Eculizumab, the active ingredient in SOLIRIS, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b9. SOLIRIS inhibits terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS. The precise mechanism by which eculizumab exerts its therapeutic effect in gMG patients is unknown, but is presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction. The precise mechanism by which eculizumab exerts its therapeutic effect in NMOSD is unknown, but is presumed to involve inhibition of aquaporin-4-antibody induced terminal complement C5b-9 deposition.

SOLIRIS is a complement inhibitor indicated for:

The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complementmediated 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).

The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. 

The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are antiaquaporin-4 (AQP4) antibody positive.

• For intravenous infusion only
• Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial.

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain. 

The most frequently reported adverse reactions in the NMOSD placebo- controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

SOLIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Use caution when administering SOLIRIS to patients with any other systemic infection. 

Infusion-Related Reactions: Monitor patients during infusion, interrupt for reactions, and institute appropriate supportive measures