Molecule
Human botulinum neurotoxin a/b immune globulin is a human immunoglobulin G indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. MedsAcross supplies Human botulinum neurotoxin a/b immune globulin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
BabyBIG contains antibodies specific for botulinum neurotoxin types A and B that bind to and neutralize circulating toxin types A and B in the patient.
Source: US FDA prescribing information
For Intravenous Use Only Intravenous use only. Recommended dose is 1.0 mL/kg (50 mg/kg) given as a single intravenous infusion. Reconstitute in 2 mL Sterile Water for Injection USP and initiate infusion within 2 hours of reconstitution. Administer BabyBIG through a separate intravenous line. Begin infusion slowly (0.5 mL/kg/h), if no untoward reaction in 15 minutes, increase rate to 1.0 mL/kg/h. DO NOT EXCEED THE RECOMMENDED DOSE, CONCENTRATION, AND RATE OF INFUSION.
Source: US FDA prescribing information
As with other immunoglobulin preparations, BabyBIG should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations. [1-4] Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A. Prior history of severe reaction to other human immunoglobulin preparations. Selective immunoglobulin A deficiency with anti-IgA antibodies
Source: US FDA prescribing information
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. Assess renal function prior to and following administration. Anaphylaxis and hypersensitivity reactions may occur. 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. Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving immune globulin intravenous (human) (IGIV) therapy. Thrombotic events have occurred in patients receiving IGIV products. Monitor patients with known risk factors for thrombotic events, consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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. 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. If such vaccinations were given shortly before or after BabyBIG administration, revaccination may be necessary. [21] The passive transfer of antibodies may interfere with the response to live viral vaccines.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Human botulinum neurotoxin a/b immune globulin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| BabyBIG 50 mg/mL powder for injectionIntravenous Cold chain | California Department of Public Health | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Human botulinum neurotoxin a/b immune globulin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Human botulinum neurotoxin a/b immune globulin, including BabyBIG.
At least one listed presentation of Human botulinum neurotoxin a/b immune globulin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.