ASCENIV
Generic: HUMAN IMMUNOGLOBULIN G
Basic Information
Manufacturer
ADMA Biologics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
d74f4360-3b51-496c-96fb-84c3976958d2
Indications & Usage
1 INDICATIONS AND USAGE ASCENIV is indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).
ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).
ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions to ASCENIV (≥5% of study patients) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
[6] To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (1-800-458-4244) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.
The safety data described in this section reflects exposure to ASCENIV in two clinical studies (Study 1 and Study 2) as described below.
Study 1 In Study 1, 59 patients with PI received a total of 793 infusions of ASCENIV at a median dose of 505 mg/kg (range 284 to 1008 mg/kg) every 3 weeks or 4 weeks for up to 12 months (mean 346 days; range 36 to 385 days).
Of the 793 infusions administered during this trial, 7 (11.9%) patients received premedication prior to 7 (0.9%) infusions [see Clinical Studies (14)] .
The most common adverse reactions occurring in ≥5% of patients in Study 1 are presented in Table 2.
Table 2: Adverse Reactions in ≥ 5% of Patients in Study 1 Adverse Reactions* Number (%) of Patients (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) Epistaxis 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) *Adverse reactions were defined as events occurring within 72 hours after the end of an ASCENIV infusion Study 2 (Pediatric Study) In Study 2, 16 pediatric patients with PI aged 2 to 11 years received 91 infusions of ASCENIV at a median dose of 541 mg/kg (range 300-800 mg/kg) every 3 or 4 weeks for approximately 5 months.
The most common adverse reactions in Study 2 are presented in Table 3 below.
Table 3: Adverse Reactions in Study 2 Adverse Reactions* Number (%) of Patients (N=16) Number (%) of Infusions (N=91) Chest Pain 1 (6) 1 (1) Epistaxis 1 (6) 1 (1) Fatigue 1 (6) 1 (1) Hypersensitivity 1 (6) 1 (1) Diarrhea 1 (6) 1 (1) Headache** 4 (25) 5 (5) Otitis** 2 (13) 2 (2) Viral Rash 1 (6) 1 (1) Vomiting 1 (6) 1 (1) Nausea 3 (19) 4 (4) *Adverse reactions were defined as events occurring within 72 hours after the end of an ASCENIV infusion **Includes multiple related terms.
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.
The following adverse reactions have been identified and reported during the post-approval use of IGIV products: Respiratory, thoracic and mediastinal disorders: Apnea, Acute Respiratory Distress Syndrome (ARDS), cyanosis, dyspnea, bronchospasm.
Cardiac disorders: Cardiac arrest, vascular collapse, hypotension.
Nervous system disorder: Coma, loss of consciousness, seizures, tremor.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis.
Blood and lymphatic system disorders: Pancytopenia, leukopenia.
General disorders and administration site conditions: Pyrexia, rigors.
Gastrointestinal disorders: Hepatic dysfunction, abdominal pain.
[6] To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (1-800-458-4244) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.
The safety data described in this section reflects exposure to ASCENIV in two clinical studies (Study 1 and Study 2) as described below.
Study 1 In Study 1, 59 patients with PI received a total of 793 infusions of ASCENIV at a median dose of 505 mg/kg (range 284 to 1008 mg/kg) every 3 weeks or 4 weeks for up to 12 months (mean 346 days; range 36 to 385 days).
Of the 793 infusions administered during this trial, 7 (11.9%) patients received premedication prior to 7 (0.9%) infusions [see Clinical Studies (14)] .
The most common adverse reactions occurring in ≥5% of patients in Study 1 are presented in Table 2.
Table 2: Adverse Reactions in ≥ 5% of Patients in Study 1 Adverse Reactions* Number (%) of Patients (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) Epistaxis 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) *Adverse reactions were defined as events occurring within 72 hours after the end of an ASCENIV infusion Study 2 (Pediatric Study) In Study 2, 16 pediatric patients with PI aged 2 to 11 years received 91 infusions of ASCENIV at a median dose of 541 mg/kg (range 300-800 mg/kg) every 3 or 4 weeks for approximately 5 months.
The most common adverse reactions in Study 2 are presented in Table 3 below.
Table 3: Adverse Reactions in Study 2 Adverse Reactions* Number (%) of Patients (N=16) Number (%) of Infusions (N=91) Chest Pain 1 (6) 1 (1) Epistaxis 1 (6) 1 (1) Fatigue 1 (6) 1 (1) Hypersensitivity 1 (6) 1 (1) Diarrhea 1 (6) 1 (1) Headache** 4 (25) 5 (5) Otitis** 2 (13) 2 (2) Viral Rash 1 (6) 1 (1) Vomiting 1 (6) 1 (1) Nausea 3 (19) 4 (4) *Adverse reactions were defined as events occurring within 72 hours after the end of an ASCENIV infusion **Includes multiple related terms.
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.
The following adverse reactions have been identified and reported during the post-approval use of IGIV products: Respiratory, thoracic and mediastinal disorders: Apnea, Acute Respiratory Distress Syndrome (ARDS), cyanosis, dyspnea, bronchospasm.
Cardiac disorders: Cardiac arrest, vascular collapse, hypotension.
Nervous system disorder: Coma, loss of consciousness, seizures, tremor.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis.
Blood and lymphatic system disorders: Pancytopenia, leukopenia.
General disorders and administration site conditions: Pyrexia, rigors.
Gastrointestinal disorders: Hepatic dysfunction, abdominal pain.