1 INDICATIONS AND USAGE
ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis inadults.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
ONPATTRO should be administered by a healthcare professional.
ONPATTRO is administered via intravenous (IV) infusion. Dosing is based on actual body weight.
For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg once every 3 weeks.
For patients weighing 100 kg or more, the recommended dosage is 30 mg once every 3 weeks.
Missed Dose
If a dose is missed, administer ONPATTRO as soon as possible.
•If ONPATTRO is administered within 3 days of the missed dose, continue dosing according to the patient’soriginal schedule.
•If ONPATTRO is administered more than 3 days after the missed dose, continue dosing every 3 weeks thereafter.
2.2 Required Premedication
All patients should receive premedication prior to ONPATTRO administration to reduce the risk of infusion-relatedreactions (IRRs) [see Warnings and Precautions (5.1)]. Each of the following premedications should be given on the dayof ONPATTRO infusion at least 60 minutes prior to the start of infusion:
•Intravenous corticosteroid (e.g., dexamethasone 10 mg, or equivalent)
•Oral acetaminophen (500 mg)
•Intravenous H1 blocker (e.g., diphenhydramine 50 mg, or equivalent)
•Intravenous H2 blocker (e.g., ranitidine 50 mg, or equivalent)
For premedications not available or not tolerated intravenously, equivalents may be administered orally.
For patients who are tolerating their ONPATTRO infusions but experiencing adverse reactions related to thecorticosteroid premedication, the corticosteroid may be reduced by 2.5 mg increments to a minimum dose of 5 mg ofdexamethasone (intravenous), or equivalent.
Some patients may require additional or higher doses of one or more of the premedications to reduce the risk of IRRs [seeWarnings and Precautions (5.1)].
2.3 Preparation Instructions
ONPATTRO must be filtered and diluted prior to intravenous infusion. The diluted solution for infusion should beprepared by a healthcare professional using aseptic technique as follows:
•Remove ONPATTRO from the refrigerator and allow to warm to room temperature. Do not shake or vortex.
•Inspect visually for particulate matter and discoloration. Do not use if discoloration or foreign particles arepresent. ONPATTRO is a white to off-white, opalescent, homogeneous solution. A white to off-white coatingmay be observed on the inner surface of the vial, typically at the liquid-headspace interface. Product quality is not
impacted by presence of the white to off-white coating.
•Calculate the required dose of ONPATTRO based on the recommended weight-based dosage [see Dosage and
Administration (2.1)].
•Withdraw the entire contents of one or more vials into a single sterile syringe.
•Filter ONPATTRO through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
•Withdraw the required volume of filtered ONPATTRO from the sterile container using a sterile syringe.
•Dilute the required volume of filtered ONPATTRO into an infu