Rabies immune globulin (KedRab)

Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Yashasvi Aryaputra[2];

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## Overview

Rabies immune globulin (KedRab) is a human rabies immunoglobulin (HRIG) that is FDA approved for the passive, transient post-exposure prophylaxis of rabies infection. Common adverse reactions include injection site pain, headache, muscle pain, and upper respiratory tract infection.

## Adult Indications and Dosage

### FDA-Labeled Indications and Dosage (Adult)

##### Indications:

* Rabies immune globulin (KedRab) 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. Rabies immune globulin (KedRab) should be administered concurrently with a full course of rabies vaccine.

* Do not administer additional (repeat) doses of Rabies immune globulin (KedRab) once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.

* Do not administer Rabies immune globulin (KedRab) to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer.1

##### Dosage:

* Post-exposure prophylaxis consists of a single dose of Rabies immune globulin (KedRab) and a full course of rabies vaccine. The recommended dose of Rabies immune globulin (KedRab) is 20 IU/kg body weight, given at the time of the first vaccine dose. Rabies immune globulin (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, Rabies immune globulin (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 Rabies immune globulin (KedRab) should be given because Rabies immune globulin (KedRab) partially suppresses active antibody production following vaccination. For the same reason, additional doses of Rabies immune globulin (KedRab) should not be given, even if the antibody response to vaccination is delayed.

### Off-Label Use and Dosage (Adult)

#### Guideline-Supported Use

There is limited information regarding Rabies immune globulin (KedRab) Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

#### Non–Guideline-Supported Use

There is limited information regarding Rabies immune globulin (KedRab) Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

## Pediatric Indications and Dosage

### FDA-Labeled Indications and Dosage (Pediatric)

##### Indications:

* Rabies immune globulin (KedRab) 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. Rabies immune globulin (KedRab) should be administered concurrently with a full course of rabies vaccine.

* Do not administer additional (repeat) doses of Rabies immune globulin (KedRab) once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.

* Do not administer Rabies immune globulin (KedRab) to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer.1

##### Dosage:

* Post-exposure prophylaxis consists of a single dose of Rabies immune globulin (KedRab) and a full course of rabies vaccine. The recommended dose of Rabies immune globulin (KedRab) is 20 IU/kg body weight, given at the time of the first vaccine dose. Rabies immune globulin (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, Rabies immune globulin (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 Rabies immune globulin (KedRab) should be given because Rabies immune globulin (KedRab) partially suppresses active antibody production following vaccination. For the same reason, additional doses of Rabies immune globulin (KedRab) should not be given, even if the antibody response to vaccination is delayed.

### Off-Label Use and Dosage (Pediatric)

#### Guideline-Supported Use

There is limited information regarding Rabies immune globulin (KedRab) Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

#### Non–Guideline-Supported Use

There is limited information regarding Rabies immune globulin (KedRab) Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

## Contraindications

* None

## Warnings

##### 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 Rabies immune globulin (KedRab), because Rabies immune globulin (KedRab) may interfere with the anamnestic response to the vaccine (ACIP)1.

##### Anaphylactic Shock

* Rabies immune globulin (KedRab) should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock. Rabies immune globulin (KedRab) can induce a fall in blood pressure associated with an anaphylactic reaction, even in patients who tolerated previous treatment with human immunoglobulin.

* Discontinue Rabies immune globulin (KedRab) injection immediately if there is an allergic or anaphylactic type reaction. In case of shock, implement standard medical treatment. Epinephrine should be available for treatment of acute anaphylactic symptoms.

##### Hypersensitivity

* Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity.

* Rabies immune globulin (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 Rabies immune globulin (KedRab).

##### Thrombosis

* Patients at increased risk of thrombosis or thrombotic complications should be monitored for at least 24 hours after Rabies immune globulin (KedRab) administration.

* Patients at increased risk of thrombosis include patients with acquired or hereditary hypercoagulable states, prolonged immobilization, in-dwelling vascular catheters, advanced age, estrogen use, a history of venous or arterial thrombosis, cardiovascular risk factors (including history of atherosclerosis and/or impaired cardiac output), and hyperviscosity syndromes (including cryoglobulinemias, fasting chylomicronemia and/or high triglyceride levels, and monoclonal gammopathies).

* Consider measurement of baseline blood viscosity in patients at risk for hyperviscosity.

##### Hemolysis

* Hemolysis may occur in patients receiving immune globulin products, particularly those who are determined to be at increased risk. Patients at increased risk include those with non-O blood group types, those with underlying associated inflammatory conditions, and those receiving high cumulative doses of immune globulins over the course of several days.

* Clinical symptoms and signs of hemolysis include fever, chills and dark urine. If any of these occur, perform appropriate laboratory testing and administer medical therapy as indicated.

##### Live Attenuated Virus Vaccines

* Rabies immune globulin (KedRab) administration may interfere with the development of an immune response to live attenuated virus vaccines.

* Avoid immunization with measles vaccine within 4 months after Rabies immune globulin (KedRab) administration.

* Avoid immunization with other live attenuated virus vaccines within 3 months after Rabies immune globulin (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 Rabies immune globulin (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

* Rabies immune globulin (KedRab) is derived from human plasma; therefore, the potential exists that Rabies immune globulin (KedRab) administration may transmit infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

* The risk of transmitting an infectious agent has been minimized by

* Screening plasma donors for prior exposure to certain viruses.

* Testing for certain viral infections.

* Inactivating and removing certain viruses during the manufacturing process.

Despite these measures, Rabies immune globulin (KedRab) administration can still potentially transmit infectious diseases. There is also the possibility that unknown infectious agents may be present in Rabies immune globulin (KedRab).

Any infection considered to have possibly been transmitted by this product should be reported by the physician or other healthcare provider to Kedrion Biopharma Inc. Customer Service (1-855-353-7466) or FDA at 1-800-FDA-1088.

## Adverse Reactions

### Clinical Trials Experience

* Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates of adverse reactions in clinical trials of another drug and may not reflect the rates observed in clinical practice.

* Rabies immune globulin (KedRab) was evaluated in three single-center, controlled clinical trials. Subjects in the clinical studies of Rabies immune globulin (KedRab) were healthy adults, primarily white and ranged in age from 18 to 72 years. A total of 160 subjects were treated in these three studies, including 91 subjects who received single intramuscular doses of Rabies immune globulin (KedRab) (20 IU/kg) with or without rabies vaccine.

* TABLE 1 summarizes adverse events (assessed by the investigator as related or unrelated to study treatment) occurring in >3% of subjects in the clinical trials of Rabies immune globulin (KedRab). The most frequent adverse events in the Rabies immune globulin (KedRab) group (>6%) were injection site pain, headache, muscle pain, and upper respiratory tract infection (TABLE 1).

This image is provided by the National Library of Medicine.

* Less common adverse events were joint pain, dizziness, fatigue, abdominal pain, blood in urine, nausea, feeling faint, bruising, sunburn, and white blood cells in urine.

### Postmarketing Experience

There is limited information regarding Rabies immune globulin (KedRab) Postmarketing Experience in the drug label.

## Drug Interactions

* Do not administer additional (repeat) doses of Rabies immune globulin (KedRab) once vaccination has been initiated, since additional doses of Rabies immune globulin (KedRab) may interfere with the immune response to the vaccine.

* Do not administer Rabies immune globulin (KedRab) into the same anatomical site(s) as rabies vaccine.

* Rabies immune globulin (KedRab) contains other antibodies that may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Avoid immunization with live virus vaccines within 3 months after Rabies immune globulin (KedRab) administration, or in the case of measles vaccine, within 4 months after Rabies immune globulin (KedRab) administration.

## Use in Specific Populations

#### Pregnancy

Pregnancy Category (FDA):  Risk Summary

* Rabies immune globulin (KedRab) has not been studied in pregnant women. Therefore, the risk of major birth defects and miscarriage in pregnant women who are exposed to Rabies immune globulin (KedRab) is unknown. Animal developmental or reproduction toxicity studies have not been conducted with Rabies immune globulin (KedRab). It is not known whether Rabies immune globulin (KedRab) can cause harm to the fetus when administered to a pregnant woman or whether Rabies immune globulin (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.

Pregnancy Category (AUS):  There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rabies immune globulin (KedRab) in women who are pregnant.

#### Labor and Delivery

There is no FDA guidance on use of Rabies immune globulin (KedRab) during labor and delivery.

#### Nursing Mothers

Risk Summary

* There is no information regarding the presence of Rabies immune globulin (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 Rabies immune globulin (KedRab) and any potential adverse effects on the breastfed infant from Rabies immune globulin (KedRab) or from the underlying maternal condition.

#### Pediatric Use

* The safety and effectiveness of Rabies immune globulin (KedRab) in the pediatric population have not been established.

#### Geriatic Use

* Clinical studies of Rabies immune globulin (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.

#### Gender

There is no FDA guidance on the use of Rabies immune globulin (KedRab) with respect to specific gender populations.

#### Race

There is no FDA guidance on the use of Rabies immune globulin (KedRab) with respect to specific racial populations.

#### Renal Impairment

There is no FDA guidance on the use of Rabies immune globulin (KedRab) in patients with renal impairment.

#### Hepatic Impairment

There is no FDA guidance on the use of Rabies immune globulin (KedRab) in patients with hepatic impairment.

#### Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rabies immune globulin (KedRab) in women of reproductive potentials and males.

#### Immunocompromised Patients

There is no FDA guidance one the use of Rabies immune globulin (KedRab) in patients who are immunocompromised.

## Administration and Monitoring

#### Administration

* When the bite site is known and infiltration at the bite site is feasible:

* Infiltrate as much of the dose as possible into and around any detectable bite wounds. Inject any remaining volume intramuscularly into the upper arm deltoid region or, in small children, into the anterolateral aspect of the thigh. Administer the remaining Rabies immune globulin (KedRab) at site(s) distant from the site of the rabies vaccine.

* Avoid administration into the gluteal region, where absorbance is unpredictable (unless the exposure site is in the gluteal region):

* 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 Rabies immune globulin (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.

* If intramuscular administration is contraindicated (e.g., in patients with uncorrectable bleeding disorders), administer Rabies immune globulin (KedRab) subcutaneously. However, note that there are no clinical efficacy data to support administration of Rabies immune globulin (KedRab) by the subcutaneous route.

* Do not mix with the rabies vaccine or administer in the same syringe with the rabies vaccine.

* Do not administer into the same anatomical site(s) as rabies vaccine.

* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, DO NOT use Rabies immune globulin (KedRab); discard the vial.

#### Monitoring

* Blood viscosity: At baseline in patients at risk for hyperviscosity.

* Signs and symptoms of thrombosis: In patients at risk for thrombosis or thrombotic complications, for at least 24 hours after administration.

* Signs and symptoms of hypersensitivity: In patients with a history of prior systematic allergic reactions after administration of human immune globulin products.

* Signs and symptoms of hemolysis.

## IV Compatibility

There is limited information regarding the compatibility of Rabies immune globulin (KedRab) and IV administrations.

## Overdosage

There is limited information regarding Rabies immune globulin (KedRab) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

## Pharmacology

Rabies immune globulin (KedRab)

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ATC code | J06BB05
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### Mechanism of Action

* Rabies is a zoonotic disease caused by RNA viruses in the family Rhabdoviridae, genus Lyssavirus. Virus is typically present in the saliva of rabid mammals and is transmitted primarily through a bite. Rabies immune globulin (KedRab) is infiltrated into the inoculation site (i.e., at the beginning of anti-rabies PEP) to 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.

### Structure

There is limited information regarding Rabies immune globulin (KedRab) Structure in the drug label.

### Pharmacodynamics

* A protective threshold for rabies virus neutralizing activity (RVNA) has never been established. However, the WHO has generally accepted a RVNA of at least 0.5 IU/mL measured 14 days after initiation of PEP as protective. By comparison, the ACIP recommends complete neutralization of rabies virus at a 1:5 serum dilution by a rapid fluorescent focus inhibition test (RFFIT) from 1 to 2 weeks after prophylaxis; this corresponds to RVNA ~0.1-0.2 IU/mL. In support of these recommendations, there has been almost no documented clinical disease when the current rabies PEP regimen is administered appropriately (ACIP) 1.

* Rabies immune globulin (KedRab) has the potential to attenuate the patient's immune response to rabies vaccine. This was evaluated in a double-blind, randomized study where 16 healthy subjects were administered either Rabies immune globulin (KedRab) (20 IU/kg IM) or saline placebo followed by three doses of a rabies vaccine (TABLE 3). Lower RVNA levels were seen in the Rabies immune globulin (KedRab) + vaccine group compared to the placebo + vaccine group at all time-points beginning on Day 14, confirming that Rabies immune globulin (KedRab) interferes with the host immune response to rabies vaccine.

### Pharmacokinetics

* A randomized, single-dose, two-period, two-treatment, two-sequence, double-blind, crossover study assessed the pharmacokinetics of Rabies immune globulin (KedRab). Twenty-six healthy volunteer subjects were randomized to receive a single IM injection of 20 IU/kg HRIG on two separate occasions (Rabies immune globulin (KedRab) or Comparator HRIG). Subjects received the second treatment (A or B) following the 42-day test period and a 21-day washout period. Single dose IM injection of Rabies immune globulin (KedRab) resulted in maximum plasma RVNA levels of 0.25 IU/mL. The median Tmax was 7 days (range: 3 – 14 days). The elimination half-life was approximately 17.9 days. A statistical analysis of the pharmacokinetic parameters showed that Rabies immune globulin (KedRab) was not bioequivalent to the Comparator HRIG (TABLE 3).

This image is provided by the National Library of Medicine.

* A plot of plasma rabies virus neutralizing antibody titer concentration versus time (FIGURE 1) demonstrated that, in both treatment groups, plasma rabies virus neutralizing antibody concentrations declined in a biphasic manner after the absorption phase was complete.

This image is provided by the National Library of Medicine.

* Additionally, a prospective, randomized, double-blind, non-inferiority, study evaluated the pharmacokinetics, safety and effectiveness of simulated post-exposure prophylaxis with Rabies immune globulin (KedRab) with co-administration of active rabies vaccine in 118 healthy subjects. Subjects were randomized into two treatment groups (59 per treatment group) to receive intramuscular Rabies immune globulin (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 peak plasma RVNA was 71.9 IU/mL and 53.9 IU/mL for Rabies immune globulin (KedRab) and comparator HRIG respectively. For both treatment groups, the median Tmax was 14 days (range: 14 – 49 days). The half-lives were 48.6 hours and 52.7 hours for Rabies immune globulin (KedRab) and comparator HRIG respectively.

* Bioequivalent assessment showed that Rabies immune globulin (KedRab) was not bioequivalent to the comparator HRIG when co-administered with a five-dose rabies vaccine regimen (TABLE 4). Furthermore, the RVNA on Day 3 was lower in the Rabies immune globulin (KedRab) with rabies vaccine group relative to the Comparator HRIG with vaccine group (0.188±0.051 vs 0.229±0.054, P=0.0005). However, these pharmacokinetic differences are not expected to affect clinical outcomes.

This image is provided by the National Library of Medicine.

### Nonclinical Toxicology

##### Animal Toxicology and/or Pharmacology

* Intramuscular administration of a single dose of Rabies immune globulin (KedRab) to rats at 60 and 120 IU/kg (3-fold and 6-fold higher than the recommended human dose of 20 IU/kg), did not result in any signs of toxicity.

## Clinical Studies

* The efficacy of Rabies immune globulin (KedRab) administered concurrently with rabies vaccine was studied in a single-center, randomized, comparator HRIG-controlled clinical study. Study subjects were healthy adults 18 to 72 years of age who were without significant acute or chronic illness. A total of 118 subjects (59 per treatment group) received intramuscular Rabies immune globulin (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 subjects was 45 years; subjects were, predominantly white (93%), and 64% were women. The efficacy variable was RVNA, as assessed by RFFIT, on Day 14. Efficacy analyses were performed on the As-Treated Population, which comprised the 116 study subjects who received Rabies immune globulin (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 subjects (98.2%) in the Rabies immune globulin (KedRab) group and 59/59 subjects in the comparator HRIG group (TABLE 5). The lower limit of the 90% CI was greater than the pre-specified non-inferiority margin of -10%; thus, Rabies immune globulin (KedRab) was non-inferior to comparator HRIG.

This image is provided by the National Library of Medicine.

* Additional efficacy analyses included pharmacokinetics.

## How Supplied

* Each carton of Rabies immune globulin (KedRab) contains a single-use vial containing 2 mL or 10 mL of ready-to-use solution with a potency of 150 IU/mL.

* The 2-mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg (33 lb). (NDC 76125-150-02). The 10-mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg (165 lb). (NDC 76125-150-10).

### Storage

* Store Rabies immune globulin (KedRab) at 2-8 °C (36-46 °F). Do not freeze.

* Keep vial in carton until use.

* Rabies immune globulin (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.

## Images

### Drug Images

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### Package and Label Display Panel

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## Patient Counseling Information

* The Rabies immune globulin (KedRab) manufacturing process includes three valid and effective viral elimination steps. In addition, the process allows the removal of thrombogenic activity.

* Inform patients that Rabies immune globulin (KedRab) is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk of Rabies immune globulin (KedRab) transmitting an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing. Inform patients of symptoms of a possible viral infection, including headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or, in the case of hepatitis, jaundice.

## Precautions with Alcohol

Alcohol-Rabies immune globulin (KedRab) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

## Brand Names

* KedRab

## Look-Alike Drug Names

There is limited information regarding Rabies immune globulin (KedRab) Look-Alike Drug Names in the drug label.

## Drug Shortage Status

Drug Shortage

## Price

## References

The contents of this FDA label are provided by the National Library of Medicine.