Hyperrab

— 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

    • Hyperrab Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rabies immune globulin (human) 300 IU/mL; soln for IM inj; preservative-free; latex-free.

    Pharmacological Class

    Immune globulin.

    How Supplied

    Single-dose vial (1mL, 3mL, 5mL)—1

    Storage

    • Store HyperRAB at 2 to 8°C (36 to 46°F). Do not freeze. 

    • HyperRAB may be stored at room temperatures not to exceed 25°C (77°F) for up to 6 months. 

    • Use within 6 months after removal from refrigeration at any time prior to the expiration date, after which the product must be used or discarded. Do not return to refrigeration. 

    • Do not use after expiration date printed on the label. Discard unused portion.

    Manufacturer

    Grifols Biologicals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    HyperRAB provides immediate, passive, rabies virus neutralizing antibody coverage until the previously unvaccinated patient responds to rabies vaccine by actively producing antibodies.

    Hyperrab Indications

    Indications

    Postexposure prophylaxis of rabies (along with rabies vaccine).

    Limitations of Use

    Only vaccinate persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer. For unvaccinated persons, the combination of HyperRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HyperRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

    Hyperrab Dosage and Administration

    Adult

    See full labeling. Give by IM inj preferably at the time of 1st vaccine dose; may be given through 7th day after 1st vaccine dose is given. Not previously vaccinated: 20 IU/kg (0.0665mL/kg) once. If feasible, up to full dose should be infiltrated in area around wound and the rest (if any) into deltoid muscle of upper arm or lateral thigh muscle.

    Adult

    Use HyperRAB in combination with rabies vaccine series to be effective. Do not use HyperRAB alone for prevention. Administer HyperRAB within 7 days after the first dose of rabies vaccine.

     

    Rabies Postexposure Prophylaxis Schedule

    Not previously vaccinated

    • Wound cleansing: 

      • Clean all wounds immediately and thoroughly with soap and water. Irrigate the wounds with a virucidal agent (eg, povidone-iodine solution, if available).

    • HyperRAB 20 IU/kg body weight OR 0.0665 mL/kg body weight as a single dose: 

      • Administer HyperRAB as soon as possible after exposure, preferably at the time of the first vaccine dose.

      • Infiltrate full dose thoroughly in the area around and into the wound(s), if anatomically feasible.

      • Inject the remainder, if any, intramuscularly at an anatomical site distant from the site of the vaccine administration.

      • Do not exceed the recommended dose.

    • Rabies vaccine:

      • Administer on day 0.

      • Complete the rabies vaccination series for previously unvaccinated persons.

    Previously vaccinated

    • Wound cleansing: 

      • Clean all wounds immediately and thoroughly with soap and water. Irrigate the wounds with a virucidal agent (eg, povidone-iodine solution, if available).

    • HyperRAB: Do not administer.

    • Rabies vaccine:

      • Administer on day 0.

      • Complete the rabies vaccination series for previously vaccinated persons.

    Children

    Not established.

    Administration

    • Administer HyperRAB at the time of the first vaccine dose (day 0), but no later than day 7.

    • Infiltrate the full dose of HyperRAB in the area around the wound (if feasible). Dilute HyperRAB with an equal volume of dextrose, 5% (D5W), if additional volume is needed to infiltrate the entire wound. Do not dilute with normal saline.

    • Insect the rest (if any) of the HyperRAB dose intramuscularly into the deltoid muscle of the upper arm or into the lateral thigh muscle, and distant from the site of vaccine administration.

    • Do not use HyperRAB with the same syringe or needle or in the same anatomic site as the vaccine.

    Hyperrab Contraindications

    Not Applicable

    Hyperrab Boxed Warnings

    Not Applicable

    Hyperrab Warnings/Precautions

    Warnings/Precautions

    Previously immunized with rabies vaccine with a confirmed adequate rabies antibody titer: not recommended. Contains human plasma; monitor for possible infection transmission. IgA-deficiency. Prior history of allergic reactions to human immunoglobulins. Have epinephrine inj available. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Hypersensitivity Reactions

    • Severe hypersensitivity reactions may occur. 

    • Increased risk of developing severe hypersensitivity and anaphylactic reactions in patients with a history of prior systemic allergic reactions to human immunoglobulin preparations or in patients with isolated immunoglobulin A (IgA) deficiency.

    • Have epinephrine available to treat acute allergic symptoms.

    Transmissible Infectious Agents

    • HyperRAB is purified from human plasma obtained from healthy donors and may carry risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the CJD agent.

    • Report all infections thought to have potentially been transmitted by this product to Grifols Therapeutics LLC [1-800-520-2807].

    Pregnancy Considerations

    Risk Summary

    • No available data to inform of drug-associated risk in pregnant women.

    • It is now known whether HyperRAB can cause fetal harm when given to a pregnant woman or can affect reproduction capacity.

    • Only administer HyperRAB to a pregnant women if it is clearly needed.

    Nursing Mother Considerations

    Risk Summary

    • No information regarding the presence of HyperRAB in human milk, the effect on the breastfed infant, or the effects on milk production.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HyperRAB and any potential adverse effects on the breastfed infant.

    Pediatric Considerations

    • Safety and efficacy in the pediatric population have not been established.

    Geriatric Considerations

    • Safety and efficacy in the geriatric population have not been established.

    Hyperrab Pharmacokinetics

    See Literature

    Hyperrab Interactions

    Interactions

    Do not administer repeated doses after administration of rabies vaccine; may suppress immune response to the vaccine. Avoid live vaccines for 4 months (eg, measles, mumps, polio, rubella).

    Hyperrab Adverse Reactions

    Adverse Reactions

    Inj site pain or nodule, headache, abdominal pain, diarrhea, flatulence, nasal congestion, oropharyngeal pain; hypersensitivity reactions.

    Hyperrab Clinical Trials

    Clinical Trials

    • Two clinical trials evaluated HyperRAB in 20 healthy adults who received a single IM dose of 20 IU/kg HyperRAB or HyperRAB S/D. Rabies neutralizing antibody titers were monitored in serum for 21 days.

    • Both HyperRAB formulations achieved detectable titers of neutralizing antibodies to the rabies virus that persisted throughout the 21 day study period.

    Hyperrab Note

    Not Applicable

    Hyperrab Patient Counseling

    Patient Counseling

    • Discuss the risks and benefits to the patient, before prescribing or administering it to the patient. 

    • Advise patients that severe, potentially life-threatening allergic reactions could occur in those who are allergic to human immune globulin products or in those who are deficient in IgA. 

    • Inform the patient that HyperRAB is made from human plasma and may carry a risk of transmitting infectious agents that can cause disease. 

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