There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of donidalorsen in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of donidalorsen during pregnancy.
Available pharmacodynamic/toxicological data in animals have shown excretion of donidalorsen/metabolites in milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from donidalorsen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No clinical data on the effect of this medicinal product on human fertility are available. Donidalorsen had no effect on fertility and early embryonic development toxicity in murine models.
Donidalorsen has no or negligible influence on the ability to drive and use machines.
The most frequently observed adverse drug reactions (ADRs) in patients treated with 80 mg donidalorsen every 4 weeks were injection site reactions (24.4%).
Adverse reactions associated with donidalorsen obtained from clinical trials are tabulated below. All ADRs are listed by system organ class and frequency; 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse drug reactions to donidalorsen:
| System organ class | Adverse drug reaction | Frequency |
| Immune system disorders | Hypersensitivity (including anaphylaxis) | Common |
| General disorders and administration site conditions | Injection site reactionsa | Very common |
| Investigations | Hepatic enzyme increasedb | Very common |
a Injection site reactions include also: erythema, discolouration, pain, pruritus, induration, haematoma, bruising, exfoliation, hypersensitivity and swelling.
b mainly mild, and mostly in alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
In clinical trials, a serious hypersensitivity reaction of anaphylaxis was reported in one patient. Symptoms included generalised rash, dyspnoea, chest pain and peri-oral swelling.
During double-blinded, placebo-controlled trials, injection site reactions were observed. All injection site reactions were non serious, mild to moderate in severity, and generally resolved over time. In some patients, the injection site reactions such as injection site erythema, injection site pruritus, and injection site discolouration persisted for 2 or more days. In one patient who received higher than labelled doses in accordance with the protocol, injection site discoloration led to permanent discontinuation of treatment.
The safety of donidalorsen was evaluated in a double-blind placebo-controlled clinical trial in a subset of 7 adolescent patients aged 12 to 17 years. The safety profile in these adolescent patients was similar to the profile observed in adult patients.
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