Botulism Immune Globulin IV

Botulism Immune Globulin IV is a prescription medicine used for the treatment of infant botulism caused by toxin types A or B in patients below one year of age.

• Botulism Immune Globulin IV is available under the following different brand names: BabyBIG

Common side effects of Botulism Immune Globulin IV include:

• mild skin rash or redness on the baby’s face, chest, back, or stomach
• chills
• body aches
• wheezing
• vomiting

Serious side effects of Botulism Immune Globulin IV include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• tenderness, redness, warmth, cold feeling, or blue/purple appearance in the arms or legs
• fussiness
• blue lips
• pale skin
• little or no urination
• fewer wet diapers than usual
• yellowing of skin
• dark-colored urine
• confusion
• severe weakness
• vomiting
• loss of coordination or motor skills
• fever
• neck stiffness
• sensitivity to light
• weakness
• sleepiness
• vomiting

Rare side effects of Botulism Immune Globulin IV include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

• Powder for injection-preservative free
• 100 mg/vial

Infant botulism caused by toxin type A or B

Pediatric dosage

• Children younger than 1 year: 100 mg/kg IV infusion; infuse at 25 mg/kg/h for the first 15 minutes, if well tolerated may increase the rate to 50 mg/kg/h
• Children aged a year and older: Not indicated
• The titer of antibodies in the reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 2.7 IU/mL

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Botulism Immune Globulin IV has no noted severe interactions with any other drugs.
• Botulism Immune Globulin IV has no noted serious interactions with any other drugs.
• Botulism Immune Globulin IV has no noted moderate interactions with any other drugs.
• Botulism Immune Globulin IV has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Documented hypersensitivity; selective immunoglobulin A deficiency

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Botulism Immune Globulin IV?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Botulism Immune Globulin IV?"

Cautions

• Aseptic meningitis syndrome was reported
• Acute renal dysfunction may occur
• Assess renal function before and following administration
• Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy
• Hemolytic anemia can develop after IGIV therapy owing to enhanced RBC sequestration
• The product is made from human plasma and may contain infectious agents (eg, viruses) and, theoretically, the Creutzfeldt-Jakob disease agent
• Patients should not be volume-depleted (hypovolemic) before therapy
• For IV infusion only; do not exceed recommended rate of administration

Pregnancy and Lactation

• Not indicated for adults

Lactation

• Not indicated for adults