VARIZIG (varicella zoster immune globulin- human solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN (UNII: 33T61IWL27) (HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN - UNII:33T61IWL27)

Available from:

Aptevo BioTherapeutics LLC

INN (International Name):

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN

Composition:

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN 125 [iU]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. 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. - There is no convincing evidence that VARIZIG reduces the incidence of chickenpox infection after exposure to VZV. - There is no convincing evidence that established infections with VZV can be modified by VARIZIG administration. - There is no indication for the prophylactic use of VARIZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

Product summary:

NDC 70504-0126-2: 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VARIZIG- VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN) SOLUTION
APTEVO BIOTHERAPEUTICS LLC
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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:
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.
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
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).
WARNINGS AND PRECAUTIONS
Thrombotic events (5.1)
Coagulation disorders (5.2)
Hypersensitivity (5.3)
Transmissible infectious agents (5.4)
ADVERSE REACTIONS
Most common adverse reactions from clinical trials are pain at t