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Rabies immune globulin (human): Drug information

Rabies immune globulin (human): Drug information
(For additional information see "Rabies immune globulin (human): Patient drug information" and see "Rabies immune globulin (human): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • HyperRAB;
  • HyperRAB S/D [DSC];
  • Imogam Rabies-HT;
  • Kedrab
Brand Names: Canada
  • HyperRAB;
  • HyperRAB S/D [DSC];
  • Imogam Rabies Pasteurized [DSC];
  • Kamrab
Pharmacologic Category
  • Blood Product Derivative;
  • Immune Globulin
Dosing: Adult

Note: Potency varies among currently available products; use caution to ensure correct dose is administered.

Rabies, postexposure prophylaxis

Rabies, postexposure prophylaxis: Local wound infiltration/IM: 20 units/kg in a single dose, rabies immune globulin (human) (HRIG) should always be administered as part of rabies vaccine regimen. If anatomically feasible, the full rabies immune globulin dose should be infiltrated around and into the wound(s); remaining volume should be administered IM at a site distant from the vaccine administration site. HRIG should be administered as soon as possible after exposure, preferably at time of first rabies vaccine dose. If rabies vaccine was initiated without HRIG, HRIG may be administered through the seventh day after the administration of the first dose of the vaccine (day 0). Administration of HRIG is not recommended after the seventh day post vaccine since an antibody response to the vaccine is expected during this time period.

Note: Not recommended for use in persons with a history of complete rabies vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Rabies immune globulin (human): Pediatric drug information")

Note: Not recommended for use in persons with a history of vaccination (preexposure or postexposure) and documentation of antibody response. Potency varies among currently available products; use caution to ensure correct dose is administered.

Postexposure prophylaxis

Postexposure prophylaxis: Infants, Children, and Adolescents: Local wound infiltration/IM: 20 units/kg single dose administered as soon as possible after exposure and as part of a rabies vaccine regimen; do not exceed recommended dose since passive antibody can interfere with response to rabies vaccine. If anatomically feasible, the full rabies immune globulin (RIG) dose should be infiltrated around and into the wound(s); any remaining volume should be administered IM at a site distant from the vaccine administration site. If rabies vaccine was initiated without rabies immune globulin, rabies immune globulin may be administered through the seventh day after the first vaccine dose. Administration of RIG is not recommended after the seventh day postvaccine since an antibody response to the vaccine is expected during this time period.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (8% to 15%)

Local: Pain at injection site (31% to 33%)

1% to 10%:

Central nervous system: Fatigue (2% to 6%), dizziness (1% to 6%)

Dermatologic: Sunburn (≤3%)

Gastrointestinal: Diarrhea (8%), flatulence (8%), nausea (4%), abdominal pain (1% to 4%)

Genitourinary: Leukocyturia (3% to 5%), hematuria (2% to 4%)

Hematologic & oncologic: Bruise (1% to 3%)

Local: Injection site nodule (8%)

Neuromuscular & skeletal: Myalgia (7% to 9%), arthralgia (≤6%)

Respiratory: Upper respiratory tract infection (9% to 10%), nasal congestion (8%), oropharyngeal pain (8%)

Frequency not defined:

Central nervous system: Malaise

Dermatologic: Skin rash

Genitourinary: Nephrotic syndrome

Hypersensitivity: Anaphylaxis, angioedema

Local: Local soreness/soreness at injection site, tenderness at injection site

Neuromuscular & skeletal: Stiffness (at injection site)

Miscellaneous: Fever (mild)

<1%, postmarketing, and/or case reports: Hypersensitivity reaction, hypoesthesia, limb pain

Contraindications

Imogam Rabies-HT: Should not be administered in repeated doses once vaccine treatment has been initiated (may interfere with active immunity of vaccine).

HyperRAB, Kedrab: There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; discontinue immediately and institute supportive emergency measures if hypersensitivity or anaphylaxis occurs. Use with caution in patients with isolated immunoglobulin A deficiency or a history of systemic hypersensitivity to human immunoglobulins. Medications for the treatment of acute allergic reactions should be available for immediate use.

• Hemolysis: May occur; risk is increased in patients with non-O blood group types, underlying associated inflammatory conditions, and those receiving high cumulative doses of immune globulins over several days. Monitor patients for signs and symptoms of hemolysis (eg, fever, chills, dark urine).

• Thrombosis: Use with caution in patients at increased risk of thrombosis (eg, acquired or hereditary hypercoagulable states, prolonged immobilization, indwelling vascular catheters, advanced age, estrogen use, history of thrombosis, cardiovascular risk factors, hyperviscosity syndromes). Monitor these patients for at least 24 hours after administration; consider measuring a baseline blood viscosity in patients at risk for hyperviscosity.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease agent and, theoretically, the Creutzfeldt-Jakob disease agent), which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

Other warnings/precautions:

• Administration: Not for intravenous administration.

• Administration: Administration is a medical urgency (not emergency); however, do not delay decision to treat.

• Appropriate use: A single dose is recommended; repeating the dose may interfere with maximum active immunity expected from the vaccine. Repeated doses of Imogam Rabies-HT after vaccine treatment has been initiated are contraindicated.

• Immunizations: Antibodies may interfere with the immune response to live vaccines. Live vaccines should be given ≥3 months after rabies immune globulin (defer live vaccines ≥4 months after HyperRAB); measles vaccine should be given ≥4 months after Kedrab.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Imogam Rabies-HT: 300 units/2 mL (2 mL)

Solution, Injection [preservative free]:

HyperRAB: 300 units/mL (1 mL); 900 units/3 mL (3 mL); 1500 units/5 mL (5 mL)

HyperRAB S/D: 300 units/2 mL (2 mL [DSC]); 1500 units/10 mL (10 mL [DSC])

Kedrab: 300 units/2 mL (2 mL); 1500 units/10 mL (10 mL) [latex free, pyrogen free]

Generic Equivalent Available: US

Yes

Pricing: US

Solution (HyperRAB Injection)

300 units/mL (per mL): $816.60

900UNIT/3ML (per mL): $816.60

1500 unit/5 mL (per mL): $816.59

Solution (Imogam Rabies-HT Injection)

300 units/2 mL (per mL): $543.08

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Injectable, Intramuscular:

HyperRAB S/D: 150 units/mL ([DSC])

Generic: 150 units/mL ([DSC])

Solution, Injection:

HyperRAB: 300 units/mL (1 mL, 5 mL)

Kamrab: 300 units/2 mL (2 mL)

Administration: Adult

IM: Postexposure wound infiltration: For wound infiltration and IM use only; do not administer IV. Clean wounds immediately with soap and water; irrigate wounds with viricidal agent (eg, povidone-iodine) if available. If anatomically feasible, the full rabies immune globulin (human) (HRIG) dose should be infiltrated around and into the wound(s); remaining volume should be administered IM in the deltoid muscle of the upper arm or lateral thigh muscle. Per the manufacturer, the gluteal area should be avoided to reduce the risk of sciatic nerve damage or unpredictable absorbance, unless gluteal region is exposure site. Do not administer rabies vaccine in the same syringe or at the same administration site as HRIG. For extensive wounds, do not exceed the calculated dose. If the location of the wound is unknown or if infiltration is difficult at the bite site (eg, lips, fingers, knee), administer the full dose at a site distant from the site of the rabies vaccination. If additional volume is needed to infiltrate the wound(s), may dilute with an equal volume of D5W (HyperRAB) or NS (Kedrab, Imogam) (Ref); HyperRAB should not be diluted with NS.

Administration: Pediatric

Parenteral: Postexposure wound infiltration: Thoroughly cleanse wound(s) with soap and water; irrigate wounds with viricidal agent (eg, povidone-iodine) if available. If anatomically feasible, the full rabies immune globulin (RIG) dose should be infiltrated around and into the wound(s); remaining volume should be administered IM in the deltoid muscle of the upper arm or lateral thigh muscle at a site distant from rabies vaccine administration. Per the manufacturer, the gluteal area should be avoided to reduce the risk of sciatic nerve damage or unpredictable absorbance (unless exposure area is the gluteal area). Do not administer IV. If IM administration is contraindicated (eg, patients with uncorrectable bleeding disorders), Kedrab may be administered SubQ; however, no clinical efficacy data are available to support administration SubQ. Do not administer rabies vaccine in the same syringe or at the same administration site as RIG. For extensive wounds, do not exceed the calculated dose. For extensive wounds, do not exceed the calculated dose. If the location of the wound is unknown or if infiltration is difficult at the bite site (eg, lips, fingers, knee), administer the full dose at a site distant from the site of the rabies vaccination​. If additional volume is needed to infiltrate the wound(s), may dilute with an equal volume of D5W (HyperRAB) or NS (Kedrab, Imogam) (Ref); HyperRAB should not be diluted with NS. 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.

Use: Labeled Indications

Rabies, postexposure prophylaxis: Component of postexposure prophylaxis for patients with suspected rabies exposure. Provides passive immunity until active immunity with rabies vaccine is established. Not for use in patients with a history of complete vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response, as these patients require only the vaccination. Each exposure to possible rabies infection should be individually evaluated.

Factors to consider include: species of biting animal, circumstances of biting incident (provoked vs unprovoked bite), type of exposure to rabies infection (bite vs nonbite), vaccination status of biting animal, presence of rabies in the region. See product information for additional details.

Medication Safety Issues
International issues:

Bayrab [Philippines, Turkey] may be confused with Bayhep-B which is a brand name for hepatitis B immune globulin [Philippines, Turkey]; Bayrho-D which is brand name for RhoD immune globulin [Israel, Turkey]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rabies Vaccine: Rabies Immune Globulin (Human) may diminish the therapeutic effect of Rabies Vaccine. Management: Do not administer additional or repeated doses of rabies immune globulin once rabies vaccine has been administered. The rabies immune globulin should also not be administered in the same site as the vaccine. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vaccines (Live): Rabies Immune Globulin (Human) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted. Pregnancy is not a contraindication to postexposure prophylaxis. Pre-exposure prophylaxis may be indicated during pregnancy if the risk for exposure to rabies is significant (CDC 2011).

Breastfeeding Considerations

Immunoglobulins are excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Mechanism of Action

Rabies immune globulin is a solution of globulins dried from the plasma or serum of selected adult human donors who have been immunized with rabies vaccine and have developed high titers of rabies antibody.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Berirab p | Hyperrab s/d;
  • (AT) Austria: Berirab p;
  • (BD) Bangladesh: Rabix ig;
  • (BR) Brazil: Soro anti rabico | Soro antirrabico;
  • (CN) China: Human Rabies Immunoglobulin;
  • (CO) Colombia: Favirab | Hyperrab;
  • (CZ) Czech Republic: Berirab | Favirab | Serum antirabic;
  • (DE) Germany: Berirab | Tollwutglobul;
  • (DO) Dominican Republic: Hyperab;
  • (EC) Ecuador: Imogan | Rabuman;
  • (EE) Estonia: Berirab | Imogam rabies;
  • (ES) Spain: Lyssuman;
  • (FR) France: Berirab | Imogam rage;
  • (GR) Greece: Berirab;
  • (ID) Indonesia: Favirab;
  • (IN) India: Berirab p | Rabishield | Zyrig;
  • (IT) Italy: Rabuman;
  • (KE) Kenya: Favirab;
  • (KW) Kuwait: Berirab p;
  • (LT) Lithuania: Imogam rabies | Serum antirabic;
  • (LV) Latvia: Imogam rabies | Imogam rage | Serum antirabic;
  • (MX) Mexico: Berirab p;
  • (MY) Malaysia: Berirab p | Hyperrab;
  • (NO) Norway: Berirab | Berirab p | Imogam rabies;
  • (NZ) New Zealand: Imogam rabies;
  • (PH) Philippines: Bayrab | Berirab p | Imogam rabies | Rabuman;
  • (PK) Pakistan: Bayrab | Favirab | Rabies antitoxin;
  • (PL) Poland: Berirab | Imogam rage;
  • (PR) Puerto Rico: Hyperrab | Imogam Rabies HT | Kedrab;
  • (PT) Portugal: Imogam rage;
  • (PY) Paraguay: Imogam rabia;
  • (RO) Romania: Imogam rage;
  • (RU) Russian Federation: Human Rabies Immunoglobulin | Immunoglobulin antirabic;
  • (SA) Saudi Arabia: Berirab;
  • (SK) Slovakia: Favirab;
  • (TH) Thailand: Berirab p | Favirab | Hrig | Imogam rabies | Rabies Antiserum Berna;
  • (TR) Turkey: Rabies antiserum | Rabies Antiserum Berna;
  • (TW) Taiwan: Hyperrab s/d;
  • (UA) Ukraine: Immunoglobulin antirabic | Rebinolin;
  • (VE) Venezuela, Bolivarian Republic of: Imogan;
  • (ZA) South Africa: Rabigam | Rabipor
  1. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018.
  2. Centers for Disease Control and Prevention, “CDC Health Information for International Travel 2014.” New York: Oxford University Press; 2014.
  3. Centers for Disease Control and Prevention. Precautions or contraindications for rabies vaccination. 2011. Available at https://www.cdc.gov/rabies/specific_groups/doctors/vaccination_precautions.html.
  4. Centers for Disease Control, “Recommendations of the Advisory Committee on Immunization Practices (ACIP): General Recommendations on Immunization,” MMWR Recomm Rep, 2002, 51(RR-2):1-36.
  5. Centers for Disease Control and Prevention, “Use of a Reduced (4-Dose) Vaccine Schedule for Postexposure Prophylaxis to Prevent Human Rabies,” MMWR Recomm Rep, 2010, 59(RR-2):1-9. Available at http://www.cdc.gov/mmwr/PDF/rr/rr5902.pdf [PubMed 20300058]
  6. HyperRAB (rabies immune globulin [human] injection) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2022.
  7. Imogam (rabies immune globulin [human] injection) [prescribing information]. Swiftwater, PA: Sanofi Pasteur; October 2014.
  8. Imogam Rabies - HT (rabies immune globulin [human] USP, injection) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; December 2020.
  9. Kedrab (rabies immune globulin [human] injection) [prescribing information]. Fort Lee, NJ: Kedrion Biopharma; received May 2021.
  10. Lang J and Plotkin SA, “Rabies Risk and Immunoprophylaxis in Children,” Adv Pediatr Infect Dis, 1997, 13:219-55. [PubMed 9544314]
  11. Manning SE, Rupprecht CE, Fishbein D, et al. Human rabies prevention--United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28. [PubMed 18496505]
  12. Strady A, Lang J, Lienard M, et al, “Antibody Persistence Following Pre-exposure Regimens of Cell-Culture Rabies Vaccines: 10-Year Follow-up and Proposal for a New Booster Policy,” J Infect Dis, 1998, 177(5):1290-5. [PubMed 9593014]
  13. Willoughby RE Jr and Hammarin AL, "Prophylaxis Against Rabies in Children Exposed to Bats," Pediatr Infect Dis Jp, 2005, 24(12):1109-10. [PubMed 16371876]
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