Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 ).
To report SUSPECTED ADVERSE REACTIONS, contact the California Department of Public Health at 1-510-231-7600 and http://www.infantbotulism.org/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Two clinical studies of BabyBIG were performed: (1) an adequate and well-controlled study to evaluate safety and efficacy of BabyBIG, which used BabyBIG Lot 1, and (2) an open label study to collect additional safety data and confirm efficacy, which used BabyBIG Lot 2 [ see CLINICAL STUDIES (14) ].
[16, 17] Different methodologies were used to collect adverse events in the controlled study and open label study.
Minor clinical events that were not recorded as adverse events in the controlled study were recorded as adverse events in the open label study.
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 ).
Like all medications, Babybig can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: