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Generic Name: Vaccinia Immune Globulin Intravenous (Human)

Category: Immunizing agent (passive)

Dosage forms: Parenteral, Injection

Vaccinia Immune Globulin Intravenous (Human) (Vac-SIN-ee-a im-yoon GLOB-u-lin IN-tra-ve-nas) is to be consumed to treat infections generated by Vaccinia virus. This medication is found only with doctor's prescription, in the following dosage forms: Parenteral and Injection (U.S. and Canada).

Drug Description:

CNJ-016, Vaccinia Immune Globulin Intravenous (Human) (VIGIV (Vaccinia immune globulin intravenous)), is a solvent/detergent highly soluble treated sterile solution of purified gamma globulin (IgG) chunk of human plasma encompassing antibodies to Vaccinia virus. The drug is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and encompasses no preservative.

Post administration of the drug, a temporary enhancement of calmly transferred antibodies in patient's blood may conclude in disingenuous positive results in serological testing e.g. anti-HBs. VIGIV (vaccinia immune globulin intravenous) is available as a 15 mL single dose vial containing ≥ 50,000 U/vial. NDC Number to be determined.

Indications:

Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous) ) is indicated for the treating and/or enhancing of the following conditions: Eczema vaccinatum; continuous Vaccinia; serious 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 oone or the other 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.

Dosage:

The dose will be different for different patients.

Initial 2 to 5 mg orally or intravenously once a day for 1 to 2 days, later flexibility of dose according to results of the International Normalized Ratio (INR) or prothrombin time (PT), is the most recommended dosage pattern for patients suffering the diseases below. Dieases like; Congestive Heart Failure; Thromboembolic Stroke Prophylaxis; Myocardial Infarction; Prevention of Thromboembolism in Atrial Fibrillation; Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery; Deep Vein Thrombosis - First Event; Deep Vein Thrombosis - Recurrent Event; Deep Vein; Thrombosis Prophylaxis after Knee Replacement Surgery; Prosthetic Heart Valves - Tissue Valves;  Prosthetic Heart Valves - Mechanical Valves; Pulmonary Embolism - First Event; Pulmonary Embolism - Recurrent Event; Chronic Central Venous Catheterization.

Usual Adult Dose for Chronic Central Venous Catheterization is 1 mg orally or intravenously once a day.

Contradictions:

While getting treated with one should be considered with severe ocular complications due to vaccinia virus, the drug is repudiated for administration in the presence of confined vaccinia keratitis. The medication is not recommended to be administered in individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immunoglobulin preparations.7, 8, 9 drug inhibits element amounts of IgA. While CNJ-016 inhibits fewer than 40 μg/mL IgA, people with selective IgA deficiency can evolve antitoxin to IgA and hence, could have anaphylactic response to consecutive intake of blood products that contain IgA, including this drug.

Preparation for Administration

Exclude the tab portion of the vial cap and neat the rubber stopper with 70% alcohol or equivalent. Strictly restrict the shaking of vial; Avoid foaming. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

The solution is to be administered precisely with a committed intravenous line with a rate of injection of not greater than 2 mL/min. For patients with their weight below 50 kg, it is suggested to animate the brand at a rate no greater than 0.04 mL/kg/minute (133.3 U/kg/minute). The maximum appraise rate of infusion has been 4 mL/min. The dosage and the rate of infusion have not been evaluated in pediatric or geriatric patients with this drug, hence, intake of the same should be avoided by this audience.

Storage:

Store the drug at 36° to 46°F (2° to 8°C). Do not administer Vaccinia Immune Globulin Intravenous (VIGIV) if it passes its expiration date. If product is found frozen, administer it within 60 days of defrost at 2-8°C. Intravenous infusion should begin within 4 hours after entering the vial.

Side Effects:

No serious or severe interactions of the drug have been observed post administration of Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous)). However, drug exposure to date has been in healthy volunteers. The majority of adverse events reported in a clinical trial evaluating the pharmacokinetics of VIGIV (vaccinia immune globulin intravenous) in healthy volunteers were mild and were similar to those regarded as causally related to infusion of other protein products, such as headache, nausea, dizziness, feeling hot, feeling cold and rigors.

Post-marketing Experience along with Other IGIV Products are;

Below is a list of adverse reactions that have been identified and reported during the post-approval use od the drug: 17, 18, 19, 20, 21, 22, 23, 24, 30

Types

Detailed Effects like:

Respiratory

Cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm

Cardiovascular

Thromboembolism, hypotension

Neurological

Seizures, tremor

Hematologic

Hemolysis, positive direct antiglobulin (Coombs) test

General/Body as a Whole

Pyrexia, rigors

Musculoskeletal

Back pain

Gastrointestinal

Hepatic dysfunction, abdominal pain

 

Rare and Uncommon Adverse Events:

Types

Detailed Effects like:

Respiratory

Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Associated Lung Injury (TRALI)

Integumentary: Bullous dermatitis, epidermolysis, erythema multiforme, Stevens-Johnson syndrome

Cardiovascular

Cardiac arrest, vascular collapse

Neurological

Coma, loss of consciousness

Hematologic

Pancytopenia, leukopenia

Precautions:

  • The drug should be strictly administered only intravenously. The solution should be disposed without using it if the solution is turbid.
  • Pediatric and Geriatric Use: Safety and effectiveness in the pediatric or geriatric populations have not been established or liable.

The drug beneficiary should be checked for pulmonary adverse reactions. If trali is suspected, relevant tests should be conducted for getting guided whether the presence of anti-neutrophil antibodies is in both the product and patient serum.