Onpattro Drug

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ONPATTRO® (patisiran) Treatment for the …

(5 days ago) ONPATTRO is a prescription medicine for adults that treats the polyneuropathy caused by an illness called hereditary ATTR (hATTR) amyloidosis. It was a huge help for me to talk to someone else with this disease. I decided to make education a priority, informing my family and helping them understand this disease.

Onpattro.com

Category:  Health Detail Drugs


Onpattro: Uses, Dosage, Side Effects & Warnings - …

(5 days ago) Onpattro (patisiran) is the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatments. Onpattro is used for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Drugs.com

Category:  Health Detail Drugs


Onpattro (Patisiran Lipid Complex Injection): Uses, Dosage

(Just Now) ONPATTRO is not expected to cause drug-drug interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes. Clinical Studies. The efficacy of ONPATTRO was demonstrated in a randomized, double-blind, placebo-controlled, multicenter clinical trial in adult patients with polyneuropathy caused by hATTR amyloidosis (NCT 01960348).

Rxlist.com

Category:  Health Detail Drugs


Drug Approval Package: Onpattro (patisiran)

(8 days ago) Drug Approval Package: Onpattro (patisiran) Company: Alnylam Pharmaceuticals, Inc. Application Number: 210922. Approval Date: 08/10/2018. Drugs@FDA information available about Onpattro. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling.

Accessdata.fda.gov

Category:  Pharmaceutical Detail Drugs


FDA approves first-of-its kind targeted RNA-based …

(5 days ago) Onpattro also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. Approval of Onpattro was …

Fda.gov

Category:  Health Detail Drugs


The Onpattro story and the clinical translation of

(1 days ago) The Onpattro story and the clinical translation of nanomedicines containing nucleic acid-based drugs Nat Nanotechnol . 2019 Dec;14(12):1084-1087. doi: 10.1038/s41565-019-0591-y.

Pubmed.ncbi.nlm.nih.gov

Category:  Health Detail Drugs


ONPATTRO® (patisiran) Dosing and Preparation Guide

(Just Now) with other drugs. • ONPATTRO should not be delivered via pneumatic tube systems 10. Discard any unused portion of ONPATTRO. Important Safety Information Adverse Reactions The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion-related reactions (19%). Sterile

Onpattrohcp.com

Category:  Health Detail Drugs


Onpattro: Dosage, Side Effects, Uses, and More

(8 days ago) Onpattro is a prescription medication that contains the active drug patisiran. It comes as a liquid solution that’s given by healthcare …

Healthline.com

Category:  Health Detail Drugs


In first, FDA approves RNA interference drug from Alnylam

(9 days ago) The FDA approved Onpattro only for adult patients with polyneuropathy caused by ATTR amyloidosis, rather than the disease more broadly. Like other first-in-class rare disease drugs, Onpattro will be expensive. Alnylam set a list price for Onpattro of $9,500 per vial, which — depending on dosing — averages out to $450,000 per year.

Biopharmadive.com

Category:  Health Detail Drugs


The Onpattro story and the clinical translation of

(9 days ago) The regulatory approval of Onpattro, a lipid nanoparticle-based short interfering RNA drug for the treatment of polyneuropathies induced by hereditary transthyretin amyloidosis, paves the way for

Nature.com

Category:  Health Detail Drugs


Alnylam Prices First Gene Silencing Drug At $450,000 Per

(1 days ago) This morning, after 16 years and $2.5 billion in investment, the Cambridge, Mass.-based company Alnylam finally turned a 1998 biology breakthrough into a medicine: a drug called Onpattro to treat

Forbes.com

Category:  Health Detail Drugs


Onpattro: How it works, dosage, alternatives, and more

(Just Now) Onpattro is available only as a brand-name medication. It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication.

Medicalnewstoday.com

Category:  Health Detail Drugs


Onpattro (patisiran) FDA Approval History - Drugs.com

(3 days ago) Onpattro FDA Approval History. Last updated by Judith Stewart, BPharm on Aug 15, 2018.. FDA Approved: Yes (First approved August 10, 2018) Brand name: Onpattro Generic name: patisiran Dosage form: Injection Company: Alnylam Pharmaceuticals, Inc. Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR) Onpattro (patisiran) is a small …

Drugs.com

Category:  Pharmaceutical Detail Drugs


FULL PRESCRIBING INFORMATION: CONTENTS* - Food and …

(5 days ago) studies of ONPATTRO cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. A total of 224 patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis ( hATTR

Accessdata.fda.gov

Category:  Health Detail Drugs


Onpattro Dosage Guide - Drugs.com

(2 days ago) 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. If a dose is missed, administer ONPATTRO as soon as possible.

Drugs.com

Category:  Health Detail Drugs


Onpattro: 7 things you should know - Drugs.com

(8 days ago) Onpattro does not inhibit or induce any cytochrome P450 enzymes or transporters at clinically relevant plasma concentrations and is not a substrate of cytochrome P450 enzymes. Onpattro is not expected to cause drug-drug interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes.

Drugs.com

Category:  Health Detail Drugs


Billing and Coding Guide - ONPATTRO® (patisiran)

(6 days ago) reimbursement-related questions about ONPATTRO. Contact Alnylam Assist® at 1 -833 -256 2748. Coverage, coding, and payment in the hospital outpatient department ONPATTRO® (patisiran) received US Food and Drug Administration (FDA) approval on August 10, 2018, and is indicated for the treatment of the polyneuropathy of hereditary

Onpattrohcp.com

Category:  Hospital Detail Drugs


Drug Trial Snapshot: ONPATTRO - FDA

(8 days ago) ONPATTRO is a drug for the treatment of nerve damage in adult patients with hereditary transthyretin-mediated amyloidosis. Transthyretin-mediated amyloidosis is the buildup of abnormal deposits of

Fda.gov

Category:  Health Detail Drugs


Alnylam touts data replication for next-generation

(Just Now) Alnylam executives announce data replication between the approved drug Onpattro and the investigational drug Vutrisiran, which the company seeks to position as a simpler next-generation treatment for transthyretin-mediated amyloidosis (ATTR).

Biotech.vision

Category:  Health Detail Drugs


How ONPATTRO® (patisiran) Works ONPATTRO®

(6 days ago) Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO ® (patisiran). In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.

Onpattrohcp.com

Category:  Health Detail Drugs


Onpattro Prices, Coupons & Patient Assistance - Drugs.com

(2 days ago) Onpattro (patisiran) is a member of the miscellaneous metabolic agents drug class and is commonly used for Amyloidogenic Transthyretin Amyloidosis. Onpattro Prices. The cost for Onpattro intravenous solution (2 mg/mL) is around $9,928 for a supply of 5 milliliters, depending on the pharmacy you visit.

Drugs.com

Category:  Pharmacy Detail Drugs


Reimbursement Guide for ONPATTRO® (patisiran)

(1 days ago) Proper preparation of ONPATTRO® (patisiran) requires filtration to remove particulates. An additional vial may be required depending on the type of filter used and the amount of product that remains in the filter (hold-up volume). The calculator found in the ONPATTRO Dosing & Administration Guide assumes that 1 mL of drug product

Onpattrohcp.com

Category:  Health Detail Drugs


Dosing & Administration ONPATTRO® (patisiran)

(9 days ago) a Certain weights may require an additional vial of ONPATTRO due to drug product remaining in the filter. The guide above assumes that 1 mL of drug product remains in the filter when determining the number of vials needed. *The Dosing Guide is a tool for reference. Before administration, all dose quantities should be confirmed by a qualified

Onpattrohcp.com

Category:  Health Detail Drugs


Treatment With ONPATTRO® (patisiran)

(9 days ago) ONPATTRO is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). ONPATTRO is used in adults only. For additional information about ONPATTRO, please see the full Prescribing Information .

Onpattro.com

Category:  Health Detail Drugs


Onpattro European Medicines Agency

(8 days ago) Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves. Onpattro is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk

Ema.europa.eu

Category:  Health Detail Drugs


Onpattro Intravenous: Uses, Side Effects, Interactions

(Just Now) Drugs & Medications ; Onpattro Vial ; Onpattro Vial - Uses, Side Effects, and More Generic Name(S): patisiran (lipid complex) View Free Coupon . …

Webmd.com

Category:  Medications Detail Drugs


Onpattro (patisiran) dosing, indications, interactions

(2 days ago) This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2: This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3: This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4

Reference.medscape.com

Category:  Health Detail Drugs


ONPATTRO Dosage & Rx Info Uses, Side Effects

(5 days ago) ONPATTRO prescription and dosage sizes information for physicians and healthcare professionals. Pharmacology, adverse reactions, warnings and side effects.

Empr.com

Category:  Health Detail Drugs


NDC Code 71336-1000-1 Onpattro Patisiran

(5 days ago) The NDC Code 71336-1000-1 is assigned to a package of 1 vial, single-dose in 1 carton > 5 ml in 1 vial, single-dose of Onpattro, a human prescription drug labeled by Alnylam Pharmaceuticals, Inc.. The product's dosage form is injection, lipid complex and is administered via intravenous form. Field Name. Field Value.

Ndclist.com

Category:  Pharmaceutical Detail Drugs


Onpattro vs Tegsedi Comparison - Drugs.com

(9 days ago) View side-by-side comparisons of medication uses, ratings, cost, side effects and interactions. Onpattro patisiran. Remove Onpattro from your drug comparison. Tegsedi inotersen. Remove Tegsedi from your drug comparison. Onpattro (patisiran) contains small lipid nanoparticles that contain small interfering RNAs that break down deposits of

Drugs.com

Category:  Health Detail Drugs


Vutrisiran HELIOS-A results bolster its FDA application

(9 days ago) 1 day ago · Onpattro, however, will face competition from vutrisiran. Alnylam’s development of vutrisiran as a direct competitor for Onpattro will limit the company’s total revenue, as increased patient share for one drug will directly impact and reduce the patient share of the other.

Clinicaltrialsarena.com

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Onpattro® (Patisiran) – Commercial Medical Benefit Drug Policy

(Just Now) Medical Benefit Drug Policy Onpattro Onpattro (patisiran) is a double-stranded small interfering RNA (siRNA) that targets a sequence of mRNA conserved across wild-type and all TTR variants and can thereby degrade and reduce serum levels and protein deposits in …

Uhcprovider.com

Category:  Health Detail Drugs


Patisiran - Database for Drug and Drug Target Info

(7 days ago) The approval for Onpattro was granted to Alnylam Pharmaceuticals, Inc. in August of 2018. Onpattro has been granted Fast Track, Priority Review and Breakthrough Therapy, and Orphan Drug designations. Type Biotech Groups Approved, Investigational Biologic Classification Gene Therapies Other gene therapies Synonyms. Patisiran; External IDs

Go.drugbank.com

Category:  Pharmaceutical Detail Drugs


Onpattro - The Internet Drug Index for prescription drug

(8 days ago) What should I avoid while using patisiran (Onpattro)? Follow your doctor's instructions about any restrictions on food, beverages, or activity. What other drugs will affect patisiran (Onpattro)? Other drugs may affect patisiran, including prescription and over-the-counter medicines, vitamins, and herbal products.

Rxlist.com

Category:  Vitamin,  Doctor Detail Drugs


Side Effects ONPATTRO® (patisiran)

(7 days ago) ONPATTRO is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). ONPATTRO is used in adults only. For additional information about ONPATTRO, please see the full Prescribing Information .

Onpattro.com

Category:  Health Detail Drugs


210922Orig1s000 - Food and Drug Administration

(1 days ago) Onpattro (patisiran) is a new molecular entity with a proposed indication for treating polyneuropathy (PN) among adult patients with hATTR-PN. Patisiran is a small interfering ribonucleic acid that targets TTR messenger ribonucleic acid (mRNA) in order to suppress the production of TTR. It has been designated an Orphan drug and received a Fast

Accessdata.fda.gov

Category:  Health Detail Drugs


ONPATTRO Loss of Exclusivity (LOE). When do the ONPATTRO

(2 days ago) Which patents cover Onpattro, and when can generic versions of Onpattro launch? Onpattro is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twenty-four patents protecting this drug. This drug has four hundred and sixty-four patent family members in thirty-five countries. The generic ingredient in ONPATTRO is patisiran …

Drugpatentwatch.com

Category:  Health Detail Drugs


DailyMed - ONPATTRO- patisiran injection, lipid complex

(3 days ago) Anti-drug antibodies to ONPATTRO were evaluated by measuring antibodies specific to PEG 2000-C-DMG, a lipid component exposed on the surface of ONPATTRO. In the placebo-controlled and open-label clinical studies, 7 of 194 (3.6%) patients with hATTR amyloidosis developed anti-drug antibodies during treatment with ONPATTRO.

Dailymed.nlm.nih.gov

Category:  Health Detail Drugs


Onpattro, The First FDA-approved RNAi Drug - RNA / BOC

(7 days ago) Onpattro is the research achievement of the past two decades and is an important milestone, paving the way for the clinical transformation of LNP nanomedicines containing nucleic acid-based drugs, thereby enabling many new therapies based on silencing or expressing target genes.However, the widespread application of RNAi technology still has

Rna.bocsci.com

Category:  Health Detail Drugs


Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure

(3 days ago) The patisiran drug substance is a novel small interfering RNA (siRNA) formulated as a lipid nanoparticle.21 lipid nanoparticle technology is used as a delivery system for RNAi therapeutics and gene therapy22, 23 to protect therapeutic oligonucleotides from degradation by endogenous enzymes in biological fluids24 and to facilitate targeted siRNA

Ncbi.nlm.nih.gov

Category:  Health Detail Drugs


Approval Package for: APPLICATION NUMBER - Food and …

(1 days ago) Drug, and Cosmetic Act (FDCA) for Onpattro (patisiran) lipid complex injection 2mg/mL. This new drug application provides for the use of Onpattro (patisiran) lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. We have completed our review of this application, as amended.

Accessdata.fda.gov

Category:  Health Detail Drugs


Federal prosecutors launch Alnylam marketing probe

(4 days ago) Busy launching several new drugs, RNA biotech Alnylam posted a big revenue increase in 2020—and it expects more growth in 2021, partly thanks to its top-selling Onpattro drug. But now the U.S

Fiercepharma.com

Category:  Health Detail Drugs


ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

(9 days ago) No formal clinical drug interaction studies have been performed. Onpattro is not expected to be affected by inhibitors or inducers of cytochrome P450 enzymes or to cause drugdrug interactions, -

Ema.europa.eu

Category:  Health Detail Drugs

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FAQ about Onpattro Drug

What is the generic name for Onpattro?

Onpattro Approval History. FDA Approved: Yes (First approved August 10, 2018) Brand name: Onpattro Generic name: patisiran Dosage form: Injection Company: Alnylam Pharmaceuticals, Inc. Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR) Onpattro (patisiran) is a small interfering ribonucleic acid...

What is Onpattro used for?

Onpattro is a type of drug called an RNA interference therapy (sometimes called a gene silencer). Onpattro reduces the amount of abnormal proteins made by your liver. This means there’s less buildup of amyloid deposits. Onpattro comes as a liquid in a single-dose vial. The drug is given as an intravenous (IV) infusion, which goes into your vein.

What is the approval history of Onpattro?

Onpattro Approval History. FDA Approved: Yes (First approved August 10, 2018) Brand name: Onpattro Generic name: patisiran Dosage form: Injection Company: Alnylam Pharmaceuticals, Inc. Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR) Onpattro (patisiran) is a small interfering ribonucleic acid (siRNA)...

Is Onpattro a lipid nanoparticle-based drug?

… The regulatory approval of Onpattro, a lipid nanoparticle-based short interfering RNA drug for the treatment of polyneuropathies induced by hereditary transthyretin amyloidosis, paves the way for clinical development of many nucleic acid-based therapies enabled by nanoparticle delivery.