CNJ-016

CNJ-016- human vaccinia virus immune globulin injection
Cangene Corporation

WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS

Blood glucose measurement in patients receiving VIGIV must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase method (monitor and test strips) must not be used for blood glucose testing in patients receiving VIGIV, since maltose in IGIV products has been shown to give falsely high blood glucose levels in these testing systems. This could result in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.

Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products [see 5.2 Interference with Blood Glucose Testing].

1 INDICATIONS AND USAGE

CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) is indicated for the treatment and/or modification of the following conditions:

Eczema vaccinatum
Progressive vaccinia
Severe generalized vaccinia
Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.

Exercise caution when using VIGIV in the treatment of patients having complication due to vaccinia vaccination that include concomitant vaccinia keratitis, since a single study in rabbits has demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis (1).

VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis.

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

2.1 Dosage for Treatment of Severe Complications of Vaccinia Vaccination

VIGIV should be administered at a dose of 6,000 Units per kg, as soon as symptoms appear and are judged to be due to severe vaccinia-related complication. Consideration may be given to repeat dosing, depending on the severity of the symptoms and response to treatment; however, clinical data on repeat doses are lacking. The administration of higher doses (e.g. 9,000 Units per kg) may be considered in the event that the patient does not respond to the initial 6,000 Units per kg dose. In clinical trials, doses of up to 24,000 Units per kg administered to healthy volunteers were well tolerated [see 14 CLINICAL STUDIES].

2.2 Preparation

Visually inspect parenteral products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use CNJ-016 if the solution is turbid.
DO NOT SHAKE VIAL. SHAKING VIAL MAY CAUSE FOAMING.
Remove the entire contents of the vial to obtain the labeled dosage of CNJ-016. If partial vials are required for the dosage calculation, the entire contents of the vial should be withdrawn to ensure accurate calculation of the dosage requirement.
CNJ-016 is compatible with 0.9% Sodium Chloride USP. No other drug interactions or compatibilities have been evaluated. If a pre-existing catheter must be used, the line should be flushed with 0.9% Sodium Chloride USP before use. Do not dilute more than 1:2 (v/v).
CNJ-016 vial is for single use only. Do not reuse or save CNJ-016 for future use.
CNJ-016 contains no preservatives. Discard partially used vials.

2.3 Administration

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. CNJ-016 should not be used if the solution is turbid.
Administer CNJ-016 intravenously through a dedicated intravenous line with the rate of infusion of no greater than 2 mL/min.
The maximum rate of infusion utilized for CNJ-016 is 4 mL/min [see 6.1 Clinical Trials Experience].
For patients weighing less than 50 kg, infuse the product at a rate no greater than 0.04 mL/kg/minute (133.3 Units per kg/minute).
Slower infusion rate may be needed for patients who develop a minor adverse reaction (e.g. flushing) or for patients with risk factors for thrombosis/thromboembolism.
For patients with pre-existing renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload, do not exceed the recommended infusion rate and follow the infusion schedule closely.
For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg [see 5.3 Thrombotic Events].

3 DOSAGE FORMS AND STRENGTHS

Solution of gamma globulin (5% or 50 mg/mL)
20 mL single-dose vial containing antibodies to vaccinia virus at ≥50,000 Units per vial

4 CONTRAINDICATIONS

VIGIV is contraindicated in isolated vaccinia keratitis.
VIGIV is contraindicated in individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations.
VIGIV is contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity, as it contains trace amounts of IgA (40 mcg/mL).

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Severe immediate hypersensitivity reactions to plasma-derived products may occur, for example, in patients with IgA deficiency or hypersensitivity to human globulin. Although acute systemic allergic reactions were not seen in clinical trials with VIGIV [see 6.1 Clinical Trials Experience], administer the product only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. In case of hypotension, allergic or anaphylactic reaction, discontinue the administration of VIGIV immediately and give supportive care as needed. In case of shock, observe the current medical standards for shock treatment.

5.2 Interference with Blood Glucose Testing

Some types of blood glucose testing systems (for example those based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods) could falsely interpret the maltose contained in VIGIV as glucose [see BOXED WARNING]. This could result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Accordingly, when administering VIGIV or other parenteral maltose-containing products, measure blood glucose with a glucose-specific method.

Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.

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