Varizig

Generic name: varicella zoster immune globulin
Drug class: Immune globulins

Medically reviewed by  A Ras MD.

What is Varizig used for?

Varizig is a prescription medicine that is used to decrease how bad chickenpox infection.

Description

VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles).

VARIZIG is intended for single use and should be administered intramuscularly [see 2 DOSAGE AND ADMINISTRATION].

The product potency is expressed in IU by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 IU of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative.

The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG.

The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per milliliter.

The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova® 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses.

The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies.The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general.

 

Table 2 Virus Reduction Values (Log10) Obtained through Validation Studies

Enveloped

Non-Enveloped

Genome

RNA

DNA

RNA

DNA

Virus

HIV-1

BVDV

PRV

HAV

EMC

MMV

PPV

Family

retro

flavi

herpes

picorna

parvo

Size (nm)

80–100

50–70

120–200

25–30

30

20–25

18–24

Anion Exchange Chromatography (partitioning)

Not evaluated

2.3

n.e.

3.4

n.e.

20N Filtration (size exclusion)

≥4.7

≥3.5

≥5.6*

n.e.

4.8

n.e.

4.1

Solvent/Detergent (inactivation)

≥4.7

≥7.3

≥5.5

Not evaluated

Total Reduction (log10)

≥9.4

≥10.8

≥11.1

2.3

4.8

3.4

4.1

*The PRV was retained by the 0.1 µm pre-filter during the virus validation. Since manufacturing employs a 0.1 µm pre-filter before the 20N filter, the claim of ≥5.6 reduction is considered applicable.

Abbreviations:

HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2

BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV)

PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes

HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general

EMC: encephalomyocarditis virus; model for HAV and for small non-enveloped viruses in general

MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general

n.e.: not evaluated

Mechanism of Action

VARIZIG provides passive immunization for non-immune individuals exposed to VZV, reducing the severity of varicella infections (5).

Before taking Varizig, tell your doctor:

  • If you are allergic to Varizig; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have IgA deficiency.
  • If you have any of these health problems: Bleeding problems or low platelet count.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Varizig with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Varizig?

  • Tell all of your health care providers that you take Varizig. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Talk with your doctor before getting any vaccines while you take Varizig and after you stop taking it. Vaccine use with Varizig may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
  • If you are 65 or older, use Varizig with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Varizig while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Varizig best taken?

Use Varizig as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of Varizig that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • The chance of blood clots may be raised with Varizig. The chance may be higher in older people, if you have to be in a bed or chair for a long time, if you take estrogen products, or if you have certain catheters. Some health problems like thick blood, heart problems, or a history of blood clots raise the chance of having blood clots. Blood clots can happen if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.

What are some other side effects of Varizig?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Varizig?

  • If you need to store Varizig at home, talk with your doctor, nurse, or pharmacist about how to store it

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

 

53270-0126-1 Vial Label
Outer Carton Label 53270-0126-2

SRC: NLM .

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