Varicella-Zoster Immunoglobulin

Registered South African indications:

• Prophylaxis of varicella

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Not indicated for adults and children who are immune to varicella-zoster virus
• Although varicella-zoster immunoglobulin may prevent infection in healthy children, it is not indicated, as the ensuing natural infection is usually mild
• Varicella-zoster immunoglobulin is not indicated for the treatment of clinical varicella (chickenpox) or herpes zoster (shingles), or for the prevention of disseminated zoster

Cautions

• Pregnancy
• Breastfeeding
• Intravascular administration
• Immunoglobulin A deficiency

Forms avail. in SA and covered in this monograph: inj

Prophylaxis of varicella in high risk patients who have been exposed to the varicella-zoster virus, including:
- Pregnant women with negative varicella–zoster virus immune status especially up to early in the third trimester
- Neonates whose mothers developed varicella infection within 7 days before or 7 days after delivery
- Neonates whose mothers have no history of varicella and/or a negative immune status
- Premature infants < 28 weeks of gestation or newborns with low birth weight
- Adults and children with no history of varicella and/or a negative immune status, receiving immunosuppressive therapy or who have congenital or acquired immunodeficiency disorders

• IM: > 15 IU/kg as soon as possible, but ideally not more than 96 hours after exposure

See additional prescribing points

See adult dosage

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; no information available

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache
• Malaise

Cardiovascular Disorders

• Tachycardia
• Hypotension

Gastrointestinal Disorders

• Nausea and vomiting

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Skin reaction
• Erythema
• Pruritus
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactic shock
• Fever

• Live attenuated virus vaccines
• Serological tests

None routine. Specific cases may require

• Haematocrit 

Administration directions

• Warm the ampoule to body temperature before injecting intramuscularly
• Usual recommended site for adults is the deltoid
• Usual recommended site for infants is the lateral aspect of the thigh
• If a large volume (> 2 ml for children or > 5 ml for adults) is required, it is recommended that this be administered in divided doses, at different anatomical sites
• Must not be mixed with other medicinal products

Notes on use of Human Varicella-Zoster Immunoglobulin

• Whenever possible, contacts without a definite history of chickenpox should be screened for antibody by a sensitive test (e.g. ELISA, radioimmunoassay or immunofluorescence)
• There is no need to test neonates for antibody
• If antibodies to Varicella-Zoster virus are detectable, Human Varicella-Zoster Immunoglobulin is generally NOT needed
• The following infants will possess maternal antibody and do NOT require Human Varicella-Zoster Immunoglobulin:
  • Infants born more than seven days after the onset of maternal chickenpox
  • Infants whose mothers have a positive history of chickenpox and/or a positive antibody result
  • Infants whose mothers develop zoster (shingles) before or after delivery

Human Varicella-Zoster immunoglobulin contains mainly immunoglobulin G, with a specifically high content of antibodies against varicella-zoster virus. These antibodies are thought to bind to proteins on the varicella virus, preventing or reducing the severity and progression of varicella infections.

Injection (per ml) 100 IU

• Vazigam (NBI)