HYPERRAB Solution for injection (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

GRIFOLS USA, LLC

Λέξεις κλειδιά

13533-318

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1. Indications and Usage

HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitation of Use: Persons who have ...

2. Dosage and Administration

For infiltration and intramuscular use only. The strength of HYPERRAB is 300 IU/mL. 2.1 Dose Use HYPERRAB in combination with rabies vaccine series to be effective. Do not use HYPERRAB alone ...

3. Dosage Forms and Strengths

HYPERRAB is a sterile, 300 IU/mL solution for injection supplied in 1 mL, 3 mL and 5 mL single-dose vials. The 1 mL vial is sufficient for a child weighing 15 kg. The 3 mL vial is sufficient for a person ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater ...

6. Adverse Reactions

The most common adverse reactions in >5% of subjects during clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

There are no data on the postmarketing use of HYPERRAB (300 IU/mL). The following adverse reactions have been identified during post approval use of the predecessor formulation, HYPERRAB S/D. Because these ...

7. Drug Interactions

Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.(1) Other antibodies ...

8.1. Pregnancy

Risk Summary There are no data with HYPERRAB use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with HYPERRAB. It is not known whether HYPERRAB ...

8.2. Lactation

Risk Summary There is no information regarding the presence of HYPERRAB in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding ...

8.4. Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5. Geriatric Use

Safety and effectiveness in geriatric population have not been established.

10. Overdosage

Because Rabies Immune Globulin (Human) may partially suppress active production of antibody in response to the rabies vaccine, do not give more than the recommended dose of rabies immune globin (human).(1) ...

11. Description

HYPERRAB is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of human antirabies immune globulin for infiltration and intramuscular administration. HYPERRAB ...

12.1. 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.(1)

12.2. Pharmacodynamics

The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in ...

12.3. Pharmacokinetics

In a clinical study of 12 healthy human subjects receiving a 20 IU/kg intramuscular dose of HYPERRAB detectable passive rabies neutralizing antibody was present by 24 hours and persisted through the 21 ...

14. Clinical Studies

HYPERRAB was administered to a total of 20 healthy adult subjects in two clinical trials [see Clinical Pharmacology (12.3)]. A single intramuscular dose of 20 IU/kg HYPERRAB (12 subjects) or HYPERRAB ...

15. References

Centers for Disease Control and Prevention. Human rabies prevention — United States, 2008: Recommendations of the Advisory Committee on Immunization Practices. MMWR. 2008;57(RR03):1-26, 28. World Health ...

16.1. How Supplied

HYPERRAB is supplied in 1 mL, 3mL and 5 mL singledose vials with a potency value of not less than 300 IU/mL. HYPERRAB contains no preservative and is not made with natural rubber latex. NDC Number Size ...

16.2. Storage and Handling

Store HYPERRAB at (2 to 8°C, 36 to 46°F). Do not freeze. Do not use after expiration date. Discard unused portion.

17. Patient Counseling Information

Discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Inform the patient who is allergic to human immune globulin products that severe, ...