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PATIENT ELIGIBILITY GUIDELINES FOR PATIENT ASSISTANCE

  • Patients must be United States citizens or permanent residents, and must physically reside in the United States or its territories.
  • Proof of residency will not routinely be required but may be requested at any time through an audit (i.e, copy of valid driver’s license or recent utility bill).
  • Patients’ annual gross income must not exceed 250% of the Federal Poverty Level (FPL). Valid proof of income will be required.
  • Patients must be uninsured.
  • Patients must be under the care of a licensed prescriber with an established clinical practice located in the United States or its territories.
  • Patient diagnosis and dosing must be consistent with U.S. Food and Drug Administration regulations.
  • Patients will receive one (1) prescribed dose.
  • Patients receiving federally funded benefits will not be eligible to receive assistance under the Program. Such excluded patient benefits include, but may not be limited to: Medicare, Medicaid (including spend downs), Tricare, and VA benefits.


This program is subject to change or discontinuation by Kedrion Biopharma, Inc. at any time, for any reason, and with or without prior notice. This portal is administered by Medmonk for the KEDRAB Patient Assistance Program.


INDICATIONS AND USAGE

KEDRAB® (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 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.

• Hemolysis may occur in patients receiving immune globulin products, particularly those who are determined to be at increased risk. Clinical symptoms and signs of hemolysis include fever, chills and dark urine. If any of these occur, appropriate laboratory testing should be performed and medical therapy administered as indicated.

• KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines. After KEDRAB administration, immunization with measles vaccine should be avoided within 4 months; other live attenuated virus vaccines avoided within 3 months.

• 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 may interfere with serologic tests for red cell antibodies such as the antiglobulin test (Coombs’ test).

• KEDRAB is derived from human plasma; therefore, the potential exists that KEDRAB administration may transmit infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in KEDRAB.

• In clinical trials, the most common adverse reactions in subjects treated with KEDRAB were injection site pain (33%), headache (15%), muscle pain (9%), and upper respiratory tract infection (9%).

Please see Full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.