Consumer medicine information

Soliris 300 mg/30 mL Concentrated solution for infusion

Eculizumab

BRAND INFORMATION

Brand name

Soliris

Active ingredient

Eculizumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Soliris 300 mg/30 mL Concentrated solution for infusion.

1. Why am I using Soliris?


Soliris contains the active ingredient eculizumab rmc. Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS).
Soliris is also used to treat adult patients with a disease of the central nervous system that mainly affects the eye nerves and the spinal cord called Neuromyelitis Optica Spectrum Disorder (NMOSD).
For more information, see Section 1. Why am I using Soliris? in the full CMI.

2. What should I know before I use Soliris?


Do not use if you have ever had an allergic reaction to Soliris or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Soliris? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Soliris and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Soliris?


Soliris will be given to you directly into the vein (intravenously) by a doctor or nurse. Each infusion will take approximately 25 - 45 minutes in adults, and 1 to 4 hours in paediatric patients.
More instructions can be found in Section 4. How do I use Soliris? in the full CMI.

5. What should I know while using Soliris?

Things you should do
  • Remind any doctor, nurse, dentist or pharmacist you visit that you are using Soliris.
  • If you forget or miss a Soliris infusion, call your doctor immediately.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not stop taking Soliris without checking with your doctor.
Looking after your medicine
  • Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or pharmacy.
  • Soliris vials in the original package may be removed from refrigerated storage (up to 25°C) for only one single period of up to 3 days. At the end of this period unopened product can be put back in the refrigerator.

For more information, see Section 5. What should I know while using Soliris? in the full CMI.

6. Are there any side effects?


For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Soliris

Active ingredient

Eculizumab

Schedule

S4

 

Boxed Warnings

Warning: serious meningococcal infection.
Soliris increases the risk of meningococcal infections.
Life-threatening meningococcal infections/sepsis have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognised and treated early (see Section 4.4 Special Warnings and Precautions for Use).
Vaccinate patients against meningococcal infection (Neisseria meningitidis), at least 2 weeks prior to receiving Soliris, unless the risk of delaying Soliris therapy outweighs the risk of meningococcal infection.
Vaccinate and/or revaccinate according to current national vaccination guidelines such as the Australian Immunisation Handbook; vaccines against serogroups A, B, C, Y and W135 are recommended.
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.
Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

1 Name of Medicine

Eculizumab rmc.

2 Qualitative and Quantitative Composition

Soliris is supplied as 300 mg single-use glass vials containing 30 mL of 10 mg/mL sterile, preservative-free Soliris solution per vial.
Excipients with known effect. Sodium chloride (5 mmol).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Soliris (eculizumab rmc) concentrated solution for intravenous infusion is a sterile, clear, colourless, preservative-free solution.

4 Clinical Particulars

4.9 Overdose

No case of overdose has been reported during clinical studies. Supportive and symptomatic care should be provided in the event of overdose.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No studies have been conducted to assess the genotoxic potential of eculizumab rmc.
Carcinogenicity. No studies have been conducted to assess the carcinogenic potential of eculizumab rmc.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Formulated at pH 7.0.
CAS number. CAS registry number: 219685-50-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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