First ready-to-use liquid glucagon available in
a single-dose vial and syringe kit for rescue
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology, neurology, and
gastroenterology, today announced that Gvoke® (glucagon injection)
Kit is now available by prescription. Gvoke Kit contains one (1)
single-dose sterile syringe with markings for 0.1 mL (0.5 mg
pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose
vial containing 0.2 mL of solution.
“We are pleased to offer another ready-to-use rescue form of
Gvoke for the millions of people with diabetes at increased risk of
a severe low blood sugar event. Gvoke Kit contains the same
room-temperature liquid-stable glucagon as in Gvoke HypoPen® and
Gvoke® PFS but may be preferred by those who would rather draw up
the appropriate rescue dose using a vial and syringe,” said Kevin
McCulloch, Xeris’ Chief Commercial Officer. “Awareness of the
benefits to patients of having their Gvoke nearby is growing
quickly, and we expect availability of Gvoke Kit to add to the
growing interest.”
ABOUT Gvoke®
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first
prescription, ready-to-use, pre-mixed, pre-measured glucagon
injection, were approved by the FDA in September 2019 for use in
the United States. Gvoke is indicated for the treatment of severe
hypoglycemia in pediatric and adult patients with diabetes ages 2
years and above. In August 2021, the FDA approved Gvoke® Kit, the
first ready-to-use glucagon available in a single-use vial and
single-use syringe kit for rescue.
INDICATION AND IMPORTANT SAFETY INFORMATION
GVOKE is indicated for the treatment of severe hypoglycemia in
adult and pediatric patients with diabetes ages 2 years and
above.
INDICATION AND IMPORTANT SAFETY INFORMATION
GVOKE is indicated for the treatment of severe hypoglycemia in
adult and pediatric patients with diabetes ages 2 years and
above.
IMPORTANT SAFETY INFORMATION
Contraindications
GVOKE is contraindicated in patients with pheochromocytoma
because of the risk of substantial increase in blood pressure,
insulinoma because of the risk of hypoglycemia, and known
hypersensitivity to glucagon or to any of the excipients in GVOKE.
Allergic reactions have been reported with glucagon and include
anaphylactic shock with breathing difficulties and hypotension.
Warnings and Precautions
GVOKE is contraindicated in patients with pheochromocytoma
because glucagon may stimulate the release of catecholamines from
the tumor. If the patient develops a dramatic increase in blood
pressure and a previously undiagnosed pheochromocytoma is
suspected, 5 to 10 mg of phentolamine mesylate, administered
intravenously, has been shown to be effective in lowering blood
pressure.
In patients with insulinoma, administration of glucagon may
produce an initial increase in blood glucose; however, GVOKE
administration may directly or indirectly (through an initial rise
in blood glucose) stimulate exaggerated insulin release from an
insulinoma and cause hypoglycemia. GVOKE is contraindicated in
patients with insulinoma. If a patient develops symptoms of
hypoglycemia after a dose of GVOKE, give glucose orally or
intravenously.
Allergic reactions have been reported with glucagon. These
include generalized rash, and in some cases, anaphylactic shock
with breathing difficulties and hypotension. GVOKE is
contraindicated in patients with a prior hypersensitivity
reaction.
GVOKE is effective in treating hypoglycemia only if sufficient
hepatic glycogen is present. Patients in states of starvation, with
adrenal insufficiency or chronic hypoglycemia, may not have
adequate levels of hepatic glycogen for GVOKE administration to be
effective. Patients with these conditions should be treated with
glucose.
Necrolytic migratory erythema (NME), a skin rash commonly
associated with glucagonomas (glucagon-producing tumors) and
characterized by scaly, pruritic erythematous plaques, bullae, and
erosions, has been reported postmarketing following continuous
glucagon infusion. NME lesions may affect the face, groin, perineum
and legs or be more widespread. In the reported cases NME resolved
with discontinuation of the glucagon, and treatment with
corticosteroids was not effective. Should NME occur, consider
whether the benefits of continuous glucagon infusion outweigh the
risks.
Adverse Reactions
Most common (≥5%) adverse reactions associated with GVOKE are
nausea, vomiting, injection site edema (raised 1 mm or greater),
and hypoglycemia.
Drug Interactions
Patients taking beta-blockers may have a transient increase in
pulse and blood pressure when given GVOKE. In patients taking
indomethacin, GVOKE may lose its ability to raise blood glucose or
may even produce hypoglycemia. GVOKE may increase the anticoagulant
effect of warfarin.
Please see full Prescribing Information for GVOKE on
www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc.
by Pyramid Laboratories Inc., Costa Mesa, CA 92626.
About Xeris Biopharma
Xeris (Nasdaq: XERS) is a biopharmaceutical company developing
and commercializing unique therapies for patient populations in
endocrinology, neurology, and gastroenterology. Xeris has three
commercially available products; Gvoke®, a ready-to-use liquid
glucagon for the treatment of severe hypoglycemia, Keveyis®, the
first and only FDA-approved therapy for primary periodic paralysis,
and Recorlev® for the treatment of endogenous Cushing’s syndrome.
Xeris also has a robust pipeline of development programs to extend
the current marketed products into important new indications and
uses and bring new products forward using its proprietary
formulation technology platforms, XeriSol™ and XeriJect™,
supporting long-term product development and commercial
success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For
more information, visit www.xerispharma.com or follow us on
Twitter, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma, including statements
regarding the availability of Gvoke® Kit in the U.S., the market
and therapeutic potential of Gvoke HypoPen®, Gvoke® PFS, and Gvoke®
Kit, the timing commercialization of Gvoke® Kit and other
statements containing the words "will," "would," "continue," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including, without limitation, the impact of COVID-19 on
its business operations, its reliance on third-party suppliers for
Gvoke® , the regulatory approval of Gvoke® Kit, its ability to
market and sell its products, if approved, and other factors
discussed in the "Risk Factors" section Xeris’ Annual Report on
Form 10-K filed with the Securities and Exchange Commission, as
well as discussions of potential risks, uncertainties, and other
important factors in Xeris’ subsequent filings with the Securities
and Exchange Commission. Any forward-looking statements contained
in this press release speak only as of the date hereof, and Xeris
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
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version on businesswire.com: https://www.businesswire.com/news/home/20220316005150/en/
Investor Contact: Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com (312) 736-1237
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