Adzynma

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Adzynma Generic Name & Formulations

General Description

ADAMTS13, recombinant-krhn 500 IU, 1500 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

How Supplied

Single-dose vial—1 (w. supplies)

Generic Availability

NO

Mechanism of Action

Adzynma is a recombinant form of the endogenous ADAMTS13. ADAMTS13 is a plasma zinc metalloprotease that regulates the activity of von Willebrand factor (VWF) by cleaving large and ultralarge VWF multimers to smaller units and thereby reducing the platelet binding properties of VWF and its propensity to form microthrombi.

Adzynma Indications

Indications

For prophylactic or on demand enzyme replacement therapy (ERT) in patients with congenital thrombotic thrombocytopenic purpura (cTTP).

Adzynma Dosage and Administration

Adults and Children

Give as IV infusion at a rate of 2–4mL/min. Prophylaxis: 40 IU/kg once every other week; may give once weekly based on prior prophlylactic regimen or clinical response. On-demand: 40 IU/kg on Day 1, then 20 IU/kg on Day 2, then 15 IU/kg once daily from Day 3 and beyond until 2 days after acute event resolved. 

Adzynma Contraindications

Not Applicable

Adzynma Boxed Warnings

Not Applicable

Adzynma Warnings/Precautions

Warnings/Precautions

Immediately discontinue if severe allergic reactions occur. Potential for immunogenicity. Neutralizing antibodies may develop. Pregnancy. Nursing mothers. 

Adzynma Pharmacokinetics

See Literature

Adzynma Interactions

Not Applicable

Adzynma Adverse Reactions

Adverse Reactions

Headache, diarrhea, migraine, abdominal pain, nausea, upper RTI, dizziness, vomiting; hypersensitivity reactions.

Adzynma Clinical Trials

See Literature

Adzynma Note

Not Applicable

Adzynma Patient Counseling

See Literature

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