Pronunciation:

vax-IN-ee-a i-MUNE GLOB-ue-lin, HUE-man

Brand Names:

• Vaccinia Immune Globulin, Human

Warnings:

Immune globulin intravenous (human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable. Higher rates of renal failure were associated with IGIV products containing sucrose and administered at daily doses of 400 mg/kg or greater. Vaccinia immune globulin contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg .

Uses of This Medicine:

Vaccinia immune globulin is used to treat infections caused by the vaccinia virus.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin 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 in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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

Proper Use of This Medicine:

Make sure you discuss the risks and benefits of this medicine with your doctor.

Report all infections thought to have been possibly transmitted by this product by having your doctor call Cangene Corporation at 1-877-CANGENE.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form:
  • For treatment and/or medical problems due to vaccinia virus:
    • Adults—Dose is based on weight and will be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Precautions While Using This Medicine:

Tell your healthcare provider if you have ever had a reaction to a vaccination.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence unknown

Fever

headache

nausea

stiff neck or back

Observed postmarketing

Back, leg or stomach pain

black, tarry stools

bleeding gums

blistering, peeling, loosening of skin

bluish color of fingernails, lips, skin, palms, or nail beds

blurred vision

change in consciousness

chest pain

chills

cold, clammy, pale skin

confusion

convulsions

cough

coughing that produces a pink frothy sputum

dark urine

decreased urination

diarrhea

difficulty or labored breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

fatigue

general body swelling

itching

irregular heartbeats

joint or muscle pain

light-colored stools

loss of appetite

loss of bladder control

loss of consciousness

muscle spasms or jerking of all extremities

nausea or vomiting

no blood pressure or pulse

noisy breathing

nosebleeds

not breathing

pain in chest, groin, or legs, especially the calves

painful or difficult urination

red irritated eyes

red skin lesions, often with a purple center

severe, sudden headache

severe weakness or numbness in arm or leg

shortness of breath

slow heart rate

slurred speech

sore throat

sores, ulcers, or white spots in mouth or on lips

stopping of heart

sudden loss of coordination

suddenly sweating

swelling in legs and ankles

swollen glands

tightness in chest

troubled breathing

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

vision changes

wheezing

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

eye disorder

energy increased

feeling unusually cold

feeling hot

lack or loss of strength

lip dry

muscle pain

shakiness in legs, arms, hands, feet

shivering

trembling or shaking of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.