Rozanolixizumab

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. It is given as a subcutaneous infusion once a week for 6 weeks by a healthcare provider. The brand name is Rystiggo.

Rozanolixizumab works by blocking a protein called the neonatal Fc receptor (FcRn). This protein helps harmful IgG antibodies survive in people with generalized myasthenia gravis (gMG). By reducing these antibody levels, the drug can improve muscle strength in people with gMG. Rozanolixizumab belongs to the drug class called neonatal Fc receptor blockers.

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

Rozanolixizumab is administered as an injection under your skin (subcutaneously) by your healthcare provider.

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

Infusion rate

Rozanolixizumab is infused at a rate of 20 mL/hour.

• You will be monitored during the infusion and for at least 15 minutes after for hypersensitivity reactions.

You should complete all age-appropriate vaccinations before you start a treatment cycle of rozanolixizumab. Do not receive live or live-attenuated vaccines during treatment.

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). The use of vaccines during rozanolixizumab 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 and you should complete all your age-appropriate vaccines according to vaccination guidelines before starting a new treatment cycle.
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Based on animal data, rozanolixizumab may cause harm to an unborn baby. It is not known if rozanolixizumab passes into breast milk.

The most common side effects of rozanolixizumab 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

Rozanolixizumab can cause the following serious side effects.

• Hypersensitivity reactions, including angioedema, swelling, 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.
• An increased 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 rozanolixizumab. 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 such as a 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. Complete your age-appropriate vaccines according to immunization guidelines before starting a new treatment cycle. Receiving live or live-attenuated vaccines during treatment is not recommended.
• Aseptic meningitis has also been reported. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with rozanolixizumab such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.

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.

Dose of Rozanolixizumab for Generalized Myasthenia Gravis (gMG):

• Less than 50 kg: 420 mg
• 50 kg to less than 100 kg: 560 mg
• 100 kg or more: 840 mg

Do not flush the line after use because the infusion volume has been adjusted to account for losses in the line.

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

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

Avoid receiving live vaccines while you are being treated with this medicine.

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 derivatives 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.

Active ingredient: rozanolixizumab-noli

Inactive ingredients (Rystiggo): histidine, L-histidine hydrochloride monohydrate, polysorbate 80, proline, and water for injection, USP.

Available in a single-dose vial for subcutaneous infusion in the following strengths:

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

The concentration of each vial is 140 mg/mL.

Rozanolixizumab is manufactured by UCB Inc., a biopharmaceutical company headquartered in Brussels, Belgium.