Vaccinia immune globulin, human (Intravenous)

Vaccinia immune globulin is used to treat infections that come from the vaccinia virus.

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

In deciding to use a medicine, you must consider the risks of taking it against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adult patients, and there is no specific information available comparing the use of vaccinia immune globulin in children to its use in other age groups.

Geriatric

Many medicines have not been studied specifically in older adults. As a result, it may not be known if they work exactly the same way in older people as they do in younger adults or if they cause different side effects or issues in older people. There is no specific information comparing the use of vaccinia immune globulin in the elderly to its use in other age groups.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and may not include all possible interactions.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food because interactions may occur. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Vaccinia keratitis—Use is not recommended.

• Hyperviscosity, known or suspected—May increase the risk of serious side effects.

• Immunoglobulin A (IgA) deficiency—Increased risk for allergic reactions.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

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. Your health care professional may also 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.

In the U.S.

• Vaccinia Immune Globulin, Human

Find detailed information on biosimilars for this medication.

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.