Soliris

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  • Anemias
  • Miscellaneous neurodegenerative disorders
  • Myasthenia gravis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Alexion Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    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 C5b-9. Soliris inhibits terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS.

    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.

    Soliris Boxed Warnings

    Boxed Warning

    Serious meningococcal infections.

    Soliris Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious meningococcal infections (septicemia and/or meningitis). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent eculizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider eculizumab interruption 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

    YES

    Soliris Pharmacokinetics

    Absorption

    Steady state was achieved 4 weeks after starting treatment.

    Distribution

    Volume of distribution: 5–8 L.

    Elimination

    Half-life: ~270 to 414 hours. Plasma exchange or infusion increases clearance and reduced half-life to 1.26 hours.

    Soliris Interactions

    Not Applicable

    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

    Not Applicable

    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

    Alexion Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    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 C5b-9. 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 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.

    Soliris Boxed Warnings

    Boxed Warning

    Serious meningococcal infections.

    Soliris Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious meningococcal infections (septicemia and/or meningitis). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent eculizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider eculizumab interruption 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

    YES

    Soliris Pharmacokinetics

    Absorption

    Steady state was achieved 4 weeks after starting treatment.

    Distribution

    Volume of distribution: 5–8 L.

    Elimination

    Half-life: ~270 to 414 hours. Plasma exchange or infusion increases clearance and reduced half-life to 1.26 hours.

    Soliris Interactions

    Not Applicable

    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

    Not Applicable

    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

    Alexion Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    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 C5b-9. 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.

    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.

    Soliris Boxed Warnings

    Boxed Warning

    Serious meningococcal infections.

    Soliris Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious meningococcal infections (septicemia and/or meningitis). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent eculizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider eculizumab interruption 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

    YES

    Soliris Pharmacokinetics

    Absorption

    Steady state was achieved 4 weeks after starting treatment.

    Distribution

    Volume of distribution: 5–8 L.

    Elimination

    Half-life: ~270 to 414 hours. Plasma exchange or infusion increases clearance and reduced half-life to 1.26 hours.

    Soliris Interactions

    Not Applicable

    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

    Not Applicable

    Soliris Patient Counseling

    See Literature

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