Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that data on GRANIX® (tbo-filgrastim) Injection, TREANDA®
(bendamustine HCl) Injection and TRISENOX® (arsenic trioxide)
Injection will be presented during poster sessions at the 2016 ASH
Annual Meeting to be held at the San Diego Convention Center in San
Diego, CA on December 3-6, 2016. Additional bendamustine abstracts
were also accepted for publication in an online issue of Blood to
be issued during the annual meeting.
“We look forward to sharing real world data and outcomes
research from our Oncology portfolio that provide deeper insights
into our products,” said Richard Nieman, M.D., Senior Vice
President, Global Medical Affairs, Teva Pharmaceuticals. “The
presentations at this year’s ASH Meeting further highlight Teva’s
commitment to providing innovative medicines that positively impact
our healthcare system, treatment and management of disease, and the
lives of people, particularly those affected by cancer.”
Teva-sponsored data to be presented include:
GRANIX® (tbo-filgrastim) Injection
- P2504: Real-World Safety
Experience for Short-Acting Recombinant Human Granulocyte
Colony-Stimulating Factor.
- This abstract will be presented during
Granulocytes, Monocytes, and Macrophages on Sunday, December 4,
2016, 6:00 p.m. to 8:00 p.m. in Hall GH
- P2407: Budget Impact Analysis of
Treating Chemotherapy Patients with Health Care
Provider-Administered Tbo-Filgrastim, Filgrastim-Sndz, and
Filgrastim in the United States.
- This abstract will be presented during
Outcomes Research—Malignant Conditions on Saturday, December 3,
2016, 5:30 p.m. to 7:30 p.m. in Hall GH
- P4786: Budget Impact Analysis of Treating Chemotherapy
Patients with Patient-Administered Tbo-Filgrastim, Filgrastim-Sndz,
and Filgrastim in the United States.
- This abstract will be presented during Outcomes
Research—Malignant Conditions on Monday, December 5, 2016, 6:00
p.m. to 8:00 p.m. in Hall GH
TREANDA®
(bendamustine HCl) Injection
- P2406: Differences in Healthcare
Utilization in Chronic Lymphocytic Leukemia (CLL) Patient Treated
With Bendamustine plus Rituximab (BR) Versus Fludarabine,
Cyclophosphamide, and Rituximab (FCR).
- This abstract will be presented during
Outcomes Research—Malignant Conditions on Saturday, December 3,
2016, 5:30 p.m. to 7:30 p.m. in Hall GH
TRISENOX® (arsenic trioxide) Injection
- P4034: Long-Term Safety
Experience with Arsenic Trioxide in Patients with Acute
Promyelocytic Leukemia.
- This abstract will be presented during
Acute Myeloid Leukemia: Commercially Available Therapy, excluding
Transplantation on Monday, December 5, 2016, 6:00 p.m. to 8:00
p.m. in Hall GH
GRANIX® (tbo-filgrastim) Injection
Indication
GRANIX is a leukocyte growth factor indicated to reduce the
duration of severe neutropenia in patients with non-myeloid
malignancies receiving myelosuppressive anti-cancer drugs
associated with a clinically significant incidence of febrile
neutropenia.
Important Safety Information for GRANIX®
(tbo-filgrastim) Injection
- Splenic rupture: Splenic
rupture, including fatal cases, can occur following the
administration of human granulocyte colony-stimulating factors
(hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen
or splenic rupture in patients who report upper abdominal or
shoulder pain after receiving GRANIX.
- Acute respiratory distress syndrome
(ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate
patients who develop fever and lung infiltrates or respiratory
distress after receiving GRANIX, for ARDS. Discontinue GRANIX in
patients with ARDS.
- Allergic reactions: Serious
allergic reactions, including anaphylaxis, can occur in patients
receiving hG-CSFs. Reactions can occur on initial exposure.
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.
- Use in patients with sickle cell
disease: Severe and sometimes fatal sickle cell crises can
occur in patients with sickle cell disease receiving hG-CSFs.
Consider the potential risks and benefits prior to the
administration of GRANIX in patients with sickle cell disease.
Discontinue GRANIX in patients undergoing a sickle cell
crisis.
- Capillary leak syndrome (CLS):
CLS can occur in patients receiving hG-CSFs 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.
- Most common treatment-emergent
adverse reaction: The most common treatment-emergent adverse
reaction that occurred in patients treated with GRANIX at the
recommended dose with an incidence of at least 1% or greater and
two times more frequent than in the placebo group was bone
pain.
Please see Full Prescribing Information for
GRANIX® (tbo-filgrastim) Injection
TREANDA®
(bendamustine HCl) Injection
Indications
TREANDA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL). Efficacy relative to first-line
therapies other than chlorambucil has not been established.
TREANDA is indicated for the treatment of patients with indolent
B-cell non-Hodgkin lymphoma (NHL) that has progressed during or
within six months of treatment with rituximab or a
rituximab-containing regimen.
Important Safety Information for TREANDA®
(bendamustine HCl) Injection
- Contraindication: TREANDA is
contraindicated in patients with a known hypersensitivity (e.g.,
anaphylactic and anaphylactoid reactions) to bendamustine.
- Myelosuppression: TREANDA caused
severe myelosuppression (Grade 3-4) in 98% of patients in the two
NHL studies. Three patients (2%) died from myelosuppression-related
adverse reactions. If myelosuppression occurs, monitor leukocytes,
platelets, hemoglobin (Hgb), and neutrophils frequently.
Myelosuppression may require dose delays and/or subsequent dose
reductions if recovery to the recommended values has not occurred
by the first day of the next scheduled cycle.
- Infections: Infection, including
pneumonia, sepsis, septic shock, hepatitis and death have occurred.
Patients with myelosuppression following treatment with TREANDA are
more susceptible to infections. Patients treated with TREANDA are
at risk for reactivation of infections including (but not limited
to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and
herpes zoster. Patients should undergo appropriate measures
(including clinical and laboratory monitoring, prophylaxis, and
treatment) for infection and infection reactivation prior to
administration.
- Anaphylaxis and Infusion
Reactions: Infusion reactions to TREANDA have occurred commonly
in clinical trials. Symptoms include fever, chills, pruritus, and
rash. In rare instances severe anaphylactic and anaphylactoid
reactions have occurred, particularly in the second and subsequent
cycles of therapy. Monitor clinically and discontinue drug for
severe (Grade 3-4) reactions. Ask patients about symptoms
suggestive of infusion reactions after their first cycle of
therapy. Consider measures to prevent severe reactions, including
antihistamines, antipyretics, and corticosteroids in subsequent
cycles in patients who have experienced Grade 1 or 2 infusion
reactions.
- Tumor Lysis Syndrome: Tumor
lysis syndrome associated with TREANDA treatment has occurred. The
onset tends to be within the first treatment cycle of TREANDA and,
without intervention, may lead to acute renal failure and death.
Preventive measures include vigorous hydration and close monitoring
of blood chemistry, particularly potassium and uric acid levels.
There may be an increased risk of severe skin toxicity when TREANDA
and allopurinol are administered concomitantly.
- Skin Reactions: Fatal and
serious skin reactions have been reported with TREANDA treatment
and include, toxic skin reactions, [Stevens-Johnson Syndrome (SJS),
toxic epidermal necrolysis (TEN), and drug reaction with
eosinophilia and systemic symptoms (DRESS)], bullous exanthema and
rash. Events occurred when TREANDA was given as a single agent and
in combination with other anticancer agents or allopurinol. Where
skin reactions occur, they may be progressive and increase in
severity with further treatment. Monitor patients with skin
reactions closely. If skin reactions are severe or progressive,
withhold or discontinue TREANDA.
- Hepatotoxicity: Fatal and
serious cases of liver injury have been reported with TREANDA.
Combination therapy, progressive disease or reactivation of
hepatitis B were confounding factors in some patients. Most cases
were reported within the first three months of starting therapy.
Monitor liver chemistry tests prior to and during bendamustine
therapy.
- Other Malignancies: There are
reports of pre-malignant and malignant diseases that have developed
in patients who have been treated with TREANDA, including
myelodysplastic syndrome, myeloproliferative disorders, acute
myeloid leukemia, and bronchial carcinoma.
- Extravasation Injury: TREANDA
extravasations have been reported in postmarketing resulting in
hospitalizations from erythema, marked swelling, and pain. Assure
good venous access prior to starting TREANDA infusion and monitor
the intravenous infusion site for redness, swelling, pain,
infection, and necrosis during and after administration of
TREANDA.
- Embryo-fetal Toxicity: TREANDA
can cause fetal harm when administered to a pregnant woman. Women
should be advised to avoid becoming pregnant while using
TREANDA.
- Most Common Adverse Reactions:
- The most common non-hematologic adverse
reactions for CLL (frequency ≥15%) are pyrexia, nausea, and
vomiting.
- The most common non-hematologic adverse
reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting,
diarrhea, pyrexia, constipation, anorexia, cough, headache, weight
decreased, dyspnea, rash, and stomatitis.
- The most common hematologic
abnormalities for both indications (frequency ≥15%) are
lymphopenia, anemia, leukopenia, thrombocytopenia, and
neutropenia.
TO REPORT ADVERSE REACTIONS: Contact us at 1-800-896-5855
or usmedinfo@tevapharm.com
Please see Full Prescribing Information for
TREANDA® (bendamustine HCl) Injection
TRISENOX® (arsenic trioxide) Injection
Indication
TRISENOX® is indicated for induction of remission and
consolidation in patients with acute promyelocytic leukemia (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.
Important Safety Information for TRISENOX®
(arsenic trioxide) Injection
WARNING: APL DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION
ABNORMALITIES, AND ELECTROLYTE MONITORING
APL Differentiation Syndrome: Patients with APL treated
with TRISENOX have experienced symptoms similar to a syndrome
called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or
APL differentiation syndrome, characterized by fever, dyspnea,
weight gain, pulmonary infiltrates and pleural or pericardial
effusions, with or without leukocytosis. This syndrome can be
fatal. High-dose steroids have been administered at the first
suspicion of the APL differentiation syndrome and appear to
mitigate signs and symptoms. At the first signs that could suggest
the syndrome (unexplained fever, dyspnea and/or weight gain,
abnormal chest auscultatory findings or radiographic
abnormalities), immediately initiate high-dose steroids
(dexamethasone 10 mg intravenously BID), irrespective of the
leukocyte count, and continue for at least 3 days or longer until
signs and symptoms have abated. The majority of patients do not
require termination of TRISENOX therapy during treatment of the APL
differentiation syndrome.
Cardiac Conduction Abnormalities: Before initiating
therapy, perform a 12-lead ECG, assess serum electrolytes and
creatinine, correct preexisting electrolyte abnormalities, and
consider discontinuing drugs known to prolong QT interval. Arsenic
trioxide can cause QT interval prolongation and complete
atrioventricular block. QT prolongation can lead to a torsade de
pointes-type ventricular arrhythmia, which can be fatal. 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, preexisting QT interval prolongation,
congestive heart failure, administration of potassium-wasting
diuretics, or other conditions that result in hypokalemia or
hypomagnesemia. One patient (also receiving amphotericin B) had
torsade de pointes during induction therapy for relapsed APL with
arsenic trioxide.
- Contraindications: TRISENOX is
contraindicated in patients who are hypersensitive to arsenic.
- APL Differentiation Syndrome:
Nine of 40 patients with APL treated with TRISENOX, at a dose of
0.15 mg/kg, experienced the APL differentiation syndrome.
- Cardiac Conduction
Abnormalities: Torsade de Pointes, Complete Heart Block, and QT
Prolongation: Sixteen of 40 patients (40%) had at least one ECG
tracing with a QTc interval greater than 500 msec. Prolongation of
the QTc was observed between 1 and 5 weeks after TRISENOX infusion,
and then returned towards baseline by the end of 8 weeks after
TRISENOX infusion. Monitor ECG weekly and more frequently for
clinically unstable patients. For QTc greater than 500 msec,
complete corrective measures and reassess the QTc with serial ECGs
prior to initiating TRISENOX. During TRISENOX therapy, maintain
potassium concentrations above 4 mEq/L and magnesium concentrations
above 1.8 mg/dL. Reassess patients who reach an absolute QT
interval value > 500 msec and immediately correct concomitant
risk factors, if any, while the risk/benefit of continuing versus
suspending TRISENOX therapy should be considered. The risk may be
increased when TRISENOX is coadministered with medications that can
lead to electrolyte abnormalities (such as diuretics or
amphotericin B).
- 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. Advise pregnant women of the potential risk to a
fetus. Advise females and males of reproductive potential to use
effective contraception during and after treatment with
TRISENOX.
- Lactation: TRISENOX is excreted
in human milk. Because of the potential for serious adverse
reactions in nursing infants, discontinue breastfeeding during
treatment with TRISENOX.
- Laboratory Tests: Electrolyte
and glucose levels, as well as hepatic, renal, hematologic, and
coagulation profiles should be monitored at least twice weekly, and
more frequently for clinically unstable patients during the
induction phase and at least weekly during the consolidation
phase.
- Drug Interactions: Avoid the
concomitant use of TRISENOX with medications that can prolong the
QT/QTc interval or those that can lead to electrolyte
abnormalities. Concomitant use of drugs that can prolong the QT/QTc
interval with TRISENOX may increase the risk of serious QT/QTc
interval prolongation. Electrolyte abnormalities increase the risk
of serious QT/QTc interval prolongation. Monitor ECGs and
electrolytes more frequently in patients who are unable to avoid
concomitant use of these medications and TRISENOX.
- Pediatric Use: In a pediatric
study, the toxicity profile observed in 13 pediatric patients with
APL between the ages of 4 and 20 receiving TRISENOX was similar to
that observed in adult patients. Additional drug-related toxicities
reported included: gastrointestinal disorders, metabolic and
nutrition disorders, respiratory disorders, cardiac failure
congestive, neuralgia, and enuresis. One case each of pulmonary
edema and caecitis were considered serious reactions. No children
less than 4 years of age were enrolled in the trial due to the
rarity of APL in this age group.
- 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:
Most patients experienced some drug related toxicity, most commonly
leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and
abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough,
rash or itching, headaches, and dizziness. These adverse effects
have not been observed to be permanent or irreversible nor do they
usually require interruption of therapy.
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or
USMedinfotevapharma.com
Please see Full Prescribing Information for
TRISENOX® (arsenic trioxide) Injection
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 millions of patients
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 a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 were $19.7 billion. For
more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
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 develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from investments in our
pipeline of specialty and other products; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents, confidentiality agreements and other
measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability,
major hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with
internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant
disruptions of our information technology systems or breaches of
our data security; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in tax liabilities; 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; variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner; environmental risks; and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
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, whether as a
result of new information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20161130005112/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, 215-591-8912United StatesorRan Meir,
215-591-3033United StatesorTomer Amitai, 972 (3)
926-7656IsraelorPR Contacts:Iris Beck Codner, 972 (3)
926-7687IsraelorDenise Bradley, 215-591-8974United
StatesorNancy Leone, 215-284-0213United States
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