Rozanolixizumab

Pronunciation: roz-an-o-lik-i-zoo-mab
Generic name: rozanolixizumab-noli
Brand name: Rystiggo
Dosage form: subcutaneous injection
Drug class: Selective immunosuppressants

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

What is rozanolixizumab?

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

Rozanolixizumab'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, rozanolixizumab can improve muscle strength in people with myasthenia gravis (see What is the mechanism of action for Rystiggo?). Rozanolixizumab belongs to the drug class known as monoclonal antibodies and it may also be called a selective immunosuppressant.

Rozanolixizumab gained FDA approval on June 27, 2023, under the brand name Rystiggo. There is no rozanolixizumab generic or biosimilar.

Rozanolixizumab uses

Rozanolixizumab is used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive.

Rozanolixizumab side effects

The most common rozanolixizumab 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 rozanolixizumab. Your doctor will monitor you during your infusion for hypersensitivity reactions. Seek medical attention if you develop an allergic reaction following the infusion.

Rozanolixizumab can increase your risk of infection, including reactivation of the hepatitis B virus in those who already have it. Rozanolixizumab 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 rozanolixizumab. Receiving live or live-attenuated vaccines during treatment with rozanolixizumab 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.

Related/similar drugs

Before taking this medicine

To make sure rozanolixizumab 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 rozanolixizumab. 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, rozanolixizumab may cause fetal harm. It is unknown if rozanolixizumab passes into breast milk.

How will I receive rozanolixizumab?

Rozanolixizumab is administered by your healthcare provider in their clinic.

• Rozanolixizumab 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 rozanolixizumab 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 rozanolixizumab.
• The safety of administering a treatment cycle of rozanolixizumab infusion sooner than every 63 days from the start of the previous treatment cycle has not been established.

Rozanolixizumab infusion rate

How long the infusion takes depends on your dose of medicine, but rozanolixizumab 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.

Rozanolixizumab dosage

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

What happens if I miss a dose?

If a scheduled dose is missed, rozanolixizumab 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 rozanolixizumab is administered by a healthcare provider, it is unlikely that you will overdose.

What should I avoid while receiving rozanolixizumab?

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

What other drugs will affect rozanolixizumab?

Care should be taken when using rozanolixizumab 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.

Rozanolixizumab 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.

Rozanolixizumab 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 rozanolixizumab?

UCB, Inc. makes rozanolixizumab under the brand name Rystiggo.

Rozanolixizumab 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 rozanolixizumab.

Further information

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

Medical Disclaimer