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Medications and Drugs

Brand Names: BabyBIG

Generic Name: botulism immune globulin (Pronunciation: BOT ue lizm im MYOON GLOB yoo lin)

What is botulism immune globulin (BabyBIG)?

Botulism immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection caused by botulism toxin type A and B.

Botulism immune globulin is used to treat infant botulism caused by toxin type A or B. This medication is used in children who are younger than 1 year old.

Botulism immune globulin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of botulism immune globulin (BabyBIG)?

Your baby will remain under constant supervision during treatment with botulism immune globulin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your baby's caregivers at once if the baby has a serious side effect such as:

  • trouble breathing, blue lips, pale skin;
  • urinating less than usual, fewer wet diapers than usual;
  • fever with headache, neck stiffness, sleepiness, sensitivity to light, vomiting;
  • trouble swallowing, noisy breathing, slow breathing;
  • vomiting, diarrhea, more wet diapers than usual; or
  • feeding problems, white patches in the mouth.

Less serious side effects may include:

  • mild skin rash or redness on the baby's face, chest, back, or stomach;
  • fussiness, excessive crying; or
  • stuffy nose, cough, chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about botulism immune globulin (BabyBIG)?

Before your baby receives botulism immune globulin, tell your doctor if the baby has kidney disease, diabetes, a life-threatening infection, or if the baby is dehydrated, or has recently received any vaccinations.

Your baby should not receive live-virus vaccines against polio, measles, mumps, rubella, or rotavirus for at least 5 months after receiving botulism immune globulin. Live vaccines may not work as well during this time. If your baby was recently vaccinated before treatment with botulism immune globulin, he or she may need to be vaccinated again to be fully protected. Follow your doctor's instructions.

Botulism immune globulin can be harmful to the kidneys, and these effects are increased when this medication is used together with other drugs that can harm the kidneys. Before your baby is treated with botulism immune globulin, tell your doctor if the baby is receiving chemotherapy, medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain medicines, or any IV antibiotics.

To be sure this medication is not causing harmful effects, your baby may need blood tests. Do not miss any follow-up appointments after treatment with botulism immune globulin.

Botulism immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of treating your child with this medication.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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