THOUSAND OAKS, Calif.,
June 3, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced the launch of KYPROLIS
CENTRAL, an online media resource about the impact of living with
relapsed or refractory multiple myeloma. Intended to drive
awareness of a rare blood cancer that is increasingly becoming more
prevalent in the United States
(U.S.), KYPROLIS CENTRAL provides real-life stories from relapsed
multiple myeloma patients, as well as educational materials and
third party resources.1
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7811631-kyprolis-central/
"In my opinion, one of the most difficult parts of living with
multiple myeloma is the uncertainty. Relapse is always in the back
of my mind," said Michele A., a relapsed multiple myeloma patient
from Ludlow, Mass. "I've found
that talking to others helps me cope with this uncertainty, and I
hope that sharing my story publicly will generate more awareness
and help others navigating relapsed multiple myeloma."
Multiple myeloma is an incurable blood cancer, characterized by
a recurring pattern of remission and relapse.2 It
is a disease that, in 2012, accounted for approximately one percent
of all cancers globally.3,4 In the U.S., there were more
than 95,000 people living with, or in remission from, multiple
myeloma in 2013.1
Each of the patients featured on KYPROLIS CENTRAL has been
treated with Kyprolis® (carfilzomib) following a
relapse. Kyprolis is a second-generation proteasome inhibitor
indicated in the U.S. in combination with dexamethasone or with
lenalidomide plus dexamethasone for the treatment of patients with
relapsed or refractory multiple myeloma who have received one to
three lines of therapy.5,6 Kyprolis is also indicated as
a single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have received one or more lines of
therapy.6
Resources available on KYPROLIS CENTRAL are intended to share
the experiences of patients living with relapsed multiple myeloma
and educate about this complex disease. With each relapse, disease
burden worsens, which can have a great impact on
patients.7 The journey back to remission requires
teamwork and patients need to know they are not alone.
About Kyprolis® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed.8 Kyprolis
has been shown to block proteasomes, leading to an excessive
build-up of proteins within cells.8 In some cells,
Kyprolis can cause cell death, especially in myeloma cells because
they are more likely to contain a higher amount of abnormal
proteins.8,9
Kyprolis is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia, and the European Union. Additional
regulatory applications for Kyprolis are underway and have been
submitted to health authorities worldwide.
For more information, please visit www.kyprolis.com.
Patient Support Program
Onyx Pharmaceuticals 360™ is
a patient support program that provides patients prescribed
Kyprolis with an Onyx Oncology Nurse Ambassador (ONA). The ONA is a
single point of contact who takes the time to help Kyprolis
patients and their caregivers identify supports and resources most
important to them based on their particular needs, and helps
facilitate those connections allowing patients and their caregivers
time to focus on treatment. Whether it's helping patients with
insurance verification for Kyprolis, with connections to local
independent third-party organizations that may provide
transportation and lodging assistance, helping connect to programs
that may be able to help to make treatment more affordable, or
helping connect with other patients through a network of
independent third-party organizations, program ONAs are available.
Connections with independent third-party organizations are made as
a courtesy and Amgen has no influence over program requirements or
eligibility/acceptance criteria. For more information, please
visit www.kyprolis.com/assistance-during-treatment.
Important Safety Information Regarding
Kyprolis® (carfilzomib) for Injection
INDICATIONS
- KYPROLIS® (carfilzomib) is indicated in
combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS is indicated as a single agent for the treatment of
patients with relapsed or refractory multiple myeloma who have
received one or more lines of therapy.
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- Patients > 75 years, the risk of cardiac failure
is increased. Patients with New York Heart Association Class III
and IV heart failure, recent myocardial infarction, conduction
abnormalities, angina, or arrhythmias may be at greater risk for
cardiac complications and should have a comprehensive medical
assessment (including blood pressure and fluid management) prior to
starting treatment with KYPROLIS and remain under close
follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event
of drug-induced pulmonary toxicity, discontinue
KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions,
including life-threatening reactions, have occurred in
patients receiving KYPROLIS. Symptoms include fever, chills,
arthralgia, myalgia, facial flushing, facial edema, vomiting,
weakness, shortness of breath, hypotension, syncope, chest
tightness, or angina. These reactions can occur immediately
following or up to 24 hours after administration of KYPROLIS.
Premedicate with dexamethasone to reduce the incidence and severity
of infusion reactions. Inform patients of the risk and of symptoms
of an infusion reaction and to contact a physician immediately if
they occur.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuro-radiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full Prescribing Information
at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About Amgen's Commitment to Oncology
Amgen Oncology is
committed to helping patients take on some of the toughest cancers,
such as those that have been resistant to drugs, those that
progress rapidly through the body and those where limited treatment
options exist. Amgen's supportive care treatments help patients
combat certain side effects of strong chemotherapy, and our
targeted medicines and immunotherapies focus on more than a dozen
different malignancies, ranging from blood cancers to solid tumors.
With decades of experience providing therapies for cancer patients,
Amgen continues to grow its portfolio of innovative and biosimilar
oncology medicines.
Forward-Looking Statements
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forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
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estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
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Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
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consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
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Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
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References
1. National Cancer Institute. SEER Stat Fact Sheets:
Myeloma.
2. Jakubowiak A. Management Strategies for Relapsed/Refractory
Multiple Myeloma: Current Clinical Perspectives. Semin
Hematol. 2012; 49(suppl 1):S16-S32.|3. International Agency for
Research on Cancer, GLOBOCAN 2012 database.
4. American Cancer Society. Multiple Myeloma.
5. Orlowski RZ and Kuhn DJ. Proteasome Inhibitors in Cancer
Therapy: Lessons from the First Decade. Clin Cancer Res. 2008; 14(6):1649-1657.
6. KYPROLIS® [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals Inc.,
an Amgen Inc. subsidiary. 2016.
7. Song X, Cong Z and Wilson K.
Real-world tretatment patterns, comorbidities, and
disease-related complications in patients with multiple myeloma in
the United States. Curr Med Res
Opin. 2016;32(1):95-103.
8. Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors in
Multiple Myeloma: 10 Years Later. Blood. 2012;
120(5):947-959.
9. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012;
121(6):893-897.
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SOURCE Amgen