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Patented Methodologies

Learn how ASCENIV is manufactured using patented methodologies for donor screening and plasma pooling*

ASCENIV—The only IVIG produced from blending RSV plasma with normal source plasma1*

Graphic showing hyperimmune plasma vs normal source plasma
  • Hyperimmune donors with RSV antibodies are identified using ADMA’s proprietary screening technology2,3
  • Plasma is collected from US FDA-licensed plasma collection centers3
Graphic showing antibodies in test tube
  • Proprietary microneutralization assay quantifies levels of neutralizing antibodies in hyperimmune plasma donor samples2
Graphic for ASCENIV and hyperimmune plasma

ASCENIV is the only IVIG product available that is manufactured using patented methodologies for donor screening and plasma pooling*

  • Normal source plasma is blended with RSV plasma to produce a tailored plasma pool derived from a minimum of 1,000 unique donors
  • Provides a broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins4
  • Meets potency requirements for 21CFR6403

*ADMA BIOLOGICS PATENTS ISSUED 9,107,906 - 9,714,283 - 9,815,886.
FDA=US Food and Drug Administration; IgG=immunoglobulin G.


Focused on what matters most: Safety, quality, and efficacy

ADMA has created a robust, sustainable, reproducible, and controlled process for ASCENIV, the only IVIG produced from blending RSV plasma and normal source plasma1*

Icon for sustainable supply of RSV and normal source plasma

Sustainable supply of RSV and normal source plasma

Icon for established lot-to-lot consistency

Established Lot-to-lot consistency

Icon for high quality impurity profile

High-quality impurity profile

Icon for end-to-end control of Ig manufacturing functions

End-to-end control of Ig manufacturing functions

Icon for reproducible results

Reproducible results

Icon for quality in every vial

Quality in every vial

We are committed to excellence when producing specialty plasma-derived products designed to safely and effectively treat the immune compromised


Inside ASCENIV—efficacy to prevent serious infections4

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:


serious acute bacterial infections (SBIs)*

Count on ASCENIV to reduce infection-related quality-of-life impact

Efficacy results (PPPY) in the same 1-year study (secondary endpoints):


hospitalizations due to infection

One patient from the study group was hospitalized because of a postoperative local wound infection from elective surgery


unscheduled medical visits PPPY

24 out of 59 patients (41%) had a total of 54 unscheduled medical visits due to infections


missed days of work/school/
activity PPPY due to infection

23 patients (39%) had a total of 93 missed days of work/school/activity due to infections out of a total of 21,535 patient days (<0.5%)


days of antibiotic use PPPY

37 patients (63%) used antibiotics due to infection (includes therapeutic use)

*SBIs were defined as a rate of <1.0 cases of bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscess, and bacterial meningitis per person-year.4
PPPY=per patient per year.

Dosing, Administration & Storage

ASCENIV dosing, administration & storage

For adults and adolescents (12 to 17 years of age) with PI4

For intravenous use only


300 to 800 mg/kg every 3 to 4 weeks*

*Frequency/amount of IgG therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

Initial infusion rate
(for first 15 minutes)

0.5 mg/kg/min
(0.005 mL/kg/min)

Maintenance infusion rate (if tolerated)

Increase gradually every 15 minutes up to 8 mg/kg/min
(0.08 mL/kg/min)

  • No apparent differences in efficacy or safety between 3- and 4-week dosing4
  • The dose may be adjusted over time to achieve the desired trough levels and clinical response4
  • ASCENIV dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/dL with a target of 600 mg/dL. Starting with the second infusion, adjust the dose proportionally, targeting a trough of ≥600 mg/dL, based on the previous trough and the associated dose4

ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion4

  • Available in a single-use, non-latex, tamper-evident 5 g/50 mL vial4
  • Begin with an initial infusion rate of 0.5 mg/kg/min. If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate4
  • Monitor patient vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a slower rate which is comfortable for the patient4
  • Ensure that patients with preexisting renal insufficiency are not volume-depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer ASCENIV at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates4
Vial and box for ASCENIV


  • Once vial is entered, use promptly
  • Store at 2-8 °C (36-46 °F) for up to 36 months from the date of manufacture
  • Do not freeze
  • Within the first 24 months of shelf-life, product may be stored up to 4 weeks at ≤25 °C (77 °F). After storage at room temperature product must be used or discarded


ASCENIVa demonstrated safety profile4

  • The total number of adverse reactions (ARs) was 158 (a rate of 0.20 ARs per infusion)
  • Fifty-eight subjects (98%) had an adverse reaction during the study. The proportion of subjects who had at least one adverse reaction was similar for both the 3- and 4-week cycles. The most common adverse reactions observed in this clinical trial were headache (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%)
  • No study drug–related serious adverse events (SAEs) were reported, although 2 SAEs (postoperative wound infection and migraine) were documented1

Adverse reactions (within 72 hours after the end of an ASCENIV infusion) in ≥5% of subjects

Adverse Reactions

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)

Product Characteristics

Product characteristics4

  • ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion1
  • The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections
  • Purified, sterile, ready-to-use preparation
  • Clear to opalescent liquid (colorless to pale yellow)
  • Normal IgG subclass distribution
  • Formulated in water for injection containing 0.100 M-0.140 M sodium chloride, 0.20 M-0.29 M glycine, 0.15%-0.25% polysorbate 80, and pH 4.0-4.6. Contains no sucrose
  • Contains ≤200 μg/mL of immunoglobulin A
  • Mean half-life of ASCENIV:
    – 28.5 ± 4.4 days for patients on a 3-week dosing regimen 
    – 39.7 ± 11.6 days for patients on a 4-week dosing regimen

The only IGIV available that is manufactured using ADMA Biologics’ patented methodologies for donor screening and plasma pooling.*

Vial for ASCENIV

Size of vial not to scale.

Available in a single-use, non-latex, tamper-evident 5 g/50 mL vial.


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 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).


Important Safety Information for ASCENIV™


  • 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 IVIG 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.
  1. Data on file, ADMA Biologics. 

  2. Wasserman RL, Lumry W, Harris J, et al. Efficacy, safety, and pharmacokinetics of a new 10% liquid intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses in subjects with primary immunodeficiency disease. J Clin Immunol. 2016;36(6):590-599. 

  3. 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. 

  4. ASCENIV Prescribing Information. ADMA Biologics; 2019.