Human Botulinum Neurotoxin A/b Immune Globulin
Generic Name: human botulinum neurotoxin a/b immune globulin
Brand Names:
Babybig
11 DESCRIPTION BabyBIG, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative.
Overview
11 DESCRIPTION BabyBIG, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative.
Uses
1 INDICATIONS AND USAGE BabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION For Intravenous Use Only Intravenous use only ( 2 ) Recommended dose is 1.0 mL/kg (50 mg/kg) given as a single intravenous infusion ( 2 ). Reconstitute in 2 mL Sterile Water for Injection USP and initiate infusion within 2 hours of reconstitution ( 2.1 ). Administer BabyBIG through a separate intravenous line ( 2.3 ). Begin infusion slowly (0.5 mL/kg/h); if no untoward reaction in 15 minutes, increase rate to 1.0 mL/kg/h ( 2.2 , 2.3 ). DO NOT EXCEED THE RECOMMENDED DOSE, CONCENTRATION, AND RATE OF INFUSION ( 2.3 ). 2.1 Preparation for Administration BabyBIG does not contain a preservative.
Side Effects
6 ADVERSE REACTIONS Serious adverse reactions were not observed in clinical trials using BabyBIG. The most common adverse reaction observed with BabyBIG treatment during clinical trials (>5%) was skin rash. Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products. [15] The incidence of these reactions was less than 5% of all infusions in BabyBIG clinical trials, and these reactions were most often related to infusion rates. [7] The most common adverse reaction occurring in at least 5% of the patients treated with BabyBIG in a controlled clinical study was mild and transient erythematous rash of the face or trunk ( 6.1 ).
Interactions
7 DRUG INTERACTIONS Admixtures of BabyBIG with other drugs have not been evaluated. It is recommended that BabyBIG be administered separately from other drugs or medications that the patient may be receiving [ see DOSAGE AND ADMINISTRATION (2) ]. Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines such as polio, measles, mumps, and rubella; therefore, vaccination with live virus vaccines such as MMR (measles, mumps, and rubella), MMRV (measles, mumps, rubella, and varicella), and monovalent varicella vaccines should be deferred until six months after administration of BabyBIG. This interval may be shortened if exposure to measles is likely.
Warnings
5 WARNINGS AND PRECAUTIONS Only administer BabyBIGas an intravenous infusion, since other routes of administration have not been evaluated. Do not use BabyBIG if the reconstituted solution is turbid [ see DOSAGE AND ADMINISTRATION (2.1) ]. Assess renal function prior to and following administration ( 5.1 , 5.2 ). Anaphylaxis and hypersensitivity reactions may occur ( 5.4 ). This risk should be considered when an IgA-deficient patient is to receive subsequent administration of blood products containing IgA after previous treatment with BabyBIG ( 4 ). Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving immune globulin intravenous (human) (IGIV) therapy ( 5.6 ). Thrombotic events have occurred in patients receiving IGIV products. 4 CONTRAINDICATIONS As with other immunoglobulin preparations, BabyBIG should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.
Storage
NDC 68403-1100-6, 100 mg ± 20 mg lyophilized immunoglobulin single-dose vial individually packaged in a carton. Store the vial containing the lyophilized product between 2° and 8°C (35.6° to 46.4°F). Do not store BabyBIG in the reconstituted state. Use reconstituted BabyBIG within 2 hours. Do not use beyond expiration date, and dispose unused product in accordance with local requirements.
Frequently Asked Questions
What is Human Botulinum Neurotoxin A/b Immune Globulin used for?▼
1 INDICATIONS AND USAGE BabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age ( 1 ).
What are the side effects of Human Botulinum Neurotoxin A/b Immune Globulin?▼
6 ADVERSE REACTIONS Serious adverse reactions were not observed in clinical trials using BabyBIG. The most common adverse reaction observed with BabyBIG treatment during clinical trials (>5%) was skin rash. Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products. [15] The incidence of these reactions was less than 5% of all infusions in BabyBIG clinical trials, and these reactions were most often related to infusion rates. [7] The most common adverse reaction occurring in at least 5% of the patients treated with BabyBIG in a controlled clinical study was mild and transient erythematous rash of the face or trunk ( 6.1 ).
What are the important warnings for Human Botulinum Neurotoxin A/b Immune Globulin?▼
5 WARNINGS AND PRECAUTIONS Only administer BabyBIGas an intravenous infusion, since other routes of administration have not been evaluated. Do not use BabyBIG if the reconstituted solution is turbid [ see DOSAGE AND ADMINISTRATION (2.1) ]. Assess renal function prior to and following administration ( 5.1 , 5.2 ). Anaphylaxis and hypersensitivity reactions may occur ( 5.4 ). This risk should be considered when an IgA-deficient patient is to receive subsequent administration of blood products containing IgA after previous treatment with BabyBIG ( 4 ). Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving immune globulin intravenous (human) (IGIV) therapy ( 5.6 ). Thrombotic events have occurred in patients receiving IGIV products. 4 CONTRAINDICATIONS As with other immunoglobulin preparations, BabyBIG should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.