculosis If TARPEYO is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. In patients with latent tuberculosis or tuberculin reactivity TARPEYO should be discontinued. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including TARPEYO. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a TARPEYO-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a TARPEYO-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including TARPEYO. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive treatment with TARPEYO. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including TARPEYO, may exacerbate systemic fungal infections; therefore, avoid TARPEYO use in the presence of such infections. Amebiasis Corticosteroids, including TARPEYO, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating TARPEYO in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including TARPEYO, should be discontinued in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including TARPEYO, in patients with cerebral malaria. Ocular Herpes Simplex Virus Infection Corticosteroids, including TARPEYO, may exacerbate ocular herpes simplex virus infections; therefore, avoid TARPEYO use in the presence of such infections. Kaposi's Sarcoma Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi's sarcoma. Immunizations Corticosteroid therapy, including TARPEYO, may decrease the immune response to some vaccines. 5.3 Other Corticosteroid Effects TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.
Who should not take Tarpeyo
TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations. Hypersensitivity to budesonide or any of the ingredients in TARPEYO. ( 4 )
Overdose — what happens if you take too much
Reports of acute toxicity and/or death following overdosage of corticoids are rare. In the event of acute overdosage, no specific antidote is available. Treatment consists of supportive and symptomatic therapy.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Potent CYP3A4 Inhibitors (e.g. ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations: avoid concomitant use. ( 7.1 ) 7.1 Interaction with CYP3A4 Inhibitors Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors; e.g. ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine [see Clinical Pharmacology ( 12.3 )] . Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide [see Clinical Pharmacology ( 12.3 )] .
How long does Budesonide stay in your body?
The elimination half-life of budesonide is about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label reports the true (terminal) plasma elimination half-life from IV dosing as 2 to 3.6 hours, the same in healthy adults and Crohn's disease patients. The APPARENT half-life after ORAL dosing is longer — mean 6.3 ± 1.6 hours (range 2 to 8 hours) after a single 9 mg dose in healthy fasted subjects — because absorption is slower than elimination (flip-flop kinetics), not because the drug lingers; use the ~2–3.6 h IV figure as the elimination half-life. Budesonide is NOT a prodrug and has NO longer-lasting active metabolite: its two major CYP3A4 metabolites (6β-hydroxy budesonide and 16α-hydroxy prednisolone) have negligible corticosteroid activity (<1/100 of the parent). Liver impairment: budesonide is a high-hepatic-clearance drug, so systemic exposure rises with impaired liver function — patients with moderate impairment (Child-Pugh B) had a 3.5-fold higher AUC than those with normal liver function, and the label says to avoid use in severe impairment (Child-Pugh C). Kidney impairment: the label gives no PK half-life change (budesonide is cleared hepatically, not renally). Older adults: the label states studies did not include enough patients aged 65+ to characterize any difference. This is an elimination half-life, not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Budesonide (oral) FDA label, §12.3 Pharmacokinetics — DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Tarpeyo ranks — best-rated corticosteroid for:
Dosage forms
Capsule, delayed release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Tarpeyo treat?
- Tarpeyo (Budesonide) may be used to treat perennial allergic rhinitis, inflammatory bowel diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Tarpeyo work?
- Tarpeyo is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How much does Tarpeyo cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.75 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Pred Forte — about $0.60 on the same basis.
- Is there a coupon or discount for Tarpeyo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tarpeyo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tarpeyo?
- Tarpeyo is marketed by Calliditas. You can see Calliditas's full profile, rating, and other products on pharmaranks.
- Is Tarpeyo a brand-name or generic drug?
- Tarpeyo is a brand-name product with the active ingredient Budesonide.
- Is Tarpeyo available over the counter?
- No. Tarpeyo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tarpeyo come in?
- Tarpeyo is currently marketed as capsule, delayed release, per the FDA's National Drug Code Directory.
- What class of drug is Tarpeyo?
- Tarpeyo is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Tarpeyo FDA-registered?
- Tarpeyo is on record with the U.S. FDA under application number NDA215935. You can verify this on its official FDA label.
- Is Tarpeyo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Tarpeyo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Tarpeyo?
- Tarpeyo's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions ( 5.1 )] Risks of immunosuppression [see Warnings and Precautions ( 5.2 )] Other corticosteroid effects [see Warnings and Precauti… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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