rozanolixizumab at a glance
Medicine class
Monoclonal antibody and neonatal Fc receptor inhibitor
Licensed use
Add-on therapy for antibody-positive generalised myasthenia gravis in adults
Administration
A subcutaneous infusion, usually into the lower abdomen
Supervision
Initiated and supervised by a specialist neuromuscular or neuroinflammatory team
What is rozanolixizumab used for?
The selected UK product is licensed for:
Add-on treatment of generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies or anti-muscle-specific tyrosine kinase antibodies.
How does rozanolixizumab work?
FcRn normally protects IgG antibodies from breakdown. Rozanolixizumab blocks FcRn, increasing IgG removal and reducing harmful IgG autoantibodies that disrupt communication between nerves and muscles in generalised myasthenia gravis.
rozanolixizumab preparations and strengths
Injection
Route: Parenteral
Strengths: 140 mg/mL
How to take rozanolixizumab
Rozanolixizumab is infused under the skin using a syringe or infusion pump. A trained patient or caregiver may administer it when the specialist team considers this appropriate.
Use the lower left or lower right abdomen below the belly button.
Do not infuse into skin that is tender, bruised, red, hard, scarred or affected by stretch marks.
Allow refrigerated vials to reach room temperature naturally; do not heat them.
Do not use solution that is cloudy, contains particles or has changed colour.
Follow the supplied instructions and training from the healthcare team.
rozanolixizumab side effects
Common or expected effects
- Headache or migraine
- Diarrhoea
- Fever
- Upper respiratory tract infection
- Nausea or vomiting
- Rash
- Joint pain
- Injection-site pain, redness, inflammation or discomfort
Get urgent medical advice
- Swelling of the tongue or throat, breathing difficulty or another significant hypersensitivity reaction
- Severe headache with fever, neck stiffness, nausea or vomiting, which may indicate aseptic meningitis
- Symptoms of a clinically important infection, such as persistent fever or marked illness
rozanolixizumab in pregnancy
Human pregnancy data are limited. Rozanolixizumab may reduce maternal antibodies and their transfer to the fetus, potentially reducing the newborn's passive protection. Use during pregnancy requires specialist assessment of benefits and risks, including planning of live vaccines for an exposed infant.
rozanolixizumab while breastfeeding
It is not known whether rozanolixizumab enters human milk. A risk cannot be excluded, particularly during the first days after birth when maternal IgG concentrations in milk are higher; continued treatment requires an individual specialist assessment of benefits and risks.
rozanolixizumab interactions
Formal interaction studies have not been performed. Important mechanism-based interactions include:
IgG-based treatments, including monoclonal antibodies and intravenous immunoglobulin
Rozanolixizumab may lower their circulating concentrations and reduce their effect, so specialist scheduling and efficacy monitoring are needed.
Fc–peptide fusion proteins
Circulating concentrations and clinical effect may be reduced through interference with FcRn recycling.
Intravenous or subcutaneous immunoglobulin, plasma exchange, plasmapheresis or immunoadsorption
These treatments may reduce circulating rozanolixizumab concentrations.
Common questions about rozanolixizumab
Answers are fully visible for fast scanning and source review.
What is rozanolixizumab used for?
It is an add-on treatment for adults with generalised myasthenia gravis who have anti-AChR or anti-MuSK antibodies.
Is rozanolixizumab an immunosuppressant?
It is classified as an immunosuppressant and FcRn inhibitor because it lowers circulating IgG, including disease-causing autoantibodies.
How is rozanolixizumab administered?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.