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Kedrab. Reliable Coverage for Every Rabies Exposure

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Kedrab. Reliable Coverage for Every Rabies Exposure Indicated for post-exposure prophylaxis (PEP) of rabies infection KEDRAB. RELIABLE COVERAGE FOR EVERY RABIES EXPOSURE Eliminate the HRIG Dosing and Administration Guesswork Ready-to-use human rabies immune globulin (HRIG) solution1 May be stored at room temperature not exceeding 25°C (77°F) for up to one month. Use within one month; do not return to refrigeration1 150 IU/mL potency, the standard for nearly 50 years2 No need for dilution with dextrose1 No need for new HRIG protocols or staff trainings 2-mL vial/300 IU 10-mL vial/1500 IU INDICATIONS AND USAGE KEDRABTM (Rabies Immune Globulin [Human]) is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. • Additional doses of KEDRAB should not be administered once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine. • KEDRAB should not be administered to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer. SELECTED IMPORTANT SAFETY INFORMATION • 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 vaccine (ACIP). Please see page 6 for full Important Safety Information and full Prescribing Information on pages 7-19. Visit KEDRAB.com or call 1-855-353-7466 to order KEDRAB today. ANIMAL BITES VARY. IS THE VOLUME OF YOUR HRIG DOSE ADEQUATE FOR TREATING ALL RABIES EXPOSURES? PEP Is Crucial in Preventing Rabies The Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) provide guidance on the safe use of vaccines and related biological products including PEP.3 When administered according to ACIP guidelines, PEP is essentially 100% effective in preventing human rabies.4 Three Components of PEP In a person exposed to rabies and not previously vaccinated against the virus, prompt and proper PEP consists of the following 3 components.5 1. Wound Cleansing 2. Administration 3. Vaccination Against All PEP should begin with of HRIG the Rabies Virus immediate and thorough HRIG should be administered Rabies vaccine stimulates the cleansing of all bite wounds at any time up to and including patient’s immune system to with soap and water, including 7 days after the first dose produce virus-neutralizing a virucidal agent.1 of vaccine. antibodies (active immunization), which occurs approximately Infiltrate as much of the dose 7-10 days after initiation of as possible into and around any the vaccine series.5 detectable bite wounds.1 PEP Failure May Be Caused By: • Not administering HRIG6 • Only injecting HRIG intramuscularly when bite site(s) are known6 • Not injecting HRIG into all bite wound(s)6 • Less than thorough infiltration of HRIG at the exposure site(s)4-7 SELECTED IMPORTANT SAFETY INFORMATION (CONTINUED) KEDRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock. KEDRAB can induce a fall in blood pressure associated with an anaphylactic reaction, even in patients who tolerated previous treatment with human immunoglobulin. KEDRAB should be discontinued immediately if there is an allergic or anaphylactic type reaction. In case of shock, standard medical treatment should be implemented. Epinephrine should be available. Rabies Exposures and Potential Infiltration Sites With 150 IU/mL HRIG* Multiple lacerations around ankle Bite from: Dog Patient: 28-year-old female Weight: 117 lb mL of HRIG needed: 7.1 mL Infected cat bite and lacerations to the skin Bite from: Cat Patient: 32-year-old female Weight: 160 lb mL of HRIG needed: 9.7 mL Multiple lacerations on the calf Bite from: Raccoon Patient: 9-year-old male Weight: 89 lb mL of HRIG needed: 5.4 mL Puncture wounds on hand Bite from: Bat Patient: 64-year-old male Weight: 195 lb mL of HRIG needed: 11.8 mL * Images and accompanying information are for illustrative purposes only and do not represent actual patient cases. Please see page 6 for full Important Safety Information and full Prescribing Information on page 7-19. KEDRAB. HRIG DEPENDABILITY IN THE 150 IU/mL POTENCY YOU KNOW AND TRUST Two Vial Sizes1 2-mL vial 10-mL vial The 2-mL vial contains a total The 10-mL vial contains a total of 300 IU, which is sufficient for of 1500 IU, which is sufficient for a child weighing 15 kg (33 lb). an adult weighing 75 kg (165 lb). NDC 76125-150-02 NDC 76125-150-10 Significant Global Experience Kamada, the manufacturer of KEDRAB, has sold more than 1.4 million vials of the product in 9 countries outside the United States since 2006,8 demonstrating significant clinical experience with the product.9 Kedrion Biopharma is a world leading supplier of high-titer rabies plasma, the raw material used in the manufacture of HRIG.10 Ordering Options Kedrion Biopharma Customer Service Authorized Distributors 1-855-353-7466 • ASD Healthcare • Cardinal SPD 1-855-751-7951 • FFF Enterprises [email protected] • McKesson Plasma and Biologics • Prodigy Health Please see page 6 for full Important Safety Information and full Prescribing Information on pages 7-19. DOSAGE AND ADMINISTRATION Dosage1 The recommended dose of KEDRAB is 20 IU/kg body weight, given at the time of the first vaccine dose. KEDRAB and the first dose of rabies vaccine should be given as soon as possible after exposure, as delays are potentially lethal. However, should a delay occur, KEDRAB should be administered at any time up to and including seven days after the first dose of vaccine. The rabies vaccine should be given according to the manufacturer’s instructions. No more than the recommended dose of KEDRAB should be given because KEDRAB partially suppresses active antibody production following vaccination. For the same reason, additional doses of KEDRAB should not be given, even if the antibody response to vaccination is delayed. Administration1 KEDRAB is for wound infiltration and intramuscular use. Do not administer intravenously. Known Bite Site Unknown Bite Site • Infiltrate as much of the dose as possible into • Administer the full KEDRAB dose by the and around any detectable bite wounds intramuscular route at a site distant from the • Inject any remaining volume intramuscularly site of the rabies vaccination into the upper arm deltoid region or, in small children, into the anterolateral aspect of the thigh • Administer the remaining KEDRAB at site(s) distant from the site of the rabies vaccine Please see full Prescribing Information on pages 7-19 for full dosage and administration information. KEDRAB Dose Calculator Access the online calculator: 1. Open the camera on your phone. 2. Hover over the QR code. 3. Open the link to access or visit KEDRABDoseCalculator.com. SELECTED IMPORTANT SAFETY INFORMATION (CONTINUED) Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity. KEDRAB contains a small quantity of IgA. Patients who are deficient in IgA have the potential to develop IgA antibodies and may have anaphylactic reactions following administration of blood components containing IgA. The healthcare provider should assess the risks of this reaction against the benefits of administering KEDRAB. Patients at increased risk of thrombosis or thrombotic complications should be monitored for at least 24 hours after KEDRAB administration. INDICATIONS AND USAGE KEDRABTM (Rabies Immune Globulin [Human]) is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. • Additional doses of KEDRAB should not be administered once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine. • KEDRAB should not be administered to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer. IMPORTANT SAFETY INFORMATION • 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 vaccine (ACIP). • KEDRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock. KEDRAB can induce a fall in blood pressure associated with an anaphylactic reaction, even in patients who tolerated previous treatment with human immunoglobulin. KEDRAB should be discontinued immediately if there is an allergic or anaphylactic type reaction. In case of shock, standard medical treatment should be implemented. Epinephrine should be available. • Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity. KEDRAB contains a small quantity of IgA. Patients who are deficient in IgA have the potential to develop IgA antibodies and may have
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