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Soliris Generic Name & Formulations
Legal Class
Rx
General Description
Eculizumab 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Complement inhibitor.
How Supplied
Single-dose vials (30mL)—1
Manufacturer
Generic Availability
NO
Soliris Indications
Indications
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.
Soliris Dosage and Administration
Adult
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
<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
Contraindications
Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.
Soliris Boxed Warnings
Boxed Warning
Serious meningococcal infections.
Soliris Warnings/Precautions
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.
REMS
Soliris Pharmacokinetics
See Literature
Soliris Interactions
Soliris Adverse Reactions
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.
Soliris Clinical Trials
See Literature
Soliris Note
Notes
For women exposed to Soliris during pregnancy, call (215) 616-3558.
Soliris Patient Counseling
See Literature
Soliris Generic Name & Formulations
Legal Class
Rx
General Description
Eculizumab 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Complement inhibitor.
How Supplied
Single-dose vials (30mL)—1
Manufacturer
Generic Availability
NO
Soliris Indications
Indications
Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
Soliris Dosage and Administration
Adult
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
Not established.
Soliris Contraindications
Contraindications
Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.
Soliris Boxed Warnings
Boxed Warning
Serious meningococcal infections.
Soliris Warnings/Precautions
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.
REMS
Soliris Pharmacokinetics
See Literature
Soliris Interactions
Soliris Adverse Reactions
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.
Soliris Clinical Trials
See Literature
Soliris Note
Notes
For women exposed to Soliris during pregnancy, call (215) 616-3558.
Soliris Patient Counseling
See Literature
Soliris Generic Name & Formulations
Legal Class
Rx
General Description
Eculizumab 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Complement inhibitor.
How Supplied
Single-dose vials (30mL)—1
Manufacturer
Generic Availability
NO
Soliris Indications
Indications
Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AchR) antibody positive.
Soliris Dosage and Administration
Adult
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
Not established.
Soliris Contraindications
Contraindications
Unresolved serious Neisseria meningitidis infection. Individuals not vaccinated against Neisseria meningitidis.
Soliris Boxed Warnings
Boxed Warning
Serious meningococcal infections.
Soliris Warnings/Precautions
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.
REMS
Soliris Pharmacokinetics
See Literature
Soliris Interactions
Soliris Adverse Reactions
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.
Soliris Clinical Trials
See Literature
Soliris Note
Notes
For women exposed to Soliris during pregnancy, call (215) 616-3558.
Soliris Patient Counseling
See Literature
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