Soliris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Eculizumab 300mg;  ;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Eculizumab 300 mg

Dosage:

300mg/30mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Eculizumab 300mg       Excipient: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Units in package:

Vial, glass, 30 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lonza Biologics Porrino S L

Therapeutic indications:

SOLIRIS® is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH)to reduce haemolysis.

Product summary:

Package - Contents - Shelf Life: Vial, glass, - 30 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 days not refrigerated stored at or below 25°C protect from light. store in carton

Authorization date:

2010-12-22

Patient Information leaflet

230330_NZCMI (REF: 230330_DS)
1/4
NEW ZEALAND CONSUMER MEDICINE
INFORMATION
SOLIRIS
®
_eculizumab _
CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION 300MG/ML
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Soliris.
It does not contain all the available
information.
It does not take the place of talking
to your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Soliris
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SOLIRIS IS USED
FOR
Soliris is a medicine containing an
active substance called eculizumab,
which belongs to a class of
medicines called monoclonal
antibodies.
Soliris is used for the treatment of
patients with a disease that affects
blood cells called Paroxysmal
Nocturnal Haemoglobinuria (PNH).
_HOW IT WORKS _
Patients with PNH lack naturally
occurring protective proteins on the
surface of some of their blood cells.
In unaffected individuals, these
proteins protect blood cells from
damage and destruction by the
body’s inflammatory response. PNH
patients lack these protective
proteins and their red blood cells
can be destroyed, which can lead to
low blood counts (anaemia),
tiredness, difficulty in functioning,
pain, dark urine, kidney failure,
shortness of breath, and blood
clots.
Soliris can block the body’s
inflammatory response, and its
ability to attack and destroy
vulnerable PNH red blood cells. In
this way Soliris improves anaemia,
tiredness, and other signs and
symptoms of PNH.
Patients with aHUS have an
inflammatory condition which
affects the blood system and
kidney. This can lead to reduced or
lost function of the kidneys or other
organs, low blood counts (low
platelets and anaemia), tiredness
and difficulty functioning. Soliris
works by blocking the body’s
inflammatory response and its
ability to attack and destroy its own
vulnerable blood and kidney cells.
BEFORE YOU ARE GI

Summary of Product characteristics

NEW ZEALAND DATA SHEET
221220_SOLIRIS DS
Page 1 of 32
1. PRODUCT NAME
Soliris
®
300mg/30mL solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10mg/mL (300mg/30mL) eculizumab.
Eculizumab is a genetically-engineered humanised monoclonal antibody
produced from murine
myeloma cells.
Excipients with known effect: sodium chloride (5 mmol).
For the full list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Solution for infusion.
Sterile, clear, colourless, preservative-free solution in glass vials.
The product is formulated at
pH 7.0.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Soliris is indicated for the treatment of patients with:
•
Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis.
•
atypical Haemolytic Uraemic Syndrome (aHUS)
WARNING: SERIOUS MENINGOCOCCAL INFECTION
SOLIRIS
® INCREASES THE RISK OF MENINGOCOCCAL INFECTIONS
•
VACCINATE PATIENTS AGAINST MENINGOCOCCAL INFECTION (_NEISSERIA
MENINGITIDES_) 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; 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.
NEW ZEALAND DATA SHEET
221220_SOLIRIS DS
Page 2 of 32
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE REGIMEN
Patients must be administered a meningococcal vaccine at least two
weeks prior to receiving
Soliris therapy. Refer to Box Warning and Section 4.4 – Special
Warnings and Precautions for
Use; Meningococcal Infection and Immunisation, for vaccination
information before initiating
Soliris treatmen