Generic Name: botulism immune globulin (BOT ue lizm im MYOON GLOB yoo lin)Brand Names: 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 is the most important information I should know about 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.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.What should I discuss with my healthcare provider before my child receives 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:
a life-threatening infection;
if the baby is dehydrated; or
if the baby has recently received any vaccinations.
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.Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with botulism immune globulin.
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.
Since botulism immune globulin is usually given as a single IV infusion, your baby is not likely be on a daily dosing schedule.
Since botulism immune globulin is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur.
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.
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.
Usual Pediatric Dose for Botulism:
Less than one year of age with infant botulism caused by toxin type A or B:1 mL/kg (50 mg/kg), given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made. Add 2 mL sterile water for injection to the 100 mg vial, resulting in 50 mg/mL solution. Infusion should begin within 2 hours after reconstitution is complete and should be concluded within 4 hours of reconstitution. The infusion should begin slowly. Administration should start at 0.5 mL per kg body weight per hr (25 mg/kg/hr). If no untoward reactions occur after 15 minutes, the rate may be increased to the maximum infusion rate of 1 mL/kg/hr (50 mg/kg/hr). The total dose should take 97.5 minutes total elapsed time.
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:
medicines to treat a bowel disorder;
medication to prevent organ transplant rejection;
pain or arthritis medicines, including aspirin or ibuprofen (Advil, Motrin); or
any IV antibiotics.
This list is not complete and there may be other drugs that can interact with botulism immune globulin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.