Lanadelumab interacts in the following cases:
As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor.
There are no or limited data from the use of lanadelumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity. As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
It is unknown whether lanadelumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. Afterwards, lanadelumab could be used during breast-feeding if clinically needed.
Lanadelumab’s effect on fertility has not been evaluated in humans. Lanadelumab had no effect on male or female fertility in cynomolgus monkeys.
Lanadelumab has negligible influence on the ability to drive or use machines.
The most commonly (52.4%) observed adverse reaction associated with lanadelumab was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.
Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%).
The following list summarises adverse reactions observed in the HELP study that included 84 subjects with HAE, who received at least one dose of lanadelumab.
The frequency of adverse reactions listed is defined using the following convention: 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).
Common: Hypersensitivity*
Common: Dizziness
Common: Rash maculo-papular
Common: Myalgia
Very common: Injection site reactions**
Common: Alanine aminotransferase increased, Aspartate aminotransferase increased
* Hypersensitivity includes: pruritus, discomfort and tingling of tongue.
** Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
The safety of lanadelumab was evaluated in a subgroup of 23 subjects aged 12 to <18 years old. Results of the subgroup analysis were consistent with overall study results for all subjects.
Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.
The development of ADA including neutralising antibodies against lanadelumab did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
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