BabyBIG (Page 2 of 5)

5.4 Anaphylaxis

  • Severe reactions, such as angioedema and anaphylactic shock, although not observed during clinical trials with BabyBIG, are a possibility.[8, 9] Clinical anaphylaxis may occur even when the patient is not known to be sensitive to immune globulin products. A reaction may be related to the rate of infusion; therefore, carefully adhere to the infusion rates as outlined under “DOSAGE AND ADMINISTRATION (2.3).” If anaphylaxis or a drop in blood pressure occurs, discontinue the infusion and administer epinephrine.[1-4]
  • Although acute systemic allergic reactions were not seen in clinical trials with BabyBIG, epinephrine should be available for treatment of acute allergic symptoms [see ADVERSE REACTIONS (6.1) ]. If hypotension or anaphylaxis occurs, discontinue the administration of BabyBIG immediately and give supportive care as needed.

5.5 Aseptic Meningitis Syndrome

  • An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV administration.[10-13] The syndrome usually begins within several hours to two days following IGIV treatment. It is characterized by symptoms and signs that include the following: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per cubic millimeter, predominately from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Conduct a thorough neurological examination in patients exhibiting such symptoms and signs to rule out other causes of meningitis.[10-13] AMS may occur more frequently in association with high total doses (2 g/kg) of IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.[1, 10-13] AMS was not observed in clinical trials of BabyBIG.

5.6 Hyperproteinemia, Hyponatremia, and Serum Viscosity

Hyperproteinemia, hyponatremia, and increased serum viscosity have been observed following administration of IGIV products. It is clinically critical to distinguish true hyponatremia from pseudohyponatremia caused by decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher risk of thromboembolic events. These adverse events have not been observed with BabyBIG.

5.7 Thrombotic Events

Thrombotic events may occur following IGIV treatment. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer BabyBIG at the minimum rate of infusion practicable.

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 (%)
*
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.
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)
*
Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.
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.

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