What is the dosage of Kedrab?

Kedrab is available in 2 dosages, including 150 unt/ml Injection 2 ml and 150 unt/ml Injection 10 ml

How is Kedrab administered?

Kedrab is administered as a Injectable

Kedrab

(rabies immune globulin, human)

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Dosage & Administration

For wound infiltration and intramuscular use. ( 2)

Post-exposure prophylaxis: single dose of KEDRAB with a full course of rabies vaccine

20 IU/kg body weight KEDRAB

Do not exceed recommended dose.

Do not repeat KEDRAB doses once vaccine treatment is initiated.

* Administer as soon as possible after exposure
* Infiltrate area around wound with full dose
* Inject any remaining KEDRAB intramuscularly, at a site distant from the site of rabies vaccine administration

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Kedrab Prescribing Information

For wound infiltration and intramuscular use.

Dosage

Post-exposure prophylaxis consists of a single 20 IU/kg body weight dose of KEDRAB and a full course of rabies vaccine (See Table 1).

Table 1: Rabies Post-exposure Prophylaxis Schedule*
* Adapted from reference 1.
†These regimens are applicable for all age groups, including children.
ǂ Day 0 is the day the first dose of vaccine is administered. Refer to vaccine manufacturer's instructions or to the recommendations of the Advisory Committee on Immunization Practices (ACIP) 1,2for appropriate rabies vaccine formulations, schedules, and dosages.
§Any person with a history of rabies vaccination and a documented history of antibody response to the prior vaccination.
Vaccination Status	Intervention	Regimen†
Not previously vaccinated	Wound Cleansing	Cleanse all wounds immediately and thoroughly with soap and water. Irrigate the wounds with a viricidal agent such as a povidone-iodine solution, if available.
	KEDRAB ®20 IU/kg body weight	Administer KEDRAB as soon as possible after exposure, preferably at the time of the first rabies vaccine dose. However, should a delay occur, administer KEDRAB at any time up to and including seven days after the first dose of rabies vaccine. If there is a delay, initiate post-exposure prophylaxis at any time after exposure. Infiltrate the area around and into the wound(s), if anatomically feasible, with the full dose of KEDRAB. Inject the remainder, if any, intramuscularly at an anatomical site distant from the site of rabies vaccine administration. Do not exceed the recommended dose of KEDRAB because this can partially suppress active production of rabies virus antibodies. [see Drug Interactions ( 7)] Do not administer additional doses of KEDRAB, even if the antibody response to vaccination is delayed. ( 7) Use separate syringes, needles, and anatomical injection sites for KEDRAB and for rabies vaccine.
	Rabies Vaccine	Administer rabies vaccine on Day 0 and on subsequent vaccine administration daysǂ at an anatomical site that is distant from the KEDRAB administration site(s). Complete a rabies vaccination series
Previously vaccinated§	Wound cleansing	Cleanse all wounds immediately and thoroughly with soap and water. Irrigate the wounds with a viricidal agent such as povidone-iodine solution if available.
	KEDRAB ®	Do not administer KEDRAB. [see Warnings and Precautions ( 5.1)]
	Rabies Vaccine	Administer rabies vaccine on Day 0.ǂ Complete a rabies vaccination series for previously vaccinated persons.†
Other Considerations	Tetanus prophylaxis and/or antibiotics	Provide treatment if medically indicated

Administration

Infiltrate as much of the KEDRAB dose as possible into and around any detectable bite wounds if infiltration at the bite site is feasible. 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 (e.g., lips, fingers, knee), administer the full KEDRAB dose by the 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), administer 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if either of these conditions exists, and contact Kedrion Biopharma Inc. at 1-855-353-7466. Do not discard the vial.

KEDRAB is supplied in single-dose vials containing 2 mL or 10 mL of ready-to-use solution with a nominal potency of 150 IU/mL (Note that more than one vial may be required for a single patient treatment).

The 2 mL vial contains a total of 300 IU, which is sufficient for a child weighing 15 kg (33 lb)
The 10 mL vial contains a total of 1500 IU, which is sufficient for an adult weighing 75 kg (165 lb)

The final product is assayed with human rabies immunoglobulin reference standard that is calibrated against the WHO International Standard.

Pregnancy

Risk Summary

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. In the U.S. general population, the estimated background of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies.

Lactation

Risk Summary

There is no information regarding the presence of KEDRAB in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered 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 Use

Safety and effectiveness have been established in children. In a pediatric study of 30 patients ranging in age from 0.5 to 14.9 years, KEDRAB presented no serious adverse reactions through day 84. Of the 30 patients, 28 (93.3%) achieved a Day-14 RVNA titer ≥0.5 IU/mL, the WHO recommended level. None of the patients who were followed until the end of the study (28/30 patients) developed rabies infection through day 84. [see Clinical Trials ( 14)]

Adverse reactions that occurred in ≥3.3% of patients within the first 14 days of KEDRAB and the first rabies vaccination administration are listed in Section 6.1.

The clinical trial conducted in the pediatric population is described in Section 14.

Additional evidence to support the use of KEDRAB in children comes from Real World Evidence. Based on claims data, 172 U.S. children (≤17 years) were treated with KEDRAB between 2018-2020. Based on Center for Disease Control data, no children in the U.S. treated with post-exposure prophylaxis have been reported to have had rabies between 2018-April 2021.

Geriatric Use

Clinical studies of KEDRAB did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Clinical experience with HRIG products has not identified differences in effectiveness between elderly and younger patients (ACIP) 1.

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 (ACIP) 1.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. History of prior systemic allergic reactions to human immunoglobulin preparations places patients at greater risk. Have epinephrine available for treatment of acute allergic symptoms. Patients with isolated immunoglobulin A (IgA) deficiency may develop severe hypersensitivity reactions to KEDRAB or, subsequently, to the administration of blood products that contain IgA.

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 Serologic 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.