TARPEYO Touchpoints®: Support for TARPEYO® Access & Prescriptions

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.

How to prescribe TARPEYO

There are 3 approaches to prescribing TARPEYO:

Complete downloaded form

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

ENROLLMENT FORM

covermymeds®

Complete the Enrollment Form online at CoverMyMeds.com

Search for TARPEYO, complete online form, and submit

covermymeds®

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.

Image of the TARPEYO prescription bottle, showing the medication packaging for reference.

When prescribing, always select TARPEYO (NDC 81749-004-01).
There is no generic equivalent for TARPEYO.

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

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

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

Image of the TARPEYO enrollment form, highlighting the steps for completion, including supporting documents to submit and faxing instructions. The form also includes a CoverMyMeds option for electronic submission.

Access Enrollment Form and helpful diagnosis codes.

ENROLLMENT FORM VIEW ICD-10 CODES

What can you expect after submitting an Enrollment Form?

You will receive a follow-up phone call from a TARPEYO Touchpoints Care Navigator

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

Touchpoints will begin the benefits investigation

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)

Touchpoints will explore financial support options for your patients to reduce or eliminate their out-of-pocket costs

Touchpoints will fill the prescription through PANTHERx Rare Pharmacy and arrange for home delivery directly to your patientʼs doorstep

Touchpoints will provide ongoing support to your patients during their treatment journey