Teva Announces Updated Indication and Vial Presentation for GRANIX® (tbo-filgrastim) Injection in United States
2018年8月6日 - 9:00PM
ビジネスワイヤ(英語)
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced today that the U.S. Food and Drug Administration (FDA)
has approved GRANIX® (tbo-filgrastim) Injection for a new vial
presentation and indication in pediatric patients 1 month and
older. GRANIX is indicated to reduce the duration of severe
neutropenia in adult and pediatric patients 1 month and older with
nonmyeloid malignancies receiving myelosuppressive anticancer drugs
associated with a clinically significant incidence of febrile
neutropenia.
The new vial presentation of the product will be available for
use in 300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled
syringe presentations will continue to be available as well.
“The new pediatric indication and vial presentation of GRANIX
expand the range of treatment options that can be of benefit to
both patients and healthcare providers,” said Brendan O’Grady, EVP
and Head of North America Commercial at Teva.
GRANIX was approved by the FDA in August 2012. GRANIX vials are
expected to be available in the U.S. shortly.
Important Safety Information
- Contraindication: GRANIX is
contraindicated in patients with a history of serious allergic
reactions to filgrastim or pegfilgrastim products.
- Fatal Splenic Rupture: Splenic
rupture, including fatal cases, can occur following the
administration of filgrastim products. Evaluate patients who report
upper abdominal or shoulder pain for an enlarged spleen or splenic
rupture. Discontinue GRANIX if splenic rupture is suspected or
confirmed.
- Acute Respiratory Distress Syndrome
(ARDS): ARDS can occur in patients receiving filgrastim
products. Evaluate patients who develop fever and lung infiltrates
or respiratory distress after receiving GRANIX, for ARDS.
Discontinue GRANIX in patients with ARDS.
- Serious Allergic Reactions:
Serious allergic reactions, including anaphylaxis, can occur in
patients receiving GRANIX. Reactions can occur on initial exposure.
The administration of antihistamines‚ steroids‚ bronchodilators‚
and/or epinephrine may reduce the severity. Permanently discontinue
GRANIX in patients with serious allergic reactions. Do not
administer GRANIX to patients with a history of serious allergic
reactions to filgrastim or pegfilgrastim.
- Sickle Cell Disorders: Severe
and sometimes fatal sickle cell crises can occur in patients with
sickle cell disorders receiving filgrastim products. Discontinue
GRANIX if sickle cell crisis occurs.
- Glomerulonephritis:
Glomerulonephritis can occur in patients receiving filgrastim
products. The diagnoses were based on azotemia, hematuria
(microscopic and macroscopic), proteinuria, and renal biopsy.
Generally, events of glomerulonephritis resolved after dose
reduction or discontinuation of the filgrastim product. If
glomerulonephritis is suspected, evaluate for cause. If causality
is likely, consider dose-reduction or interruption of GRANIX.
- Capillary Leak Syndrome (CLS):
CLS can occur in patients receiving filgrastim products and is
characterized by hypotension, hypoalbuminemia, edema and
hemoconcentration. Episodes vary in frequency, severity and may be
life-threatening if treatment is delayed. Patients who develop
symptoms of CLS should be closely monitored and receive standard
symptomatic treatment, which may include a need for intensive
care.
- Potential for Tumor Growth
Stimulatory Effects on Malignant Cells: The granulocyte
colony-stimulating factor (G-CSF) receptor, through which GRANIX
acts, has been found on tumor cell lines. The possibility that
GRANIX acts as a growth factor for any tumor type, including
myeloid malignancies and myelodysplasia, diseases for which GRANIX
is not approved, cannot be excluded.
- Leukocytosis: White blood cell
counts of 100‚000/mm3 or greater were observed in approximately 2%
of patients receiving filgrastim products at dosages above
5 mcg/kg/day. In patients with cancer receiving GRANIX as an
adjunct to myelosuppressive chemotherapy‚ to avoid the potential
risks of excessive leukocytosis‚ it is recommended that GRANIX
therapy be discontinued if the ANC surpasses 10‚000/mm3 after the
chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least
twice weekly during therapy. Dosages of GRANIX that increase the
ANC beyond 10‚000/mm3 may not result in any additional clinical
benefit. In patients with cancer receiving myelosuppressive
chemotherapy‚ discontinuation of filgrastim products therapy
usually resulted in a 50% decrease in circulating neutrophils
within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7
days.
- Simultaneous Use with Chemotherapy
and Radiation Therapy Not Recommended: The safety and efficacy
of filgrastim products, including GRANIX, given simultaneously with
cytotoxic chemotherapy have not been established. Because of the
potential sensitivity of rapidly dividing myeloid cells to
cytotoxic chemotherapy‚ do not use GRANIX in the period 24 hours
before through 24 hours after the administration of cytotoxic
chemotherapy. The safety and efficacy of GRANIX have not been
evaluated in patients receiving concurrent radiation therapy. Avoid
the simultaneous use of GRANIX with chemotherapy and radiation
therapy.
- Nuclear Imaging: Increased
hematopoietic activity of the bone marrow in response to growth
factor therapy has been associated with transient positive
bone-imaging changes. Consider this when interpreting bone-imaging
results.
- Aortitis: Aortitis has been
reported in patients receiving another filgrastim product. It may
occur as early as the first week after start of therapy.
Manifestations may include generalized signs and symptoms such as
fever, abdominal pain, malaise, back pain, and increased
inflammatory markers (e.g., c-reactive protein and white blood cell
count). Consider aortitis in patients who develop these signs and
symptoms without known etiology. Discontinue GRANIX if aortitis is
suspected.
- Most common treatment-emergent
adverse reaction: Most common adverse reaction (≥1%) to GRANIX
is bone pain.
Please see Full Prescribing Information for GRANIX here.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE
and TASE: TEVA) is a global leader in generic medicines, with
innovative treatments in select areas, including CNS, pain and
respiratory. We deliver high-quality generic products and medicines
in nearly every therapeutic area to address unmet patient needs. We
have an established presence in generics, specialty, OTC and API,
building on more than a century-old legacy, with a fully integrated
R&D function, strong operational base and global infrastructure
and scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of GRANIX®, which are
based on management’s current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and
unknown, that could cause our future results, performance or
achievements to differ significantly from that expressed or implied
by such forward-looking statements. Important factors that could
cause or contribute to such differences include risks relating
to:
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, may result in a
further downgrade of our credit ratings; and our inability to raise
debt or borrow funds in amounts or on terms that are favorable to
us;
- our business and operations in general,
including: failure to effectively execute our restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into S&M practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change
in our business;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2017, including the sections
thereof captioned "Risk Factors" and "Forward Looking Statements,"
and in our subsequent quarterly reports on Form 10-Q and other
filings with the Securities and Exchange Commission, which are
available at www.sec.gov and www.tevapharm.com. Forward-looking
statements speak only as of the date on which they are made, and we
assume no obligation to update or revise any forward-looking
statements or other information contained herein, whether as a
result of new information, future events or otherwise. You are
cautioned not to put undue reliance on these forward-looking
statements.
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Teva Pharmaceutical Industries Ltd.IR ContactsUnited StatesKevin
C. Mannix, 215-591-8912orRan Meir, 972 (3) 926-7516orPR
ContactsUnited StatesDoris Saltkill, 913-777-3343orIsraelYonatan
Beker, 972 (54) 888 5898
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