Rozanolixizumab interacts in the following cases:
As rozanolixizumab interferes with the FcRn recycling mechanism of immunoglobulin G (IgG), the serum concentrations of IgG-based medicinal products (e.g. monoclonal antibodies and intravenous immunoglobulin [IVIg]) and Fc–peptide fusion proteins are expected to be decreased if administered concomitantly or within 2 weeks after administration of rozanolixizumab. It is recommended to initiate these treatments 2 weeks after administration of rozanolixizumab and to monitor for attenuated efficacy of these medicinal products when administered concomitantly.
Treatment with IV or SC immunoglobulins, PLEX/plasmapheresis and immunoadsorption may reduce circulating levels of rozanolixizumab.
Treatment with rozanolixizumab in patients with impending or manifest myasthenic crisis has not been studied. The sequence of therapy initiation between established therapies for MG crisis and rozanolixizumab, and their potential interactions, should be considered.
There are limited amount of data from the use of rozanolixizumab in pregnant women. In animal studies, offspring from treated dams had very low levels of IgG at birth, as expected by the pharmacological mode of action of rozanolixizumab. However, animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Treatment of pregnant women with rozanolixizumab should only be considered if the clinical benefit outweighs the risks.
As rozanolixizumab is expected to reduce maternal antibody levels, and is also expected to inhibit the transfer of maternal antibodies to the foetus, reduction in passive protection to the newborn is anticipated. Therefore, risks and benefits of administering live/live attenuated vaccines to infants exposed to rozanolixizumab in utero should be considered.
It is unknown whether rozanolixizumab is excreted in human milk. Maternal IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of rozanolixizumab could be considered during breast-feeding only if the clinical benefit outweighs the risks.
The effect of rozanolixizumab on human fertility is not known. Animal studies do not indicate harmful effects with respect to fertility.
Rozanolixizumab has no or negligible influence on the ability to drive and use machines.
The most commonly reported adverse reactions were headache (48.4%), diarrhoea (25.0%) and pyrexia (12.5%).
Adverse reactions from clinical studies in gMG are listed in the table below, classified by MedDRA System Organ Class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Frequency categories 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).
List of adverse reactions:
| MedDRA system organ class | Adverse reactions | Frequency category |
|---|---|---|
| Nervous system disorders | Headache1 | Very common |
| Gastrointestinal disorders | Diarrhoea | Very common |
| Skin and subcutaneous tissue disorders | Rash2 | Common |
| Angioedema3 | Common | |
| Musculoskeletal and connective tissue disorders | Arthralgia | Common |
| General disorders and administration site conditions | Pyrexia | Very common |
| Injection site reactions4 | Common |
1 Includes headache and migraine.
2 Includes rash, rash papular and rash erythematous 3 Includes swollen tongue 4 Includes injection site rash, reaction, erythema, inflammation, discomfort, and infusion site erythema, pain.
In MG0003, headache was the most common reaction reported in 31 (48.4%) and 13 (19.4%) of the patients treated with rozanolixizumab and placebo, respectively. Headache occurred most frequently after the first infusion of rozanolixizumab and within 1 to 4 days after infusion. Except for 1 (1.6%) severe headache, all headaches were either mild (28.1% [n=18]) or moderate (18.8% [n=12]) and there was no increase in incidences of headache with repeated cyclic treatment.
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