| Congenital agammaglobulinemia

Asceniv vs Gammaplex

Side-by-side clinical, coverage, and cost comparison for congenital agammaglobulinemia.

Deep comparison between: Asceniv vs Gammaplex with Prescriber.AI

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Safety signalsGammaplex has a higher rate of injection site reactions vs Asceniv based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Gammaplex but not Asceniv, including UnitedHealthcare

Category

Asceniv

Gammaplex

At A Glance

RouteIV infusion

FrequencyEvery 3-4 weeks

ClassIgG replacement therapy

RouteIV infusion

FrequencyEvery 3-4 weeks

ClassImmune globulin (IgG replacement)

Indications

Congenital agammaglobulinemia
Common Variable Immunodeficiency
X-linked agammaglobulinemia
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency

Common Variable Immunodeficiency
X-linked agammaglobulinemia
Congenital agammaglobulinemia
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency
Immune thrombocytopenic purpura

Dosing

Congenital agammaglobulinemia, Common Variable Immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich Syndrome, Severe Combined Immunodeficiency 300 to 800 mg/kg IV every 3 to 4 weeks; start infusion at 0.5 mg/kg/min for the first 15 minutes and increase gradually up to 8 mg/kg/min if tolerated.

Common Variable Immunodeficiency, X-linked agammaglobulinemia, Congenital agammaglobulinemia, Wiskott-Aldrich Syndrome, Severe Combined Immunodeficiency 300-800 mg/kg (3-8 mL/kg) IV every 3-4 weeks; initial infusion rate 0.5 mg/kg/min for 15 minutes, then increase gradually every 15 minutes to 8 mg/kg/min.

Immune thrombocytopenic purpura 1 g/kg (10 mL/kg) IV on 2 consecutive days (total dose 2 g/kg); initial infusion rate 0.5 mg/kg/min for 15 minutes, then increase gradually every 15 minutes to 8 mg/kg/min.

Contraindications

Previous anaphylactic or severe systemic reaction to human immune globulin
IgA deficiency with antibodies to IgA and history of hypersensitivity

Previous anaphylactic or severe systemic reaction to human immune globulin
IgA deficiency with antibodies to IgA and a history of hypersensitivity

Drug Interactions

163View drug interactions

Adverse Reactions

Most common (>=5%) Headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, nausea

Postmarketing Apnea, ARDS, cyanosis, dyspnea, bronchospasm, cardiac arrest, vascular collapse, hypotension, coma, loss of consciousness, seizures, tremor, Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis, pancytopenia, leukopenia, pyrexia, rigors, hepatic dysfunction, abdominal pain

Most common (>=5%) in PI Headache, migraine, pyrexia

Most common (>=5%) in ITP Headache, vomiting, pyrexia, nausea, arthralgia, dehydration

Serious Thrombotic events, hemolysis; in ITP subjects: headache, vomiting, dehydration

Postmarketing Tachycardia, thromboembolism, hypertension, flushing, nausea, chills, chest discomfort, pyrexia, back pain, polymyositis, headache, dyspnea, rash, urticaria

Pharmacology

ASCENIV is an intravenous immunoglobulin replacement therapy that provides a broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins; IgG antibodies act as opsonins to increase phagocytosis and elimination of pathogens from the circulation.

Polyclonal human IgG that provides replacement therapy for primary humoral immunodeficiency via a broad spectrum of opsonic and neutralizing IgG antibodies against pathogens and their toxins through antigen binding and effector functions; the mechanism of action in both PI and ITP has not been fully elucidated.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Asceniv