VARIZIG- human varicella-zoster immune globulin injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Kamada Ltd.

Administreringsrute:

INTRAMUSCULAR

Indikasjoner:

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. - Individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG. - IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction. - VARIZIG contains less than 40 micrograms per milliliter of IgA. 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 6ADVERSE REACTIONS and 14CLINICAL 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 mother. The dosing recommendations in the treatment of pediatric patients are by body weight [see 2DOSAGE AND ADMINISTRATION ]. The safety and effectiveness of VARIZIG have been evaluated for post-exposure prophylaxis in the VARIZIG expanded access clinical trial in 374 pediatric patients, including immunocompromised pediatric patients: - 94 preterm newborns and infants, - 53 term newborns, - 45 infants and toddlers, - 176 children and, - 43 adolescents. In the EAP, follow up data were available for 110 VARIZIG treatments in infants (including newborns, pre-term infants, and infants less than 1 year old). Three severe infections were reported, all three with pox count greater than 100, one of which also had pneumonia and another one also developed probable varicella encephalitis. Clinical studies of VARIZIG administered intramuscularly for post-exposure prophylaxis did not include sufficient numbers of geriatric subjects (aged 65 and over) to determine whether they respond differently from younger subjects. Use caution when administering VARIZIG to patients aged 65 and over who are judged to be at increased risk of thrombotic events [see 5WARNINGS AND PRECAUTIONS ]. Do not exceed recommended doses and administer VARIZIG intramuscularly only. In the EAP, both adult (n=37) and pediatric immunocompromised subjects (n=235) were treated. Twelve immunocompromised subjects developed clinical varicella and none developed varicella pneumonitis; however at least five are reported to have received concomitant acyclovir and due to incomplete reporting, it is not known if others also received acyclovir.

Produkt oppsummering:

NDC 49591-126-51: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 international units of anti-VZV in a glass tubing vial and a package insert. Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

VARIZIG- HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN INJECTION, SOLUTION
KAMADA LTD.
----------
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
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):
≤: less than or equal to
>: greater than
WEIGHT OF PATIENT (KG)
DOSE (INTERNATIONAL UNITS)
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 international units 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