Kedrab

— THERAPEUTIC CATEGORIES —
  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Kedrab Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rabies immune globulin (human) 150 IU/mL; soln for IM inj; preservative-free.

    Pharmacological Class

    Immune globulin.

    How Supplied

    Single-use vial (2mL, 10mL)—1

    Storage

    Store Kedrab at 2-8 °C (36-46 °F). Do not freeze.

    Kedrab may be stored at room temperatures not exceeding 25 °C (77 °F) for up to one month.

    Use within one month after removal from refrigeration. Do not return to refrigeration.

    Do not use after the expiration date printed on the label.

    Manufacturer

    Kedrion Biopharma

    Generic Availability

    NO

    Mechanism of Action

    Kedrab is infiltrated into the inoculation site(s) in previously unvaccinated persons, to provide immediate passive rabies virus neutralizing antibody protection until the patient's immune system responds to vaccination by actively producing antibodies.

    Kedrab Indications

    Indications

    Post-exposure prophylaxis of rabies infection, to be given with a full course of rabies vaccine.

    Kedrab Dosage and Administration

    Adults and Children

    Prior to administration, follow recommendations for local treatment of wounds. Not previously vaccinated: administer as soon as possible after exposure; may give up to 7 days after first vaccine dose. 20 IU/kg as single dose with first dose of rabies vaccine. If feasible, infiltrate dose into and around the wound; inj remainder, if any, via IM into an anatomical site distant from the rabies vaccine site. Avoid repeat doses of Kedrab once vaccine treatment is initiated. Use separate syringes, needles, and anatomical inj sites for Kedrab and for rabies vaccine.

    Administration

    If feasible, infiltrate as much of the Kedrab dose as possible into and around any detectable bite wounds at the site. Administer any remaining Kedrab intramuscularly into anatomical site(s) distant from the site of the rabies vaccine.

    • When the bite site is unknown or indeterminate (undetectable) or if infiltration is difficult at the bite site (eg, lips, fingers, knee), give the full Kedrab dose via intramuscular route at a site distant from the site of rabies vaccination.
    • If a large intramuscular volume is required (>2 mL for children or >5 mL for adults), give the total volume in divided doses at different sites.
    • Do not mix Kedrab with the rabies vaccine or administer in the same syringe with the rabies vaccine.
    • Discard unused portion of the product in the vial.

    Kedrab Contraindications

    Not Applicable

    Kedrab Boxed Warnings

    Not Applicable

    Kedrab Warnings/Precautions

    Warnings/Precautions

    Previously completed pre- or post-exposure vaccination and confirmed adequate rabies titer: not recommended. Have epinephrine available. History of allergic reactions to human immunoglobulins; monitor. IgA deficiency. Contains human plasma; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Previous Rabies Vaccination

    • 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 (as per ACIP).

    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, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 
    • Report all infections suspected possibly to have been transmitted by this product to Kedrion Biopharma Inc. at (855) 353-7466.

    Pregnancy Considerations

    Kedrab has not been studied in pregnant women. Therefore, the risk of major birth defects and miscarriage in pregnant women who are exposed to Kedrab is unknown.

    Animal developmental or reproduction toxicity studies have not been conducted with Kedrab. 

    It is not known whether Kedrab can cause harm to the fetus when administered to a pregnant woman or whether Kedrab can affect reproductive capacity.

    Nursing Mother Considerations

    There is no information regarding the presence of Kedrab in human milk, the effects on the breastfed infant, or the effects on milk production. 

    Consider the health benefits of breastfeeding along with the mother's clinical need for Kedrab and any potential adverse effects on the breastfed infant from Kedrab or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness have been established in children. 

    Geriatric Considerations

    Clinical experience with HRIG products has not identified differences in effectiveness between elderly and younger patients (as per ACIP).

    Kedrab Pharmacokinetics

    Elimination

    Half-life: ~17.9 days. 

    Kedrab Interactions

    Interactions

    Avoid measles vaccine within 4 months of Kedrab; avoid other live attenuated vaccines within 3 months. May interfere with serologic tests (eg, Coombs’ test).

    Kedrab Adverse Reactions

    Adverse Reactions

    Inj site pain, headache, muscle pain, joint pain, dizziness, fatigue, pyrexia, extremity pain, bruising, vomiting; anaphylaxis.

    Kedrab Clinical Trials

    Clinical Trials

    The efficacy of Kedrab given concurrently with the rabies vaccine was studied in a single-center, randomized, comparator human rabies immune globulin (HRIG)-controlled clinical study. Patients were healthy adults 18–72 years of age who had no significant acute or chronic illness. A total of 118 patients (59 per treatment group) received intramuscular Kedrab or comparator HRIG at a dose of 20 IU/kg on Day 0, and rabies vaccine on Days 0, 3, 7, 14 and 28. The mean age of study patients was 45 years. 

    • The efficacy variable was rabies virus neutralizing activity (RVNA), as assessed by Rapid Fluorescent Focus Inhibition Test (RFFIT), on Day 14.
    • Efficacy analyses were performed on the As-Treated Population, which comprised 116 study patients who received Kedrab or comparator HRIG and at least 3 of the 5 doses of rabies vaccine before Day 14.
    • Efficacy, considered when RVNA titer is 0.5 IU/mL or higher on Day 14 (as established by the WHO), was met by 56/57 patients (98.2%) in the Kedrab group versus 59/59 patients (100%) in the comparator HRIG group. The lower limit of the 90% CI was greater than the pre-specified non-inferiority margin of -10%; thus, Kedrab was non-inferior to comparator HRIG.

    Kedrab was also evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis was indicated. Patients were treated with Kedrab at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per ACIP recommendations for rabies post-exposure prophylaxis. The patients ranged in age from 0.5–14.9 years. 

    • The efficacy variables were RVNA as assessed by RFFIT on Day 14 and occurrence of rabies disease through Day 84 after administration of Kedrab.
    • Efficacy analyses were performed on the As-Treated Population, which comprised all 30 study patients.
    • In the As-Treated Population, the geometric mean (SD) Day-14 RVNA titer was 18.89 (31.61) IU/mL and the median Day-14 RVNA titer was 8.81 (range 0.21–153.62) IU/mL.
    • Of the 30 treated pediatric patients, 28 patients (93.3%) had a Day-14 RVNA titer ≥0.5 IU/mL, the WHO recommended level. None of the 28/30 patients who were followed for the duration of the study developed rabies infection through day 84.

    Kedrab Note

    Not Applicable

    Kedrab Patient Counseling

    Patient Counseling

    Inform patients that Kedrab is made from human plasma and may contain infectious agents that can cause disease (eg, viruses and, theoretically, the CJD agent). Symptoms of a possible viral infection include headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or, in the case of hepatitis, jaundice. Patients should contact their healthcare provider if any of these symptoms develop.

    Advise patients that it is necessary to complete the rabies vaccine series.

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