VariZig

VARIZIG- human varicella-zoster immune globulin solution
Saol Therapeutics Inc.

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

*Extractable volumes are confirmed using a 21 gauge needle as per USP General Chapters <1> Injections.

Weight of Patient VARIZIG Dose Volume to Administer* (milliliters)
Kilograms Pounds IU Number of Vials
≤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

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.

2.2 Administration

For intramuscular use only.

Divide the intramuscular dose and administer in two or more injection sites, depending on patient size. Do not exceed 3 milliliters per injection site.

Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant.

To prevent the transmission of infectious agents from one person to another, use a new disposable sterile syringe and needle for each individual patient.

3 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. Each 125 IU vial of VARIZIG contains less than 156 milligrams of total protein, mostly human immune globulin G (IgG). VARIZIG contains no preservative and is intended for single use only. VARIZIG does not contain mercury.

4 CONTRAINDICATIONS

  • 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.

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Events

Thrombotic events may occur during or following treatment with immune globulin products (1, 2, 3). Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

5.2 Coagulation Disorders

Administer VARIZIG intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG if the expected benefits outweigh the potential risks.

5.3 Hypersensitivity

Severe hypersensitivity reactions may occur following VARIZIG administration. Administer VARIZIG in a setting with appropriate equipment, medication and personnel trained in the management of hypersensitivity, anaphylaxis and shock. In the case of hypersensitivity, discontinue administration of VARIZIG immediately and provide appropriate treatment.

VARIZIG contains trace amounts of IgA (less than 40 micrograms per milliliter). Patients with known antibodies to IgA have a greater risk of severe hypersensitivity and anaphylactic reactions. VARIZIG is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reactions [see 4 CONTRAINDICATIONS ].

5.4 Transmissible Infectious Agents

Because VARIZIG is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The plasma donors are screened for the presence of certain infectious agents and the manufacturing process for VARIZIG includes measures to inactivate and remove certain viruses [see 11 DESCRIPTION]. Despite these measures, products derived from human plasma can still potentially transmit diseases. No cases of transmission of viral diseases, vCJD or CJD have been associated with the use of VARIZIG.

Report all infections thought by a physician to have been transmitted by VARIZIG to Saol Therapeutics at 1-833-644-4216. Discuss the risks and benefits of this product with the patient before administering it to the patient [see 17 PATIENT COUNSELING INFORMATION].

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