Vaccinia Immune Globulin, Human (Intravenous)

Vaccinia immune globulin (VIG) uses the antibodies of people who developed smallpox resistance to intravenously treat progressive vaccinia after a smallpox infection. Here is more information about the drug.

Overview

Vaccinia immune globulin, human, is only made available by a doctor's prescription, and comes in parenteral and injection forms, the latter in the US and Canada. It is used to treat infections caused by the vaccinia virus. It has been given the brand name VIGIV and can treat multiple conditions.

This medication was developed in the 1960s with a plan to ameliorate the side effects that emerged following a smallpox immunization process. The original composition contained high levels of protein aggregates and was thus administered intramuscularly, and is unavailable at the moment. VIG, human, is the only available treatment for people who might suffer complications associated with vaccinia vaccination.

Preparation of VIGIV involves a collection of plasma from healthy, screened donors who have high amounts of an anti-vaccinia antibody that meets the minimum potency requirements. Each plasma used in the manufacture of VIGIV is tested for hepatitis B virus, hepatitis C virus, surface antigen, and HIV, using the FDA licensed serological tests.

VIGIV is considered a valuable insurance which should be reserved in case a patient receives an experimental vaccine that involves a vaccinia carrier virus, or as a viable complications manager for the smallpox vaccine in case a bioterrorism threat is imminent.

Conditions treated

VIG, human, is used to treat or modify the listed conditions, which are complications that can arise after a smallpox vaccination:

  • Severe generalized vaccine
  • Eczema vaccinatum
  • Aberrant infections
  • Vaccinia infections
  • Eczematous skin lesions

Type of medicine

  • Immune globulins

Side effects

Along with its essential needs, VIGIV may cause a number of unwanted effects. While not all these side effects will manifest, if they do medical attention may be required. Some of the side effects of VIGIV include:

Incidence unknown

  • Nausea
  • Headache
  • Fever
  • Stiff back or neck

Observed post-marketing

  • Abdominal pain
  • Dyspnea
  • Arthralgia
  • Dizziness
  • Contact dermatitis
  • Urticarial
  • URI
  • Skin lacerations
  • Erythema
  • Flushing
  • Chest pain
  • Blurred vision
  • Confusion
  • Cough
  • Black Stools
  • Chills
  • Convulsions
  • Cold and pale skin
  • Bleeding gums
  • Bluish fingernails, lips, nail heads, palms or skin
  • Change in consciousness
  • Loss of appetite
  • Irregular heartbeats
  • Loss of bladder control
  • Fatigue
  • Difficulty or labored breathing
  • Dark urine
  • Dizziness, lightheadedness or fainting when getting up from a sitting or lying position
  • Itching
  • Decreased urine
  • Body swelling
  • Red and irritated eyes
  • Sudden headaches that are severe
  • Shortness of breath
  • Nose bleeding
  • Noisy breathing
  • Weakness or numbness of the legs and more especially the calves
  • No blood pressure
  • Muscle spasms
  • Groin and chest pains
  • Unconsciousness
  • Breathing problems
  • Vision changes
  • Swollen glands
  • Chest tightness
  • Sore throat
  • Slurred speech
  • Loss of coordination
  • Wheezing
  • Yellow skin or eyes
  • Tightness in the chest

Some of the side effects do not necessarily need medical attention, as they will probably disappear once the body adjusts to the medicine. A medical practitioner is in the right place to inform the patient of ways to alleviate the side effects. Visit a health care professional for any questions or a side effect is bothering you.

Most common side effects experienced include:

  • Muscle pain
  • Shivering
  • Feeling hot
  • Trembling of the feet and hands
  • Dry lips
  • Unusually cold
  • Eye disorder
  • Increased energy
  • Itching, crawling, burning, prickling or tingling feelings

This is not a complete list of all side effects, and you may experience others. If you see or experience other forms of side effects, contact a doctor for further medical advice, or report it to FDA at 1-800-FDA-1088.

Dosage

Dosage depends on individual patients and, therefore, is different from patient to patient. Follow your doctor's instructions as indicated on the label. If your doctor gives you a different dosage, do not change it unless the doctor tells you to. Listed below is only the average dose of this medicine.

How much you take also depends on the strength of the medicine. Similarly, the time between doses, the number of prescriptions taken each day and the duration you have to take your medicine for depends wholly on the medical challenge you are experiencing that necessitates the use of this medication.

Adult dose for smallpox injection reaction

The initial dose should be 100 mg/kg, which is 2mL/kg by IV infusion. This should be injected over about 70 minutes. If the patient is unresponsive to a lower dose, increase it and give 200 mg/kg or 500 mg/kg by IV infusion.

The infusion rate should be conducted in this manner: 1 mL/kg/hour for the first 30 minutes. Subsequently, 2 mL/kg/hour for the next 30 minutes and finally 3 mL/kg/hour for the remainder solution.

The infusion should be temporarily interrupted or slowed in case of minor adverse reactions, such as flushing. Other forms of severe adverse reactions, such as anaphylaxis or high blood pressure, can occur, and should be mediated by halting infusion and administering epinephrine, with or without diphenhydramine.

Interactions

Currently, VIG interacts moderately with a total of 21 drugs (54 brand and generic names) and thus should be monitored closely. Below is a comprehensive list of the drugs:

  • ACAM2000 (smallpox vaccine)
  • Attenuvax (measles virus vaccine)
  • BCG
  • Biavax II (mumps virus vaccine / rubella virus vaccine)
  • Cerebyx (fosphenytoin)
  • Di-Phen (phenytoin)
  • Dilantin (phenytoin)
  • Dryvax (smallpox vaccine)
  • Ethotoin
  • FluMist (influenza virus vaccine, live, trivalent)
  • FluMist Quadrivalent (influenza virus vaccine, live, trivalent)
  • Fosphenytoin
  • Influenza virus vaccine, h1n1, live
  • Influenza virus vaccine, live, trivalent
  • M-M-R II (measles virus vaccine / mumps virus vaccine / rubella virus vaccine)
  • M-R-Vax II (measles virus vaccine / rubella virus vaccine)
  • Measles virus vaccine
  • Measles virus vaccine / mumps virus vaccine / rubella virus vaccine
  • Measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine
  • Measles virus vaccine / rubella virus vaccine
  • Mephenytoin
  • Meruvax II (rubella virus vaccine)
  • Mesantoin (mephenytoin)
  • Mumps virus vaccine
  • Mumps virus vaccine / rubella virus vaccine
  • Mumpsvax (mumps virus vaccine)
  • Orimune (poliovirus vaccine, live, trivalent)
  • Peganone (ethotoin)
  • Phenytek (phenytoin)
  • Phenytoin
  • Phenytoin Sodium (phenytoin)
  • Phenytoin Sodium, Extended Release (phenytoin)
  • Phenytoin Sodium, Prompt (phenytoin)
  • Poliovirus vaccine, live, trivalent
  • ProQuad (measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine)
  • Rotarix (rotavirus vaccine)
  • RotaShield (rotavirus vaccine)
  • RotaTeq (rotavirus vaccine)
  • Rotavirus vaccine
  • Rubella virus vaccine
  • Smallpox vaccine
  • Stamaril (yellow fever vaccine)
  • TheraCys (bcg)
  • Tice BCG (bcg)
  • Tice BCG Vaccine (bcg)
  • Typhoid vaccine, live
  • Varicella virus vaccine
  • Varivax (varicella virus vaccine)
  • Vivotif Berna (typhoid vaccine, live)
  • Vivotif Berna Vaccine (typhoid vaccine, live)
  • Yellow fever vaccine
  • YF-Vax (yellow fever vaccine)
  • Zostavax (zoster vaccine live)
  • Zoster vaccine live

Warnings

Pregnancy

The FDA has assigned VIG to pregnancy category C. No adequate controlled data exist showing any risks to pregnant women.

Breastfeeding

Similarly to pregnancy, no adequate data exists to determine the risks of using the drug while breastfeeding. Mothers should weigh the benefits against the potential dangers of the drug before using it.

Hemolysis

Administration of VIGIV has been associated with antiglobulin hemolysis. Thus, one should monitor for any signs of hemolytic anemia which might occur due to high doss either administered singly or over an extended period.

Allergies

Inform your doctor of any allergies against this or any other medication. Further, tell your doctor of any allergic reactions to food, preservatives, dyes or animals.

Geriatric

There is insufficient data that compares this drug's function in older adults with that among young people. Most medicines have not been studied in older people, and, therefore, one cannot conclude on the drug causing different side effects among them.

Acute renal failure

Renal failure is a likely occurrence when using VIG. People predisposed to it include:

  • Sepsis
  • Volume depletion
  • Diabetes mellitus
  • Paraproteinemia
  • Any preexisting renal insufficiency
  • Taking nephrotoxic drugs at the moment

Storage

VIGIV should be stored at moderately low temperatures of between 2 and 8 degrees Celsius or 35.6 and 46.4 degrees Fahrenheit. Intravenous infusion should begin within six hours after entering the vial.

Summary

Vaccinia immune globulin, human (VIGIV), is a sterile liquid immunoglobin (Ig) used to treat infections caused by the vaccinia virus. It is only available only with a doctor's prescription and cannot be taken at free will. Each lot of VIGIV contains anti-vaccinia virus antibody, which is collected from people who meet the minimum potency threshold. This medicine is used to treat an array of conditions, including aberrant infections and vaccinia infections.

Before deciding to use the drug, weigh the risks with the benefits. This decision shall be made at the discretion of your doctor. The dosage will depend on the type of condition being treated and the weight of the individual. All these are factors your doctor will consider before giving the appropriate dose.

VIGIV, an immune globulin medicine, has several side effects ranging from general body pains to changing of skin or lip color. Get in touch with your doctor immediately you observe any side effects. The drug interacts with several other medicines, it is thus essential to discuss the drug use with a healthcare professional before using it. As indicated, the drug should be kept at low temperatures.

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Last Reviewed:
December 22, 2017
Last Updated:
April 05, 2018
Content Source: