Rystiggo (rozanolixizumab-noli)
Rozanolixizumab-noli is used to treat certain types of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness).
Pronunciation: pronunciation varies by local usage.
- Generic name
- rozanolixizumab-noli
- Brand names
- RYSTIGGO
- Drug class
- Fc receptor blocker
- Form
- Injection: 280 mg/2 mL (140 mg/mL), 420 mg/3 mL (140 mg/mL), 560 mg/4 mL (140 mg/mL), or 840 mg/6 mL (140 mg/mL) in single-dose vials
- Route
- Subcutaneous infusion
- Legal status
- Prescription-only medicine; to be administered by a healthcare provider only
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia
Australia: Rystiggo · Full directory
What rozanolixizumab-noli is and how it works
Rozanolixizumab-noli is used to treat certain types of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Rozanolixizumab is in a class of medications called Fc receptor blockers. It works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body. (2) (1)
Rozanolixizumab-noli is given by subcutaneous (under the skin) infusion by a doctor or a nurse in a hospital or a clinic. It is usually given once weekly for at least 6 weeks, and the doctor will determine if and how frequently it continues after that. The doctor or nurse monitors the patient during and for 15 minutes after finishing the infusion. It may be prescribed for other uses; ask your doctor or pharmacist for more information.
Mechanism of action: how rozanolixizumab-noli works
Rozanolixizumab-noli is in a class of medications called Fc receptor blockers. It works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body. RYSTIGGO causes a reduction in IgG levels. (2) (1)
What is Rozanolixizumab-noli used for?
Generalized myasthenia gravis (gMG) in antibody-positive adults
The US label states that 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. Myasthenia gravis is a disorder of the nervous system that causes muscle weakness. Rozanolixizumab-noli works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body. (1) (2)
Before taking rozanolixizumab-noli
Do not take / not appropriate for
- Vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO because RYSTIGGO causes a reduction in IgG levels. Once treatment has started, do not have any vaccinations without talking to your doctor. (during treatment) (1) (2)
Tell your clinician about
- If you are allergic to rozanolixizumab, any other medications, or any of the ingredients in rozanolixizumab-noli injection; ask your pharmacist for a list of the ingredients.
- What prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- If you have a history of current infection or chronic infection such as hepatitis B or C, HIV, or herpes.
- If you are pregnant, plan to become pregnant, or are breast-feeding; if you become pregnant while receiving rozanolixizumab-noli, call your doctor.
- Before starting infusions, your doctor will make sure you have received all necessary vaccines; the need to administer age-appropriate vaccines according to immunization guidelines should be evaluated before initiation of a new treatment cycle.
Rozanolixizumab-noli dosage and how to take it
- Rozanolixizumab-noli comes as a solution (liquid) to be given by subcutaneous (under the skin) infusion by a doctor or a nurse in a hospital or a clinic. It is usually given once weekly for at least 6 weeks. Your doctor will determine if and how frequently you will continue to receive rozanolixizumab after that.
- For subcutaneous infusion only, using an infusion pump at a rate of up to 20 mL/hour, once weekly for 6 weeks. RYSTIGGO should only be prepared and infused by a healthcare provider.
- The recommended dosage is based on body weight: 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.
- Your doctor or nurse will monitor you during and for 15 minutes after finishing the infusion.
- Unless your doctor tells you otherwise, continue your normal diet.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)
Missed dose
If a scheduled dose is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point; thereafter, resume the original dosing schedule until the treatment cycle is completed. Keep all appointments with your doctor and for infusions; if you miss a scheduled appointment for an infusion, you can still receive it up to 4 days after the original scheduled time. If it has been more than 4 days, skip that dose and resume the regular schedule. Contact the prescribing clinic for rescheduling instructions; do not alter the schedule without advice from the treatment team.
Overdose
The US label does not include an overdose section, so overdose signs and management for rozanolixizumab-noli are not established by these sources. This medicine is given by a healthcare provider. If you think too much was given, or you have severe symptoms, contact the treating service or a poison-information service urgently, or seek emergency care. (1)
Rozanolixizumab-noli side effects
Rozanolixizumab-noli may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away. Some side effects can be serious; if you experience any of the serious symptoms listed, call your doctor immediately.
Headache
What to notice: Headache after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Diarrhea
What to notice: Diarrhea after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Rash
What to notice: Rash after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Nausea
What to notice: Nausea after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Stomach pain
What to notice: Stomach pain after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Joint pain
What to notice: Joint pain after receiving the infusion.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Injection-site reaction
What to notice: Bruising, swelling, or redness at the site of injection.
What to do: Tell your doctor if this symptom is severe or does not go away. (2)
Possible infection
What to notice: Fever; pain or burning on urination, increased frequency of urination; cough, shortness of breath, difficulty breathing; or other signs and symptoms of infection.
What to do: Call your doctor immediately. RYSTIGGO may increase the risk of infection; treatment is delayed in patients with an active infection until the infection is resolved, and if a serious infection occurs, appropriate treatment is given and withholding RYSTIGGO is considered until the infection has resolved. (2) (1)
Possible aseptic meningitis (drug-induced aseptic meningitis)
What to notice: Headache, fatigue, stiff neck, drowsiness, unresponsiveness, sensitivity to bright lights, or seizures.
What to do: Call your doctor immediately. Serious adverse reactions of aseptic meningitis have been reported in patients treated with RYSTIGGO; if symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. (2) (1)
Hypersensitivity reaction
What to notice: Angioedema and rash have occurred with RYSTIGGO; management depends on the type and severity of the reaction.
What to do: Patients are monitored during treatment and for 15 minutes after the infusion is complete. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed, or the patient should seek medical attention. (1)
Serious warnings
Infections — serious
Symptoms: Signs and symptoms of infection; MedlinePlus lists fever, pain or burning on urination or increased frequency of urination, and cough, shortness of breath, or difficulty breathing as symptoms for which to call your doctor immediately.
Action: Treatment is delayed in patients with an active infection until the infection is resolved, and patients are monitored for signs and symptoms of infection during treatment. If a serious infection occurs, appropriate treatment is administered and withholding RYSTIGGO is considered until the infection has resolved. Contact your clinician promptly. (1) (2)
Aseptic meningitis — serious
Symptoms: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported. MedlinePlus lists headache, fatigue, stiff neck, drowsiness, unresponsiveness, sensitivity to bright lights, and seizures as symptoms for which to call your doctor immediately.
Action: Monitor for symptoms; if symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. (1) (2)
Hypersensitivity reactions — serious
Symptoms: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO.
Action: Monitor patients during treatment and for 15 minutes after administration is complete for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed, or the patient should seek medical attention. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Medications that bind to the human neonatal Fc receptor (FcRn), e.g. immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass | Concomitant use of RYSTIGGO with these medications may lower systemic exposures and reduce effectiveness of such medications. | Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternative therapies. (1) |
| Vaccines (live-attenuated or live vaccines) | 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. | Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle. Once treatment has started, do not have any vaccinations without talking to your doctor. (1) (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
If you are pregnant, plan to become pregnant, or are breast-feeding, tell your doctor. If you become pregnant while receiving rozanolixizumab-noli, call your doctor. There is a pregnancy registry that monitors outcomes in patients with myasthenia gravis, including women exposed to RYSTIGGO during pregnancy and/or breastfeeding. Detailed pregnancy risk data are not established by these sources. (2) (1)
Breastfeeding
There are no data on the presence of rozanolixizumab-noli in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for RYSTIGGO and any potential adverse effects on the breastfed child from RYSTIGGO or from the underlying maternal condition. (1)
Children and adolescents
Safety and effectiveness in pediatric patients have not been established. (1)
Monitoring
Before starting
- Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle.
- Tell the doctor about any history of current infection or chronic infection such as hepatitis B or C, HIV, or herpes.
- Tell the doctor about allergies to rozanolixizumab, any other medications, or any of the ingredients in rozanolixizumab-noli injection.
- Tell the doctor about all prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products being taken or planned.
- Tell the doctor if pregnant, planning to become pregnant, or breast-feeding.
During treatment
- Monitor for clinical signs and symptoms of infection; if a serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved.
- Monitor for symptoms of aseptic meningitis; if symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.
- Monitor patients during treatment and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions.
- Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor when used concomitantly.
Storage
Prior to use, allow vials to reach room temperature for approximately 30 minutes. Do not use heating devices. Keep the vial in the original carton to protect from light until ready to use. Do not shake. Vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 20 days in the original carton. Infuse RYSTIGGO within 4 hours of puncturing the vial. Each RYSTIGGO vial is for one-time use only; RYSTIGGO does not contain preservatives, and any remaining solution is discarded. Refrigerated storage conditions before room-temperature storage are not established by these sources.
Professional information
Clinician-facing context only. Use the current local label, dosing table, preparation and administration instructions, and monitoring requirements.
United States
Indication: Myasthenia gravis (certain types)
Dose summary: For subcutaneous infusion only. The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks, based on body weight: 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 using an infusion pump at a rate of up to 20 mL/hour. 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. If a scheduled dose is missed, it may be administered up to 4 days after the scheduled time point; thereafter, resume the original dosing schedule until the treatment cycle is completed.
Hepatic guidance
Not established by these sources.
Overdose note
Frequently asked questions
How is rozanolixizumab-noli given?
It comes as a solution (liquid) to be given by subcutaneous (under the skin) infusion by a doctor or a nurse in a hospital or a clinic. It is usually given once weekly for at least 6 weeks, and the doctor will determine if and how frequently it continues after that. RYSTIGGO should only be prepared and infused by a healthcare provider. (2) (1)
What happens if I miss a scheduled infusion?
If a scheduled dose is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point; thereafter, resume the original dosing schedule until the treatment cycle is completed. If it has been more than 4 days, skip that dose and resume the regular schedule. Contact the prescribing clinic with any questions. (2) (1)
Can I receive vaccines while being treated with rozanolixizumab-noli?
Immunization with vaccines during RYSTIGGO treatment has not been studied, and the safety of immunization with live or live-attenuated vaccines and the response to any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment. Before starting infusions, your doctor will make sure you have received all necessary vaccines. Once treatment has started, do not have any vaccinations without talking to your doctor. (1) (2)
What serious side effects should I watch for?
Some side effects can be serious. Call your doctor immediately if you experience fever; pain or burning on urination or increased frequency of urination; cough, shortness of breath, or difficulty breathing; or headache, fatigue, stiff neck, drowsiness, unresponsiveness, sensitivity to bright lights, or seizures. Infections, aseptic meningitis, and hypersensitivity reactions including angioedema and rash have been reported with RYSTIGGO; patients are monitored during treatment and for 15 minutes after the infusion. (2) (1)
What is the mechanism of action of rozanolixizumab-noli?
Rozanolixizumab-noli is in a class of medications called Fc receptor blockers. It works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body. RYSTIGGO causes a reduction in IgG levels. (2) (1)
References
- RYSTIGGO (rozanolixizumab-noli) injection, solution — full prescribing informationDailyMed, U.S. National Library of Medicine (FDA label, UCB) · United States · accessed 2026-10-13 · source 1
- Rozanolixizumab-noli Injection: MedlinePlus Drug InformationMedlinePlus, U.S. National Library of Medicine · United States · accessed 2026-10-13 · source 2
- RYSTIGGO (rozanolixizumab-noli), UCB — BLA761286 application overviewU.S. Food and Drug Administration (Drugs@FDA, openFDA) · United States · accessed 2026-10-13 · source 3
Brand names by country
Single-ingredient rozanolixizumab-noli names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- RYSTIGGOinjection, solution · 140 mg/mL · ucb, inc.regulator source
United Kingdom
- RystiggoMHRA licensed emc smpc confirmed · 140 mg/mL · UCB Pharma Limited
Canada
- RystiggoHealth Canada approved confirmed · not specified in fetched source · UCB Canada Inc.
Australia
- Rystiggoreference source
View brands in additional countries.
European Union
Rystiggo