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Effective URL: https://kedrab.com/ma-kedrab-benefits/
Submission: On November 15 via api from US — Scanned from DE
Effective URL: https://kedrab.com/ma-kedrab-benefits/
Submission: On November 15 via api from US — Scanned from DE
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Intended for US Healthcare Professionals Only Important Safety Information » | Full Prescribing Information » Enroll * ABOUT KEDRAB * EFFICACY * SAFETY * MANUFACTURING * DOSAGE AND ADMINISTRATION * DOSE CALCULATOR * HRIG ADMINISTRATION VIDEO * STORAGE & HANDLING * ORDERING AND REIMBURSEMENT * ABOUT RABIES * RABIES PREVALENCE * POST-EXPOSURE PROPHYLAXIS * PATIENT PROFILES * RESOURCES * RABIES PREVENTION SCENARIOS * PRODUCT REPLACEMENT PROGRAM * FORMULARY MONOGRAPH * PRESS RELEASES * PROFESSIONAL ORGANIZATIONS * FAQs * RABIES * POST-EXPOSURE PROPHYLAXIS * KEDRAB * ABOUT KEDRAB * EFFICACY * SAFETY * MANUFACTURING * DOSAGE AND ADMINISTRATION * DOSE CALCULATOR * HRIG ADMINISTRATION VIDEO * STORAGE & HANDLING * ORDERING AND REIMBURSEMENT * ABOUT RABIES * RABIES PREVALENCE * POST-EXPOSURE PROPHYLAXIS * PATIENT PROFILES * RESOURCES * RABIES PREVENTION SCENARIOS * PRODUCT REPLACEMENT PROGRAM * FORMULARY MONOGRAPH * PRESS RELEASES * PROFESSIONAL ORGANIZATIONS * FAQs * RABIES * POST-EXPOSURE PROPHYLAXIS * KEDRAB THE FIRST AND ONLY HRIG STUDIED IN CHILDREN1 Learn more about KEDRAB (Rabies Immune Globulin [Human]) – the only FDA-approved human rabies immune globulin (HRIG) studied in children.1 Kedrion Biopharma is committed to rabies education, prevention, and clinical excellence and maintains valuable relationships within the rabies prevention community. THE KEDRAB BROCHURE Please complete the form below to receive your information. Required * First Name: * Last Name: * Phone: * Email: * Ask to receive a call from a Kedrion Biopharma representative for more information about KEDRAB and details on how to order. Terms and Conditions: Kedrion Biopharma Inc. (“Kedrion Biopharma”) respects the privacy of your personal information. Kedrion Biopharma, and companies providing services to Kedrion Biopharma, may use the information that you provide to send you marketing or informational materials, analyze and use your information to improve or develop services and programs, and contact you about marketing programs or research about health topics that may be of interest to you. Kedrion Biopharma, and companies providing services to Kedrion Biopharma, will not sell or rent your personally identifiable information. For more information regarding our Privacy Policy, click here. Reference: 1. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2021. Expand INDICATIONS AND USAGE KEDRAB is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB because KEDRAB may interfere with the anamnestic response to the rabies vaccine. HYPERSENSITIVITY REACTIONS: Hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. IgA deficient patients with antibodies against IgA are at greater risk. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. LIVE ATTENUATED VIRUS VACCINES: KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines. If feasible, delay immunization with measles vaccine for 4 months, and other live attenuated virus vaccines for 3 months, after KEDRAB administration. INTERFERENCE WITH SEROLOGICAL TESTING: A transient rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results of serologic tests after KEDRAB administration. Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, and D, may interfere with serologic tests for red cell antibodies such as the antiglobulin test (Coombs’ test). TRANSMISSIBLE INFECTIOUS AGENTS: Because KEDRAB is made from human plasma donors hyper-immunized with rabies vaccine, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Kedrion Biopharma Inc. at 1-855-353-7466. ADVERSE REACTIONS: The most common adverse events in adult subjects treated with KEDRAB in clinical trials were injection site pain, headache, muscle pain, and upper respiratory tract infection. In pediatric subjects treated with KEDRAB and a full course of rabies vaccine, the most common adverse events were injection site pain, headache, fever, pain in extremity, bruising (hematoma), fatigue and vomiting. Less common adverse reactions (≤5%) in pediatric patients were injection site redness (erythema), injection site swelling (edema), muscle pain, oral pain, and wound complication. Insomnia was reported as a less common adverse reaction (<5%) in pediatric patients occurring after 14 days of administration. DRUG INTERACTIONS: Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis and have a confirmed adequate rabies antibody titer should receive only a booster rabies vaccine (without KEDRAB) because KEDRAB may interfere with the anamnestic response to the vaccine (ACIP). KEDRAB can interfere with the immune response to the rabies vaccine. For this reason, do not exceed the recommended KEDRAB dose or give additional (repeat) doses of KEDRAB once rabies vaccination has been initiated. KEDRAB can inactivate the rabies vaccine. For this reason, do not administer KEDRAB in the same syringe as the rabies vaccine or near the anatomical site of administration of the rabies vaccine. To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-353-7466 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Click here for full Prescribing Information. KEDRION BIOPHARMA CUSTOMER SERVICE Phone: 1-855-353-7466 Email: US_CustomerService@kedrion.com Fax: 1-855-751-7951 RABIES UPDATES If you are interested in receiving the most current information about KEDRAB, proper PEP, and educational rabies resources, enroll now. Enroll ABOUT KEDRAB Efficacy Safety Manufacturing DOSAGE & ADMINISTRATION Dose Calculator HRIG Administration Video Storage & Handling ORDERING AND REIMBURSEMENT ABOUT RABIES Rabies Prevalence Post-exposure Prophylaxis Patient Profiles RESOURCES Rabies Prevention Scenarios Product Replacement Program Formulary Monograph Press Releases Professional Organizations FAQS Rabies Post-exposure Prophylaxis KEDRAB Important Safety Information Full Prescribing Information Privacy Policy | Terms of Use | Contact | Sitemap | ©2021 Kedrion Biopharma Inc. All Rights Reserved. June 2021 KR-0766-00-2020E Expand INDICATIONS AND USAGE KEDRAB is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB because KEDRAB may interfere with the anamnestic response to the rabies vaccine. HYPERSENSITIVITY REACTIONS: Hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. IgA deficient patients with antibodies against IgA are at greater risk. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. LIVE ATTENUATED VIRUS VACCINES: KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines. If feasible, delay immunization with measles vaccine for 4 months, and other live attenuated virus vaccines for 3 months, after KEDRAB administration. INTERFERENCE WITH SEROLOGICAL TESTING: A transient rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results of serologic tests after KEDRAB administration. Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, and D, may interfere with serologic tests for red cell antibodies such as the antiglobulin test (Coombs’ test). TRANSMISSIBLE INFECTIOUS AGENTS: Because KEDRAB is made from human plasma donors hyper-immunized with rabies vaccine, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Kedrion Biopharma Inc. at 1-855-353-7466. ADVERSE REACTIONS: The most common adverse events in adult subjects treated with KEDRAB in clinical trials were injection site pain, headache, muscle pain, and upper respiratory tract infection. In pediatric subjects treated with KEDRAB and a full course of rabies vaccine, the most common adverse events were injection site pain, headache, fever, pain in extremity, bruising (hematoma), fatigue and vomiting. Less common adverse reactions (≤5%) in pediatric patients were injection site redness (erythema), injection site swelling (edema), muscle pain, oral pain, and wound complication. Insomnia was reported as a less common adverse reaction (<5%) in pediatric patients occurring after 14 days of administration. DRUG INTERACTIONS: Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis and have a confirmed adequate rabies antibody titer should receive only a booster rabies vaccine (without KEDRAB) because KEDRAB may interfere with the anamnestic response to the vaccine (ACIP). KEDRAB can interfere with the immune response to the rabies vaccine. For this reason, do not exceed the recommended KEDRAB dose or give additional (repeat) doses of KEDRAB once rabies vaccination has been initiated. KEDRAB can inactivate the rabies vaccine. For this reason, do not administer KEDRAB in the same syringe as the rabies vaccine or near the anatomical site of administration of the rabies vaccine. To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-353-7466 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Click here for full Prescribing Information. KEDRION BIOPHARMA CUSTOMER SERVICE Phone: 1-855-353-7466 Email: US_CustomerService@kedrion.com Fax: 1-855-751-7951 RABIES UPDATES If you are interested in receiving the most current information about KEDRAB, proper PEP, and educational rabies resources, enroll now. Enroll ABOUT KEDRAB Efficacy Safety Manufacturing DOSAGE & ADMINISTRATION Dose Calculator HRIG Administration Video Storage & Handling ORDERING AND REIMBURSEMENT ABOUT RABIES Rabies Prevalence Post-exposure Prophylaxis Patient Profiles RESOURCES Rabies Prevention Scenarios Product Replacement Program Formulary Monograph Press Releases Professional Organizations FAQS Rabies Post-exposure Prophylaxis KEDRAB Important Safety Information Full Prescribing Information Privacy Policy | Terms of Use | Contact | Sitemap | ©2021 Kedrion Biopharma Inc. All Rights Reserved. June 2021 KR-0766-00-2020E Notifications