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:
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:
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:
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (30mL)—1
