Formulary
Rozanolixizumab: Indications, Dosing, Side Effects and Interactions
Rozanolixizumab is a humanised recombinant immunoglobulin G4P (IgG4P) monoclonal antibody that binds to the neonatal Fc receptor (FcRn), thereby reducing the...
MedNext Academy | 3 min read
Rozanolixizumab: Indications, Dosing, Side Effects and Interactions
Rozanolixizumab is a humanised recombinant immunoglobulin G4P (IgG4P) monoclonal antibody that binds to the neonatal Fc receptor (FcRn), thereby reducing the...
Drug action
Rozanolixizumab is a humanised recombinant immunoglobulin G4P (IgG4P) monoclonal antibody that binds to the neonatal Fc receptor (FcRn), thereby reducing the levels of circulating IgG, including pathogenic IgG autoantibodies, and improving neuromuscular transmission.
Indications and dose
**Myasthenia gravis (under expert supervision)**
- **Adult** (By Subcutaneous Infusion): (body-weight 100 kg and above) 840 mg once weekly for 6 weeks, subsequent 6-week treatment cycles to be administered according to clinical evaluation.
Cautions
Active infections; administration of vaccinations Cautions, further information Vaccination Administer vaccinations at least 4 weeks before starting treatment. If vaccinations are required during treatment, administer them at least 2 weeks after the last infusion of a treatment cycle and 4 weeks before starting the next cycle-immunisation with vaccines during treatment has not been studied. Live or live attenuated vaccines should be avoided during treatment-safety is unknown. M
Side effects
Common or very common Angioedema; arthralgia; diarrhoea; fever; headaches; skin reactions; tongue swelling Frequency not known Increased risk of infection; meningitis aseptic
Interactions
**Other interactions (5):**
- As rozanolixizumab interferes with the FcRn recycling mechanism of immunoglobulin G (IgG), the serum concentrations of IgG-based medicinal products (e.g.
- 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.
- Vaccination during treatment with rozanolixizumab has not been studied and the response to any vaccine is unknown.
- Because rozanolixizumab causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with rozanolixizumab (see sections 4.4 and 5.3).
Pregnancy
Use only if potential benefit outweighs risk. M
Breast feeding
Avoid during first few days after birth (possible risk from transfer of antibodies to infant). After this time, use only if potential benefit outweighs risk. M
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Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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