Loading…
SOLIRIS is a brand name for Eculizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics (Paroxysmal Nocturnal Hemoglobinuria) 07/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment and 4.4 Administration 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 3 Reconstitution ............................................................................................................... 4 Administration ............................................................................................................
5 Missed Dose ................................................................................................................ 10 5 OVERDOSAGE...........................................................................................................
10
). Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.
Other Systemic Infections:
Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections. Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with Neisseria and encapsulated bacteria.
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported. Counsel patients about gonorrhea prevention and advise regular testing for patients at risk.
Additionally, Aspergillus infections have occurred in immunocompromised and Soliris (eculizumab for injection) Page 7 of 57 neutropenic patients. Patients should be provided with information from the Patient Information Brochure to increase their awareness of potential serious infections and their signs and symptoms.
Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to national guidelines.
1 Dosing Considerations • Soliris should be administered by a qualified healthcare professional. • Administer vaccinations for the prevention of infection due to Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type b according to the NACI guidelines (see 3 Serious Warnings and Precautions Box).
• Use caution when administering Soliris to patients with any systemic infection. Serious infections, infectious agents and subsequent treatments for these infections should be documented for all patients treated with Soliris. • Do not administer as an IV Push or Bolus Injection.
, Serious Meningococcal Infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Meningococcal infections Cases of serious or fatal meningococcal infections have been reported in patients treated with Soliris.
Meningococcal infections may become rapidly life-threatening or fatal if not recognized and treated early. • Comply with the most current National Advisory Committee on Immunization (NACI) recommendations for meningococcal vaccination in patients with complement deficiencies.
• All patients must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing Soliris (eculizumab for injection) Page 6 of 57 a meningococcal infection; revaccinate according to current medical guidelines for vaccine use.
• 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.
Serious Meningococcal Infections:
Due to its mechanism of action, the use of Soliris increases the patient's susceptibility to meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated against meningococcal infections prior to, or at the time of, initiating Soliris.
Patients who initiate Soliris treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Patients must be vaccinated or revaccinated according to current national vaccination guidelines for vaccination use. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Soliris is contraindicated in patients who are hypersensitive to this drug, murine proteins, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Do not initiate Soliris therapy in patients: • with unresolved Neisseria meningitidis infection • who are not currently vaccinated against Neisseria meningitidis (unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination) Please refer to section 7 WARNINGS AND PRECAUTIONS , Serious Meningococcal Infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• The dose and/or infusion rate must not be changed without consulting the prescribing or treating healthcare professional. • Personnel trained in emergency measures should be readily available during the Soliris infusion and for a specified time after infusion.
• If a patient experiences an anaphylactic or another acute reaction, immediately discontinue the Soliris infusion, initiate appropriate medical treatment and seek the attention of a healthcare professional (see 7 Warnings and Precautions).
• If severe or serious reactions occur, subsequent infusions should only occur in a setting where resuscitation measures are available. Home infusion Home infusion under the supervision of a healthcare professional may be considered for patients after evaluation and recommendation from the prescribing or treating physician.
Home infusions should be performed by a qualified healthcare professional. Appropriate medical infrastructure, resources and procedures must be established and available to the healthcare professional administering home infusions. 2 Recommended Dose and Dosage Adjustment Recommended Dosage Regimen - PNH For patients 18 years of age and older (≥ 40 kg bw), Soliris therapy consists of: • 600 mg every 7 days for the first 4 weeks, followed by Soliris (eculizumab for injection) Page 8 of 57 • 900 mg for the fifth dose 1 week later, then • 900 mg every 2 weeks thereafter.
Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points (see 7 WARNINGS AND PRECAUTIONS). Recommended Dosage Regimen – atypical HUS, gMG and NMOSD For patients 18 years of age and older (≥ 40 kg bw), Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by • 1200 mg for the fifth dose 1 week later, then • 1200 mg every 2 weeks thereafter Dosage Regimen in Pediatrics – PNH and atypical HUS For pediatric patients with PNH and atypical HUS, and with body weights (bw) below 40 kg, administer Soliris based upon body weight, according to the following schedule (Table 1): Table 1: Dosing recommendations in < 40 kg patients, less than 18 years of age with PNH and atypical HUS Patient Body Weight Induction Maintenance 30 kg to less than 40 kg 600 mg weekly x 2 doses 900 mg at week 3; then 900 mg every 2 weeks 20 kg to less than 30 kg 600 mg weekly x 2 doses 600 mg at week 3; then 600 mg every 2 weeks 10 kg to less than 20 kg 600 mg weekly x 1 dose 300 mg at week 2; then 300 mg every 2 weeks 5 kg to less than 10 kg 300 mg weekly x 1 dose 300 mg at week 2; then 300 mg every 3 weeks The dosage estimated to be used in pediatric patients with PNH or atypical HUS and weighing less than 40 kg is identical.
Modeling of dosage is based on maintaining Soliris serum level at 50 μg/mL. Supplemental dose For adult patients with atypical HUS, gMG or NMOSD, and pediatric patients with atypical HUS, supplemental dosing of Soliris is required in the setting of concomitant support with plasmapheresis (PP) or plasma exchange (PE); or fresh frozen plasma infusion (PI) (Table 2).
The goal of the additional dosing after plasma intervention is to restore and maintain the plasma concentration above targeted therapeutic concentration. The impact of IVIg on eculizumab levels in patients with gMG has not been studied.
Soliris (eculizumab for injection) Page 9 of 57 Table 2 :
Supplemental dose of Soliris after plasmapheresis/plasma exchange/plasma infusion Type of Intervention Most Recent Soliris Dose Soliris Dose with Each PP/PE/PI Intervention Timing of Supplemental Soliris Dose Plasmapheresis or plasma exchange 300 mg 300 mg per each plasmapheresis or plasma exchange session Within 60 minutes after each plasmapheresis or plasma exchange600 mg or more 600 mg per each […]
Vaccination, particularly with a vaccine against serogroup B meningococcal infection, may further activate complement. As a result, patients with complement-mediated diseases, including PNH, atypical HUS, gMG and NMOSD, may experience increased signs and symptoms of their underlying disease, such as hemolysis (PNH), TMA complications (atypical HUS), MG exacerbation (gMG) or relapse (NMOSD).
Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. For patients stabilized on Soliris and receiving maintenance therapy, and for whom additional vaccination is warranted, careful consideration should be given to the timing of vaccination (or booster in patients previously vaccinated against meningococcal infections) relative to administration of Soliris.
e. within one week following a Soliris infusion). Cases of serious or fatal meningococcal infections have been reported in Soliris treated patients. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.
Patients should be informed of these signs and symptoms and steps to take to seek medical care immediately (see