ONPATTRO 2 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PATISIRAN AS SODIUM

Available from:

MEDISON PHARMA LTD

ATC code:

N07XX12

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PATISIRAN AS SODIUM 2 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ALNYLAM NETHERLANDS B.V, THE NETHERLANDS

Therapeutic area:

PATISIRAN

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

Authorization date:

2020-09-21

Summary of Product characteristics

1
PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Onpattro 2 mg/mL
concentrate for solution for infusion.
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.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
White to off-white, opalescent, homogeneous solution (pH: 6.6-7.5).
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
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated under the supervision of a physician
knowledgeable in the management of
amyloidosis.
Posology
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.
Vitamin A supplementation at approximately 2 500 IU vitamin A per day
is advised for patients
treated with Onpattro (see section 4.4).
_ _
_Required premedication _
All patients should receive premedication prior to Onpattro
administration to reduce the risk of
infusion-related reactions (IRRs) (see section 4.4). 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 (dexamethasone 10 mg, or equivalent)
•
Oral paracetamol (500 mg)
2
•
Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent)
•
Intravenous H2 blocker (ranitidine 50 mg, or equivalent)
For premedications not available or not tolerated intravenously,
equivalents may be administered
orally.
If clinically i