US Bioservices, a specialty pharmacy that is a part of AmerisourceBergen, announced today that it has been selected by Alnylam Pharmaceuticals to be one of the specialty pharmacies to dispense ONPATTRO™ (patisiran) lipid complex injection. ONPATTRO was approved by the U.S. Food and Drug Administration on August 10, 2018 for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults and is a RNA interference (RNAi) therapy targeting transthyretin (TTR). Prior to the approval of ONPATTRO, there were no FDA-approved treatment options for hATTR amyloidosis. US Bioservices will provide comprehensive specialty pharmacy services to patients who are being treated with ONPATTRO.
“US Bioservices is proud to partner with Alnylam to facilitate access to treatment and provide integrated, personalized solutions to patients with this devastating disease,” said Kelly Ratliff, President of US Bioservices. “Over the past two decades, we have innovated to keep pace with the rapidly changing medical and scientific landscape, and we welcome the opportunity to support hATTR amyloidosis patients with polyneuropathy who are prescribed ONPATTRO.”
ONPATTRO is administered via intravenous infusion by a healthcare professional once every three weeks, and will be available through the specialty pharmacy channel at both infusion clinics and in the patient’s home, if covered under the patient’s insurance plan. US Bioservices has offered home infusion services since its inception over 20 years ago – providing the option for infusion and nursing services in the convenience of the patient’s home. Because the company has a unique understanding of, and appreciation for, the complexities associated with intravenous infusions, especially for rare diseases, US Bioservices can provide specialized and caring patient support.
Patients prescribed ONPATTRO who receive services from US Bioservices will have access to its national team of in-home nurses who deliver trusted care and infusions in the convenience of a patient’s home. The company’s telephonic nurses will be available to provide 24/7 clinical support to patients on therapy. In-home and telephonic nurses work in a clinically-coordinated way with the prescribing physician and other members of the patient’s care team to improve access, adherence and outcomes.
ONPATTRO is distributed through a limited distribution network. To get started with ONPATTRO, healthcare professionals can visit www.AlnylamAssist.com
to access the Alnylam Assist Start Form. Alnylam Assist Case Managers will reach out within 1-2 business days of receipt of a completed Start Form and will coordinate with US Bioservices to arrange dispensing and shipment.
IMPORTANT SAFETY INFORMATION
Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. 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.
To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.
Reduced Serum Vitamin A Levels and Recommended Supplementation
ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.
Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).
The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion related reactions (19%).For additional information about ONPATTRO, see the full Prescribing Information at ONPATTRO.com
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