BabyBIG 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.

BabyBIG is used to treat infant botulism caused by toxin type A or B. BabyBIG is used in children who are younger than 1 year old.

BabyBIG may also be used for purposes not listed in this medication guide.

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

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

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

BabyBIG is given as an infusion into a vein. Your baby will receive this infusion in a clinic or hospital setting.

BabyBIG 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 BabyBIG is not causing harmful effects, your baby may need follow-up blood tests.

Your baby should not receive BabyBIG 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.

Tell the doctor if your baby has ever had:

• kidney disease;

• diabetes;

• a vaccine;

• dehydration; or

• treatment with any medicines that weaken the immune system.

BabyBIG is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

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

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

Your baby should not receive a "live" vaccine for at least 3 months after receiving BabyBIG. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, or varicella (chickenpox). The vaccine may not work as well during this time, and may not fully protect your baby from disease.

Your baby will remain under constant supervision during treatment with BabyBIG.

Get emergency medical help if your baby has 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 of BabyBIG 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.

Other drugs may affect BabyBIG, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.