VANTRELA ER label describes the product’s abuse-deterrent properties
against abuse in the three most
common routes—oral,
intranasal and intravenous
JERUSALEM--(BUSINESS WIRE)--Jan. 18, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the U.S. Food and Drug Administration (FDA) approved VANTRELATM
ER (hydrocodone bitartrate) extended-release tablets [CII] formulated
with Teva’s proprietary abuse deterrence technology. VANTRELA ER is
indicated for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which alternative
treatment options are inadequate. The product’s approval is supported by
a clinical program that evaluated the safety and efficacy of VANTRELA
ER, as well as its abuse potential in laboratory-based in vitro
manipulation and extraction studies, pharmacokinetic studies, and
clinical abuse potential (CAP) studies.
“Teva understands the risk of prescription drug abuse is a challenge
healthcare professionals face when treating millions of Americans
affected by chronic pain,” said Rob Koremans, MD, President and CEO of
Global Specialty Medicines at Teva. “Abuse-deterrent treatments provide
options for prescribers that may help deter or mitigate abuse while
still preserving access to pain medications for the patients that need
them most.”
The VANTRELA ER prescribing information (PI) describes the product’s
abuse-deterrent properties that are expected to reduce, but not totally
prevent, oral, intranasal and intravenous abuse of the drug when the
tablets are manipulated. As an opioid, VANTRELA ER is associated with
serious risks and the PI contains a Boxed Warning that includes
addiction, abuse, and misuse, which can lead to overdose and death, as
well as serious, life-threatening, or fatal respiratory depression.
Additional boxed warnings and other important safety information can be
found below and in the prescribing information.
Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific
Officer at Teva said, “While no technology can completely eliminate
abuse, Teva’s proprietary abuse deterrence technology is an important
step forward. We are committed to furthering responsible pain
management.”
Adverse reactions in ≥2% of patients in placebo-controlled trials
include nausea, constipation, headache, somnolence, vomiting, dizziness,
pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.
ABOUT VANTRELA ER
VANTRELA™ ER (hydrocodone bitartrate) extended-release
tablets [CII] is an opioid agonist indicated for the management of pain
severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are inadequate.
Limitation of Use
-
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, and because of the greater risks of
overdose and death with extended-release opioid formulations, reserve
VANTRELA ER for use in patients for whom alternative treatment options
(e.g., non-opioid analgesics or immediate-release opioids) are
ineffective, not tolerated, or would be otherwise inadequate to
provide sufficient management of pain.
-
VANTRELA ER is not indicated as an as-needed (prn) analgesic.
VANTRELA ER contains hydrocodone, a substance with a high potential for
abuse similar to other opioids, including fentanyl, hydromorphone,
methadone, morphine, oxycodone, oxymorphone, and tapentadol.
Important Safety Information
VANTRELA ER exposes patients and other users to the risks of opioid
addiction, abuse, and misuse, which can lead to overdose and death.
Assess each patient’s risk prior to prescribing VANTRELA ER and monitor
all patients regularly for the development of these behaviors and
conditions.
Serious, life-threatening, or fatal respiratory depression may occur
with the use of VANTRELA ER. Monitor for respiratory depression,
especially during initiation of VANTRELA ER or following a dose
increase. Instruct patients to swallow VANTRELA ER tablets whole;
crushing, chewing or dissolving VANTRELA ER tablets can cause rapid
release and absorption of a potentially fatal dose of hydrocodone.
Accidental ingestion of even one dose of VANTRELA ER, especially by
children, can result in a fatal overdose of hydrocodone.
Prolonged use of VANTRELA ER during pregnancy can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and treated, and requires management according to protocols
developed by neonatology experts. If opioid use is required for a
prolonged period in a pregnant woman, advise the patient of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
The concomitant use of VANTRELA ER with all cytochrome P450 3A4
inhibitors may result in an increase in hydrocodone plasma
concentrations, which could increase or prolong adverse drug effects and
may cause potentially fatal respiratory depression. In addition,
discontinuation of a concomitantly used cytochrome P450 3A4 inducer may
result in an increase in hydrocodone plasma concentration. Monitor
patients receiving VANTRELA ER and any CYP3A4 inhibitor or inducer.
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including alcohol, may result in
profound sedation, respiratory depression, coma, and death.
-
Reserve concomitant prescribing of VANTRELA ER and benzodiazepines
or other CNS depressants for use in patients for whom alternative
treatment options are inadequate.
-
Limit dosages and durations to the minimum required.
-
Follow patients for signs and symptoms of respiratory depression
and sedation.
VANTRELA ER is contraindicated in patients with: significant respiratory
depression; acute or severe bronchial asthma in an unmonitored setting
or in the absence of resuscitative equipment; known or suspected
gastrointestinal obstruction, including paralytic ileus; or
hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartrate or any
other ingredients in VANTRELA ER.
VANTRELA ER-treated patients with significant chronic obstructive
pulmonary disease or cor pulmonale, and those with a substantially
decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing
respiratory depression are at increased risk of decreased respiratory
drive including apnea, even at recommended dosages of VANTRELA ER.
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients because they may have
altered pharmacokinetics or altered clearance compared to younger,
healthier patients.
Cases of adrenal insufficiency have been reported with opioid use, more
often following greater than one month of use.
VANTRELA ER may cause severe hypotension including orthostatic
hypotension and syncope in ambulatory patients. There is an added risk
to individuals whose ability to maintain blood pressure has been
compromised by a depleted blood volume or concurrent administration of
certain CNS depressants (e.g., phenothiazines or general anesthetics).
In patients with circulatory shock, VANTRELA ER may cause vasodilation
that can further reduce cardiac output and blood pressure.
In patients who may be susceptible to the intracranial effects of CO2
retention (e.g., those with evidence of increased intracranial pressure
as can be caused by certain brain tumors), VANTRELA ER may reduce
respiratory drive, and the resultant CO2 retention can
further increase intracranial pressure. Opioids may also obscure the
clinical course in a patient with a head injury.
The hydrocodone in VANTRELA ER may cause spasm of the sphincter of Oddi.
Opioids may cause increases in serum amylase.
The hydrocodone in VANTRELA ER may increase the frequency of seizures in
patients with seizure disorders, and may increase the risk of seizures
occurring in other clinical settings associated with seizures.
Avoid the use of mixed agonist/antagonist (e.g., pentazocine,
nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine)
analgesics in patients who are receiving a course of therapy with a full
opioid agonist analgesic, including VANTRELA ER. In these patients,
mixed agonist/antagonist and partial agonist analgesics may reduce the
analgesic effect and/or may precipitate withdrawal symptoms.
VANTRELA ER may impair the mental and physical abilities needed to
perform potentially hazardous activities such as driving a car or
operating machinery.
QTc prolongation has been observed with VANTRELA ER.
Adverse reactions reported in ≥2% of patients in the placebo-controlled
trials include: nausea, constipation, headache, somnolence, vomiting,
dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.
The Full Prescribing Information, including the Boxed Warning and
Medication Guide for VANTRELA ER is available at VANTRELAER.com.
A copy of the Prescribing Information may also be requested from the US
Medical Information Contact Center for Teva Specialty Medicines at
888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com
or Teva’s Public Relations or Investor Relations contacts.
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 realize the anticipated benefits of the
acquisition of Allergan plc’s worldwide generic pharmaceuticals business
(“Actavis Generics”), and the timing of realizing such benefits; our
ability to fully and efficiently integrate Actavis Generics and to
achieve the anticipated cost savings, synergies, business opportunities
and growth prospects from the combination; the fact that we are now
dependent to a much larger extent than previously on our generic
pharmaceutical business; our ability to develop and launch new generic
products from the Actavis Generics pipeline on the anticipated
timelines; potential restrictions on our ability to engage in additional
transactions or incur additional indebtedness as a result of the
substantial amount of debt we have incurred to finance the Actavis
Generics acquisition; the fact that we will have significantly less cash
on hand than prior to the consummation of the Actavis Generics
acquisition, which could adversely affect our ability to grow; 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, including, in
particular, former Actavis Generics personnel who have transitioned to
Teva 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; the possibility of additional
adverse consequences arising from our recent FCPA-related settlement
with the U.S. government, including limitations on our conduct of
business in various countries, adverse judgments in shareholder lawsuits
and fines, penalties or other sanctions imposed by government
authorities in other countries; 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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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