Table 5 Most Frequent Local Adverse Reactions Reported in greater than 1% of Infusion During Treatment With HYQVIA  Infusion Site Reaction Number and Rate of
Reactions per Infusion
N=1129
Discomfort/pain
 122 (0.11)
 
Erythema
 32 (0.03)
 
Swelling/Edema
 35 (0.03)
 
Pruritus
 22 (0.02)
 
Rate per infusion = total number of events divided by total number of infusions

During the combined efficacy and extension trials encompassing more than 3 years, the local adverse reaction rate was 2.6 per patient-year.  During the first 12 month period (months 1-12), the rate was 3.68 local adverse reactions per patient-year.  During the subsequent 12 month period (months 13-24), the rate declined to 2.12 local adverse reactions per-patient year.  Finally, during the third 12 month period (months 25-36), the rate further declined to 0.37 local adverse reactions per patient-year.

Sixty-six of the 68 subjects who completed the efficacy clinical trial enrolled in a prospective, open-label, multicenter extension trial to assess the long-term safety and tolerability of HYQVIA. Sixty-three of 66 subjects enrolled received HYQVIA and 3 received IGIV. Of the 63 subjects who received HYQVIA, 48 completed the extension trial. The cumulative exposure of HYQVIA across the two trials was 188 subject-years and 2959 infusions, and a maximum exposure of 188 weeks or up to approximately 3.5 years. There were no clinically observable changes in the skin or subcutaneous tissue in either the efficacy or extension clinical trials.

6.2 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.

Postmarketing Experience of Immune Globulin Products

The following adverse reactions have been identified and reported during the postmarketing use of Immune Globulin products administered intravenously:

Hematologic
 Leukopenia, Pancytopenia
 
Neurological
 Transient ischemic attack, Tremor, Burning sensation, Cerebral vascular accident, Coma, Seizures, Loss of consciousness
 
Cardiovascular
 Hypotension, Hypertension, Myocardial infarction, Chest pain, Cardiac arrest, Vascular collapse
 
Respiratory
 Pulmonary edema, Dyspnea, Oxygen saturation decreased, Cyanosis, Hypoxemia, Bronchospasm, Apnea, Acute Respiratory Distress Syndrome (ARDS)
 
Gastrointestinal
 Abdominal pain, Hepatic dysfunction
 
Integumentary
 Hyperhidrosis, Allergic dermatitis, Bullous dermatitis, Epidermolysis, Erythema multiforme, Stevens-Johnson Syndrome
 
Psychiatric
 Anxiety, Insomnia
 
Musculoskeletal
 Back Pain
 
General/Body as a Whole
 Edema, Rigors
 
7 DRUG INTERACTIONS

Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines, such as mumps, rubella and varicella for up to 6 months and for a year or more to measles. [see Patient Counseling Information (17)].

Admixtures of HYQVIA with other drugs solutions have not been eva luated. Do not mi