INDICATIONS AND USAGE

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)

Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

DOSAGE

Recommended Vaccination and Prophylaxis

Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection.

Provide two weeks of antibacterial drug prophylaxis to patients if Soliris must be initiated immediately and vaccines are administered less than two weeks before starting Soliris therapy.

Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS.

Recommended Dosage Regimen – PNH

For patients 18 years of age and older, Soliris therapy consists of:

600 mg weekly for the first 4 weeks, followed by

900 mg for the fifth dose 1 week later, then

900 mg every 2 weeks thereafter.

Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

Recommended Dosage Regimen – aHUS

For patients 18 years of age and older, Soliris therapy consists of:

900 mg weekly for the first 4 weeks, followed by

1200 mg for the fifth dose 1 week later, then

1200 mg every 2 weeks thereafter.

Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

Recommended Dosage Regimen – gMG and NMOSD

For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of:

900 mg weekly for the first 4 weeks, followed by

1200 mg for the fifth dose 1 week later, then

1200 mg every 2 weeks thereafter.

Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

ADVERSE REACTIONS

Serious Meningococcal Infections

Other Infections

Monitoring Disease Manifestations after Soliris Discontinuation

Thrombosis Prevention and Management

Infusion-Related Reactions

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722/spl-doc?hl=Soliris

Solirisinformation