Generic Name and Formulations:
Varicella zoster immune globulin (human) 125 IU; per vial; lyophilized pwd for IM inj after reconstitution; contains <250mg of total protein (mostly human IgG), <40mcg/mL of IgA; preservative- and mercury-free.
Emergent BioSolutions Inc.
Indications for VARIZIG:
Postexposure prophylaxis of varicella in high risk individuals (include immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants <1 year old, adults without evidence of immunity, pregnant women). To reduce severity of varicella.
Adults and Children:
See full labeling. Administer one single-dose by IM inj ideally within 96 hours of exposure. Based on patient size: divide dose and give in ≥2 inj sites; max 3mL per inj site. Inject into deltoid muscle or anterolateral aspects of the upper thigh. Avoid gluteal region; if needed, only use upper, outer quadrant. ≤2kg: 62.5 IU; 2.1–10kg: 125 IU; 10.1–20kg: 250 IU; 20.1–30kg: 375 IU; 30.1–40kg: 500 IU; ≥40.1kg: 625 IU. Consider 2nd full dose for high risk patients with additional exposure >3 weeks after initial dose.
IgA-deficiency with IgA antibodies and history of hypersensitivity. Previous severe reaction to human immune globulin.
Risk of thrombotic events: in patients with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, prolonged immobilization periods, and/or known/suspected hyperviscosity. Monitor baseline blood viscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies. Severe thrombocytopenia. Coagulation disorders. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers.
May affect response to live virus vaccines; may defer until 3 months after Varizig administration.
Inj site pain, headache, chills, fatigue, rash, nausea; hypersensitivity reactions (discontinue if occurs).
Kit—1 (vial + diluent)