Vaccinia immune globulin (Injection)

When This Medicine Should Not Be Used

Introduction

Vaccinia Immune Globulin, Human (vax-IN-ee-a i-MUNE GLOB-ue-lin, HUE-man)

Treats conditions caused by vaccinia virus, which can affect the skin, eyes, and mouth.

Brand Name(s)

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• Your doctor will observe you while you are receiving this medicine and shortly afterward. This is to make sure you do not have any unwanted side effects from the medicine.
• Your doctor will decide whether you need to receive more than one dose of this medicine.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using antibiotics, including amikacin (Amikin), gentamicin (Garamycin), streptomycin, tobramycin, neomycin. Tell your doctor if you use pain or arthritis medicine (sometimes called "NSAIDs") such as aspirin, ibuprofen, Advil®, Aleve®, Celebrex®, Ecotrin®, or Motrin®. Your doctor should know if you use lithium, or an ACE inhibitor such as enalapril, lisinopril, Accupril®, Lotrel®, or Zestril®.
• Children and teenagers should not take aspirin or medicines that contain aspirin (such as some cold medicines) for 6 weeks after being given varicella vaccine. Carefully check the label of any pain, headache, or cold medicine you use to be sure it does not contain aspirin or salicylic acid.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding.
• Tell your doctor if you have kidney disease, diabetes, a serious infection, or a metabolic imbalance. Your doctor should know if you have a history of heart disease or stroke.
• This medicine is made from donated human plasma. Some human plasma products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human plasma has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, red, peeling skin rash.
• Blue lips, pale skin.
• Chest pain, shortness of breath, or coughing up blood.
• Fever, chills, cough, sore throat, and body aches.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your eyes, sensitivity to light.
• Pain in your lower leg (calf).
• Seizure.
• Severe headache, stiff neck, nausea, vomiting, fever, drowsiness.
• Sudden or severe headache, problems with vision, speech, or walking.

If you notice these less serious side effects, talk with your doctor:

• Back pain, muscle cramps.
• Chills or shivering.
• Feeling too hot or too cold.
• Headache, dizziness.
• Nausea, vomiting, stomach pain.
• Pain, redness, swelling, itching, or irritation where the needle is placed.
• Runny or stuffy nose, sore throat.
• Warmth or redness in your face, neck, or chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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