Pronunciation: Rye-stig-oh
Generic name: rozanolixizumab-noli
Dosage form: single-dose vial for subcutaneous injection (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, Senior Medical Editor, B. Pharm. Last updated on April 20, 2026.

What is Rystiggo?

Rystiggo is used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody-positive. It is given by subcutaneous infusion once weekly for 6 weeks by a healthcare provider.

In generalized myasthenia gravis (gMG), the immune system mistakenly attacks your nerve-muscle connection, causing weakness and fatigue. Rystiggo works by blocking a protein called FcRn, which normally recycles harmful antibodies back into your bloodstream. By stopping this recycling process, harmful antibody levels drop, reducing the immune system's attack on your muscles and easing symptoms.

In a clinical trial of 200 people with gMG, participants taking Rystiggo saw significant improvements in daily activities within 6 weeks. Up to 72% responded to treatment, compared to 31% on placebo. It is also the first approved treatment for anti-MuSK antibody-positive gMG, with all 12 anti-MuSK participants showing improvement.

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

Side Effects

Common Side Effects

The most common side effects of Rystiggo are:

• Headache
• Infections, including upper respiratory tract infections
• Diarrhea
• Fever
• Hypersensitivity (allergic) reactions
• Nausea.

Serious side effects and warnings

Rystiggo may cause the following serious side effects:

• Infections. Rystiggo may increase the risk of infection. In clinical trials, 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 or if you develop signs or symptoms of an infection, such as:
  • Fever
  • Chills
  • Frequent and/or painful urination
  • Cough
  • Runny nose
  • Wheezing
  • Shortness of breath
  • Fatigue
  • Sore throat
  • Excess phlegm
  • Nasal discharge
  • Back pain
  • Chest pain.
• Vaccinations. Complete all your age-appropriate vaccinations according to immunization guidelines before starting a new treatment cycle of Rystiggo. Administration of live or live-attenuated vaccines is not recommended during treatment with Rystiggo.
• 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 (Allergic) Reactions. Rystiggo can cause hypersensitivity reactions, including angioedema and rash, which may be serious or lead to hospitalization. Your healthcare provider will monitor you during your infusion and for 15 minutes after. Tell your healthcare provider immediately if you develop:
  • A skin rash
  • Hives
  • Itching
  • Swelling around your face, neck, or tongue
  • Nausea or vomiting
  • Abdominal pain.

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.

Before Receiving

Before you receive Rystiggo, 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). 
• Are pregnant or plan to become pregnant. Rystiggo may harm an unborn baby. Talk to your healthcare provider immediately if you become pregnant while receiving Rystiggo.
• Are breastfeeding or plan to breastfeed. 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.
• Are taking any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

There is a pregnancy exposure registry that monitors outcomes of women with Myasthenia Gravis exposed to Rystiggo during pregnancy and/or breastfeeding.

How Does Rystiggo Work? 

Rystiggo works by targeting the neonatal Fc receptor (FcRn), a protein that plays a critical role in transporting immunoglobulin G (IgG) antibodies, including autoantibodies AChR and MuSK. By blocking FcRn, Rystiggo prevents IgG antibodies from being protected against degradation. By lowering autoantibody levels, Rystiggo helps reduce the immune system's attack on healthy nerve cells, improving muscle function.

Rystiggo belongs to the drug class called neonatal Fc receptor blockers.

How Do I Receive Rystiggo?

Rystiggo is administered as a subcutaneous infusion over 15 minutes by a healthcare provider.

• One treatment cycle is one Rystiggo infusion once a week for 6 consecutive weeks.
• May be administered in an infusion center or a healthcare provider's clinic
• At-home infusions by a nurse may be possible in certain areas. 
• The infusion is given under the skin of your lower abdominal area.

What Should I Avoid While Receiving Rystiggo?

Avoid receiving live vaccines during Rystiggo infusion.

Related/similar drugs

Dosing Information

Dose of Rystiggo for Generalized Myasthenia Gravis (gMG)

• <50 kg: 420 mg subcutaneously once a week for 6 weeks.
• 50 kg to <100 kg: 560 mg subcutaneously once a week for 6 weeks.
• ≥100 kg: 840 mg subcutaneously once a week for 6 weeks.

Subsequent Treatment Cycles may be administered 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 you miss a scheduled Rystiggo infusion, contact your healthcare provider immediately. The dose may be administered up to 4 days after the originally scheduled time.

What Other Drugs Will Affect Rystiggo?

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, supplements, and herbal remedies. Especially tell them if you take any medications that bind to human neonatal Fc receptor (FcRn), including:

• Immunoglobulin products
• Monoclonal antibodies
• Certain antibody derivatives.

These combinations may reduce the effectiveness of Rystiggo.

This is not a complete list of interactions. See the Rystiggo Prescribing Information for more information.

Storage

Your healthcare provider will store Rystiggo vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. 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.

Ingredients

Active Ingredient: rozanolixizumab-noli 

Inactive Ingredients: histidine, L-histidine hydrochloride monohydrate, polysorbate 80, proline, water for injection, USP.

Available Vial Strengths:

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

Each vial has a concentration of 140 mg/mL.

Manufacturer

Rystiggo (rozanolixizumab-noli) is manufactured by UCB Inc., 1950 Lake Park Drive, Smyrna, GA 30080.

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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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