Commercial Payer Information

Commercial Payer Information

Payers create their own policies with regard to product coverage. Since information varies by payer, it is important to contact the payer directly or consult its Web site to obtain product-specific coverage.

Select a state to learn more about reimbursement coverage in that state.

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

*CPT® copyright 2016 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

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Alabama

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Alabama   2, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Alabama Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Alaska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Arizona

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Arizona Yes Specialty Yes For more information
Cigna Yes 2   For more information
Health Net Yes 4, Specialty (S-2) Yes For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross Blue Shield of Arizona Yes 3, 5   For more information
Cigna Yes 4, 5   For more information
Health Net Yes 3, 5   For more information
Humana Yes 4, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information

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Arkansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Arkansas Blue Cross and Blue Shield Yes 2, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Arkansas Blue Cross and Blue Shield Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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California

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross of California Yes 4, Specialty   For more information
Blue Shield of California Yes 4, Specialty    
Cigna Yes 2   For more information
Health Net Yes Specialty Yes For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente   Brand    
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross of California Yes 4, 5 Yes For more information
Blue Shield of California Yes 5, 6    
Cigna Yes 4, 5   For more information
Health Net Yes 2, 3, 5   For more information
Kaiser Permanente Yes 3    
UnitedHealthcare Yes 4, 5   For more information

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Colorado

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Colorado Yes 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente Formulary dependent 2, 4, Brand Yes  
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Colorado Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
Kaiser Permanente Yes 3    
UnitedHealthcare Yes 4, 5   For more information

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Connecticut

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Connecticut Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
ConnectiCare   2 Yes  
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Connecticut Yes 2, 3, 5   For more information
Cigna Yes 4, 5   For more information
ConnectiCare Yes 3, 5 Yes  
UnitedHealthcare Yes 4, 5   For more information

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Delaware

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Highmark Blue Cross Blue Shield Delaware   2    
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Highmark Blue Cross Blue Shield Delaware Yes 3, Specialty    
UnitedHealthcare Yes 4, 5   For more information

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District of Columbia DC

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Florida

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Florida, Inc. (Florida Blue) Yes 2, 4   For more information
Cigna Yes 2   For more information
Coventry Health Care of Florida Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
SantaFe HealthCare, Inc./AvMed Health Plans Yes 4, Specialty   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield, Inc. (Florida Blue) Yes 4, 5   For more information
CarePlus Health Plans Yes 4, 5 Yes  
Cigna Yes 4, 5   For more information
Coventry Health Care of Florida Yes 2, 4 Yes For more information
SantaFe HealthCare, Inc./AvMed Health Plans Yes 4, 5 Dosage dependent For more information
Humana Yes 4, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information

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Georgia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Georgia Yes 3, 4, Specialty    
Cigna Yes 2   For more information
Coventry Health Care of Georgia Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente   2, Brand    
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Georgia Yes 4, 5 Yes  
Cigna Yes 4, 5   For more information
Coventry Health Care of Georgia Yes 3, 5 Yes For more information
Kaiser Permanente Yes 3    
UnitedHealthcare Yes 4, 5   For more information

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Hawaii

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente   3    
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Hawaii Medical Service Association (HMSA) Yes 3, 5    
Kaiser Permanente Yes 3    
UnitedHealthcare Yes 4, 5   For more information

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Idaho

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross of Idaho Yes 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross of Idaho Yes 3, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Illinois

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Illinois Yes Specialty   For more information
Cigna Yes 2   For more information
Coventry Health Care of Illinois Yes 4, Specialty Preferred   For more information
Health Alliance Medical Plans   Specialty    
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Illinois Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
Coventry Health Care of Illinois Yes 3, 5 Yes For more information
Health Alliance Medical Plans Yes 4    
UnitedHealthcare Yes 4, 5   For more information

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Indiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Indiana Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Indiana Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Iowa

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Coventry Health Care of Iowa Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Wellmark Blue Cross and Blue Shield of Iowa   Specialty   For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Coventry Health Care of Iowa Yes 3, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information
Wellmark Blue Cross and Blue Shield of Iowa Yes 2, 4   For more information

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Kansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Kansas   Specialty   For more information
Cigna Yes 2   For more information
Coventry Health Care of Kansas Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Kansas Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Kentucky

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Kentucky Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Kentucky Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Louisiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Coventry Health Care of Louisiana Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Maine

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Maine Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Maine Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Maryland

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
CareFirst BlueCross BlueShield Yes 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
CareFirst BlueCross BlueShield Yes 3, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Massachusetts

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Massachusetts Yes 2 Yes  
Cigna Yes 2   For more information
Fallon Health Yes 2    
Harvard Pilgrim Health Care, Inc. Yes 2 Yes For more information
Humana Yes Specialty Yes For more information
Tufts Health Plan   4 Yes  
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross Blue Shield of Massachusetts Yes 3, 5    
Cigna Yes 4, 5   For more information
Fallon Health Yes 2, 3, 5    
Harvard Pilgrim Health Care, Inc. Yes 3, 5 Yes For more information
Tufts Health Plan   2 Yes  
UnitedHealthcare Yes 4, 5   For more information

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Michigan

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Michigan Yes 2, 4, Brand   For more information
Cigna Yes 2   For more information
Health Alliance Plan of Michigan   3   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross Blue Shield of Michigan Yes 3, 5   For more information
Cigna Yes 4, 5   For more information
Health Alliance Plan of Michigan Yes 3   For more information
UnitedHealthcare Yes 4, 5   For more information

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Minnesota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Minnesota   2, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Medica Yes Specialty (S-1)    
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Minnesota Yes 2, 4   For more information
Cigna Yes 4, 5   For more information
Medica Yes 3, 5 Yes  
UnitedHealthcare Yes 4, 5   For more information

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Mississippi

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Missouri

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Missouri Yes 3, 4, Specialty   For more information
Blue Cross and Blue Shield of Kansas City Yes Medical   For more information
Cigna Yes 2   For more information
Coventry Health Care of Missouri Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Missouri Yes 4, 5 Yes For more information
Blue Cross and Blue Shield of Kansas City Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
Coventry Health Care of Missouri Yes 3, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information

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Montana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Montana Yes Preferred, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Montana Yes 2, 4   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Nebraska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Nebraska   Specialty   For more information
Cigna Yes 2   For more information
Coventry Health Care of Nebraska Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Nebraska Yes 2, 4   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Nevada

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Nevada Yes 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Nevada Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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New Hampshire

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of New Hampshire Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of New Hampshire Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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New Jersey

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Horizon Blue Cross Blue Shield of New Jersey Yes 2, Specialty Yes  
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Horizon Blue Cross Blue Shield of New Jersey Yes 4, 5    
UnitedHealthcare Yes 4, 5   For more information

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New Mexico

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of New Mexico Yes Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of New Mexico Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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New York

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Empire BlueCross BlueShield Yes 3   For more information
Excellus BlueCross BlueShield   2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Univera Healthcare   2, Specialty   For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
EmblemHealth Yes 3, 5 Yes For more information
Empire BlueCross BlueShield Yes 4, 5 Yes For more information
Excellus BlueCross BlueShield Yes 3, 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information
Univera Healthcare Yes 4, 5   For more information

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North Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of North Carolina   4   For more information
Cigna Yes 2   For more information
Coventry Health Care of the Carolinas Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of North Carolina Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
Coventry Health Care of the Carolinas Yes 3, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information

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North Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of North Dakota   Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross Blue Shield of North Dakota Yes 2, 4   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Ohio

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Ohio Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Medical Mutual of Ohio Yes Brand, Plan preferred   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross Blue Shield of Ohio Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
Humana Yes 4, 5 Yes For more information
UnitedHealthcare Yes 4, 5   For more information

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Oklahoma

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Oklahoma Yes Preferred, Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Oklahoma Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Oregon

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente   Brand Yes  
Providence Health & Services Yes Specialty   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Kaiser Permanente Yes 3    
Providence Health & Services Yes 5, 6   For more information
Regence BlueCross BlueShield   3, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Pennsylvania

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Highmark (formerly Blue Cross of Northeastern Pennsylvania)   2   For more information
Cigna Yes 2   For more information
HealthAmerica, Coventry Health Care of Pennsylvania Yes 4, Specialty Preferred   For more information
Highmark Blue Cross Blue Shield   2   For more information
Humana Yes Specialty Yes For more information
Independence Blue Cross   2, Specialty (Medical)   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Highmark (formerly Blue Cross of Northeastern Pennsylvania) Yes 3, 5   For more information
Cigna Yes 4, 5   For more information
Highmark Blue Cross Blue Shield Yes 3, 5   For more information
Independence Blue Cross Yes 2, 3   For more information
UnitedHealthcare Yes 4, 5   For more information

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Rhode Island

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross & Blue Shield of Rhode Island Yes Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross & Blue Shield of Rhode Island Yes 2, 3, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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South Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
BlueCross BlueShield of South Carolina Yes Brand, Specialty Formulary dependent For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
BlueCross BlueShield of South Carolina Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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South Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Wellmark Blue Cross and Blue Shield of South Dakota   Specialty   For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information
Wellmark Blue Cross and Blue Shield of South Dakota Yes 3, 5   For more information

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Tennessee

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Texas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
BlueCross BlueShield of Texas Yes Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Scott & White Health Plan   2    
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
BlueCross BlueShield of Texas Yes 4, 5   For more information
Cigna Yes 4, 5   For more information
Scott & White Health Plan Yes 3, 4, 5    
UnitedHealthcare Yes 4, 5   For more information

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Utah

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Altius, Coventry Health Care Yes 4, Specialty Preferred   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
Regence BlueCross BlueShield of Utah   2, Preferred   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Altius, Coventry Health Care Yes 3, 5 Yes For more information
Cigna Yes 4, 5   For more information
Regence BlueCross BlueShield of Utah Yes 3, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Vermont

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Vermont Yes 2    
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross and Blue Shield of Vermont Yes 3, 5    
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield of Virginia Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Coventry Health Care of Virginia, Inc. Yes 4, Specialty Preferred   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Anthem Blue Cross and Blue Shield of Virginia Yes 4, 5 Yes For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

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Washington

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Group Health Cooperative Yes 2 Yes For more information
Health Net Yes Specialty Indication dependent For more information
Humana Yes Specialty Yes For more information
Kaiser Permanente   Brand Formulary dependent  
Premera Blue Cross   2, 4   For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Group Health Cooperative Yes 3 Dosage dependent For more information
Health Net Yes 3, 5   For more information
Kaiser Permanente Yes 3    
UnitedHealthcare Yes 4, 5   For more information

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West Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Cigna Yes 2   For more information
Highmark Blue Cross Blue Shield West Virginia   2, Specialty   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
West Virginia Public Employees Insurance Agency (PEIA) Yes 2, Specialty    
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Highmark Blue Cross Blue Shield West Virginia Yes 3, Specialty   For more information
UnitedHealthcare Yes 4, 5   For more information
West Virginia Public Employees Insurance Agency (PEIA) Yes 3, 4, Specialty Yes  

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Wisconsin

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Wisconsin Yes 3, 4, Specialty   For more information
Cigna Yes 2   For more information
Dean Health Plan, Inc. Yes 2 Yes For more information
Gundersen Health Plan Yes 4 Yes For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Unity Health Plans Insurance Corporation Yes 2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Cigna Yes 4, 5   For more information
Gundersen Health Plan Yes 4, 5 Dosage dependent For more information
UnitedHealthcare Yes 4, 5   For more information

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Wyoming

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Wyoming Yes Specialty   For more information
Cigna Yes 2   For more information
Humana Yes Specialty Yes For more information
UnitedHealthcare   2 Yes For more information
Medicare Part D
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Formulary dependent Yes For more information
Blue Cross Blue Shield of Wyoming Yes 2, 4   For more information
Cigna Yes 4, 5   For more information
UnitedHealthcare Yes 4, 5   For more information

R11

INDICATIONS
Anemia Due to Chronic Kidney Disease

PROCRIT® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

Anemia Due to Zidovudine in HIV-infected Patients

PROCRIT® is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

Anemia Due to Chemotherapy in Patients With Cancer

PROCRIT® is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

PROCRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT® is not indicated for patients who are willing to donate autologous blood preoperatively.

PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT® is not indicated for use:

  • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure or in whom the anemia can be managed by transfusion.
  • In patients scheduled for surgery who are willing to donate autologous blood.
  • In patients undergoing cardiac or vascular surgery.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Important Safety Information For PROCRIT®

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest PROCRIT® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery:
Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.

(See WARNINGS AND PRECAUTIONS: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism, and WARNINGS AND PRECAUTIONS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

Contraindications

PROCRIT® is contraindicated in patients with:

  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT® or other erythropoietin protein drugs
  • Serious allergic reactions to PROCRIT®

PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in:

  • Neonates, infants, pregnant women, and lactating women. When therapy with PROCRIT® is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.

Additional Important Safety Information

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

  • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), PROCRIT® and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
  • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials of patients with cancer, PROCRIT® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

  • ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

Hypertension

  • PROCRIT® is contraindicated in patients with uncontrolled hypertension. Following initiation and titration of PROCRIT®, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT®.
  • Appropriately control hypertension prior to initiation of and during treatment with PROCRIT®. Reduce or withhold PROCRIT® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

Seizures

  • PROCRIT® increases the risk of seizures in patients with CKD. During the first several months following initiation of PROCRIT®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency.

Lack or Loss of Hemoglobin Response to PROCRIT®

  • For lack or loss of hemoglobin response to PROCRIT®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to PROCRIT® therapy.

Pure Red Cell Aplasia

  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with PROCRIT®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which PROCRIT® is not approved).

  • If severe anemia and low reticulocyte count develop during treatment with PROCRIT®, withhold PROCRIT® and evaluate patients for neutralizing antibodies to erythropoietin. Contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) to perform assays for binding and neutralizing antibodies. Permanently discontinue PROCRIT® in patients who develop PRCA following treatment with PROCRIT® or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with PROCRIT®. Immediately and permanently discontinue PROCRIT® and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs.

Severe Cutaneous Reactions

  • Blistering and skin exfoliation reactions, including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including PROCRIT® ) in the postmarketing setting. Discontinue PROCRIT® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative

  • PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. In addition, do not mix PROCRIT® with bacteriostatic saline (which also contains benzyl alcohol) when administering PROCRIT® to these patient populations.

  • Serious and fatal reactions, including “gasping syndrome,” can occur in neonates and infants treated with benzyl alcohol–preserved drugs, including PROCRIT® multiple-dose vials. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively. PROCRIT® multiple-dose vials contain 11 mg of benzyl alcohol per mL. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Risk of Infectious Diseases Due to Albumin (Human) Content

  • PROCRIT® contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Dialysis Management

  • Patients may require adjustments in their dialysis prescriptions after initiation of PROCRIT®. Patients receiving PROCRIT® may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

Anemia in Patients with Chronic Kidney Disease

  • In adult patients not on dialysis:
    • Consider initiating PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL and:
      • The patient’s rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and
      • Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
    • If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT®, and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions.
  • In adult patients on dialysis:
    • Initiate PROCRIT® treatment when the hemoglobin level is less than 10 g/dL.
    • If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of PROCRIT®.
  • In pediatric patients:
    • Initiate PROCRIT® treatment only when the hemoglobin level is less than 10 g/dL.
    • If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of PROCRIT®.
  • When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
    • Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
    • If the hemoglobin rises rapidly (e.g. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT® by 25% or more as needed to reduce rapid responses.
    • For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
    • For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT® dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue PROCRIT® if responsiveness does not improve.
  • Adverse reactions in ≥5% of PROCRIT®-treated adult patients not on dialysis in clinical studies were hypertension and arthralgia.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection.

Anemia Due to Chemotherapy in Patients with Cancer

  • PROCRIT® is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • PROCRIT® is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
  • Initiate PROCRIT® in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
  • Use the lowest dose of PROCRIT® necessary to avoid RBC transfusions.
  • Reduce dose by 25% if:
    • Hemoglobin increases greater than 1 g/dL in any 2-week period or
    • Hemoglobin reaches a level needed to avoid RBC transfusion.
  • Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.

Surgery/Perisurgery

  • PROCRIT® is not indicated for use in patients scheduled for surgery who are willing to donate autologous blood.
  • PROCRIT® is not indicated for use in patients undergoing cardiac or vascular surgery.
  • Deep venous thrombosis prophylaxis is recommended during PROCRIT® therapy.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.

Anemia Due to Zidovudine in Patients with HIV infection

  • Withhold PROCRIT® if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
  • Discontinue PROCRIT® if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.
  • Adverse reactions in ≥5% of PROCRIT®-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.

Please see full Prescribing Information, including Boxed WARNINGS.

080071-171019