SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Dosing and Administration

SOLIRIS is a chronic therapy for a chronic disease.  Learn more about the importance of adherence and timely dosing.

Successfully starting patients on SOLIRIS

SOLIRIS is a chronic therapy for a chronic disease1-3

Dosing and Administration
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  • Fixed dose on time is necessary to control chronic hemolysis3
     
  • No dosing adjustments recommended based on age, weight, body surface area, renal insufficiency, or hepatic disease1,2
  • Pre-medications are not routinely required
     

Administering SOLIRIS to patients

SOLIRIS® (eculizumab) is supplied as 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free eculizumab solution. SOLIRIS should be administered as an IV infusion and must be diluted to a final concentration of 5 mg/mL prior to administration.

  • The final mixed SOLIRIS 5 mg/mL infusion volume is 120 mL for 600 mg doses (induction dose) or 180 mL for 900 mg doses (maintenance dose)

The diluted solution is a clear, colorless liquid and should be practically free of any particles.

DO NOT ADMINISTER AS AN IV PUSH OR BOLUS INJECTION.

  • If diluted solution is refrigerated, warm to room temperature (18°C-25°C [64°F-77°F] only by exposure to ambient air. The admixture must not be heated in a microwave or with any heat source.
     
  • Administer as an IV infusion over 35 minutes via gravity feed, a syringe-type pump, or an infusion pump
     
  • It is not necessary to protect diluted solution from light during administration

Next: Side Effects


IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication guidelines for vaccine use.

Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.


References:
1. SOLIRIS® prescribing information. Alexion Pharmaceuticals, Inc. 2007.
2. Data on File. Alexion Pharmaceuticals, Inc.
3. Rosse WF, Hillmen P, Schrieber AD. Immune-mediated hemolytic anemia. Hematology. (Am Soc Hematol Educ Program) January 2004:48-62.