- Only ready-to-use liquid format of bivalirudin on the
market
- Does not require reconstitution, dilution or mixing, which
helps increase efficiency for hospitals and healthcare
providers
DUBLIN, July 18, 2023 /PRNewswire/ -- Endo International
plc (OTC: ENDPQ) announced today that its Par Sterile Products
business has begun shipping bivalirudin injection in a ready-to-use
250 mg/50 mL single-use vial. It is the only ready-to-use liquid
format of bivalirudin on the market in the U.S.
"Hospital practitioners work hard to provide quality patient
care while also meeting operational challenges," said Scott Sims, Senior Vice President and General
Manager, Injectable Solutions & Generics at Endo. "With
ready-to-use products like bivalirudin, we're helping to deliver
solutions that reduce complexity for healthcare providers—so they
can focus on patient care."
In May 2023, Endo executed
agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma
Limited, India to commercialize ready-to-use bivalirudin in
the U.S. The product, manufactured by Gland Pharma Limited, is
an anticoagulant (thrombin inhibitor) that helps prevent the
formation of blood clots. It is used to prevent blood clots in
people with severe chest pain or other conditions who are
undergoing an angioplasty procedure.
Ready-to-use, or RTU, products streamline operations for
hospitals by eliminating the need to prepare or transfer the
product before patient administration. This may reduce waste and
costs, optimize convenience and workflow and reduce the chance for
preparation error—all of which support quality patient care.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Bivalirudin injection is
contraindicated in patients with:
- Significant active bleeding;
- Hypersensitivity to bivalirudin injection or its
components
WARNINGS AND PRECAUTIONS
Bleeding
Events
Bivalirudin increases the risk of bleeding.
Bivalirudin's anticoagulant effect subsides approximately one hour
after discontinuation.
Thrombotic Risk with Coronary Artery Brachytherapy
An
increased risk of thrombus formation, including fatal outcomes, has
been associated with the use of bivalirudin in gamma
brachytherapy.
ADVERSE REACTIONS
The most common adverse reaction was
bleeding (3.7%).
DRUG INTERACTIONS
In clinical trials in patients
undergoing percutaneous coronary intervention (PCI),
co-administration of bivalirudin with heparin, warfarin,
thrombolytics, or GPls was associated with increased risks of major
bleeding events compared to patients not receiving these
concomitant medications.
USE IN SPECIFIC POPULATIONS
Geriatric Use
In
studies of patients undergoing PCI, 44% were ≥65 years of age and
12% of patients were ≥75 years old. Elderly patients experienced
more bleeding events than younger patients.
Renal Impairment
The disposition of bivalirudin was
studied in PTCA patients with mild, moderate and severe renal
impairment. The clearance of bivalirudin was reduced approximately
21% in patients with moderate and severe renal impairment and was
reduced approximately 70% in dialysis- dependent patients. The
infusion dose of bivalirudin injection may need to be reduced, and
anticoagulant status monitored in patients with renal
impairment.
INDICATION AND USAGE
Bivalirudin injection is
indicated for use as an anticoagulant in patients undergoing PCI,
including patients with heparin-induced thrombocytopenia and
heparin-induced thrombocytopenia and thrombosis syndrome.
Please click for Full Prescribing Information.
About Endo
Endo (OTC: ENDPQ) is a specialty
pharmaceutical company committed to helping everyone we serve live
their best life through the delivery of quality, life-enhancing
therapies. Our decades of proven success come from passionate team
members around the globe collaborating to bring treatments forward.
Together, we boldly transform insights into treatments benefiting
those who need them, when they need them. Learn more at
www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release may be
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation including, but not limited to, the
statements by Mr. Sims, any statements relating to product launch,
efficiencies, commercialization, competition or sales, and any
statements that refer to expected, estimated or anticipated future
results or that do not relate solely to historical facts.
Statements including words or phrases such as "believe," "expect,"
"anticipate," "intend," "estimate," "plan," "will," "may," "look
forward," "intend," "guidance," "future," "potential" or similar
expressions are forward-looking statements. All forward-looking
statements in this communication reflect the Company's current
views as of the date of this communication about its plans,
intentions, expectations, strategies and prospects, which are based
on the information currently available to it and on assumptions it
has made. Actual results may differ materially and adversely from
current expectations based on a number of factors, including, among
other things, the outcome of the Company's contingency planning and
restructuring activities; the timing, impact or results of any
pending or future litigation, investigations, proceedings or
claims, including opioid, tax and antitrust related matters; any
actual or contingent liabilities; settlement discussions or
negotiations; the Company's liquidity, financial performance, cash
position and operations; the risks and uncertainties associated
with chapter 11 proceedings; the time, terms and ability to confirm
a sale of the Company's businesses under Section 363 of the U.S.
Bankruptcy Code; the risk that the Company's chapter 11 cases may
be converted to cases under chapter 7 of the Bankruptcy Code; the
adequacy of the capital resources of the Company's businesses and
the difficulty in forecasting the liquidity requirements of the
operations of the Company's businesses; the unpredictability of the
Company's financial results; the Company's ability to discharge
claims in chapter 11 proceedings; negotiations with the holders of
the Company's indebtedness and its trade creditors and other
significant creditors; the risks and uncertainties with performing
under the terms of the restructuring support agreement and any
other arrangement with lenders or creditors while in chapter 11
proceedings; the performance, including the approval, introduction,
and consumer and physician acceptance of new products and the
continuing acceptance of currently marketed products; and the
Company's ability to obtain and successfully manufacture, maintain
and distribute a sufficient supply of products to meet market
demand in a timely manner. The Company expressly disclaims any
intent or obligation to update these forward-looking statements,
except as required to do so by law.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by the
Company, as well as the Company's public periodic filings with the
U.S. Securities and Exchange Commission and with securities
regulators in Canada, including
the discussion under the heading "Risk Factors" in the Company's
most recent Annual Report on Form 10-K and any subsequent Quarterly
Reports on Form 10-Q or other filings with the U.S. Securities and
Exchange Commission.
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