Prescription Drug Information: BabyBIG (Page 2 of 5)
5.8 Hemolytic Anemia
IGIV products may contain blood group antibodies, which can act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia may develop subsequent to IGIV therapy due to enhanced red blood cell sequestration.
Monitor patients for clinical signs and symptoms of hemolysis. If these are present after BabyBIG infusion, perform appropriate confirmatory laboratory testing.
5.9 Transfusion-Related Acute Lung Injury (TRALI)
Non-cardiogenic pulmonary edema may occur in patients following IGIV treatment.[14] TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically occur within 1 to 6 hours following treatment [See PATIENT COUNSELING INFORMATION (17)].
Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient serum.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
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]
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.
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) |
In the controlled study, when only treatment emergent events are considered, 14% of the BabyBIG-treated patients experienced erythematous rash during or after study infusion. Eight percent of placebo-treated 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[18] 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 | BabyBIGN=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) |
In the open label study only, the following adverse events occurred in at least 5% of the patients:
Adverse Event | BabyBIGN=293N (%) |
---|---|
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.
RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.