Vaccinia immune globulin, human (Intravenous route)
vax-IN-ee-a i-MUNE GLOB-ue-lin, HUE-man
- Vaccinia Immune Globulin, Human
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:
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.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
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.
- For treatment and/or medical problems due to vaccinia virus:
Precautions While Using This Medicine:
Tell your healthcare provider if you have ever had a reaction to a vaccination.
Side Effects of This Medicine:
- Incidence unknown
- 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
- cold, clammy, pale skin
- coughing that produces a pink frothy sputum
- dark urine
- decreased urination
- difficulty or labored breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- general body swelling
- 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
- 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
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- yellowing of the eyes or skin
- 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
- trembling or shaking of hands or feet
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:
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:
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.
Last Updated: 11/4/2014