Data from FDA - Curated by EPG Health - Last updated 25 July 2017

Indication(s)

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. CNJ-016 is an Immune Globulin Intravenous (Human), 5% Liquid, indicated for the treatment of complications due to vaccinia vaccination (1), including: •Eczema vaccinatum •Progressive vaccinia •Severe generalized vaccinia •Vaccinia infections in individuals who have skin conditions •Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis) CNJ-016 is not indicated for isolated vaccinia keratitis or postvaccinial encephalitis (1).

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Advisory information

contraindications
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). •Isolated vaccinia keratitis (4) •History of anaphylactic or severe systemic reaction to human globulins (4) •IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity (4)
Adverse reactions
6 ADVERSE REACTIONS Drug exposure to date has primarily been evaluated in healthy volunteers. The most common adverse reactions to VIGIV treatment (>10%) include headache, nausea, rigors and dizziness in clinical trials involving VIGIV. Although there were no serious adverse events reported in VIGIV clinical trials, there has been a post-marketing case of severe vaccinia infection that developed intravascular hemolysis, leukopenia and thrombocytopenia during VIGIV treatment. The most common adverse drug reactions to CNJ-016 (>10%) are headache, nausea, rigors and dizziness. 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 6.1 Clinical Trials Experience Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. In a safety/pharmacokinetics study, 60 healthy male and female volunteers received a single intravenous dose of either 6,000 Units per kg or 9,000 Units per kg VIGIV. The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both males and females enrolled in an approximate 50:50 ratio. In a pharmacodynamic study, 32 healthy male and female volunteers were randomized to receive vaccinia vaccination (n=10), VIGIV (9,000 Units per kg) 4 days prior to vaccinia vaccination (n=10), or VIGIV (9,000 Units per kg) concurrent with vaccinia vaccination (n=12). The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both male and female enrolled in a 75:25 ratio. The ethnic background of patients included those of Caucasian, African American, Asian and Hispanic descent, with the majority of them being Caucasian. In an additional pharmacodynamic clinical study, 50 healthy male and female volunteers were randomized to receive VIGIV at 9,000 Units per kg (n=20) or at 24,000 Units per kg (n=20) or placebo (n=10) 4 days prior to vaccinia vaccination (n=30) or placebo (n=20). The population consisted of vaccinia vaccination-naïve male and female subjects, ages 18 to 33, in a 60:40 ratio. The ethnic background of patients included those of Caucasian, African American, and Hispanic descent, with the majority of them being African American. The most frequently reported adverse reactions related to VIGIV administration in all three clinical studies were headache, nausea, rigors, and dizziness. Table 1 describes the adverse reactions that were temporally related to VIGIV or placebo administration that occurred during or within three days of product infusion with a frequency of 5% or higher in any one treatment group. Table 1 Adverse Drug Reactions that Occurred TemporallyAdverse events that occurred during or within 3 days of VIGIV or placebo administration. During or Following VIGIV Administration (≥5%) SYSTEM ORGAN CLASS PREFERRED TERM CNJ-016 (%) PLACEBO 0.9% NaCl infused at 2 mL/min. N=32 (%) 6,000 U/kg Infusion rate: 4 mL/min; subjects were fasted. N=31 9,000 U/kg Infusion rate: 4 mL/min or 2 mL/min; subjects were fasted. N=39 9,000 U/kg Infusion rate: 2 mL/min; subjects were not fasted. N=20 24,000 U/kg N=20 All Body System All Preferred Terms 19 (61.3) 30 (76.9) 2 (10.0) 5 (25.0) 4 (12.5) Gastrointestinal Disorders Nausea 4 (12.9) 11 (28.2) 0 (0.0) 0 (0.0) 1 (3.1) Vomiting NOS 1 (3.2) 3 (7.7) 0 (0.0) 0 (0.0) 0 (0.0) General Disorders and Administration Site Conditions Rigors 7 (22.6) 7 (17.9) 0 (0.0) 0 (0.0) 0 (0.0) Feeling cold 4 (12.9) 6 (15.4) 0 (0.0) 0 (0.0) 0 (0.0) Pain NOS 1 (3.2) 5 (12.8) 0 (0.0) 0 (0.0) 0 (0.0) Feeling hot 3 (9.7) 1 (2.6) 0 (0.0) 0 (0.0) 0 (0.0) Asthenia 2 (6.5) 2 (5.1) 0 (0.0) 0 (0.0) 1 (3.1) Pyrexia 2 (6.5) 1 (2.6) 0 (0.0) 0 (0.0) 0 (0.0) Fatigue 0 (0.0) 2 (5.1) 0 (0.0) 0 (0.0) 1 (3.1) Edema peripheral 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) Metabolism and Nutrition Disorders Appetite decreased NOS 2 (6.5) 2 (5.1) 0 (0.0) 0 (0.0) 0 (0.0) Musculoskeletal and Connective Tissue Disorders Muscle spasm 2 (6.5) 2 (5.1) 0 (0.0) 1 (5.0) 0 (0.0) Back pain 2 (6.5) 2 (5.1) 0 (0.0) 0 (0.0) 0 (0.0) Nervous System Disorders Headache 17 (54.8) 23 (59.0) 1 (5.0) 4 (20.0) 3 (9.4) Dizziness 5 (16.1) 7 (17.9) 1 (5.0) 0 (0.0) 1 (3.1) Paraesthesia 2 (6.5) 1 (2.6) 0 (0.0) 0 (0.0) 0 (0.0) Tremor 1 (3.2) 2 (5.1) 0 (0.0) 0 (0.0) 0 (0.0) Skin and Subcutaneous Tissue Disorders Sweating increased 3 (9.7) 2 (5.1) 0 (0.0) 0 (0.0) 0 (0.0) Vascular Disorders Pallor 1 (3.2) 3 (7.7) 0 (0.0) 0 (0.0) 0 (0.0) Most adverse reactions were of mild intensity (defined in study protocols as awareness of a sign or symptom but subject can tolerate). One subject in the 9,000 Units per kg dosage group experienced syncope. There was a lower incidence of adverse reactions when VIGIV (9,000 Units per kg) was infused at 2 mL/min than 4 mL/min. There was a higher incidence of adverse reactions after administration of VIGIV in fasted subjects compared to subjects that were not fasted overnight. There were no serious adverse reactions or adverse reactions of severe intensity in the clinical studies. There were no instances of VIGIV discontinuation due to an adverse event, or reduction in dose or infusion rate. 6.2 Post-marketing Experience Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to exposure to the product. This is also the case with literature reports authored independently. There has been a case of severe vaccinia infection that developed intravascular hemolysis, leukopenia and thrombocytopenia while receiving VIGIV. However, the hemolysis did not reoccur with continued VIGIV dosing. The following is a list of adverse reactions that have been identified and reported during the post-approval use of other IGIV products: • Infusion reactions: Hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure • Renal: Acute renal dysfunction/failure, osmotic nephropathy • Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm • Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension • Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome • Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis) • Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test • Gastrointestinal: Hepatic dysfunction, abdominal pain • General/Body as a Whole: Pyrexia, rigors

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For intravenous use only. •For intravenous use. •CNJ-016 is administered at a dose of 6,000 Units per kg, as soon as symptoms for complication(s) due to vaccinia vaccination appear (2.1). •Higher doses (e.g. 9,000 Units per kg or 24,000 Units per kg) may be considered in the event that the patient does not respond to the initial dose of 6,000 Units per kg (2.1). •For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg (2.3 Administration). 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].
Use in special populations
8 USE IN SPECIFIC POPULATIONS NA 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with VIGIV; therefore, it is not known whether VIGIV can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. However, immune globulins have been widely used during pregnancy for many years without any apparent negative reproductive effects (4). The risk/benefit of VIGIV administration should be assessed for each individual case. 8.3 Nursing Mothers It is not known whether VIGIV is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VIGIV is administered to a nursing mother. 8.4 Pediatric Use Safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for VIGIV. 8.5 Geriatric Use Safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for VIGIV. 8.6 Renal Insufficiency Use VIGIV with caution in patients with pre-existing renal insufficiency and in patients at increased risk of developing renal insufficiency [see 5.8 Acute Renal Dysfunction/Failure].
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether VIGIV is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VIGIV is administered to a nursing mother.

Interactions

7 DRUG INTERACTIONS •Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary (7.1) •Antibodies in CNJ-016 may interfere with some serological tests (7.2) 7.1 Live, Attenuated Vaccines Immune globulin administration may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and varicella. Defer vaccination with live virus vaccines until approximately three months after administration of VIGIV. Revaccinate people who received VIGIV shortly after live virus vaccination three months after the administration of the VIGIV. 7.2 Drug/Laboratory Interactions •VIGIV contains maltose, which can be misinterpreted as glucose by certain types of blood glucose testing systems (for example, those based on the GDH-PQQ or glucose-dye-oxidoreductase methods). Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving VIGIV [see BOXED WARNING and 5.2 Interference with Blood Glucose Testing ]. •Antibodies present in VIGIV may interfere with some serological tests. After administration of immune globulins like VIGIV, a transitory increase of passively transferred antibodies in the patient’s blood may result in positive results in serological testing (e.g. Coombs’ test) [see 5.5 Hemolysis ].

More information

Category Value
Authorisation number BLA125109
Agency product number 7UB4J759TD
Orphan designation No
Product NDC 60492-0173
Date Last Revised 03-03-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1922334
Marketing authorisation holder Cangene Corporation
Warnings 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 ]. WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS See full prescribing information for complete boxed warning Blood glucose measurement in patients receiving Vaccinia Immune Globulin Intravenous (Human) (VIGIV) must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Maltose in IGIV products may give falsely high blood glucose levels in certain types of blood glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.