Rystiggo

Pronunciation: Rye-stig-oh
Generic name: rozanolixizumab-noli
Dosage form: subcutaneous injection
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 3, 2024.

What is Rystiggo?

Rystiggo may be used to treat certain types of generalized myasthenia gravis (gMG) in adults. Rystiggo helps improve muscle weakness and is given as an injection by a healthcare provider.

Rystiggo's mechanism of action involves blocking a protein, called neonatal Fc receptor (FcRn) that helps harmful antibodies survive in people with gMG. By lowering the number of these harmful antibodies, Rystiggo can improve muscle strength in people with myasthenia gravis (see What is the mechanism of action for Rystiggo?). Rystiggo belongs to the drug class known as monoclonal antibodies and it may also be called a selective immunosuppressant.

Rystiggo gained FDA approval on June 27, 2023. There is no Rystiggo generic or biosimilar. 

Rystiggo uses

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.

Rystiggo side effects

The most common Rystiggo side effects are:

• Headache
• Infections including the 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

Hypersensitivity reactions including angioedema and rash have occurred in some patients treated with Rystiggo. Your doctor will monitor you during your infusion for hypersensitivity reactions. Seek medical attention if you develop an allergic reaction following the infusion. 

Rystiggo can increase your risk of infection, including reactivation of the hepatitis B virus in those who already have it. Rystiggo should not be administered if you currently have an infection. Call your doctor at once if you develop fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding. You should complete your age-appropriate vaccines according to immunization guidelines before starting a new treatment cycle with Rystiggo. Receiving live or live-attenuated vaccines during treatment with Rystiggo is not recommended.

Serious events such as aseptic meningitis have also been reported. Your doctor will monitor you for symptoms and initiate treatment if necessary.

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 taking this medicine

To make sure Rystiggo is safe for you, tell your doctor if you:

• Currently have an infection or have had any infections recently
• Have received or are scheduled to receive a vaccine (immunization). All age-appropriate immunizations should be completed before starting Rystiggo. Administration of live or live-attenuated vaccines is not recommended during treatment
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Based on animal data, Rystiggo may cause fetal harm. It is unknown if Rystiggo passes into breast milk.

How will I receive Rystiggo?

Rystiggo is administered by your healthcare provider in their clinic.

• Rystiggo is given subcutaneously (this means under the skin) using an infusion pump into the lower right or lower left part of your abdominal area but not close to your navel.
• A Rystiggo infusion is usually given 1 time a week for 6 weeks (this is one treatment cycle).
• Subsequent treatment cycles may be administered depending on your response to Rystiggo.
• The safety of administering a treatment cycle of Rystiggo infusion sooner than every 63 days from the start of the previous treatment cycle has not been established.

Rystiggo infusion rate

How long the infusion takes depends on your dose of medicine, but Rystiggo is usually given at a rate of up to 20 mL/hour or 0.33 mL/minute.

• This means that most infusions will take 9 to 18 minutes.
• You will be monitored for hypersensitivity reactions during the infusion and for at least 15 minutes afterward.

Rystiggo dosage

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: Rystiggo 420 mg (3 mL of Rystiggo to be infused over 9 minutes)
• 50 kg to less than 100 kg: Rystiggo 560 mg (4 mL of Rystiggo to be infused over 12 minutes)
• 100 kg or more: 840 mg (6 mL of Rystiggo to be infused over 18 minutes).

The line should not be flushed after use as the volume of the infusion has been adjusted to account for losses in the line.

Related/similar drugs

Ultomiris, pyridostigmine, Mestinon, neostigmine, eculizumab, Vyvgart

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 happens if I overdose?

Because Rystiggo is administered by a healthcare provider, it is unlikely that you will overdose.

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.

Storage

Store vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect them from light until the time of use. Do not freeze. Do not shake.

If needed, vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days in the original carton to protect the vial from light. Once a vial has been stored at room temperature, it should not be returned to the refrigerator. Discard the vial if not used within 30 days or if the expiration date has passed, whichever occurs first.

Rystiggo ingredients

Injection: rozanolixizumab-noli 140 mg/mL in a single-dose glass vial.

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. 

Available as 280 mg, 420 mg, 560 mg, or 840 mg of rozanolixizumabnoli at a concentration of 140 mg/mL with a pH of 5.6. 

Who makes Rystiggo?

UCB, Inc. makes Rystiggo.

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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