Rozanolixizumab

RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. For subcutaneous infusion only. The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks. Body Weight of Patient Dose Volume to be Infused Less than 50 kg 420 mg 3 mL 50 kg to less than 100 kg 560 mg 4 mL 100 kg and above 840 mg 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.

None. None.

Infections: Delay administration of RYSTIGGO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with RYSTIGGO. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Aseptic Meningitis: Serious events of aseptic meningitis have been reported. Monitor for symptoms, diagnostic workup and treatment should be initiated according to the standard of care. Hypersensitivity Reactions: Angioedema and rash have occurred. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infections Aseptic Meningitis Hypersensitivity Reactions The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.

Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternate therapies.

Store 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. If needed, 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 to protect the vial from light. Once a vial has been stored at room temperature, it should not be returned to the refrigerator. The discard date is 20 days after removal of the vial from the refrigerator. Do not shake.