Rozanolixizumab

Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

• RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

• None. None.contraindicated

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. ( 2.1 ) For subcutaneous infusion only. ( 2.2 ) The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks. ( 2.2 ) Body Weight of Patient Dose Volume to be Infused Less than 50 kg 420 mg 3 mL 50 kg to less than 100 kg 560 mg 4 mL 100 kg and above 840 mg 6 mL Administer subsequent treatment cycles based on clinical evaluation; the safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established. ( 2.2 ) 2.1 Recommended Vaccination Because RYSTIGGO causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage The recommended dosage of RYSTIGGO is based on body weight, as shown below in Table 1. Table 1: Recommended Dose Based on Body Weight Body Weight of Patient Dose Volume to be Infused Less than 50 kg 420 mg 3 mL 50 kg to less than 100 kg 560 mg 4 mL 100 kg and above 840 mg 6 mL Administer the recommended dosage as a subcutaneous infusion using an infusion pump at a rate of up to 20 mL/hour once weekly for 6 weeks.

Infections: Delay administration of RYSTIGGO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with RYSTIGGO. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. ( 5.1 ) Aseptic Meningitis: Serious events of aseptic meningitis have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to the standard of care. ( 5.2 ) Hypersensitivity Reactions: Angioedema and rash have occurred. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. ( 5.3 ) 5.1 Infections RYSTIGGO may increase the risk of infection [see Adverse Reactions (6.1) ] . Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Immunization Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Aseptic Meningitis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the safety of RYSTIGGO has been evaluated in 196 patients who received at least one dose of RYSTIGGO, including 88 patients exposed to at least 5 treatment cycles and 9 patients exposed to at least 10 treatment cycles. In a placebo-controlled study (Study 1) in patients with gMG, 133 patients received RYSTIGGO [see Clinical Studies (14) ] . Of these 133 patients, approximately 56% were female, 68% were White, 12% were Asian, and 6% were of Hispanic or Latino ethnicity. The mean age at study entry was 52.5 years (range 19 to 89 years). Patients treated with RYSTIGGO received 1 treatment cycle in Study 1.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RYSTIGGO during pregnancy. Patients or their healthcare providers may contact UCBCares at 1-844-599-CARE (2273) or email ucbcares@ucb.com, so that information about the exposure of RYSTIGGO during pregnancy and/or breastfeeding can be collected. As a healthcare professional, please ask about becoming a member of the MGBase registry (https://www.mgbase.org). Risk Summary There are limited data on RYSTIGGO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Following administration of rozanolixizumab-noli to pregnant monkeys at doses greater than those used clinically, increases in embryonic death, reduced body weight, and impaired immune function were observed in the absence of maternal toxicity ( see Data ). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Rozanolixizumab-noli exhibited nonlinear pharmacokinetics. Rozanolixizumab-noli exposure increased in a greater than dose-proportional manner over a dose range from 1 mg/kg to 20 mg/kg (two times the maximum recommended dose) following subcutaneous administration.

• Jun 26, 2023BLABLA761286Ucb Inc

1. 1Myasthenia Gravis27230%
2. 2Drug Ineffective15217%
3. 3Headache14316%
4. 4Diarrhoea9511%
5. 5Fatigue798.8%
6. 6Nausea768.5%
7. 7Asthenia687.6%
8. 8Dyspnoea606.7%
9. 9Pyrexia495.5%
10. 10Vomiting475.3%
11. 11Therapeutic Response Shortened444.9%
12. 12Hospitalisation414.6%
13. 13Therapy Interrupted404.5%
14. 14Dysphagia394.4%
15. 15Dizziness384.3%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Rozanolixizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
  Completed · Phase 1 · Interventional · 15 enrolled · UCB Biopharma SRL
  NCT06720714updated 2026-06-04
• A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
  Active not recruiting · Phase 3 · Interventional · 113 enrolled · UCB Biopharma SRL
  NCT05063162updated 2026-05-22
• Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
  Recruiting · Phase 4 · Interventional · 40 enrolled · UCB Biopharma SRL
  NCT07246564updated 2026-05-22
• Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)
  Not yet recruiting · Observational · 50 enrolled · Centre Hospitalier Universitaire de Nice
  NCT07570589updated 2026-05-11
• A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
  Recruiting · Phase 2 · Phase 3 · Interventional · 12 enrolled · UCB Biopharma SRL
  NCT06149559updated 2026-05-08
• An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
  Enrolling by invitation · Phase 3 · Interventional · 12 enrolled · UCB Biopharma SRL
  NCT06540144updated 2026-05-08
• A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
  Not yet recruiting · Phase 3 · Interventional · 120 enrolled · UCB Biopharma SRL
  NCT07463521updated 2026-03-17
• A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
  Not yet recruiting · Phase 3 · Interventional · 100 enrolled · UCB Biopharma SRL
  NCT07465289updated 2026-03-11
• A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
  Completed · Phase 3 · Interventional · 200 enrolled · UCB Biopharma SRL
  NCT03971422updated 2025-12-24
• A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
  Completed · Phase 3 · Interventional · 62 enrolled · UCB Biopharma SRL
  NCT05681715updated 2025-11-06

Frequently asked questions

How does Rozanolixizumab work?

Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

What is Rozanolixizumab used for?

According to FDA labeling, Rozanolixizumab carries indications including: RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rozanolixizumab?

Rozanolixizumab is classified as Monoclonal antibodies, Neonatal fragment crystallizable receptor (FcRn) inhibitors, Neonatal Fc Receptor Blocker, Neonatal Fc Receptor Blockers.

What are the brand names for Rozanolixizumab?

Rozanolixizumab is marketed under brand names including Rystiggo.

What are the contraindications for Rozanolixizumab?

Rozanolixizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.