There are no or limited amount of data from the use of apadamtase alfa in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The use of apadamtase alfa during pregnancy may only be considered after a thorough individual risk benefit analysis by the treating physician before and during treatment.
There is insufficient information on the excretion of rADAMTS13 in human or animal milk but it is unlikely that it is excreted in human milk due to its high molecular weight. The decision either to discontinue breast-feeding or discontinue apadamtase alfa should take into account the importance of this medicinal product to the mother.
No human data are available on the effects of rADAMTS13 on male and female fertility. Animal data do not indicate direct or indirect harmful effects with respect to male or female fertility.
Recombinant ADAMTS13 may have a minor influence on the ability to drive and use machines. Dizziness and somnolence may occur following the administration of apadamtase alfa.
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%).
The adverse drug reactions (ADRs) are listed in the table below.
Adverse reactions are listed below 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.
Adverse reactions reported in patients treated with apadamtase alfa:
| MedDRA system organ class (SOC) | Adverse reaction by preferred term (PT) | Frequency category by subject |
| Infections and infestations | Upper respiratory tract infection | Very common |
| Blood and lymphatic system disorders | Thrombocytosis | Common |
| Nervous system disorders | Headache | Very common |
| Dizziness | Very common | |
| Migraine | Very common | |
| Somnolence | Common | |
| Gastrointestinal disorders | Diarrhoea | Very common |
| Nausea | Very common | |
| Constipation | Common | |
| Abdominal distension | Common | |
| General disorders and administration site conditions | Asthenia | Common |
| Feeling hot | Common | |
| Investigations | ADAMTS13 activity abnormal | Common |
There is limited information from controlled studies of apadamtase alfa in paediatric patients. The safety assessment in paediatric patients is based on the safety data from one phase 3 clinical study comparing apadamtase alfa to plasma-based therapies (fresh frozen plasma [FFP], pooled solvent/detergent [S/D] treated plasma, or factor VIII:von Willebrand factor [FVIII-VWF] concentrates, as assigned by the investigator) and one phase 3b study. The studies included 20 and 1 paediatric patients aged 2 to 17 years of age in the prophylactic and on-demand cohorts, respectively. Overall, the safety profile in these paediatric patients was similar to that observed in the adult population.
One neonate aged 36 hours old was treated with apadamtase alfa in a compassionate use program and had no reported safety or immunogenicity concerns after 2 years of prophylactic treatment.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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