Section 07 · Monograph

Rozanolixizumab

Reviewed Nov 2026FDA label

RystiggoFcRn blocker

Indications

Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive or anti-muscle-specific tyrosine kinase (MuSK) antibody positive — the first FDA-approved therapy covering both AChR-positive and MuSK-positive gMGFDA-labeled

Humanized IgG4 monoclonal antibody that binds the neonatal Fc receptor (FcRn) with high affinity
Blocks the IgG-FcRn interaction responsible for recycling endogenous IgG, redirecting bound IgG (including pathogenic autoantibodies) toward lysosomal degradation rather than recirculation
Produces a dose-dependent reduction in total serum IgG, including anti-AChR and anti-MuSK autoantibodies that mediate neuromuscular junction damage in gMG
Shares a mechanism with efgartigimod, reducing pathogenic and protective IgG nonspecifically, which underlies its infection-risk profile

Weight-based subcutaneous infusion administered once weekly for 6 consecutive weeks per treatment cycle
Dosing by body weight: <50 kg → 420 mg; 50-100 kg → 560 mg; ≥100 kg → 840 mg
Administered via a subcutaneous infusion pump over approximately 15 minutes to several hours to the abdomen, typically in a healthcare setting or by trained caregiver/patient
Subsequent treatment cycles given based on clinical evaluation; cycles must be separated by at least 63 days between cycle start dates
Reassess dosing tier if patient's weight shifts across a defined weight band

No dose adjustment established for renal or hepatic impairment; use with caution and monitor

None documented in the FDA label — no absolute contraindications are listed for rozanolixizumab-noli

May reduce the efficacy of co-administered FcRn-dependent therapeutics such as IVIG and other human IgG Fc-domain-containing monoclonal antibodies — monitor closely or consider discontinuation if concomitant therapy is essential
Theoretical reduction in circulating levels of passively administered antibody therapies
Live/live-attenuated vaccines: administer prior to starting therapy when feasible due to potential blunted immune/antibody response during treatment

Headache (most common)
Infections (upper respiratory tract, urinary tract)
Diarrhea
Pyrexia (fever)
Hypersensitivity reactions
Nausea
Aseptic meningitis (serious; presents with headache, neck stiffness, photophobia, nausea/vomiting, fever)
Angioedema and rash
Injection/infusion site reactions
Paresthesia

Screen for active infection before each cycle; delay dosing until infection resolves
Educate patients on symptoms of aseptic meningitis and instruct to seek immediate evaluation if they occur
Monitor for hypersensitivity reactions during and after administration; discontinue if serious hypersensitivity occurs
Track MG-ADL and QMG clinical scores to assess response and inform re-treatment timing
Periodic assessment of infection risk given IgG-lowering mechanism; update vaccinations prior to initiation when possible
Monitor injection site for local reactions

No adequate data on use in pregnant women; rozanolixizumab is an IgG4 antibody expected to cross the placenta, with transfer increasing in the third trimester
Animal reproduction studies (cynomolgus monkeys) showed embryonic death, reduced fetal body weight, and impaired neonatal immune function at exposures exceeding the maximum recommended human dose
Because the drug reduces maternal IgG, it may reduce passive transfer of protective maternal antibodies to the fetus/neonate
No data on presence in human milk, its effects on the breastfed infant, or on milk production
Weigh the developmental and health benefits of breastfeeding against the mother's clinical need