ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ravulizumab, Quantity: 100 mg/mL

Available from:

Alexion Pharmaceuticals Australasia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections

Administration route:

Intravenous Infusion

Units in package:

each (1 x vial)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ultomiris is indicated:,? for the treatment of patients with Paroxysmal Nocturnal Haemoglobinuria (PNH),? for the treatment of patients with Atypical Haemolytic Uraemic Syndrome (aHUS),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.,? for the treatment of adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive.,Ultomiris is not intended for the acute treatment of a NMOSD relapse.

Product summary:

Visual Identification: Clear to slight translucent, clear to yellowish colour solution, practically free from particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-03-23

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 subject to additional monitoring due to approval of
an extension of indications. This will allow quick identification
of new safety information. You can help by reporting any side effects
you may get. You can report side effects to your doctor, or
directly at www.tga.gov.au/reporting-problems. 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 ULTOMIRIS?
Ultomiris contains the active ingredient ravulizumab rch.
For more information, see Section 1. Why am I using Ultomiris? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ULTOMIRIS?
Ultomiris is a medicine that affects your body’s defence system and
so can lower the ability of your immune system to fight
infections. Using this medicine increases your risk of severe
infection and sepsis (infection of the blood). You must be vaccinated
against meningococcal infection and be aware of the signs and symptoms
of a meningococcal infection. You must always carry a
“Patient Safety Card” with you.
TALK TO YOUR DOCTOR IF YOU HAVE AN INFECTION OR HAVE HAD AN ALLERGIC
REACTION TO ANY OF THE INGREDIENTS LISTED AT THE END OF THE
CMI.
For more information, see Section 2. What should I know before I use
Ultomiris? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Talk to your doctor if you have any other medical conditions or are
taking any other medicines. The effect of using Ultomiris on other
medicines has not been studied.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ULTOMIRIS?
•
Ultomiris will be given to you directly into the vein (intravenously)
by a doctor or nurse. The infusion will take approxi

Summary of Product characteristics

1
221005_ULTOMIRIS 100mg/mL PI
CCDS v8.0
This medicinal product is subject to additional monitoring in
Australia due to approval of an
extension of indications. 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 – ULTOMIRIS
® (RAVULIZUMAB
RCH) 100 MG/ML SOLUTION FOR INTRAVENOUS INFUSION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
LIFE-THREATENING MENINGOCOCCAL INFECTIONS/SEPSIS HAVE OCCURRED IN
PATIENTS TREATED
WITH ULTOMIRIS. 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_).
•
REFER TO THE MOST CURRENT EDITION OF THE AUSTRALIAN IMMUNISATION
HANDBOOK FOR
MENINGOCOCCAL VACCINATION GUIDELINES.
•
IMMUNISE PATIENTS WITH MENINGOCOCCAL VACCINES AT LEAST 2 WEEKS PRIOR
TO
ADMINISTERING THE FIRST DOSE OF ULTOMIRIS, UNLESS THE RISKS OF
DELAYING ULTOMIRIS
THERAPY OUTWEIGH THE RISK OF DEVELOPING A MENINGOCOCCAL INFECTION (SEE
_SECTION 4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ FOR ADDITIONAL GUIDANCE ON
THE
MANAGEMENT OF THE RISK OF MENINGOCOCCAL INFECTION).
•
VACCINATION REDUCES, BUT DOES NOT ELIMINATE, THE RISK OF MENINGOCOCCAL
INFECTIONS.
MONITOR PATIENTS FOR EARLY SIGNS OF MENINGOCOCCAL INFECTIONS AND
EVALUATE
IMMEDIATELY IF INFECTION IS SUSPECTED.
1
NAME OF THE MEDICINE
Ravulizumab _rch_
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultomiris is a formulation of ravulizumab _rch_ which is a long acting
humanised monoclonal
IgG2/4K antibody produced in Chinese hamster ovary (CHO) cell culture
by recombinant DNA
technology.
Ultomiris is supplied as a single use vial containing 100 mg/mL (300
mg in 3 mL or 1100 mg in 11
mL) of ravulizumab _rch_.
_For the full list of excipients, see section 6.1 List of Excipients_.
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PHARMACEUTICAL FORM
Concentrated solution for intravenous infusion.
Ultomiris 100 mg/mL is a translucent, clear to yellowish c