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ONPATTRO is a brand name for Patisiran, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ONPATTRO (patisiran) is indicated for the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada. Therefore, Health Canada has not authorized an indication for pediatric…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 7
1 Adverse Reaction Overview The most frequently occurring adverse reactions reported in ONPATTRO-treated patients (≥ 10% of patients and occurring ≥ 3 percentage points more frequently than in placebo-treated patients) were peripheral edema and infusion-related reactions (see 7 WARNINGS AND PRECAUTIONS).
7%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 years. Of these 224 patients, 186 patients received ≥ 1 year of treatment, 137 patients received ≥ 2 years of treatment, and 52 patients received ≥ 3 years of treatment.
7 months. 2 Dosage and Dosage Adjustment). , having baseline left ventricular (LV) wall thickness ≥ 13 mm, with no history of hypertension or aortic valve disease. Adverse reactions for ONPATTRO are defined as those adverse events occurring at a ≥ 3 percentage point higher frequency in patients treated with ONPATTRO, compared with placebo, and other potentially relevant adverse events based on other studies with ONPATTRO.
0), sorted under the respective System Organ Class (SOCs) (Table 2). Page 13 of 32 Table 2 – Adverse Reactions That Occurred at a ≥ 3 Percentage Point Higher Frequency with ONPATTRO Compared to Placebo in the APOLLO Trial ONPATTRO N=148 (%) Placebo N=77 (%) General disorders and administration site conditions Peripheral edema 30 22 Immune system disorders Infusion-related reaction* 19 9 Gastrointestinal disorders Dyspepsia 8 4 Musculoskeletal and connective tissue disorders Muscle spasms Arthralgia 8 7 1 0 Respiratory, thoracic and mediastinal disorders Dyspnea 7 0 Skin and subcutaneous tissue disorders Erythema 7 3 Infections and infestations Bronchitis Rhinitis Sinusitis 6 4 4 3 0 0 Ear and labyrinth disorders Vertigo 5 1 *Infusion-related reaction symptoms include but are not limited to: arthralgia or pain (including back, neck, or musculoskeletal pain), flushing (including erythema of face or skin warm), nausea, abdominal pain, dyspnea or cough, chest discomfort or chest pain, headache, pruritus, rash, chills, dizziness, fatigue, increased heart rate or palpitations, hypotension (which may include syncope), hypertension, facial edema.
). 3 mg/kg administered via intravenous (IV) infusion once every 3 weeks. Dosing is based on body weight, to a maximum dose of 30 mg. For patients weighing ≥ 100 kg, the recommended dose of ONPATTRO should not exceed 30 mg. Required Premedication All patients should receive premedication prior to ONPATTRO administration to reduce the risk of infusion-related reactions (IRRs) (see 7 WARNINGS AND PRECAUTIONS).
Each Page 5 of 32 of the following premedications 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 acetaminophen (500 mg) • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent) • Intravenous H2 blocker (famotidine 20 mg, or equivalent) For premedications not available or not tolerated intravenously, equivalents may be administered orally.
If clinically indicated, the corticosteroid may be tapered to a minimum dose of 5 mg of dexamethasone (intravenous), or equivalent, for patients who are tolerating their infusions well. Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed (see 7 WARNINGS AND PRECAUTIONS).
Vitamin A Supplementation Supplementation with the recommended daily amount of vitamin A is recommended (see 7 WARNINGS AND PRECAUTIONS). • Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use.
3 Pharmacokinetics). 3 Pharmacokinetics). ONPATTRO has not been studied in patients with moderate or severe hepatic impairment. 3 Pharmacokinetics). 3 CLINICAL PHARMACOLOGY, Pharmacokinetics). ONPATTRO has not been studied in patients with severe renal impairment or end-stage renal disease.
3 Reconstitution ONPATTRO must be diluted prior to IV infusion. The diluted solution for infusion sho uld be prepared by a healthcare professional using aseptic technique as follows: • Remove ONPATTRO from the refrigerator. Do not shake or vortex.
, anaphylaxis or anaphylactoid reactions) to patisiran or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pharmacokinetics). 3 Less Common Clinical Trial Adverse Reactions General disorders and administration site conditions: extravasation, including phlebitis or thrombophlebitis, infusion or injection site swelling, dermatitis, cellulitis, erythema or injection site redness, burning sensation, or injection site pain.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Immunogenicity Anti-drug antibodies to ONPATTRO were evaluated by measuring antibodies specific to PEG2000-C-DMG, a lipid component exposed on the surface of ONPATTRO.
6%) patients with hATTR amyloidosis developed anti-drug antibodies, as measured during treatment with ONPATTRO. One additional patient had pre-existing anti-drug antibodies. Anti-drug antibody titers were low and transient with no evidence of an effect on clinical efficacy, the safety profile, or the pharmacokinetic or pharmacodynamic profiles of ONPATTRO.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. In addition, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease.
For these reasons, comparison of the incidence of antibodies to ONPATTRO with the incidence of antibodies to other products may be misleading. Vitamin A Levels Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
Treatment with ONPATTRO reduces serum TTR levels, which results in reduced levels of retinol binding protein and vitamin A in the serum (see 7 WARNINGS AND PRECAUTIONS).
• Inspect visually for particulate matter and discoloration. Do not use if discoloration or foreign particles are present. ONPATTRO is a white to off-white, opalescent, homogeneous solution. A white to off-white coating may 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. 2 Recommended Dose and Dosage Adjustment). • Withdraw the entire contents of one or more vials into a single sterile syringe. 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. 9% sodium chloride solution for a total volume of 200 mL. Use infusion bags that are DEHP-free. • Gently invert the bag to mix the solution.
Do not shake. Do not mix or dilute with other drugs. • Discard unused portion of ONPATTRO. • Inspect the infusion bag visually for particulate matter and discoloration prior to administration. DO NOT use if solution contains particles.
• Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution, as sterility may be impaired. • ONPATTRO does not contain preservatives. The diluted solution should be administered immediately after preparation.
If not used immediately, store in the infusion bag at room temperature (15 °C to 30 °C) for up to 16 hours (including infusion time). Do not freeze. 3 Reconstitution). 2-micron polyethersulfone (PES) in-line infusion filter. Use infusion sets and lines that are di(2-ethylhexyl)phthalate-free (DEHP-free).
Page 7 of 32 • Infuse the diluted solution of ONPATTRO intravenously over approximately 80 minutes at an initial infusion rate of approximately 1 mL/min for the first 15 minutes; then, if well tolerated, increase to approximately 3 mL/min for the remainder of the infusion.
The duration of infusion may be extended in the event of an IRR (see 7 WARNINGS AND PRECAUTIONS). • Administer only through a free-flowing venous access line. Monitor the infusion site for possible infiltration during drug administration.
Suspected extravasation should be managed according to local standard practice for non-vesicants. • Observe the patient during the infusion and, if clinically indicated, following the infusion (see 7 WARNINGS AND PRECAUTIONS). 9% sodium chloride solution to ensure that all ONPATTRO has been administered.
5 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’s original schedule. • If ONPATTRO is administered more than 3 days after the missed dose, continue dosing every 3 weeks thereafter.
5 OVERDOSAGE Reported experience with overdose […]