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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 FDA-approved HRIG studied in children1


THE ONE-FOR-ALL HRIG SOLUTION

TRUST KEDRAB–A HUMAN RABIES IMMUNE GLOBULIN (HRIG) FOR PERSONS OF ALL AGES WITH
ANY RABIES EXPOSURE AT ANY TIME*




KEDRAB–THE ONLY HRIG SOLUTION WITH



ESTABLISHED SAFETY AND EFFECTIVENESS

in adults and children1

View the data for KEDRAB Safety and Effectiveness >


ROOM TEMPERATURE STABILITY

(not exceeding 25°C/77°F) for up to 30 days†

>


FREE PRODUCT REPLACEMENT PROGRAM

if unusable due to expiration, temperature excursion, or natural disaster‡

>


*Please see the full Prescribing Information for additional information on
patients not previously vaccinated, administering HRIG up to and including seven
days after the first dose of rabies vaccine, previously vaccinated patients and
any patients with a history or increased risk of hypersensitivity.
†KEDRAB is stable at room temperature for 30 days, not exceeding 25°C (77°F) and
at 2-8°C (36-46°F). DO NOT FREEZE. Use within one month; do not return to
refrigeration.
‡More information is available upon request.




2-mL vial
300 IU

10-mL vial

1500 IU

NO NEED TO DILUTE WITH DEXTROSE

KEDRAB® (Rabies Immune Globulin [Human]) is designed, dosed, and packaged in
accordance with American Society of Hospital Pharmacists (ASHP) guidelines on
preventing medication errors.1,2

WATCH THIS VIDEO TO LEARN MORE ABOUT POST-EXPOSURE PROPHYLAXIS AND THE BENEFITS
OF KEDRAB.

            


References: 1. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.;
2021. 2. Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ.
ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst
Pharm. 2018;75:1493-1517. doi:10.2146/ajhp170811.



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-0761-00-2020



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-0761-00-2020




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