Vaccinia Immune Globulin (Intravenous)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free; solvent-detergent treated]:

CNJ-016: ≥50,000 units/15 mL (15 mL) [contains maltose 10% and polysorbate 80 0.03%]

• CNJ-016

Antibodies obtained from pooled human plasma of individuals immunized with the smallpox vaccine provide passive immunity

Distribution

Vd: 6.6 L

Time to Peak

Plasma: 1.8 to 2.6 hours

Half-Life Elimination

30 days (range: 13 to 67 days)

Vaccinia conditions: Treatment and/or modification of the following conditions:

- 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.

- 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

The Advisory Committee on Immunization Practices (ACIP) recommends the following (CDC 2009; CDC [Rotz 2001]; CDC [Wharton 2003]):

Use is recommended for:

- Inadvertent inoculation (considering severity, toxicity of affected person, and pain)

- Eczema vaccinatum

- Generalized vaccinia (severe form or if underlying illness is present)

- Progressive vaccinia

Use may be considered for:

- Severe ocular complications except isolated keratitis

Use is not recommended for:

- Inadvertent inoculation that is not severe

- Mild or limited generalized vaccinia

- Nonspecific rashes, erythema multiforme, or Stevens-Johnson syndrome

- Postvaccinial encephalitis or encephalomyelitis

Vaccinia conditions: IV: 6,000 units/kg as soon as symptoms appear; may repeat dose based on severity of symptoms and response to treatment (specific data are lacking); 9,000 units/kg may be considered if patient does not respond to initial dose. Single doses up to 24,000 unit/kg were tolerated in healthy volunteers. Note: Maximum dose for patients with risk factors for thrombosis: 12,000 units/kg/day.

Do not shake; avoid foaming. Do not administer if solution is turbid. Remove the entire contents of the vial to obtain the labeled dosage; 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. Do not dilute more than 1:2 (v/v). Infusion should begin within 4 hours after entering vial.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vaccinia immune globulin intravenous (human), the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to vaccinia immune globulin intravenous (human) or other human immunoglobulins. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding: It is not known whether vaccinia immune globulin intravenous (human) passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking Vaccinia and who wish to breast-feed should discuss this with their doctor.

Children: Studies on Vaccinia have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin intravenous (human) in children with use in other age groups.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaccinia immune globulin intravenous (human) in the elderly with use in other age groups.

Other medicines: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking vaccinia immune globulin intravenous (human), it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Vaccines made from a live virus - Vaccinia immune globulin intravenous (human) may interfere with how well the vaccine will work

Other medical problems: The presence of other medical problems may affect the use of vaccinia immune globulin intravenous (human). Make sure you tell your doctor if you have any other medical problems, especially:

• Vaccinia keratitis - Use is not recommended

• Hyperviscosity, known or suspected - May increase chance for serious side effects

• Immunoglobulin A (IgA) deficiency - Increased risk for allergic reaction

Initial dose: 100 mg/kg (2 mL/kg) by IV infusion over approximately 70 minutes. May repeat, depending on symptom severity and response.

If no response: 200 mg/kg or 500 mg/kg by IV infusion.

Infusion rate: 1 mL/kg/hour for the first 30 minutes, then 2 mL/kg/hour for 30 minutes, then 3 mL/kg/hour for the remainder of the infusion.

Intravenous immune globulins have been associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. IGIV products containing sucrose as a stabilizer and given at daily doses of 400 mg/kg or greater account for a proportionately greater share of the total number. VIGIV contains 5% sucrose as a stabilizer. Patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65 years, volume depletion, sepsis, paraproteinemia, or who are receiving nephrotoxic drugs may be at increased risk. Caution is recommended in patients with preexisting renal insufficiency or who are at risk of developing renal insufficiency. Clinicians should ensure that patients are not volume depleted before starting VIGIV infusion.

Data not available