ELK GROVE VILLAGE, Ill. /PRNewswire/ -- Orsini Healthcare Specialty Pharmacy announced that it has been selected by Alnylam Pharmaceuticals, Inc to distribute ONPATTRO™ (patisiran) lipid complex injection. Orsini Healthcare Specialty Pharmacy is one of two specialty pharmacies selected to provide nationwide distribution for ONPATTRO.
ONPATTRO is the first-of-its kind RNA interference (RNAi) therapeutic approved by the United States Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Hereditary amyloidosis (hATTR amyloidosis) represents a major unmet medical need with significant morbidity and mortality. The median survival is 4.7 years following diagnosis. ONPATTRO is administered through intravenous (IV) infusion once every three weeks by a healthcare professional, at either an infusion clinic or in the patient's home, if covered under the patient's insurance plan.
"The approval of ONPATTRO is an important milestone for patients with hATTR amyloidosis with polyneuropathy, who have had limited treatment options," said David Frobel, Senior Vice President at Orsini Healthcare. "Orsini Healthcare is proud to be able to be part of the distribution network for ONPATTRO and to be able to support patients and their families with this devastating disease."
Orsini Healthcare has a national nursing program with access to over 1200 nurses specialized in the administration of complex infusions in the home setting. This network will be available to patients prescribed ONPATTRO.
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.