ONPATTRO patisiran 10 mg/5 mL concentrated injection for infusion vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

patisiran, Quantity: 10 mg

Tilgængelig fra:

Alnylam Australia Pty Ltd

Lægemiddelform:

Injection, concentrated

Sammensætning:

Excipient Ingredients: PEG2000-C-DMG; sodium chloride; DLin-MC3-DMA; water for injections; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; cholesterol; distearoylphosphatidylcholine

Indgivelsesvej:

Intravenous Infusion

Enheder i pakken:

Single vial

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Produkt oversigt:

Visual Identification: A sterile, preservative-free, white to off-white, opalescent, homogeneous liquid for intravenous infusion in a Type I clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2022-11-21

Indlægsseddel

Onpattro CMI Ver 1.0
1
ONPATTRO®
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.
1.
WHY AM I USING ONPATTRO?
Onpattro contains the active ingredient patisiran. Onpattro is used to
treat an illness which runs in families called hereditary
transthyretin-mediated amyloidosis (hATTR amyloidosis).
For more information, see Section 1. Why am I using Onpattro? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ONPATTRO?
Do not use if you have ever had an allergic reaction to patisiran 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
Onpattro? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Onpattro and affect how it works.
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 ONPATTRO?
•
The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body
weight given once every 3 weeks.
•
Onpattro will be given to you by a doctor or nurse. It is given as a
drip into a vein (‘intravenous infusion’) usually over
about 80 minutes.
More instructions can be found in Section 4. How do I use Onpattro? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ONPATTRO?
THINGS YOU
SHOULD DO
•
Tell your doctor if you are pregnant or breastfeeding, or are planning
to become pregnant
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Onpattro.
THINGS YOU
SHOULD NOT DO
•
Your doctor will tell you how long you need to receive Onpattro. Do
not stop treatment with Onpattro
unless your doctor tells you to.
DRIVING OR USING
MACHINES
•
Onpattr

Produktets egenskaber

1
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
https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – ONPATTRO
® (PATISIRAN)
1.
NAME OF THE MEDICINE
Patisiran
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Each vial contains patisiran sodium equivalent to 10 mg patisiran
formulated as lipid
nanoparticles.
Excipients with known effect
Each mL of concentrate contains 3.99 mg sodium.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Concentrated injection for infusion (sterile concentrate).
White to off-white, opalescent, homogeneous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onpattro is indicated for the treatment of hereditary
transthyretin-mediated amyloidosis
(hATTR amyloidosis) in adult patients with stage 1 or stage 2
polyneuropathy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated under the supervision of a physician
knowledgeable in the
management of amyloidosis.
DOSAGE
The recommended dose of Onpattro is 300 micrograms per kg body weight
administered via
intravenous (IV) infusion once every 3 weeks.
Dosing is based on actual body weight. For patients weighing ≥ 100
kg, the maximum
recommended dose is 30 mg.
▼

2
Vitamin A supplementation at approximately 2500 IU vitamin A per day
is advised for
patients treated with Onpattro (see section 4.4 Special Warnings and
Precautions for Use).
_Required premedication _
All patients should receive premedication prior to Onpattro
administration to reduce the risk
of infusion-related reactions (IRRs) (see section 4.4
Special Warnings and Precautions for
Use). Each of the following medicinal products should be given on the
day of Onpattro
infusion at least 60 minutes prior to the start of infusion:
•
Intravenous corticosteroid (dexameth