Select therapeutic use:

Anemias:

Indications for: SOLIRIS

Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitations of Use:

Not for treating Shiga toxin E. coli-related HUS.

Adult Dosage:

Give by IV infusion over 35mins; monitor for ≥1hr after completion. ≥18yrs: PNH: initially 600mg weekly for the first 4 weeks, followed by 900mg for the fifth dose 1 week later, then 900mg every 2 weeks thereafter. aHUS: initially 900mg weekly for the first 4 weeks, followed by 1200mg for the fifth dose 1 week later, then 1200mg every 2 weeks thereafter. Supplemental dosing after PE/PI: see full labeling.

Children Dosage:

<18yrs: PNH: not established. aHUS: Give by IV infusion over 1–4hrs via gravity feed, syringe-type pump, or infusion pump; monitor for ≥1hr after completion. 5–<10kg: induction: 300mg weekly for 1 dose; maintenance: 300mg at Week 2, then 300mg every 3 weeks; 10–<20kg: induction: 600mg weekly for 1 dose; maintenance: 300mg at Week 2, then 300mg every 2 weeks; 20–<30kg: induction: 600mg weekly for 2 doses; maintenance: 600mg at Week 3, then 600mg every 2 weeks; 30–<40kg: induction: 600mg weekly for 2 doses; maintenance: 900mg at Week 3, then 900mg every 2 weeks; ≥40kg: induction: 900mg weekly for 4 doses; maintenance: 1200mg at Week 5, then 1200mg every 2 weeks. Supplemental dosing after PE/PI: see full labeling.

SOLIRIS Contraindications:

Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.

Boxed Warning:

Serious meningococcal infections.

SOLIRIS Warnings/Precautions:

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue eculizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including disseminated gonococcal infections], S. pneumoniae, H. influenza type b esp. in children); give prophylactic vaccinations accordingly. Systemic infections. PNH: risk of hemolysis after treatment discontinuation; monitor for at least 8 weeks. aHUS: risk of thrombotic microangiopathy (TMA) after treatment discontinuation; monitor for at least 12 weeks; if TMA occurs, consider reinitiating eculizumab, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures. Monitor platelets, serum LDH, and creatinine during and after therapy. Pregnancy. Nursing mothers.

SOLIRIS Classification:

Complement inhibitor.

Adverse Reactions:

Headache, nasopharyngitis, back pain, nausea, diarrhea, hypertension, upper RTI, abdominal pain, vomiting, anemia, cough, peripheral edema, UTI, pyrexia, musculoskeletal pain, dizziness, influenza, arthralgia, pharyngitis, contusion; meningococcal infection (may be fatal), infusion-related reactions.

Note:

For women exposed to Soliris during pregnancy, call (215) 616-3558.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-dose vials (30mL)—1

Miscellaneous neurodegenerative disorders:

Indications for: SOLIRIS

Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

Adult Dosage:

Give by IV infusion over 35mins; monitor for ≥1hr after completion. Initially 900mg weekly for the first 4 weeks, followed by 1200mg for the fifth dose 1 week later, then 1200mg every 2 weeks thereafter. Supplemental dosing after PE/PI: see full labeling.

Children Dosage:

Not established.

SOLIRIS Contraindications:

Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.

Boxed Warning:

Serious meningococcal infections.

SOLIRIS Warnings/Precautions:

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue eculizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including disseminated gonococcal infections], S. pneumoniae, H. influenza type b esp. in children); give prophylactic vaccinations accordingly. Systemic infections. PNH: risk of hemolysis after treatment discontinuation; monitor for at least 8 weeks. aHUS: risk of thrombotic microangiopathy (TMA) after treatment discontinuation; monitor for at least 12 weeks; if TMA occurs, consider reinitiating eculizumab, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures. Monitor platelets, serum LDH, and creatinine during and after therapy. Pregnancy. Nursing mothers.

SOLIRIS Classification:

Complement inhibitor.

Adverse Reactions:

Headache, nasopharyngitis, back pain, nausea, diarrhea, hypertension, upper RTI, abdominal pain, vomiting, anemia, cough, peripheral edema, UTI, pyrexia, musculoskeletal pain, dizziness, influenza, arthralgia, pharyngitis, contusion; meningococcal infection (may be fatal), infusion-related reactions.

Note:

For women exposed to Soliris during pregnancy, call (215) 616-3558.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-dose vials (30mL)—1

Myasthenia gravis:

Indications for: SOLIRIS

Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AchR) antibody positive.

Adult Dosage:

Give by IV infusion over 35mins; monitor for ≥1hr after completion. Initially 900mg weekly for the first 4 weeks, followed by 1200mg for the fifth dose 1 week later, then 1200mg every 2 weeks thereafter. Supplemental dosing after PE/PI: see full labeling.

Children Dosage:

Not established.

SOLIRIS Contraindications:

Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.

Boxed Warning:

Serious meningococcal infections.

SOLIRIS Warnings/Precautions:

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue eculizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including disseminated gonococcal infections], S. pneumoniae, H. influenza type b esp. in children); give prophylactic vaccinations accordingly. Systemic infections. PNH: risk of hemolysis after treatment discontinuation; monitor for at least 8 weeks. aHUS: risk of thrombotic microangiopathy (TMA) after treatment discontinuation; monitor for at least 12 weeks; if TMA occurs, consider reinitiating eculizumab, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures. Monitor platelets, serum LDH, and creatinine during and after therapy. Pregnancy. Nursing mothers.

SOLIRIS Classification:

Complement inhibitor.

Adverse Reactions:

Headache, nasopharyngitis, back pain, nausea, diarrhea, hypertension, upper RTI, abdominal pain, vomiting, anemia, cough, peripheral edema, UTI, pyrexia, musculoskeletal pain, dizziness, influenza, arthralgia, pharyngitis, contusion; meningococcal infection (may be fatal), infusion-related reactions.

Note:

For women exposed to Soliris during pregnancy, call (215) 616-3558.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-dose vials (30mL)—1