BioScrip Announces Availability of HEMLIBRA® for Hemophilia Patients
08 Janvier 2018 - 2:00PM
BioScrip, Inc. (NASDAQ:BIOS) ("BioScrip" or the "Company"), the
largest independent national provider of infusion and home care
management solutions, today announced that it can now dispense and
administer HEMLIBRA® (emicizumab-kxwh), a U.S. Food and Drug
Administration (FDA) approved treatment for routine prophylaxis to
prevent or reduce the frequency of bleeding episodes in adult and
pediatric patients with hemophilia A (congenital factor VIII
deficiency) with factor VIII inhibitors. HEMLIBRA® is
commercialized in the U.S. by Genentech USA, Inc.
"BioScrip continues to expand our therapy
offering to better care for the patients we support," said Robert
Roose, Senior Vice President and Chief Procurement Officer.
"Receiving the approval to dispense and administer HEMLIBRA®
underscores the fact that BioScrip is a destination of choice for
our manufacturers."
BioScrip will provide HEMLIBRA® in the patient’s
home or in an infusion suite setting, depending on the patient’s
care plan and condition. These capabilities include providing the
first dose of HEMLIBRA® where the patient’s care plan permits.
BioScrip will assist caregivers and patients to be independent with
HEMLIBRA® therapy in the comfort of their own home, when approved
by the prescriber. Prescribers may find a list of BioScrip’s
infusion pharmacies and infusion suites by visiting the Company’s
website at www.bioscrip.com.
HEMLIBRA® is administered through subcutaneous
injection of 3 mg/kg once weekly for the first 4 weeks, followed by
1.5 mg/kg once weekly. HEMLIBRA® is intended for use under the
guidance of a healthcare provider. After proper training in
subcutaneous injection technique, a patient may self-inject, or the
patient’s caregiver may administer HEMLIBRA®, if a healthcare
provider determines that it is appropriate.
About BioScrip, Inc.
BioScrip, Inc. is the largest independent
national provider of infusion and home care management solutions,
with approximately 2,200 teammates and nearly 80 service locations
across the U.S. BioScrip partners with physicians, hospital
systems, payors, pharmaceutical manufacturers and skilled nursing
facilities to provide patients access to post-acute care services.
BioScrip operates with a commitment to bring customer-focused
pharmacy and related healthcare infusion therapy services into the
home or alternate-site setting. By collaborating with the full
spectrum of healthcare professionals and the patient, BioScrip
provides cost-effective care that is driven by clinical excellence,
customer service, and values that promote positive outcomes and an
enhanced quality of life for those it serves.
Important Safety
Information
WARNING: THROMBOTIC MICROANGIOPATHY and
THROMBOEMBOLISM
Cases of thrombotic microangiopathy and
thrombotic events were reported when on average a cumulative amount
of > 100 U/kg/24 hours of activated prothrombin complex
concentrate (aPCC) was administered for 24 hours or more to
patients receiving HEMLIBRA® prophylaxis. Monitor
for the development of thrombotic microangiopathy and thrombotic
events if aPCC is administered. Discontinue aPCC and suspend dosing
of HEMLIBRA® if symptoms occur.
Warnings and Precautions
- Laboratory coagulation test interference: HEMLIBRA® interferes
with activated clotting time (ACT), activated partial
thromboplastin time (aPTT) and coagulation laboratory tests based
on aPTT, one-stage aPTT-based single-factor assays, aPTT-based
Activated Protein C Resistance (APC-R), and Bethesda assays
(clotting-based) for factor VIII (FVIII) inhibitor titers.
Intrinsic pathway clotting-based laboratory tests should not be
used.
Most Common Adverse
Reactions
The most common adverse reactions (incidence
rate ≥ 10%) were injection site reactions and headache, and
arthralgia.
You may report side effects to the FDA at (800)
FDA-1088 or www.fda.gov/medwatch. You may also report side effects
to Genentech at (888) 835-2555.
For additional Important Safety Information,
including Boxed WARNING, or go to
https://www.gene.com/download/pdf/hemlibra_prescribing.pdf.
Contact:
Robert RooseSenior Vice President, Chief
Procurement OfficerT: (720) 697-5179
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