Questions about access?
Contact a Field
Reimbursement Manager.

Icon showing an email envelope and phone, representing contact options for Tarpeyo support. Icon showing an email envelope and phone, representing contact options for Tarpeyo support.

Or call us:
1-833-444-8277

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Questions about access?
Contact a Field
Reimbursement Manager.

Or call us:
1-833-444-8277

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IMPORTANT SAFETY INFORMATION & INDICATION

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 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).

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, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed.

Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. Avoid exposure to active, easily transmitted infections (e.g., chickenpox, 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 or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

ADVERSE REACTIONS

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO-treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).

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.

INDICATION

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Please see Full Prescribing Information.

Large glowing text "97%" indicating that 97% of TARPEYO patients have paid less than $10 per prescription.

of TARPEYO patients $

Large glowing text "$10" highlighting that most TARPEYO patients have paid less than $10 per prescription.

per prescription*

Financial support options are available to reduce or eliminate out-of-pocket costs.†

Icon showing a printer, indicating the option to complete and print the downloaded TARPEYO prescription form.

Complete downloaded form

Fax to TARPEYO Touchpoints at 1-844-854-3251

ENROLLMENT FORM
Icon representing the option to complete the TARPEYO prescription form online.

covermymeds®

Complete the enrollment form online at CoverMyMeds.com

Search for TARPEYO, complete online form, and submit

covermymeds®
Icon showing an Rx symbol, representing the option to fax the completed TARPEYO prescription form to TARPEYO Touchpoints.

ePrescribe TARPEYO

Select PANTHERx Rare Pharmacy and submit

You will still need to complete an enrollment form

ENROLLMENT FORM

TARPEYO is distributed exclusively through PANTHERx Rare Pharmacy.

TARPEYO Touchpoints Enrollment

Steps to enroll patients in TARPEYO Touchpoints

Purple button graphic labeled 'Step 1' indicating the first step of completing the enrollment form.

Complete the Enrollment Form

  • Fill out required fields marked with a red asterisk (*)
  • Both patient and prescriber must sign and date the enrollment form
Purple button graphic labeled 'Step 2' indicating the second step to include supporting documents such as insurance information, lab results, kidney biopsy documentation, and clinical notes.

Include Supporting Documents

Be sure to include all relevant supporting documents:

  • Prescription benefit insurance information (front and back of card)
  • Recent lab results, including UPCR and eGFR
  • Kidney biopsy documentation
  • Clinical notes, including current and past medications
    • °ACEi/ARB and dates of any previous steroid use
Purple button graphic labeled 'Step 3' indicating the third step to fax the completed form and supporting documents to the provided number.

Fax the Completed Form

  • Fax the completed form and supporting information to 1-844-854-3251
    • ° Pharmacy Name: PANTHERx Rare Pharmacy
    • ° Pharmacy Address: 24 Summit Park Dr, Pittsburgh, PA 15275

What can you expect after submitting an enrollment form?

  • If you do not receive a call within 1 day of submitting your patientʼs enrollment form, call TARPEYO Touchpoints at 1-833-444-8277
  • Remind your patients to answer and return calls from 1-833-444-8277 and to save this number; this will help avoid delays in receiving TARPEYO
  • For the prior authorization (PA) process, Touchpoints will assist and initiate a PA if the patientʼs insurance company allows
  • If a PA request is denied, Touchpoints will review the appeals process and options with the prescriber to submit an appeal

    • Support is available with:

    • °Sample medical necessity letter and appeals templates
    • °Appeals nurse assistance
    • °Field reimbursement managers (FRM)

TARPEYO Touchpoints

TARPEYO® Touchpoints logo
Large glowing text "97%" indicating that 97% of TARPEYO patients have paid less than $10 per prescription.

of TARPEYO patients $

Large glowing text "$10" highlighting that most TARPEYO patients have paid less than $10 per prescription.

per prescription*

Financial support options are available to reduce or eliminate out-of-pocket costs.†

Icon of two hands shaking, symbolizing partnership or collaboration.

Services, assistance, and resources to help your patients easily access treatment

Icon of a document with a checklist and checkmark.

Enrollment form
connects patients to all Touchpointsʼ services

Icon of a house with a package, indicating delivery, shipment, or support access.

TARPEYO is shipped directly to your patientʼs doorstep by our exclusive specialty pharmacy

Support is available with:

  • Touchpoints Clinicians
  • Appeals nurse assistance
  • Sample medical necessity letter and appeals templates
  • Field Reimbursement Managers (FRMs)

Field Reimbursement Managers (FRMs) are available to help with insurance and payer-related questions and requirements.

Icon of a clipboard with a checklist and pen.

Your dedicated FRM can provide assistance in the following areas:

  • Completing a TARPEYO enrollment form
  • Navigating the reimbursement process, including the prior authorization process and appeals assistance
  • Answering insurance and payer-related questions and requirements
  • Exploring financial support options and issue resolutions

*All patients regardless of insurance type. This includes Commercial, Medicare, Medicaid, and cash-paying patients from January 2022 through June 2024.
†Eligibility required. Please view the full terms and conditions.

REVEAL RESOURCES

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 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).

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, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed.

Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. Avoid exposure to active, easily transmitted infections (e.g., chickenpox, 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 or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

ADVERSE REACTIONS

In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO-treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).

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.

INDICATION

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Please see Full Prescribing Information.

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