EMPAVELI pegcetacoplan 1080 mg/20 mL injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pegcetacoplan, Quantity: 1080 mg

Available from:

Swedish Orphan Biovitrum Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol

Administration route:

Subcutaneous

Units in package:

1 vial, 8 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EMPAVELI is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.

Product summary:

Visual Identification: Clear glass vial containing a clear, colourless to slightly yellowish solution. Practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 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:

2022-02-03

Patient Information leaflet

EMPAVELI*
1
EMPAVELI
®
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 EMPAVELI?
EMPAVELI contains the active ingredient pegcetacoplan. EMPAVELI is
used to treat adult patients with a disease called
paroxysmal nocturnal haemoglobinuria (PNH) who do not respond well
enough to, or cannot take, a C5 inhibitor.
For more information, see Section 1. Why am I using EMPAVELI? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EMPAVELI?
Do not use if you have ever had an allergic reaction to EMPAVELI or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE A SERIOUS BACTERIAL INFECTION THAT IS
NOT CONTROLLED.
TALK TO YOUR DOCTOR ABOUT YOUR VACCINATION HISTORY. YOU MAY NEED TO
RECEIVE SOME VACCINATIONS BEFORE YOU START TO USE
EMPAVELI.
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
EMPAVELI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines,
vitamins, and herbal supplements, as medicines can affect each other,
causing side effects.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE EMPAVELI?
EMPAVELI is intended for subcutaneous administration using a syringe
system infusion pump. This means a needle is placed
under the skin and the drug is slowly infused.
A doctor or nurse will show you how to self-administer EMPAVELI before
you use it for the first time, if they determi

Summary of Product characteristics

1
Empaveli PI 28Mar2022
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 - EMPAVELI
®
(PEGCETACOPLAN), SOLUTION FOR INJECTION
WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
USE OF EMPAVELI MAY PREDISPOSE INDIVIDUALS TO SERIOUS INFECTIONS,
ESPECIALLY THOSE
CAUSED BY ENCAPSULATED BACTERIA, SUCH AS _STREPTOCOCCUS PNEUMONIAE_,
_NEISSERIA _
_MENINGITIDIS_, AND _HAEMOPHILUS INFLUENZAE _TYPE B, WHICH MAY BECOME
RAPIDLY
LIFE-THREATENING OR FATAL IF NOT RECOGNISED AND TREATED EARLY [SEE
_SECTION 4.4, SPECIAL _
_WARNINGS AND PRECAUTIONS FOR USE_].
•
VACCINATE AND/OR REVACCINATE ACCORDING TO CURRENT NATIONAL VACCINATION
GUIDELINES
SUCH AS THE AUSTRALIAN IMMUNISATION HANDBOOK; VACCINES AGAINST
ENCAPSULATED
BACTERIA SUCH AS _STREPTOCOCCUS PNEUMONIAE_, _NEISSERIA MENINGITIDIS_,
AND
_HAEMOPHILUS INFLUENZAE _TYPE B, ARE RECOMMENDED.
•
VACCINATE PATIENTS AGAINST ENCAPSULATED BACTERIA AS RECOMMENDED AT
LEAST 2 WEEKS
PRIOR TO ADMINISTERING THE FIRST DOSE OF EMPAVELI UNLESS THE RISKS OF
DELAYING
THERAPY WITH EMPAVELI OUTWEIGH THE RISK OF DEVELOPING A SERIOUS
INFECTION.
PATIENTS WHO INITIATE EMPAVELI LESS THAN 2 WEEKS AFTER VACCINATION
MUST RECEIVE
TREATMENT WITH APPROPRIATE PROPHYLACTIC ANTIBIOTICS UNTIL 2 WEEKS
AFTER
VACCINATION. _SEE SECTION 4.4, SPECIAL WARNINGS AND PRECAUTIONS FOR
USE_ FOR
ADDITIONAL GUIDANCE ON THE MANAGEMENT OF THE RISK OF SERIOUS
INFECTION.
•
VACCINATION REDUCES, BUT DOES NOT ELIMINATE, THE RISK OF SERIOUS
INFECTIONS. MONITOR
PATIENTS FOR EARLY SIGNS OF SERIOUS INFECTIONS AND EVALUATE
IMMEDIATELY IF INFECTION
IS SUSPECTED.
1
NAME OF THE MEDICINE
Pegcetacoplan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 1080 mg pegcetacoplan in a pH 5.0, 10 mM
acetate buffer.
For the full list of excipients, see section 6.1. List of Excipients.
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Empaveli P