rabies immune globulin, human (RIG) (Rx)

>10%

Injection site pain (33%)

Headache (15%)

1-10%

Muscle pain (9%)

Upper respiratory tract infection (9%)

Joint pain (6%)

Dizziness (6%)

Fatigue (6%)

Abdominal pain (4%)

Blood in urine (4%)

Nausea (4%)

Feeling faint (4%)

Bruising (3%)

Sunburn (3%)

WBCs in urine (3%)

Contraindications

None

Cautions

Patients who can document previous complete rabies pre-exposure prophylaxis or complete postexposure prophylaxis should only receive a booster rabies vaccine without RIG, owing to RIG interference with anamnestic response to the vaccine

Hemolysis may occur, particularly in individuals at high risk (eg, thrombocytopenia, bleeding disorders)

Monitor patients at increased risk of thrombosis or thrombotic complications for at least 24 hr

Caution with prior allergic reactions to immune globulins (RIG contains small quantity of IgA)

Avoid immunization with measles vaccine within 4 months after RIG; avoid other live attenuated vaccines for 3 months

Do NOT give IV; do not inject into a blood vessel because of the risk of severe allergic or hypersensitivity reaction, including decreased blood pressure and anaphylactic shock

A transient rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results of serologic tests; passive transmission of antibodies to erythrocyte antigens (eg, A, B, and D), may interfere with serologic tests for red cell antibodies such as the antiglobulin test (Coombs test)

RIG is derived from human plasma; therefore, the potential exists for viral transmission (eg, CJD)

Pregnancy

Has not been studied in pregnant women

Animal and reproductive studies have not been conducted

Lactation

Unknown if excreted in human milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Human immune globulins from donors

Pharmcokinetics

Half-life: 17.9 days

Peak plasma time: 7 days (range: 3-14 days)

Injection

Infiltrate locally around bite; inject any remaining volume IM into the upper arm deltoid region or, in small children, into the anterolateral aspect of the thigh

If IM administration is contraindicated (eg, in patients with uncorrectable bleeding disorders), administer RIG by SC injection (there are no clinical efficacy data to support SC route)

Always administer in conjunction with rabies vaccine (HDCV); however, do not administer into the same anatomical sites as rabies vaccine

Preferably give concomitantly with vaccine but may be given through 7th day after first dose of vaccine

Do not give repeated doses of RIG once rabies vaccine treatment has started, since this may interfere with the immune response to the rabies vaccine

Do not administer RIG to patients with a history of a complete pre-exposure or postexposure vaccination regimen and confirmed adequate rabies antibody titer

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