Pronunciation: Rye-stig-oh
Generic name: rozanolixizumab-noli
Dosage form: injection for subcutaneous use (140 mg/mL)
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 14, 2025.

What is Rystiggo?

Rystiggo is used to treat generalized myasthenia gravis (gMG) in adults who are acetylcholine receptor (anti-AChR) antibody-positive or muscle-specific tyrosine kinase (anti-MuSK) antibody-positive. It is administered as a subcutaneous (under the skin) infusion by a healthcare provider 1 time a week for 6 weeks.

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

Mechanism

Rystiggo works by blocking a protein, called neonatal Fc receptor (FcRn), that helps IgG antibodies survive in people with gMG. By reducing IgG antibodies, Rystiggo improves muscle strength. Rystiggo belongs to the drug class called neonatal Fc receptor blockers. 

Clinical trials report 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.

Side effects

The most common Rystiggo side effects are:

• headache
• infections, including a cold and the flu
• diarrhea
• fever
• hypersensitivity (allergic) reactions
• nausea
• reactions around the site where the needle pierced your skin 
• stomach pain
• joint pain.

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 over approximately 15 minutes.

• It is administered once a week for 6 weeks (this is one treatment cycle).
• You may go to an infusion center, doctor's office, or outpatient hospital clinic to receive the infusion. At-home infusions with nurse assistance may also be possible.
• It usually takes 15 minutes to administer using an infusion pump under the skin of your lower abdominal area, but not close to your navel.
• Subsequent treatment cycles may be administered depending on your response to Rystiggo.

Dosing information

Rystiggo is usually administered as a treatment cycle that is given 1 time a week for 6 weeks. The usual dosage depends on body weight:

• 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 have interactions 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. 

Injection:

• 280 mg/2 mL (140 mg/mL) in a single-dose vial
• 420 mg/3 mL (140 mg/mL) in a single-dose vial
• 560 mg/4 mL (140 mg/mL) in a single-dose vial
• 840 mg/6 mL (140 mg/mL) in a single-dose vial.

Each vial has a concentration of 140 mg/mL.

Manufacturer

Rystiggo (rozanolixizumab-noli) is manufactured by UCB (Union Chimique Belge), a global biopharmaceutical company. UCB's global headquarters are 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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