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VARIZIG（Varicella Zoster Immune Globulin (Human)）for intramuscular

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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

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 Administration)

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 the injection site (3%) and headache (2%) (6).

To report SUSPECTED ADVERSE REACTIONS, contact Cangene Corporation at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

∘ Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary ( 7). USE IN SPECIFIC POPULATIONS

∘: Pregnancy: Use only if clearly needed ( 8.1)
∘: Nursing Mothers: Caution should be exercised ( 8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2015

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation and Handling

2.2 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Events

5.2 Coagulation Disorders

5.3 Hypersensitivity

5.4 Transmissible Infectious Agents

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Immunocompromised Patients

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

14 CLINICAL STUDIES

14.1Pregnant Women Exposed to Varicella Zoster Virus

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

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 marrow transplantation.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Preparation and Handling

Each vial of VARIZIG contains a minimum potency of 125 IU in 1.2 mL.

Bring VARIZIG to room temperature prior to use.

Inspect VARIZIG for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.

VARIZIG is for single use only. Discard any unused portion.

Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in Table 1.

The minimum dose is 62.5 International Units (IU) for small infants under two kilograms body weight; the maximum dose of 625 IU should be administered for all patients greater than 40 kilograms in weight.

Table 1 VARIZIG Dose and Volume of Administration
Weight of Patient		VARIZIG Dose		Volume to Administer* (milliliters)
Kilograms	Pounds	IU	Number of Vials	Volume to Administer* (milliliters)
≤2.0	≤4.4	62.5	0.5	0.6
2.1–10.0	4.5–22.0	125	1	1.2
10.1–20.0	22.1–44.0	250	2	2.4
20.1–30.0	44.1–66.0	375	3	3.6
30.1–40.0	66.1–88.0	500	4	4.8
≥40.1	≥88.1	625	5	6.0
*Extractable volumes are confirmed using a 21 gauge needle as per USP General Chapters <1> Injections.

Consider a second full dose of VARIZIG for high risk patients who have additional exposures to varicella greater than three weeks after initial VARIZIG administration.

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