Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced that the U.S. Food and Drug Administration (FDA) has
approved the use of TRISENOX® (arsenic trioxide) injection
in combination with tretinoin for the treatment of adults with
newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose
APL is characterized by the presence of the t(15;17) translocation
or PML/RAR-alpha gene expression. The approval was based on a
Priority Review by the FDA on data from published scientific
literature and a review of Teva’s global safety database for
arsenic trioxide.
“Today’s approval to expand the indication of TRISENOX is a
testament to Teva’s commitment to providing solutions to advance
cancer care,” said Paul Rittman, Senior Vice President and General
Manager, Teva Oncology. “This label expansion represents an
important benefit as TRISENOX is now an FDA-approved first line
treatment option for patients with acute promyelocytic
leukemia.”
The new indication reinforces the current practice guidelines by
the National Comprehensive Cancer Network® (NCCN).
Please see the Full Prescribing Information for TRISENOX® and
the Important Safety Information below including Boxed Warning
regarding: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION
ABNORMALITIES.
TRISENOX® (arsenic trioxide) Injection
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION SYNDROME AND
CARDIAC CONDUCTION ABNORMALITIES
Differentiation Syndrome: Patients with acute promyelocytic
leukemia (APL) treated with TRISENOX have experienced symptoms of
differentiation syndrome, which can be fatal if not treated.
Symptoms may include fever, dyspnea, acute respiratory distress,
pulmonary infiltrates, pleural or pericardial effusions, weight
gain or peripheral edema, hypotension, and renal, hepatic, or
multi-organ dysfunction, in the presence or absence of
leukocytosis. If differentiation syndrome is suspected, immediately
initiate high-dose corticosteroid therapy and hemodynamic
monitoring until resolution of signs and symptoms. Temporary
discontinuation of TRISENOX may be required.
Cardiac Conduction Abnormalities: Arsenic trioxide can cause
QTc interval prolongation, complete atrioventricular block, and a
torsade de pointes-type ventricular arrhythmia, which can be fatal.
Before initiating therapy, assess the QTc interval, correct
pre-existing electrolyte abnormalities, and consider discontinuing
drugs known to prolong QTc interval. Do not administer TRISENOX to
patients with ventricular arrhythmia or prolonged QTcF.
Contraindications: TRISENOX is contraindicated in
patients who are hypersensitive to arsenic.
Differentiation Syndrome: In clinical trials, 16-23% of
patients treated with TRISENOX for APL developed differentiation
syndrome. Differentiation syndrome has been observed with and
without concomitant hyperleukocytosis, and it has occurred as early
as day 1 of induction to as late as the second month induction
therapy. When TRISENOX is used in combination with tretinoin,
prednisone prophylaxis is advised.
Cardiac Conduction Abnormalities: In the clinical trials
of patients with newly-diagnosed low-risk APL treated with TRISENOX
in combination with tretinoin, 11% experienced QTc prolongation
> 450 msec for men and > 460 msec for women throughout the
treatment cycles. In the clinical trial of patients with relapsed
or refractory APL treated with TRISENOX monotherapy, 40% had at
least one ECG tracing with a QTc interval greater than 500 msec. A
prolonged QTc was observed between 1 and 5 weeks after start of
TRISENOX infusion, and it usually resolved by 8 weeks after
TRISENOX infusion. There are no data on the effect of TRISENOX on
the QTc interval during the infusion of the drug.
The risk of torsade de pointes is related to the extent of QT
prolongation, concomitant administration of QT prolonging drugs, a
history of torsade de pointes, pre-existing QT interval
prolongation, congestive heart failure, administration of
potassium-wasting diuretics, or other conditions that result in
hypokalemia or hypomagnesemia. The risk may be increased when
TRISENOX is co-administered with medications that can lead to
electrolyte abnormalities (such as diuretics or amphotericin
B).
Hepatotoxicity: In the clinical trials, 44% of patients
with newly-diagnosed low-risk APL treated with TRISENOX in
combination with tretinoin experienced elevated aspartate
aminotransferase (AST), alkaline phosphatase, and/or serum
bilirubin. These abnormalities resolved with temporary
discontinuation of TRISENOX and/or tretinoin. During treatment with
TRISENOX, monitor liver chemistries at least 2-3 times per week
through recovery from toxicities. Withhold treatment with TRISENOX
and/or tretinoin if elevations in AST), alkaline phosphatase,
and/or serum bilirubin occur to greater than 5 times the upper
limit of normal.
Long-term liver abnormalities can occur in APL patients treated
with TRISENOX in combination with tretinoin. In a published series,
mild liver dysfunction and hepatic steatosis were seen in 15% and
43%, respectively, of patients at a median of 7 years (range 0-14
years) after treatment with arsenic trioxide in combination with
tretinoin.
Carcinogenesis: The active ingredient of TRISENOX,
arsenic trioxide, is a human carcinogen. Monitor patients for the
development of second primary malignancies.
Embryo-Fetal Toxicity: TRISENOX can cause fetal harm when
administered to a pregnant woman. One patient who became pregnant
while receiving arsenic trioxide had a miscarriage. Conduct
pregnancy tests prior to starting treatment and advise pregnant
women of the potential risk to a fetus. Advise patients of
reproductive potential to use effective contraception during
treatment with TRISENOX and after treatment for 6 months in females
and 3 months in males. TRISENOX may also impair fertility in
males.
Lactation: TRISENOX is excreted in human milk. Because of
the potential for serious adverse reactions in the breastfed child,
discontinue breastfeeding during treatment with TRISENOX and for
two weeks after the final dose.
Patients with Renal Impairment: Exposure of arsenic
trioxide may be higher in patients with severe renal impairment.
Patients with severe renal impairment (creatinine clearance less
than 30 mL/min) should be monitored for toxicity when these
patients are treated with TRISENOX, and a dose reduction may be
warranted. The use of TRISENOX in patients on dialysis has not been
studied.
Patients with Hepatic Impairment: Since limited data are
available across all hepatic impairment groups, caution is advised
in the use of TRISENOX in patients with hepatic impairment. Monitor
patients with severe hepatic impairment (Child-Pugh Class C) who
are treated with TRISENOX for toxicity.
Most Common Adverse Reactions: The most common adverse
reactions (greater than 30%) were leukocytosis, neutropenia,
thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain,
hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia,
QTc prolongation, edema, hyperglycemia, hypokalemia,
hypomagnesemia, dyspnea, cough, rash or itching, sore throat,
arthralgia, headaches, paresthesia, and dizziness.
TO REPORT SIDE EFFECTS: Contact us at 1-888-483-8279 or
USMedinfo@tevapharma.com
Indications
TRISENOX® is indicated:
- In combination with tretinoin for
treatment of adults with newly-diagnosed low-risk acute
promyelocytic leukemia (APL) whose APL is characterized by the
presence of the t(15;17) translocation or PML/RAR-alpha gene
expression.
- For induction of remission and
consolidation in patients with APL who are refractory to, or have
relapsed from, retinoid and anthracycline chemotherapy, and whose
APL is characterized by the presence of the t(15;17) translocation
or PML/RAR-alpha gene expression.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
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 expanded indication for TRISENOX®, 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:
- the uncertainty of commercial success
of TRISENOX®;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: uncertainties relating to the potential success and our
ability to effectively execute a restructuring plan; uncertainties
relating to the potential benefits and success of our new
organizational structure and recent senior management changes; our
ability to develop and commercialize additional pharmaceutical
products; 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 restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products; our ability to consummate dispositions on terms
acceptable to us; adverse effects of political or economic
instability, major hostilities or terrorism on our significant
worldwide operations; and our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions;
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
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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version on businesswire.com: http://www.businesswire.com/news/home/20180115005254/en/
Teva Pharmaceutical Industries Ltd.IR:United States:Kevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsrael:Tomer Amitai, 972 (3)
926-7656orPR:Israel:Yonatan Beker, 972 (54) 888-5898orUnited
States:Kaelan Hollon, 202-412-7076orMichelle Larkin,
610-786-7335
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