Alternate Name(s):
SOLARIS
Classification:
Humanized Monoclonal C5 Antibody
Original Date:
December 2019
Indications:
- Atypical Hemolytic Uremic Syndrome (HUS)
Reconstitution and Stability:
- Available as 300 mg vials containing 30 mL of 10 mg/mL
- Store vials in original carton refrigerated (2-8°C) . DO NOT FREEZE
- Protect from light
- Add exact volume of 0.9% sodium chloride equal to the eculizumab required to an empty viaflex bag (see table below)
| Dose | Vial Size | Volume ot 0.9% Sodium Chloride |
Total Volume | Final Concentration |
| 300 mg | 30 mL x 1 | 30 mL | 60 mL | 5 mg/mL |
| 600 mg | 30 mL x 2 | 60 mL | 120 mL | 5 mg/mL |
| 900 mg | 30 mL x 3 | 90 mL | 180 mL | 5 mg/mL |
| 1200 mg | 30 mL x 4 | 120 mL | 240 mL | 5 mg/mL |
- Slowly inject measured volume of eculizumab into prepared bag of 0.9% sodium chloride
- Gently invert the infusion bag to ensure mixing. DO NOT SHAKE
- Diluted solution stable 24 hours refrigerated or at room temperature
- Protect from light
- Discard any unused portion in the vial as product does not contain preservatives
- Do not infuse if solution is discoloured or contains particulate matter
- Prior to administration, the admixture should adjust to room temperature (18-25°C)
Compatibility:
- Solution Compatible: 0.9% Sodium Chloride, 0.45% Sodium Chloride, 5% Dextrose in Water, Ringer's Solution
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Push | NO |
| IV Intermittent Infusion | YES - Large Volume Pump ONLY Usual Dilution: 5 mg/mL Infusion time: 35 minutes (may be up to 2 hours if patient experiences an infusion reaction) |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Induction dosing:
5 to <10 kg: 300 mg IV x 1 weekly dose
10 to <20 kg: 600 mg IV x 1 weekly dose
20 to <30 kg: 600 mg IV every week x 2 doses
30 to <40 kg: 600 mg IV every week x 2 doses
greater than or equal to 40 kg: 900 mg IV every week x 4 doses
- Maintenance dosing:
5 to <10 kg: 300 mg IV every 3 weeks, starting week 2
10 to <20 kg: 300 mg IV every 2 weeks starting week 2
20 to <30 kg: 600 mg IV every 2 weeks, starting week 3
30 to <40 kg: 900 mg IV every 2 weeks,starting week 3
greater than or equal to 40 kg: 1200 mg IV every 2 weeks, starting week 5
- Should be administered at the recommended dosage regimen time points, or within 2 days of these time points
- See product monograph or contact pharmacy for supplemental dosing with plasmapheresis/ plasma exchange/ fresh frozen plasma exchange
Potential hazards of parenteral administration:
- Administration may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions : urticaria, dyspnea, hypotension
- Headache, stuffy nose, sore throat, nausea, fever, joint aches and pains, fatigue, and herpes simplex (cold sores)
- Eculizumab increases the risk of meningococcal infections
- all patients must be vaccinated with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of Eculizumab
- revaccinate according to current medial guidelines for vaccine use: quadravalent, conjugated meningococcal vaccines against serotypes A,C,Y,W are strongly recommended
- all patients must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary
- vaccination may not prevent all meningococcal infections - Patients treated with Eculizumab have increased susceptibility to infection with other encapsulated organisms, such as Haemophilus influenza and Streptococcus pneumonia
Notes:
- Monitor patient for at least 1 hour following the completion of infusion for signs or symptoms of an infusion reaction
- Monitoring after Eculizumab Discontinuation: patients who discontinue treatment may be at increased risk for serious hemolysis (identified by serum LDH levels greater than the pre-treatment level, along with any of the following:
- a hemoglobin level of <50 g/L or a decrease of >40 g/L in 1 week or less
- angina
-change in mental status
- a 50% increase in serum creatinine level
- thrombosis - Monitor any patient who discontinues Eculizumab for at least 8 weeks to detect serious hemolysis and other reactions
- Have Epinephrine Anaphylaxis Kit at bedside