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

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.

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.

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

Your baby should not receive this medication 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.

If your baby has certain conditions, he or she may need a dose adjustment or special tests to safely use this medication. Before your baby receives botulism immune globulin, tell your doctor if the baby has:

• kidney disease;

• diabetes;

• a life-threatening infection;

• if the baby is dehydrated; or

• if the baby has recently received any vaccinations.

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 given as an injection through a needle placed into a vein. Your baby will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take over an hour to complete.

To be sure this medication is not causing harmful effects, your baby may need blood tests.

What happens if a dose is missed?

Since botulism immune globulin is usually given as a single IV infusion, your baby is not likely be on a daily dosing schedule.

What happens if an overdose is given?

Since botulism immune globulin is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur.

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

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, and may not fully protect the baby from disease.

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.

BabyBIG (botulism immune globulin) side effects

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 other drugs will affect BabyBIG (botulism immune globulin)?

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. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before your baby is treated with botulism immune globulin, tell your doctor about all other medications your baby is receiving, especially:

• chemotherapy;

• medicines to treat a bowel disorder;

• medication to prevent organ transplant rejection;

• antiviral medications;

• pain or arthritis medicines, including aspirin or ibuprofen (Advil, Motrin); or

• any IV antibiotics.

Your baby may need dose adjustments or special tests when taking any of these medications together with botulism immune globulin.

Where can I get more information?

• Your doctor or pharmacist can provide more information about botulism immune globulin.

• 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.