Indication: TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody...
Read moreIndication: TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
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For newly prescribed TAVNEOS® patients, this program can initially provide up to a 30-day supply:
To enroll your patients in the TAVNEOS® Quick Start Program:
If your patient is eligible, after the pharmacy speaks to your patient to coordinate delivery, the Quick Start supply of TAVNEOS® will be shipped directly to your patient’s home. See complete submission details below.
Helpful tips for patients enrolling in the TAVNEOS® Quick Start Program
The TAVNEOS® Quick Start program is available to adult patients whose diagnosis is aligned to the FDA-approved indication for TAVNEOS®. Additional eligibility criteria applies.
Eligibility criteria and program maximums apply. See www.tavneospro.com/copay for full Terms and Conditions.
Based on patient approval rates from October 2021 through December 2022.
Based on Patient Enrollment Forms from October 2021 through May 2024.
For additional information on hospital ordering please visit the Resources and Videos section of the website.
For questions, call the TAVNEOS® Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, Monday through Friday from 8 AM to 8 PM ET
Fax completed Patient Enrollment Form to the TAVNEOS® Hub Team |
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Phone: | 1-833-TAVNEOS (828-6367), Option 2, then Option 1 |
Fax: | 1-833-200-7366 |
Hours: | 8 AM to 8 PM ET, Monday-Friday |
ePrescribe: | AssistRx Patient Solutions Pharmacy |
Address: | 4500 W 107th Street Overland Park, KS 66207 |
NCPDP#: | 1720677 |
Fax completed Patient Enrollment Form (with the prescription section completed or eRx) to ONE Network Specialty Pharmacy |
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Phone: | 1-833-TAVNEOS (828-6367), Option 2, then Option 2 |
1-833-TAVNEOS (828-6367), Option 2, then Option 3 |
Fax: | 1-402-896-3774 | 1-866-312-4206 |
Hours: | 8 AM to 8 PM ET, Monday-Friday | 8 AM to 8 PM ET, Monday-Friday |
ePrescribe: | Amber Specialty Pharmacy | PANTHERx Rare Pharmacy |
Address: | 10004 South 152nd Street Omaha, NE 68138 | 1120 Stevenson Mill Road Suite 400 Coraopolis, PA 15108 |
NCPDP#: | 2815338 | 6008002 |
PLEASE NOTE: TAVNEOS® is a limited-distribution specialty product available commercially to patients only through select Specialty Pharmacy providers. For hub referrals, once all information is obtained and appropriate patient support is provided, the TAVNEOS® Team will transfer the enrollment and Rx to the associated specialty pharmacy for continued support toward prescription fulfillment.
Get your patient started on TAVNEOS®:
Submit the Patient Enrollment Form via fax (with the prescription section completed or eRx)
ASD Healthcare
Phone: 800-746-6273
Fax: 800-547-9413
Email: service@asdhealthcare.com
Online: www.asdhealthcare.com
Cardinal Health SPD
Phone: 866-476-1340
Email: GMB-SPD-CSOrderEntry @cardinalhealth.com
McKesson Plasma and Biologics
Phone: 877-625-2566
Fax: 888-752-7626
Email: mpborders@mckesson.com
Online:
https://connect.
mckesson.com
For additional information on hospital ordering please visit the Resources and Videos section of the website.
For questions, call the TAVNEOS® Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, Monday through Friday from 8 AM to 8 PM ETDo you wish to leave the site?
Serious hypersensitivity to avacopan or to any of the excipients.
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.
Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.
Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when coadministering TAVNEOS. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS.
TAVNEOS is available as a 10 mg capsule.
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
Please see Full Prescribing Information and Medication Guide for TAVNEOS.
To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.
important safety information Contraindications Serious hypersensitivity to avacopan or to any of the excipients.
Warnings and Precautions Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically...