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CNJ-016 Vaccinia Immune Globulin Intravenous (Human) 1 [iU]/mL Injection — NDC 60492-0173-2 (Billing 60492-0173-02)

by Emergent BioSolutions Canada Inc. · 24 VIAL, SINGLE-USE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-USE

This is a package of CNJ-016 Vaccinia Immune Globulin Intravenous (Human) 1 [iU]/mL Injection from Emergent BioSolutions Canada Inc., marketed since May 2005 and currently FDA-listed. It is this product's only package size.

NDC 60492-0173-02
🏷️ FDA NDC (as labeled) 60492-0173-2 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 60492-0173-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60492 labeler · 0173 product · 2 package
Package marketed since
Jan 12, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0360492017321
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60492-0173-2
Product NDC 60492-0173
11-digit billing NDC 60492017302
NCPDP billing unit EA — each (per item)
RxCUI 1922329, 1922334
UNII 7UB4J759TD
UPC 0360492017321
Application # BLA125109
SPL Set ID a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe
Established class (EPC) Human Immunoglobulin G
Mechanism of action Virus Neutralization
Physiologic effect Passively Acquired Immunity
Chemical class Immunoglobulins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-05-02
Route INTRAVENOUS
Dosage form INJECTION
Substance HUMAN VACCINIA VIRUS IMMUNE GLOBULIN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 083769
GCN 52825
HICL code 006559
Ingredient (HICL) Vaccinia Immune Globulin Human
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name CNJ-016 VIAL (STOCKPILE)
FDB brand name Cnj-016 (National Stockpile)
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083769
  • GCN: 52825
  • HICL (First Databank): 006559
  • AHFS class code: 80:04.00.00
  • RxCUI (RxNorm): 1922329
Why two NDCs? The FDA registers this code as 60492-0173-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60492-0173-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Human Immunoglobulin G class.

Pharmacologic class Human Immunoglobulin G
Drug family (ATC) Specific immunoglobulins
How it works Virus Neutralization
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CNJ-016 VIAL (STOCKPILE) Ingredient Vaccinia Immune Globulin Human

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60492-0173-02 You're viewing this Main listing 24 VIAL, SINGLE-USE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-USE 2018-01-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cnj-016 1 [iU]/mLthis 60492-0173-02 Emergent 24 vials — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2005
First FDA approval
May 2005
📍
2026
Currently FDA-listed
21 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Cnj-016Vaccinia Immune Globulin Intravenous (Human)
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEmergent BioSolutions Canada Inc.
FDA applicationBLA125109 (BLA)
Labeler code60492
First marketedMay 2005
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Emergent BioSolutions Canada Inc. labeler code 60492

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

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

5.3Blood Glucose Monitoring ]. WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS See full prescribing information for complete boxed warning. Blood glucose measurement in patients receiving VIGIV (vaccinia immune globulin intravenous, human) 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.

🎯 Indications and Usage 175 words ▾

1 INDICATIONS AND USAGE VIGIV (vaccinia immune globulin intravenous, human) 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.

VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis. VIGIV is an Immune Globulin (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) VIGIV is not indicated for postvaccinial encephalitis ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous use only. • For intravenous use only. • VIGIV is administered at a dose of 6000 Units per kg, as soon as symptoms for complication(s) due to vaccinia vaccination appear ( 2.1 ). • Higher doses (e.g. 9000 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 6000 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 ).

2.1Dosage for Treatment of Severe Complications of Vaccinia Vaccination Administer VIGIV at a dose of 6000 Units per kg, as soon as symptoms appear and are judged to be due to severe vaccinia-related complication. Consider repeat dosing, depending on the severity of the symptoms and response to treatment; however, clinical data on repeat doses are lacking. Consider higher doses (e.g.

9000 Units per kg) if the patient does not respond to the initial 6000 Units per kg dose. Doses up to 24,000 Units per kg administered to healthy volunteers were well tolerated in clinical trials [see 14 CLINICAL STUDIES ].

2.2Preparation • Bring VIGIV vials to room temperature prior to dosing. • If frozen, thaw vial by placing in a refrigerator at 2°C to 8°C (36°F to 46°F) until the contents are thawed for approximately 14 hours. Product can be thawed rapidly by placing at room temperature for one hour followed by a water bath at 37°C (98.6°F ) until thawed. • Do not thaw this product in a microwave oven. • Do not refreeze the vial. • DO NOT SHAKE VIAL. SHAKING VIAL MAY CAUSE FOAMING. • Remove the entire contents of the vial to obtain the labeled dosage of VIGIV.

If partial vials are required for the dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement. • VIGIV 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, flush the line with 0.9% Sodium Chloride USP before use.

VIGIV may be administered either undiluted or diluted no more than 1:2 (v/v). • VIGIV vial is for single use only. Do not reuse or save VIGIV for future use. • VIGIV contains no preservatives. Discard partially used vials.

2.3Administration • Inspect the product prior to use and do not use if solution is cloudy, discolored or contains particulates. • Administer VIGIV intravenously through a dedicated intravenous line with the rate of infusion of no greater than 2 mL/min. • 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). • Adverse drug reactions may be related to the rate of infusion. 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. • Closely monitor and carefully observe patients and their vital signs for any symptoms throughout the infusion period and immediately following an infusion. • 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

5.4Thrombosis ].

💊 Dosage Forms and Strengths 48 words ▾

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 Sterile solution available as 20 mL single-use vial containing a dose of ≥50,000 Units per vial ( 3 ).

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS VIGIV is contraindicated in: • Isolated vaccinia keratitis. • Individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. • 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 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity to human immune globulin (acute anaphylaxis) ( 5.1 ) • Acute renal dysfunction/failure ( 5.2 ) • Thrombosis may occur with immune globulin products, including VIGIV. For patients at risk of thrombosis, administer VIGIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.

Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity ( 5.4 ) • Hemolysis or hemolytic anemia ( 5.5 ) • Aseptic meningitis syndrome (AMS) ( 5.6 ) • Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] ( 5.7 ) • Transmission of infectious agents from human plasma ( 5.8 ) • Monitor renal function and urine output in patients at risk of renal failure; check baseline blood viscosity in patients at risk of hyperviscosity; and conduct confirmatory tests if hemolysis or TRALI is suspected ( 5.9 )

5.1Hypersensitivity 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

6.1Clinical 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.

5.2Acute Renal Dysfunction/Failure Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and death may occur upon use of immune globulin intravenous (Human) (IGIV) products. Use VIGIV with caution in patients with pre-existing renal insufficiency and in patients at risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, age greater than 65 years, volume depletion, paraproteinemia, sepsis, and patients receiving known nephrotoxic drugs), and administer VIGIV at the minimum rate of infusion practicable.

In these cases, it is important to ensure that patients are not volume depleted before VIGIV infusion. Do not exceed the recommended infusion rate and follow the infusion schedule closely [see

2.3Administration ]. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of VIGIV and at appropriate intervals thereafter.

If renal function deteriorates, consider discontinuing VIGIV. Most cases of renal insufficiency following administration of IGIV have occurred in patients receiving total doses containing 400 mg/kg of sucrose or greater. VIGIV does not contain sucrose.

No prospective data are currently available in patients with risk factors for renal insufficiency to identify a maximum safe dose, concentration, and/or rate of infusion for VIGIV.

5.3Blood Glucose Monitoring 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 sys… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness. The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions Canada Inc. at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a safety/pharmacokinetics study, 60 healthy male and female volunteers received a single intravenous dose of either 6000 Units per kg or 9000 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 (9000 Units per kg) 4 days prior to vaccinia vaccination (n=10), or VIGIV (9000 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 9000 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 Temporally* During or Following VIGIV Administration (≥5%) *Adverse events that occurred during or within 3 days of VIGIV or placebo administration. a 0.9% NaCl infused at 2 mL/min. b Infusion rate: 4 mL/min; subjects were fasted. c Infusion rate: 4 mL/min or 2 mL/min; subjects were fasted. d Infusion rate: 2 mL/min; subjects were not fasted.

SYSTEM ORGAN CLASS PREFERRED TERM VIGIV (%) 6000 U/kg b N=31 VIGIV (%) 9000 U/kg c N=39 VIGIV (%) 9000 U/kg d N=20 VIGIV (%) 24,000 U/kg d N=20 PLACEBO a N=32 (%) 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 Syste… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 202 words ▾

7 DRUG INTERACTIONS • Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary ( 7.1 ) • Antibodies in VIGIV may interfere with some serological tests ( 7.2 )

7.1Live, 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.

7.2Drug/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 use testing systems that are glucose-specific to test or monitor blood glucose levels in patients receiving VIGIV [see BOXED WARNING and

5.3Blood Glucose Monitoring ]. • 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

5.5Hemolysis ].

👥 Use in Specific Populations 106 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data on the use of VIGIV in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with VIGIV.

8.2Lactation Risk Summary There are no data to assess the presence or absence of VIGIV in human milk, the effects on the breastfed child or the effects on milk production/excretion.

8.4Pediatric Use Safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for VIGIV.

8.5Geriatric Use Safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for VIGIV.

🤰 Pregnancy 30 words ▾

8.1Pregnancy Risk Summary There are no data on the use of VIGIV in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with VIGIV.

🧒 Pediatric Use 20 words ▾

8.4Pediatric Use Safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for VIGIV.

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use Safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for VIGIV.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known.

12.2Pharmacodynamics Two double-blind pharmacodynamic studies were conducted in which 82 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV. In the first study, the efficacy of 9000 Units per kg of VIGIV on the immunologic and local response to Dryvax was evaluated. A total of 32 healthy subjects were randomized to receive single IV infusions of either VIGIV (9000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4.

In a second study, 50 healthy subjects were randomized to receive a single IV infusion of either VIGIV (9000 Units per kg), VIGIV (24,000 Units per kg), or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The effect of VIGIV on the immunologic response to Dryvax was determined by measuring vaccinia antibody titer (vaccinia IgG) in plasma and comparing titer levels across all three treatment arms. In addition, the effect of VIGIV on the local response (tissue) to Dryvax was assessed by evaluating the size of the pox reaction, as well as the area of erythema and induration following vaccination.

VIGIV (9000 Units per kg and 24,000 Units per kg) reduced the local and immunological response to vaccinia vaccination when it was administered 4 days prior to vaccination compared to vaccination alone. This is consistent with the hypothesis that VIGIV can neutralize vaccinia virus in vivo [see 14 CLINICAL STUDIES ]. In addition, infusions of VIGIV of up to 24,000 Units per kg were well tolerated [see

6.1Clinical Trials Experience ].

12.3Pharmacokinetics A double-blind study was conducted in which 60 healthy subjects were randomized to receive either 6000 Units per kg or 9000 Units per kg VIGIV. After intravenous administration of 6000 Units per kg to 31 healthy subjects, a mean peak plasma concentration of 161 Units per mL was achieved within two hours. The half-life of VIGIV was 30 days (range of 13 to 67 days) and the volume of distribution was 6630 mL.

Pharmacokinetic parameters were calculated based on antibody levels determined by an ELISA. The levels of vaccinia immune globulin remained in circulation for a prolonged period of time, with a mean half-life ranging from approximately 26 to 30 days. Maximum plasma concentrations (C max ) of VIGIV reached levels ranging from approximately 160 to 232 Units per mL in 1.8 to 2.6 hours.

In addition, the drug had a large volume of distribution, as demonstrated by both non-compartmental and compartmental analyses. Non-compartmental analyses demonstrated that at the two dose levels studied, the drug exhibited dose-proportionality (AUC and C max values) ( Table 3 ). The pharmacokinetic parameters estimated by compartmental analysis were similar to those calculated by non-compartmental methods.

Table 3 Non-compartmental Pharmacokinetic Parameters (mean (±SD)) Using VIGIV (6000 U/kg or 9000 U/kg) from Measured Data Arithmetic Mean (±SD) Parameter 6000 U/kg 9000 U/kg AUC 0 - ∞ (U*h/mL) 58521 (16079) 78401 (17502) AUC 0-t (U*h/mL) 49405 (13246) 71541 (13173) C MAX (U/mL) 161 (40.0) 232 (40.9) T MAX (h) 1.84 (1.12) 2.61 (2.41) T ½ (days) 30.0 (10.0) 26.2 (5.08) The plasma concentration of circulating VIGIV was also compared to a theoretical value obtained from a model of previously licensed Baxter Vaccinia Immune Globulin (VIG) product at Day 5 after IV administration of VIGIV.

Since Baxter VIG was administered intramuscularly (IM) and VIGIV is administered IV, the comparison was made at approximately five days to account for equilibration between the extravascular and intravascular compartments following IM injection. The binding capacity and neutralizing antibody act… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 24 words ▾

12.1Mechanism of Action VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known.

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied NDC 60492-0173-1: 20 mL glass vial NDC 60492-0173-2: Shelf carton containing 24 glass vials The product is supplied as a 20 mL single dose vial containing ≥50,000 Units per vial. It is packaged in a shelf carton with 24 vials and four package inserts. VIGIV does not contain natural rubber latex.

16.2Storage and Handling Product is stored frozen at or below -15°C (≤5°F). Do not use after expiration date. Use within 60 days of thawing at 2°C to 8°C (36°F to 46°F). Begin intravenous infusion within 4 hours after entering the vial. Do not reuse or save VIGIV for future use. This product contains no preservative; therefore, discard partially used vials.

📋 Description ~3 min read ▾

11 DESCRIPTION VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear to opalescent liquid.

VIGIV is manufactured from plasma collected from healthy, screened donors with high titers of anti-vaccinia antibody (meeting minimum potency specifications) that is purified by an anion-exchange column chromatography method ( 3 , 4 ). The plasma donors were boosted with vaccinia vaccine prior to donating plasma used in the production of the product. Each plasma donation used for the manufacture of VIGIV is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg) and antibodies to human immunodeficiency viruses (HIV) 1/2 and hepatitis C virus (HCV) using FDA-licensed serological tests.

Plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid Testing (NAT) for HIV-1 and HCV and found to be negative. A NAT for HBV was also performed on all Source Plasma used and found to be negative; however, the significance of a negative result has not been established. The Source Plasma has also been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 and the limit for B19 in the manufacturing pool is set not to exceed 10 4 IU of B19 DNA per mL.

The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and 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 ( 5 ). Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses ( 6 ).

In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non–lipid enveloped viruses. The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in Table 2 . Table 2 Virus Reduction Values (Log 10 ) Obtained through Validation Studies BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV); EMC: encephalomyocarditis virus; model for HAV and for small non-enveloped viruses in general; HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general; HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2; MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general; n.e.: not evaluated; PPV: porcine parvovirus; model for human parvovirus B19 and for small non-enveloped viruses in general; PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes a 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. Virus Enveloped RNA HIV-1 Enveloped RNA BVDV Enveloped DNA PRV Enveloped DNA Vaccinia Non-Enveloped RNA HAV Non-Enveloped RNA EMC Non-Enveloped DNA MMV Non-Enveloped DNA PPV Family retro flavi herpes pox picorna picorna parvo parvo Size (nm) 80–100 50–70 120–200 220–450 long x 140–260 wide 25–30 30 20–25 18–24 Anion Exchange Chromatography (partitioning) Not evaluated Not evaluated Not evaluated Not evaluated 2.3 n.e.

3.4n.e. 20N Filtration (size exclusion) ≥4.7 ≥3.5 ≥5.6 a n.e. n.e. 4.8 n.e.

4.1Solvent/Detergent (inactivation) ≥4.7 ≥7.3 ≥5.5 ≥3.7 Not evaluated Not evaluated Not evaluated Not evaluated Total Reduction (log 10 ) ≥9.4 ≥10.8 ≥11.1 ≥3.7 7.1 7.1 7.5

7.5The product potency (as determined by a plaque reduction neutralization test) is expressed in arbitrary units (U) by comparison to the FDA reference standard. Each vial contai… [Excerpted — this section continues on DailyMed.]

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Discuss the risks and benefits of VIGIV with the patient before prescribing or administration. • Inform patients of the potential for hypersensitivity reactions, especially in individuals with previous reactions to human immune globulin and in individuals deficient in IgA [see 4 CONTRAINDICATIONS and

5.1Hypersensitivity ]. Advise patients to be aware of the following symptoms associated with allergic reactions: hives, rash, chest tightness, wheezing, shortness of breath, or feeling light headed or dizzy when they stand. Caution patients to seek medical attention immediately should they experience any one or more of the above mentioned symptoms, as well as other side effects including injection site pain, chills, fever, headache, nausea, vomiting, and joint pain. • Advise patients that the maltose contained in VIGIV can interfere with some types of blood glucose monitoring systems.

Patients must use testing systems that are glucose-specific for monitoring blood glucose levels as the interference of maltose could result in falsely elevated glucose readings, which could lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia [see

5.3Blood Glucose Monitoring ]. • Advise patients that VIGIV may impair the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps, and varicella (i.e. chickenpox). Patients recently vaccinated must notify their treating physician [see

7.1Live, Attenuated Vaccines ]. • Inform patients that VIGIV is prepared from human plasma. Products made from human plasma may contain infectious agents such as viruses that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing.

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products [see

5.8Transmissible Infectious Agents ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics A double-blind study was conducted in which 60 healthy subjects were randomized to receive either 6000 Units per kg or 9000 Units per kg VIGIV. After intravenous administration of 6000 Units per kg to 31 healthy subjects, a mean peak plasma concentration of 161 Units per mL was achieved within two hours. The half-life of VIGIV was 30 days (range of 13 to 67 days) and the volume of distribution was 6630 mL.

Pharmacokinetic parameters were calculated based on antibody levels determined by an ELISA. The levels of vaccinia immune globulin remained in circulation for a prolonged period of time, with a mean half-life ranging from approximately 26 to 30 days. Maximum plasma concentrations (C max ) of VIGIV reached levels ranging from approximately 160 to 232 Units per mL in 1.8 to 2.6 hours.

In addition, the drug had a large volume of distribution, as demonstrated by both non-compartmental and compartmental analyses. Non-compartmental analyses demonstrated that at the two dose levels studied, the drug exhibited dose-proportionality (AUC and C max values) ( Table 3 ). The pharmacokinetic parameters estimated by compartmental analysis were similar to those calculated by non-compartmental methods.

Table 3 Non-compartmental Pharmacokinetic Parameters (mean (±SD)) Using VIGIV (6000 U/kg or 9000 U/kg) from Measured Data Arithmetic Mean (±SD) Parameter 6000 U/kg 9000 U/kg AUC 0 - ∞ (U*h/mL) 58521 (16079) 78401 (17502) AUC 0-t (U*h/mL) 49405 (13246) 71541 (13173) C MAX (U/mL) 161 (40.0) 232 (40.9) T MAX (h) 1.84 (1.12) 2.61 (2.41) T ½ (days) 30.0 (10.0) 26.2 (5.08) The plasma concentration of circulating VIGIV was also compared to a theoretical value obtained from a model of previously licensed Baxter Vaccinia Immune Globulin (VIG) product at Day 5 after IV administration of VIGIV.

Since Baxter VIG was administered intramuscularly (IM) and VIGIV is administered IV, the comparison was made at approximately five days to account for equilibration between the extravascular and intravascular compartments following IM injection. The binding capacity and neutralizing antibody activity of anti-vaccinia antibody in these subjects five days after intravenous administration of VIGIV (both 6000 Units per kg and 9000 Units per kg dosages) were at least as high as the theoretical values that would be achieved following the intramuscular administration of the comparator VIG (see Table 4 ).

Five days represents the approximate time of peak serum anti-vaccinia antibody concentration following intramuscular administration of other Immune Globulin (Human) products. No historical pharmacokinetic data are available for the theoretical intramuscular comparator VIG. Table 4 Test of Non-inferiority Dose VIGIV (U/kg) Plasma Levels, U/mL (Range a ) VIGIV b Plasma Levels, U/mL (Range a ) VIGIM c Ratio of Means % (97.5% Lower Confidence Interval Bound) d a Geometric mean (range) b Observed levels c Simulated levels d Expressed as a percentage relative to the geometric mean of the simulated concentrations at Day 5 after 6000 U/kg intramuscular administration 6000 60.1 (36.1–84.6) 66.2 (42.3–94.9) 90.82 (86.94) 9000 90.3 (63.4–133.8) 64.8 (47.6–87.2) 139.40 (135.27)

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Two double-blind pharmacodynamic studies were conducted in which 82 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV. In the first study, the efficacy of 9000 Units per kg of VIGIV on the immunologic and local response to Dryvax was evaluated. A total of 32 healthy subjects were randomized to receive single IV infusions of either VIGIV (9000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4.

In a second study, 50 healthy subjects were randomized to receive a single IV infusion of either VIGIV (9000 Units per kg), VIGIV (24,000 Units per kg), or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The effect of VIGIV on the immunologic response to Dryvax was determined by measuring vaccinia antibody titer (vaccinia IgG) in plasma and comparing titer levels across all three treatment arms. In addition, the effect of VIGIV on the local response (tissue) to Dryvax was assessed by evaluating the size of the pox reaction, as well as the area of erythema and induration following vaccination.

VIGIV (9000 Units per kg and 24,000 Units per kg) reduced the local and immunological response to vaccinia vaccination when it was administered 4 days prior to vaccination compared to vaccination alone. This is consistent with the hypothesis that VIGIV can neutralize vaccinia virus in vivo [see 14 CLINICAL STUDIES ]. In addition, infusions of VIGIV of up to 24,000 Units per kg were well tolerated [see

6.1Clinical Trials Experience ].

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The pharmacokinetic, pharmacodynamic and safety profiles of VIGIV were evaluated in three clinical trials. In these clinical studies, VIGIV was shown to have an acceptable safety profile when administered as single infusions of 6000 Units per kg, 9000 Units per kg or 24,000 Units per kg to healthy subjects. For the safety/pharmacokinetics study, see

12.3Pharmacokinetics .

14.1Pharmacodynamic Effect of VIGIV on Immune and Local Responses to Dryvax In a randomized, single center, double-blind study with three parallel treatment arms, the efficacy of 9000 Units per kg of VIGIV on the immunologic and local response to the smallpox vaccine Dryvax was evaluated. Thirty-two healthy female and male subjects were randomized to receive single IV infusions of either VIGIV (9000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4.

In this study, the curves for antibody titre vs. time were similar between administration of VIGIV four days prior to vaccination with Dryvax and concurrent administration of VIGIV with Dryvax. Based on area under the effective time curve from Day 4 to 32 (AUEC 4-32 ) results, the administration of VIGIV four days prior to vaccination with Dryvax slightly reduced the pox reaction and erythema area by 4 to 9% and 8 to 12%, respectively, as compared to the concurrent administration of VIGIV with the Dryvax vaccine, or with Dryvax alone.

In an additional randomized, single center, double-blind, study with five parallel treatment arms, the efficacy of two different doses of VIGIV (9000 Units per kg and 24,000 Units per kg) on the immunologic and local response to Dryvax was evaluated. Fifty healthy subjects were randomized to receive a single IV infusion of either VIGIV (9000 Units per kg), VIGIV (24,000 Units per kg), or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The administration of VIGIV four days prior to vaccinia vaccination decreased the endogenous immune response to Dryvax in a dose-dependent manner.

In addition, the mean pox reaction and erythema area diameters were smaller in size when 24,000 Units per kg of VIGIV was administered prior to vaccination with Dryvax compared to those when 9000 Units per kg of VIGIV was administered prior to vaccination with Dryvax or to those from administration of Dryvax alone. These data are consistent with the hypothesis of vaccinia virus neutralization in vivo by VIGIV.

🧪 Nonclinical Toxicology 166 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genotoxicity and fertility studies have not been conducted with VIGIV.

13.2Animal Toxicology and/or Pharmacology The efficacy of VIGIV against vaccinia virus in a mouse-tail lesion model was assessed. A range of doses of VIGIV and a previously licensed VIG were compared for their ability to reduce pox formation in this model. Using this model, it was demonstrated that VIGIV exerted an in vivo protective effect against vaccinia infection when compared to a negative control.

In addition, when using the mouse-tail lesion model with two different strains of vaccinia virus, it was observed that the protective effect of VIGIV appeared similar to that of the previously licensed VIG and a CBER reference standard. A single study in rabbits has demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis ( 7 ). Since VIGIV is a product of human origin, secondary pharmacodynamics, safety pharmacology and pharmacodynamic drug interactions were not investigated in animals.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genotoxicity and fertility studies have not been conducted with VIGIV.

📚 References 162 words ▾

15 REFERENCES 1. Kahwaji J et al., Acute Hemolysis after High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol.

2009 December 4;1993–97. 2. Daw Z, Padmore R, Neurath D, et al.

Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-601. 3.

Bowman JM, Friesen AD, Pollock JM, Taylor WE. WinRho: Rh immune globulin prepared by ion exchange for intravenous use. Canadian Med Assoc J.

1980;123:1121-5. 4. Friesen AD, Bowman JM, Price HW.

Column ion-exchange preparation and characterization of an Rh immune globulin (WinRho) for intravenous use. Journal Appl Biochem. 1981;3:164-75.

5. Horowitz B. Investigations into the application of tri(n-butyl)phosphate/detergent mixtures to blood derivatives.

Curr Stud Hematol Blood Transfus. 1989;56:83-96. 6.

Burnouf T. Value of virus filtration as method for improving the safety of plasma products. Vox Sang.

1996;70:235-6. 7. Fulginiti VA, Winograd LA, Jackson M, Ellis P.

Therapy of experimental vaccinal keratitis: Effect of idoxuridine and VIG. Arch Ophthal. 1965;74:539-44.

📄 Package Label / Principal Display Panel 28 words ▾

Principal Display Panel - Carton Label Vaccinia Immune Globulin Intravenous (Human) CNJ-016 Carton Label

Principal Display Panel - Vial Label Vaccinia Immune Globulin Intravenous (Human) CNJ-016 Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CNJ-016 (this brand).

Top reported reactions

Graft Versus Host Disease6
Septic Shock6
Nausea5
Coma4
Gastrooesophageal Reflux Disease4
Pneumonia Aspiration4
Somnolence4

Age at onset

Neonate2
Infant1
Adult27

Reporter sex

88 reports
Male · 87%
Female · 13%

Serious outcomes

Hospitalization10
Death4
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 32 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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Finished prescription product
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← 60492-0075-02 · Emergent 60492-0249-02 · Emergent →
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