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The ADZYNMA safety profile was demonstrated in a Phase 3, open-label, crossover trial (NCT03393975), adverse events occurred in 71% of the patients with ADZYNMA. ^{2 2. Scully M, et al. N Engl J Med. 2024;390(17):1584-1596.}

ADZYNMA is contraindicated in patients with life-threatening hypersensitivity to ADZYNMA or to any of its excipients.*, ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.}

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Hypersensitivity: ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.}  
Allergic-type hypersensitivity including anaphylactic reactions may occur. Patients should be informed of the early signs of hypersensitivity reactions including but not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paraesthesia, restlessness, and may progress to anaphylactic shock. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of ADZYNMA and provide appropriate supportive care.

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Immunogenicity: ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.}  
As with all therapeutic proteins, there is a potential for immunogenicity. Patients may develop antibodies to rADAMTS13 following treatment with ADZYNMA which could potentially result in a decreased response to rADAMTS13. If such antibodies are suspected and there is a lack of efficacy, consider other therapeutic strategies.

*List of excipients. Powder: Sodium chloride, Calcium chloride dihydrate, L-Histidine, Mannitol, Sucrose, Polysorbate 80 (E433). Solvent: Water for injections.

Adverse reactions in the ADZYNMA clinical trials ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.}  

In a Phase 3, open-label, crossover trial (NCT03393975), no ADZYNMA-related serious adverse events were reported. ^{2 2. Scully M, et al. N Engl J Med. 2024;390(17):1584-1596.}

The safety profile of ADZYNMA was evaluated in two studies: ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.} 


1. A global Phase 3, prospective, randomised, controlled, open-label, multicentre, two-period crossover study followed by a single-arm continuation period

2. A long-term continuation study for patients who completed the Phase 3 study

The most common adverse reactions reported in clinical studies were headache (31.5%), diarrhoea (17.8%), dizziness (16.4%), upper respiratory tract infection (15.1%), nausea (13.7%), and migraine (11%). ^{1 1. ADZYNMA (rADAMTS13) EU Summary of Product Characteristics. August 2024.}

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No patients receiving ADZYNMA had adverse events leading to treatment discontinuation or interruption. ^{2 2. Scully M, et al. N Engl J Med. 2024;390(17):1584-1596.}

* Adverse reactions are listed above by MedDRA system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data). Within each System Organ Class (SOC), ADRs are presented in order of decreasing frequency. Within each frequency grouping, ADRs are presented in order of decreasing seriousness.

Acronyms

ADAMTS13, A disintegrin and metalloproteinase with a thrombospondin motifs 13

ADR, Adverse drug reaction

cTTP, Congenital TTP

CHO, Chinese hamster ovary

DNA, Deoxyribonucleic acid

ERT, Enzyme replacement therapy

IP, Investigational product

PT, Preferred term

rADAMTS13, Recombinant ADAMTS13

SmPC, Summary of product characteristics

SoC, Standard of care

SOC, System organ class

TEAE, Treatment-emergent adverse event

TTP, Thrombotic thrombocytopenic purpura