Botulism Immune Globulin, BIG-IV injection
What is Botulism Immune Globulin, BIG-IV injection?
BOTULISM IMMUNE GLOBULIN, BIG-IV (BabyBIG®) is a solution containing human antibodies or proteins that are used to treat infant botulism. The use of BIG-IV may help reduce the time that the infant needs special care in the hospital for botulism. Generic botulism immune globulin injections are not available.
What should my health care professional know before I receive Botulism Immune Globulin, BIG-IV?
They need to know if you have any of these conditions:
immunoglobulin A deficiency
an unusual reaction to Botulism Immune Globulin, BIG-IV, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should this medicine be used?
Botulism immune globulin, BIG-IV is only for infusion into a vein. It is given by a health-care professional in a hospital or clinic setting.
What if I miss a dose?
This does not apply.
What drug(s) may interact with Botulism Immune Globulin, BIG-IV?
live virus vaccines
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking Botulism Immune Globulin, BIG-IV?
Because this product is developed from pooled blood samples of many different donors, it is theoretically possible that viruses or bacteria could be transmitted in the product. However, the BIG-IV product is tested for HIV and hepatitis, and there have been no case reports of illnesses being caused from the use of similar products.
Check with your health care professional before receiving vaccines. Live virus vaccines should not be given until 5 months after receiving BIG-IV.
What side effects may I notice from receiving Botulism Immune Globulin, BIG-IV?
Side effects that you should report to your prescriber or health care professional as soon as possible:
chest pain or tightness
decreased amount of urine or difficulty passing urine
difficulty breathing, shortness of breath, or wheezing
hives, skin rash, or itching
neck pain or difficulty moving neck
pain and tenderness at the injection site
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
muscle aches and pains
Where can I keep my medicine?
This does not apply.
March 21, 2017
U.S. FDA-approved Package Insert