Pronunciation: Rye-stig-oh
Generic name: rozanolixizumab-noli
Dosage form: single-dose vial for subcutaneous infusion (280 mg/2 mL, 420 mg/3 mL, 560 mg/4 mL, 840 mg/6 mL)
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 9, 2025.

What is Rystiggo?

Rystiggo is used to treat generalized myasthenia gravis (gMG) that is acetylcholine receptor (anti-AChR) or muscle-specific tyrosine kinase (anti-MuSK) antibody-positive in adults. It is administered subcutaneously once a week for 6 weeks by a healthcare provider.

Rystiggo works by binding to and blocking a protein called neonatal Fc receptor (FcRn), which is crucial for the transport of immunoglobulin G (IgG) antibodies, including AChR and MuSK pathogenic autoantibodies, across cells and membranes. IgGs bound to FcRn are protected from degradation, whereas unbound ones are vulnerable to degradation. By binding to and blocking FcRn, Rystiggo leaves IgG antibodies unbound, increasing their removal and reducing their damage to other proteins involved in signal transmission in gMG. Rystiggo belongs to the drug class called neonatal Fc receptor blockers. 

The MycarinG Study (NCT03971422, n=200), a Phase 3 clinical trial, reported significant improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale after 6 weeks of Rystiggo treatment.

• Some patients reported improvement in as little as 1 week.
• Up to 72% of trial participants responded to treatment.
• An open-label extension (MG0004, NCT04124965) showed repeated cycles for up to 52 infusions resulted in consistent, clinically meaningful improvements across cycles.

Rystiggo (rozanolixizumab-noli) gained FDA approval on June 27, 2023. There is no generic or biosimilar. 

Side effects

The most common Rystiggo side effects are:

• headache
• infections, including a cold and the flu
• diarrhea
• fever
• hypersensitivity (allergic) reactions
• nausea.

Serious side effects and warnings

Rystiggo may cause the following serious side effects:

• Infection: Rystiggo may increase the risk of infection. In clinical studies, the most common infections were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex infections. Your healthcare provider should check you for infections before starting and during treatment with Rystiggo. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with Rystiggo. Some of the signs and symptoms may include fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain
• Aseptic Meningitis: Rystiggo could cause aseptic meningitis. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with Rystiggo, such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
• Hypersensitivity Reactions: Rystiggo can cause swelling and rash. Your healthcare provider should monitor you during and after treatment and discontinue Rystiggo if needed. Tell your healthcare provider immediately about any undesirable reactions you experience after administration.

Safety in children has not been established.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

To make sure Rystiggo is safe for you, tell your healthcare provider about all your medical conditions, including if you:

• have a history of infection or think you have an active infection
• have received or are scheduled to receive a vaccine (immunization). The use of vaccines during Rystiggo treatment has not been studied, and the safety of live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with this medicine. Completion of age-appropriate vaccines according to vaccination guidelines before starting a new treatment cycle with Rystiggo is recommended
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Based on animal data, Rystiggo may harm an unborn baby. Talk to your healthcare provider immediately if you become pregnant while receiving Rystiggo.

Breastfeeding

It is unknown if Rystiggo passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you are receiving Rystiggo.

How is Rystiggo administered?

Rystiggo is administered by a healthcare provider as a subcutaneous infusion 1 time a week for 6 weeks (this is one treatment cycle).

• Rystiggo may be administered in an infusion center or healthcare provider's clinic, or at-home infusions by a nurse may be possible in certain areas. 
• It usually takes 15 minutes to administer the injection subcutaneously using an infusion pump.
• It is usually administered into your lower abdominal area, but not within 2 inches of your navel.
• Subsequent treatment cycles may be administered depending on your response to Rystiggo.

Dosing information

Dose of Rystiggo for AChR or MuSK antibody +ve gMG in adults

• Less than 50 kg: 420 mg (volume to be infused: 3 mL)
• 50 kg to less than 100 kg: 560 mg (volume to be infused: 4 mL)
• 100 kg or more: 840 mg (volume to be infused: 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.

What happens if I miss a dose?

If a scheduled dose is missed, Rystiggo may be administered up to 4 days after the scheduled time point.

Call your doctor for instructions if you miss an appointment for your infusion.

What should I avoid while receiving Rystiggo?

You should avoid receiving live vaccines while you are being treated with this medicine.

What other drugs will affect Rystiggo?

Care should be taken when using Rystiggo with other medications that bind to the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) because it may reduce the effectiveness of these medications.

Rystiggo may interact with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop, or change a dose of any medicine.

Ingredients

Active: rozanolixizumab-noli 

Inactive ingredients: each mL contains histidine 1.05 mg, L-histidine hydrochloride monohydrate 4.87 mg, polysorbate 80 (0.30 mg), proline 28.78 mg, and water for injection, USP. 

Rystiggo injection is available in single-dose vials as the following strengths:

• 280 mg/2 mL 
• 420 mg/3 mL
• 560 mg/4 mL
• 840 mg/6 mL.

Each vial has a concentration of 140 mg/mL.

Manufacturer

Rystiggo (rozanolixizumab-noli) is manufactured by UCB (Union Chimique Belge), with global headquarters in Brussels, Belgium.

Rystiggo Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Rystiggo.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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