|
| |
Eculizumab intravenous
Soliris™ |
|
FDA Approval: |
March 2007 |
|
Indication: |
Paroxysmal nocturnal hemoglobinuria |
|
Pharmacology: |
Monoclonal antibody |
|
Usual Dose: |
Initial dose, weeks 1-4: 600 mg by IV infusion every 7 days |
|
Contraindications: |
Serious Neisseria meningitidis infection Patients not vaccinated
against N meningitidis |
|
Warnings: |
Increases risk of meningococcal infection Meningococcal vaccine
should be given at least 2 weeks before first dose
Patients should be monitored for early symptoms of meningococcal
infection
Caution is recommended in patients with systemic infection
Monitor for intravascular hemolysis and LDH levels after
discontinuation
May cause infusion reactions (anaphylaxis/hypersensitivity)
Safety and efficacy not established in patients younger than 18
years
Lactation: Caution is recommended |
|
Pregnancy Category: |
C |
|
Side Effects: |
Most common: Headache
Nasopharyngitis
Back pain
Nausea |
|
Drug Interactions: |
Data not available |
|
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