Country: United States
Language: English
Source: NLM (National Library of Medicine)
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN (UNII: 33T61IWL27) (HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN - UNII:33T61IWL27)
Cangene BioPharma
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN 1.25 [iU] in 1 mL
INTRAMUSCULAR
VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: VARIZIG administration is intended to reduce the severity of varicella. Administer VARIZIG as soon as possible following varicella zoster virus (VZV) exposure, ideally within 96 hours for greatest effectiveness. Pregnancy category C. Animal reproduction studies have not been conducted with VARIZIG. It also is not known whether VARIZIG can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VARIZIG should be given to a pregnant woman only if clearly needed. The safety and effectiveness of VARIZIG have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 ADVERSE REACTIONS and 14 CLINICAL STUDIES]. It is not known whether VARIZIG is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VARIZIG is administered to a nursing moth
NDC 53270-0126-2: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 IU of anti-VZV in a 3 mL type 1 glass tubing vial fitted with a 13 mm rubber stopper and a 13 mm flip-off seal, and a package insert. Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.
Biologic Licensing Application
VARIZIG- VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN) LIQUID CANGENE BIOPHARMA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VARIZIG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARIZIG. VARIZIG [VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN)] FOR INTRAMUSCULAR ADMINISTRATION ONLY. STERILE SOLUTION FOR INJECTION INITIAL U.S. APPROVAL: 2012 RECENT MAJOR CHANGES Dosage and Administration, Preparation and Handling (2.1) INDICATIONS AND USAGE VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high risk individuals (1). High risk groups include: DOSAGE AND ADMINISTRATION INTRAMUSCULAR USE ONLY. Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in the following table (2.1): WEIGHT OF PATIENT (KG) DOSE (IU) NUMBER OF VIALS ≤2.0 62.5 0.5 2.1–10.0 125 1 10.1–20.0 250 2 20.1–30.0 375 3 30.1–40.0 500 4 >40.1 625 5 Discard any partial vials. The intramuscular dose should be divided and administered in two sites, dependent on patient size. Do not exceed 3 mL per injection site (2.2) DOSAGE FORMS AND STRENGTHS VARIZIG is supplied as a sterile solution for intramuscular injection and is available in a single-use vial of 125 IU in 1.2 mL (3). CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ® ® immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, infants less than one year of age, adults without evidence of immunity, pregnant women. VARIZIG administration is intended to reduce the severity of varicella. History of anaphylactic or severe systemic reactions to human immune globulins (4). IgA-deficient patients with antibodies against IgA and a history of hypersensitivity (4). Thrombotic events (5.1) Coagulation disorders (5.2) ADVERSE REACTIONS Most common adverse reactions from clinical trials are pain at the injection site (3%) and headache (2%) (6). To report SUSPECTED AD Read the complete document