adache (22 subjects, 37%), sinusitis (16 subjects, 27%), diarrhea (14 subjects, 23%), gastroenteritis viral (13 subjects, 22%),nasopharyngitis (13 subjects, 22%), upper respiratory tract infection (13 subjects, 22%), bronchitis (12 subjects, 20%), nausea(12 subjects, 20%), and acute sinusitis (11 subjects, 19%).
Adverse reactions (ARs) occurring during or within 72 hours after the end of an infusion are presented in Table 2. In this study,
the upper bound of the 1-sided 95% confidence interval for the proportion of ASCENIV infusions with one or more temporally
associated adverse reactions was 16.4%. The total number of adverse reactions was 158 (a rate of 0.20 ARs per infusion).
Table 2: Adverse Reactions (ARs) (within 72 hours after the end of an ASCENIV infusion) in ≥ 5% of Subjects
Preferred Term (MedDRA v16.0)
Number (%) of Subjects
(N=59)
Number (%) of Infusions
(N=793)
Headache 14 (24) 21 (2.6)
Sinusitis 6 (10) 7 (0.9)
Nausea 5 (9) 5 (0.6)
Acute sinusitis 4 (7) 4 (0.5)
Fatigue 4 (7) 9 (1.1)
Muscle spasms 4 (7) 4 (0.5)
Bronchitis 3 (5) 3 (0.4)
Diarrhea 3 (5) 3 (0.4)
Nose Bleed 3 (5) 4 (0.5)
Muscle Pain 3 (5) 5 (0.6)
Oropharyngeal pain 3 (5) 3 (0.4)
Pain in extremity 3 (5) 3 (0.4)
Itching 3 (5) 3 (0.4)
6.2 Postmarketing Experience
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not alwayspossible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. The followingadverse reactions have been identified and reported during the post-approval use of IGIV products:
• Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), cyanosis, dyspnea, bronchospasm.
• Cardiovascular: Cardiac arrest, vascular collapse, hypotension.
• Neurological: Coma, loss of consciousness, seizures, tremor.
• Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis.
• Hematologic: Pancytopenia, leukopenia,.
• General/Body as a Whole: Pyrexia, rigors.
• Gastrointestinal: Hepatic dysfunction, abdominal pain.
7 DRUG INTERACTIONS
Immunoglobulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps,rubella, and varicella because the continued presence of high levels of passively acquired antibody may interfere with an activeantibody response.
15,16 The immunizing physician should be informed of recent therapy with ASCENIV so that appropriatemeasures may be taken (see Patient Counseling Information [17]).
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have notbeen conducted with ASCENIV. It is not known whether ASCENIV can cause fetal harm when administered to a pregnant womanor can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks ofgestation. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2-4% and 15-20% respectively. ASCENIV should be given to pregnant women only if clearlyneeded.
8.2 Lactation
Risk Summary
No human data are available to indicate the presence or absence drug-associated risk. The developmental and health benefits ofbreast feedi |
