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BabyBIG

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

What is BabyBIG (botulism immune globulin)?

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 medicine is used in children who are younger than 1 year old.

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

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

Your baby should not receive this medicine if he or she has immune globulin A (IgA) deficiency with antibody to IgA.

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Your baby should not receive a "live" vaccine (measles, mumps, rubella, polio, rotavirus, yellow fever, varicella) for at least 3 months after receiving botulism immune globulin.

What should I discuss with my healthcare provider before my child receives BabyBIG (botulism immune globulin)?

Your baby should not receive botulism immune globulin if he or she has ever had an allergic reaction to an immune globulin, or if the child has immune globulin A (IgA) deficiency with antibody to IgA.

To make sure botulism immune globulin is safe for your baby, tell the doctor if your baby has:

  • kidney disease;

  • diabetes;

  • if the baby has recently received any vaccination;

  • if the baby is dehydrated; or

  • if the baby is being treated with any medicines that weaken the immune system.

Botulism immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is botulism immune globulin given?

To best participate in the care of your baby while he or she is being treated with botulism immune globulin, carefully follow all instructions provided by your baby's caregivers.

Botulism immune globulin is injected into a vein through an IV. Your baby will receive this IV infusion in a clinic or hospital setting.

Botulism immune globulin is usually given as a one-time treatment.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during the infusion.

To be sure botulism immune globulin is not causing harmful effects, your baby may need follow-up blood tests.

What happens if a dose is missed?

Since botulism immune globulin is used as a single dose, it does not have a daily dosing schedule.

What happens if an overdose is given?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should be avoided after receiving BabyBIG (botulism immune globulin)?

Your baby should not receive a "live" vaccine for at least 3 months after receiving botulism immune globulin. Live vaccines include measles, mumps, rubella, polio, rotavirus, yellow fever, and varicella. The vaccine may not work as well during this time, and may not fully protect your baby from disease.

BabyBIG (botulism immune globulin) side effects

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

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

Call your doctor at once if the baby has:

  • tenderness, redness, warmth, cold feeling, or blue/purple appearance in the arms or legs;

  • fussiness, trouble breathing, blue lips, pale skin;

  • little or no urinating, fewer wet diapers than usual;

  • yellowed skin, dark colored urine;

  • low levels of sodium in the body--confusion, severe weakness, vomiting, loss of coordination or motor skills; or

  • swelling around the brain or spinal cord--fever, neck stiffness, sensitivity to light, weakness, sleepiness, vomiting.

Common side effects may include:

  • mild skin rash or redness on the baby's face, chest, back, or stomach;

  • chills, body aches;

  • wheezing; or

  • vomiting.

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.

See also: Side effects (in more detail)

What other drugs will affect BabyBIG (botulism immune globulin)?

Other drugs may interact with botulism immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your baby's doctor about all medicines your baby receives.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about botulism immune globulin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-03-06, 12:09:57 PM.

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