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BabyBIG

Last reviewed on RxList: 5/7/2018
BabyBIG Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/7/2018

BabyBIG [botulism immune globulin intravenous (human) (BIG-IV)] 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. Common side effects of BabyBIG include:

  • mild and temporary red rash of the face or trunk.

The recommended dose of BabyBIG is 1.0 mL/kg (50 mg/kg) given as a single intravenous infusion. BabyBIG may interact with live viral vaccines. Tell your doctor all medications and supplements your child uses. BabyBIG is intended for use only in patients below one year of age and is not intended for use in older patients who may be pregnant or are breastfeeding.

Our BabyBIG [botulism immune globulin intravenous (human) (BIG-IV)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
BabyBIG Consumer Information

Your baby will remain under constant supervision during treatment with botulism immune globulin.

Get emergency medical help if your baby has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the baby has:

  • tenderness, redness, warmth, cold feeling, or blue/purple appearance in the arms or legs;
  • fussiness, trouble breathing, blue lips, pale skin;
  • little or no urinating, fewer wet diapers than usual;
  • yellowed skin, dark colored urine;
  • low levels of sodium in the body--confusion, severe weakness, vomiting, loss of coordination or motor skills; or
  • swelling around the brain or spinal cord--fever, neck stiffness, sensitivity to light, weakness, sleepiness, vomiting.

Common side effects may include:

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

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.

Read the entire detailed patient monograph for BabyBIG (Botulism Immune Globulin Intravenous (Human) (BIG-IV) for Injection)

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BabyBIG Professional Information

SIDE EFFECTS

  • 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[21]. 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]

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].[14,15] Different methodolog10ies 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.

The only adverse event considered possibly related to BabyBIG administration was a mild, transient erythematous rash of the face or trunk. The following table summarizes the occurrence of rash by day of study relative to day of treatment for the randomized, controlled clinical trial (RCT) and for the open label study (OLS).

Day of Study Relative to Treatment RCT OLS
Placebo*
(N=64)
BabyBIG
(N=65)
BabyBIG
(N=293)
n (%)
Day -5 0 (0) 1 (2) 6 (2)
Day -4 2 (3) 1 (2) 5 (2)
Day -3 3 (5) 4 (6) 6 (2)
Day -2 5 (8) 2 (3) 22 (8)
Day -1 4 (6) 11 (17) 28 (10)
Day 0 Before 5 (8) 9 (14) 32 (11)
During & After 2 (3) 9 (14) 39 (13)
Day +1 2 (3) 1 (2) 18 (6)
Day +2 1 (2) 2 (3) 13 (4)
Day +3 3 (5) 0 (0) 7 (2)
Day +4 1 (2) 2 (3) 11 (4)
Day +5 2 (3) 0 (0) 5 (2)
* Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.
Day 0 is the day of treatment.
In reference to treatment.

In the controlled study, when only treatment emergent events are considered, 14% of the BabyBIGtreated patients experienced erythematous rash during or after study infusion. Eight percent of placebotreated patients also experienced erythematous rash in this study. A similar rash is known to occur both in infant botulism patients who have not received any IGIV products[16] and in patients treated with other IGIVs,[2,3] making it difficult to ascertain the causality of the rash.

In the controlled study only, the following adverse events occurred in at least 5% of the patients receiving BabyBIG or placebo:

Adverse Event BabyBIG
N=65
Placebo
N=64
n (%)
N (%) of Patients with any AE 20 (31) 29 (45)
Rash erythematous 9 (14) 5 (8)
Otitis media 7 (11) 5 (8)
Pneumonia 7 (11) 9 (14)
Anemia 3 (5) 9 (14)
Hyponatremia 3 (5) 9 (14)
Hypertension 1 (2) 3 (5)
Respiratory arrest 1 (2) 6 (9)
Urinary tract infection 1 (2) 8 (13)
Convulsions 0 3 (5)
* Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.

In the open label study only, the following adverse events occurred in at least 5% of the patients:

Adverse Event BabyBIG
N=293
N (%)
Patients with Any AE 285 (97)
Blood pressure increased 221 (75)
Dysphagia 190 (65)
Irritability 121 (41)
Atelectasis 113 (39)
Rhonchi 100 (34)
Pallor 83 (28)
Loose stools 73 (25)
Dermatitis contact 70 (24)
Rash erythematous 64 (22)
Vomiting 58 (20)
Nasal congestion 54 (18)
Edema 54 (18)
Oxygen saturation decreased 51 (17)
Pyrexia 51 (17)
Body temperature decreased 48 (16)
Blood pressure decreased 47 (16)
Cardiac murmur 45 (15)
Cough 39 (13)
Rales 37 (13)
Abdominal distension 33 (11)
Breath sounds decreased 30 (10)
Dehydration 30 (10)
Agitation 29 (10)
Hemoglobin decreased 27 (9)
Stridor 26 (9)
Lower respiratory tract infection 23 (8)
Oral candidiasis 23 (8)
Injection-site reaction 21 (7)
Tachycardia NOS 20 (7)
Peripheral coldness 19 (7)
Dyspnea NOS 16 (6)
Hyponatremia 16 (6)
Injection-site erythema 15 (5)
Intubation NOS 15 (5)
Metabolic acidosis 15 (5)
Neurogenic bladder 15 (5)
Anemia 14 (5)
Tachypnea 14 (5)

Adverse event coding was used in the open label study to distinguish between minor clinical events that required no intervention and more significant events that required intervention. For example, "increased blood pressure" or "decreased blood pressure" was assigned when transient changes in blood pressure were observed, whereas "hypertension" or "hypotension" was assigned when more prolonged or significant changes were observed.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Experience with BabyBIG. No adverse reactions have been identified or reported that are ascribed to the use of BabyBIG during postapproval use. Retrospective publications have shown safety-related information consistent with the safety-related information in the approved product labeling, and no new safety-related information has been presented for BabyBIG.[22. 23]

Experience with Other IGIV Products. Some classes of adverse reactions that have not been reported in BabyBIG clinical studies or postmarketing experience have been observed with the overall postapproval use of other IGIV products, as shown in the following table.

Respiratory Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm
Cardiovascular Cardiac arrest, thromboembolism, vascular collapse, hypotension
Neurolog10ical Coma, loss of consciousness, seizures, tremor
Integumentary Steven-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis
Hematolog10ic Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
General / Body as a Whole Pyrexia, rigors
Musculoskeletal Back pain
Gastrointestinal Hepatic dysfunction, abdominal pain

Read the entire FDA prescribing information for BabyBIG (Botulism Immune Globulin Intravenous (Human) (BIG-IV) for Injection)

Related Resources for BabyBIG

© BabyBIG Patient Information is supplied by Cerner Multum, Inc. and BabyBIG Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Bowel regularity means a bowel movement every day. See Answer

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