BioCareSD February 2021 Product Catalog

FOR PATIENTS AT RISK OF INFECTION

Inside every brave patient living with primary humoral immunodeficiency (PI) is the desire to live the healthiest life possible. Introducing ASCENIV™, formerly known as RI-002, developed to help protect patients with PI. IT’sWHAT’s INSIDE THATCOUNTS ASCENIV™ is manufactured through a patented process using source plasma, which is acquired from donors screened using a microneutralization assay to detect and identify which donors possess naturally occurring neutralizing antibody titers to respiratory syncytial virus (RSV) 1 ◊ Plasma pool is derived from a minimum of 1000 unique donors and blends normal source plasma with RSV plasma In a 1-year, prospective, open-label, nonrandomized, multicenter, phase 3 study evaluating the efficacy and safety of ASCENIV™ in adult and pediatric patients with PI 2 : ◊ ZERO serious bacterial infections ◊ Secondary endpoint results: • 1.7 missed days of work/school/day care • <1 unscheduled medical visits • No hospitalizations †

AN igiv FOR PATIENTS WITH PRIMARY HUMORAL IMMUNODEFICIENCY (PI)

Indication ASCENIV (immune globulin intravenous, human) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). 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).

Contraindications ASCENIV is contraindicated in:

Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis. IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing. Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support. Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244) . After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. Adverse Reactions The most common adverse reactions to ASCENIV ( ≥ 5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. You are encouraged to report side effects of prescription drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

• Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity. Warnings and Precautions Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at risk patients, administer ASCENIV at the minimum infusion rate practicable. Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.

INTRODUCING

Visit asceniv.com for more information

ADMA BIOLOGICS PATENTS ISSUED 9,107,906 - 9,714,283 - 9,815,886 IGIV=immune globulin intravenous.

Important Safety Information for ASCENIV TM (Immune Globulin Intravenous [Human] – slra 10% Liquid)

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Study Design: A 52-week, prospective, open-label, nonrandomized, multicenter, phase 3 study that evaluated the efficacy and safety of ASCENIV (RI-002) in 59 patients with PI. IV infusions were administered at doses of 300 to 800 mg/kg every 3 or 4 weeks. Primary efficacy endpoint was the demonstration of a serious bacterial infection (SBI) rate of less than 1.0 per person-year during the 52-week treatment period. Secondary efficacy endpoints included number of missed days of work/school/activity due to infection, unscheduled visits to the physician, and days hospitalized due to infection. 2 † One patient hospitalized from study group due to post-op local wound infection from elective surgery. For additional safety information about ASCENIV, please click here to see full Prescribing Information.

References: 1. Wasserman RL, Garcia D, Greener BN, et al. Manufacturing process optimization of ADMA Biologics’ intravenous immunoglobulin products, BIVIGAM® and ASCENIV™. Immunotherapy. 2019;11(16):1423-1433. 2. ASCENIV™ Prescribing Information, ADMA Biologics, 2019.