SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Eculizumab, Quantity: 300 mg

Available from:

Alexion Pharmaceuticals Australasia Pty Ltd

INN (International Name):

Eculizumab

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate

Administration route:

Intravenous Infusion

Units in package:

1 x 30 mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SOLIRIS is indicated for the treatment of patients with: ? Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis. ? atypical Haemolytic Uraemic Syndrome (aHUS). ? Adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive. Soliris is not intended for acute treatment of a NMOSD relapse.

Product summary:

Visual Identification: 30 mL of clear colourless liquid contained in a labelled, 30 mL glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-03-20

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
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 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

Summary of Product characteristics

Version: 200623_SOLIRIS PI
1
CCDSv9.0 and 10.0
This medicinal product is subject to additional monitoring in
Australia. This will
allow quick identification of new safety information. Healthcare
professionals are asked
to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – SOLIRIS
®
(ECULIZUMAB
_RMC) _CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION
WARNING: SERIOUS MENINGOCOCCAL INFECTION
SOLIRIS INCREASES THE RISK OF MENINGOCOCCAL INFECTIONS
•
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 THE 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
4.1
T
HERAPEUTIC INDICATIONS
Soliris is indicated for the treatment of patients with:
•
Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis.
•
atypical Haemolytic Uraemic Syndrome (aHUS).
•
Adult patients with Neuromyelitis