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Indication

TARPEYO® 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) ≥1.5 g/g.

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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Important Safety Information

Contraindications: 

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.

Warnings and Precautions

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] 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 to 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).

Risks of immunosuppression: 

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections; or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (eg, chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

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, cataracts, a family history of diabetes or glaucoma, or with any other condition in which corticosteroids may have unwanted effects.

Adverse reactions: 

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO patients and ≥2% higher than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase (7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).

Drug interactions: 

Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.

Use in specific populations

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. There are risks to the mother and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.

Please see Full Prescribing Information.

References: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; 2021. 2. Barratt J, Rovin BH, Cattran D, et al. Why target the gut to treat IgA nephropathy? Kidney Int Rep. 2020;5(10):1620-1624. doi:10.1016/j.ekir.2020.08.009 3. Data on file. Calliditas Therapeutics AB. 4. Fellström BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017;389(10084):2117-2127. doi:10.1016/S0140-6736(17)30550-0 5. Chang S, Li X-K. The role of immune modulation in pathogenesis of IgA nephropathy. Front Med (Lausanne). 2020;7:92. doi:10.3389/fmed.2020.00092 6. Canetta PA, Kiryluk K, Appel GB. Glomerular diseases: emerging tests and therapies for IgA nephropathy. Clin J Am Soc Nephrol. 2014;9(3):617-625. doi:10.2215/CJN.07260713 7. Kiryluk K, Novak J. The genetics and immunobiology of IgA nephropathy. J Clin Invest. 2014;124(6):2325-2332. doi:10.1172/JCI74475 8. Bhachu JS, Scionti K, Muto M, Molyneux K, Barratt J. Targeted release- budesonide (Nefecon) modifies circulating IgA-IgG immune complex levels and levels of poorly O-galactosylated IgA in IgAN [abstract 0038]. Kidney Dis. 2018;4(3):121-122. 9. Suzuki H, Kiryluk K, Novak J, et al. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011;22(10):1795-1803. doi:10.1681/ASN.2011050464 10. Del Vecchio L, Rimoldi C, Pozzi C. Nefecon (targeted-release formulation-budesonide) for the treatment of IgA nephropathy. Future Rare Dis. 2021;1(4). doi.org/10.2217/frd-2021-0013 11. Barratt J, Lafayette R, Kristensen J, et al; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023;103:391-402. https://doi.org/10.1016/j.kint.2022.09.017 12. KDIGO Clinical Practice Guideline for Glomerulonephritis. June 2012. Accessed June 22, 2023. https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2012-GN-Guideline-English.pdf 13. Hall YN, Fuentes EF, Chertow GM, Olson JL. Race/ethnicity and disease severity in IgA nephropathy. BMC Nephrol. 2004;5:10. doi:10.1186/1471-2369-5-10 14. Trachtman H, Nelson P, Adler S, et al. DUET: A phase 2 study evaluating the efficacy and safety of sparsentan in patients with FSGS [published correction appears in J Am Soc Nephrol. 2019;30(3):518]. J Am Soc Nephrol. 2018;29(11):2745-2754. doi:10.1681/ASN.2018010091 15. Barratt J, Tumlin JA, Suzuki Y, et al. 24-week interim analysis of a randomized, double-blind, placebo-controlled phase 2 study of atacicept in patients with IgA nephropathy and persistent proteinuria. Abstract presented at: American Society of Nephrology Kidney Week; October 20-25, 2020; Denver, CO. 16. Thompson A, Carroll K, Inker LA, et al. Proteinuria reduction as a surrogate end point in trials of IgA nephropathy. Clin J Am Soc Nephrol. 2019;14(3):469-481. doi:10.2215/CJN.08600718 17. Barratt J, Feehally J. Primary IgA nephropathy: new insights into pathogenesis. Semin Nephrol. 2011;31(4):349-360. doi:10.1016/j.semnephrol.2011.06.006 18. DeSousa- Pereira P, Woof JM. IgA: structure, function, and developability. Antibodies (Basel). 2019;8(4):57. doi:10.3390/antib8040057

TARPEYO TouchpointsTM—access made easy

TARPEYO Touchpoints is available at every step of the journey.

We offer services, assistance, and resources through our exclusive specialty pharmacy Biologics by McKesson.

Download an
enrollment form for TARPEYO Touchpoints

Or call 1-833-444-8277,
Monday through Friday,
8 AM to 8 PM ET

Vector graphic of three people in a network

Team of support

  • Care Navigator as your primary contact
  • Onsite pharmacists and nurse
    educators for patient education
  • Field reimbursement team
  • Disease-specific resources and referrals
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Explore financial support options

  •  Patients may be eligible to pay as little as $0 
    per prescription through multiple programs*†‡
  • Medication at no cost to commercially insured 
    patients while coverage is pursued*§
  • Independent copay foundation referralsII
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Navigate access, including insurance paperwork

  • Benefits investigations
  • Prior authorizations
  • Appeals assistance
Sample letters are available to 
submit to health plans.
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Fill Rx and arrange for home delivery

Biologics by McKesson fills
and ships TARPEYO directly
to your patientsʼ doorsteps

Complete enrollments help avoid delays

Fill out all required fields marked with a red asterisk (*)

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Both patient and prescriber must sign and date the enrollment form

DOWNLOAD ENROLLMENT FORM
Tarpeyo Touchpoints logo

Be sure to include relevant supporting documents:

  • Insurance information (front/back of card)
  • Recent proteinuria/UPCR and eGFR values
  • Kidney biopsy documentation 
  • Clinical notes including current and past medications

Fax the completed form and supporting information to 1-844-854-3251

Vector graphic of completed form

We take patient affordability and access seriously

Vector graphic of RX copay method

$0 COPAY PROGRAM

For patients with commercial insurance: 
Your patients may be eligible to pay as little 
as $0 per prescription.*

Vector graphic of pill bottle

BRIDGE PROGRAM

Medication at no cost to 
commercially insured patients 
while coverage is pursued.*§

Other programs are also available.

Have your patients save the Touchpoints number in their phone to help avoid delays:Phone: 1-833-444-8277Fax: 1-844-854-3251Available 8 AM to 8 PM ET, Monday through Friday

*Eligibility required. Please view the full terms and conditions on TarpeyoTouchpoints.com.     
†To qualify for the TARPEYO Touchpoints Copay Assistance Program, your patient must: (a) be a resident of the United States or a US territory, (b) have a valid prescription for TARPEYO, (c) be commercially insured and approved.     
‡To qualify for the TARPEYO Touchpoints Patient Assistance Program, your patient must: (a) be a resident of the United States or a US territory, (b) have a valid prescription for TARPEYO, (c) have no coverage/not enough coverage or insurance that doesnʼt cover TARPEYO, (d) meet annual household income threshold based on household size, (e) agree to and provide income verification (so credit check, tax returns, 3 months of pay stubs, unemployment checks, or bank statements). (f) Not valid for prescriptions reimbursed in whole or in part by any government-funded program including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, DOD, TRICARE, or any state, patient foundation, or other pharmaceutical program.     
§Complete section 6 of Enrollment Form which is an additional prescription to receive a limited supply of TARPEYO at no cost for eligible patients who experience a delay in insurance coverage.     
||Calliditas Therapeutics does not operate or influence any of the independent copay foundations recommended to patients. Calliditas Therapeutics cannot guarantee copay assistance a er a referral from TARPEYO Touchpoints. Referrals to independent copay foundations are offered as an additional resource to patients, and Calliditas Therapeutics is not responsible for any information they may provide.

eGFR=estimated glomerular filtration rate; UPCR=urine protein-to-creatinine ratio.

Indication

TARPEYO® 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) ≥1.5 g/g.

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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Important Safety Information

Contraindications: 

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.

Warnings and Precautions

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] 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 to 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).

Risks of immunosuppression: 

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections; or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (eg, chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

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, cataracts, a family history of diabetes or glaucoma, or with any other condition in which corticosteroids may have unwanted effects.

Adverse reactions: 

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO patients and ≥2% higher than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase (7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).

Drug interactions: 

Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.

Use in specific populations

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. There are risks to the mother and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.

Please see Full Prescribing Information.

References: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; 2021. 2. Barratt J, Rovin BH, Cattran D, et al. Why target the gut to treat IgA nephropathy? Kidney Int Rep. 2020;5(10):1620-1624. doi:10.1016/j.ekir.2020.08.009 3. Data on file. Calliditas Therapeutics AB. 4. Fellström BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017;389(10084):2117-2127. doi:10.1016/S0140-6736(17)30550-0 5. Chang S, Li X-K. The role of immune modulation in pathogenesis of IgA nephropathy. Front Med (Lausanne). 2020;7:92. doi:10.3389/fmed.2020.00092 6. Canetta PA, Kiryluk K, Appel GB. Glomerular diseases: emerging tests and therapies for IgA nephropathy. Clin J Am Soc Nephrol. 2014;9(3):617-625. doi:10.2215/CJN.07260713 7. Kiryluk K, Novak J. The genetics and immunobiology of IgA nephropathy. J Clin Invest. 2014;124(6):2325-2332. doi:10.1172/JCI74475 8. Bhachu JS, Scionti K, Muto M, Molyneux K, Barratt J. Targeted release- budesonide (Nefecon) modifies circulating IgA-IgG immune complex levels and levels of poorly O-galactosylated IgA in IgAN [abstract 0038]. Kidney Dis. 2018;4(3):121-122. 9. Suzuki H, Kiryluk K, Novak J, et al. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011;22(10):1795-1803. doi:10.1681/ASN.2011050464 10. Del Vecchio L, Rimoldi C, Pozzi C. Nefecon (targeted-release formulation-budesonide) for the treatment of IgA nephropathy. Future Rare Dis. 2021;1(4). doi.org/10.2217/frd-2021-0013 11. Barratt J, Lafayette R, Kristensen J, et al; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023;103:391-402. https://doi.org/10.1016/j.kint.2022.09.017 12. KDIGO Clinical Practice Guideline for Glomerulonephritis. June 2012. Accessed June 22, 2023. https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2012-GN-Guideline-English.pdf 13. Hall YN, Fuentes EF, Chertow GM, Olson JL. Race/ethnicity and disease severity in IgA nephropathy. BMC Nephrol. 2004;5:10. doi:10.1186/1471-2369-5-10 14. Trachtman H, Nelson P, Adler S, et al. DUET: A phase 2 study evaluating the efficacy and safety of sparsentan in patients with FSGS [published correction appears in J Am Soc Nephrol. 2019;30(3):518]. J Am Soc Nephrol. 2018;29(11):2745-2754. doi:10.1681/ASN.2018010091 15. Barratt J, Tumlin JA, Suzuki Y, et al. 24-week interim analysis of a randomized, double-blind, placebo-controlled phase 2 study of atacicept in patients with IgA nephropathy and persistent proteinuria. Abstract presented at: American Society of Nephrology Kidney Week; October 20-25, 2020; Denver, CO. 16. Thompson A, Carroll K, Inker LA, et al. Proteinuria reduction as a surrogate end point in trials of IgA nephropathy. Clin J Am Soc Nephrol. 2019;14(3):469-481. doi:10.2215/CJN.08600718 17. Barratt J, Feehally J. Primary IgA nephropathy: new insights into pathogenesis. Semin Nephrol. 2011;31(4):349-360. doi:10.1016/j.semnephrol.2011.06.006 18. DeSousa- Pereira P, Woof JM. IgA: structure, function, and developability. Antibodies (Basel). 2019;8(4):57. doi:10.3390/antib8040057