New Labeling will Offer People Living with Chronic Myeloid Leukemia
(CML) More Treatment Flexibility
JERUSALEM--(BUSINESS WIRE)--May 5, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the
U.S. Food and Drug Administration (FDA) has approved SYNRIBO®
(omacetaxine mepesuccinate) for injection, for subcutaneous use, to
include home administration, and also approved a related Medication
Guide and Instructions for Use. With this approval, physicians who treat
adults with chronic or accelerated phase CML who are no longer
responding to, or who could not tolerate, two or more tyrosine kinase
inhibitors (TKIs) will now have the option to allow their patients to
administer SYNRIBO® therapy at home. Teva is working to
finalize a comprehensive specialty pharmacy support program which will
help facilitate successful home administration of SYNRIBO®
for HCPs, their patients and caregivers. This program is expected to “go
live” as early as possible in the second quarter of 2014.
“As we continue to expand our oncology portfolio and services at Teva,
the updated labeling for SYNRIBO® demonstrates our commitment
to improving the overall experience and lowering barriers to treatment
for people living with CML,” said Bill Campbell, Vice President and
General Manager, Teva Oncology. “Home administration can reduce the
number of required doctor office visits for patients being treated with
SYNRIBO®, while still maintaining close collaboration with
their healthcare provider to manage their treatment regimen.”
“It had been necessary for adults living with chronic or accelerated
phase CML who are prescribed SYNRIBO® to travel to their
doctor’s office twice a day for two weeks, which can be extremely
burdensome and inconvenient to both patients and their caregivers,” said
Meir Wetzler, MD, FACP, Chief of the Leukemia Section at Roswell Park
Cancer Institute. “Now, physicians can decide if their patients are
candidates for self administration, and if so, provide their patients
with guidance on how to properly administer reconstituted SYNRIBO®
in the home.”
“As an oncology nurse practitioner who has treated CML patients for
nearly 20 years, I’m thrilled to see this unique therapy become
available for home administration,” said Sandra Corbin, CRNP at Calvert
Hematology and Oncology. “Patients may initially express concern at the
thought of self-injecting—but with training and support, most can become
skilled at administering the subcutaneous injections.”
Indication
SYNRIBO® (omacetaxine mepesuccinate) for Injection, for
subcutaneous use, is indicated for the treatment of adult patients with
chronic or accelerated phase chronic myeloid leukemia (CML) with
resistance and/or intolerance to two or more tyrosine kinase inhibitors
(TKI).
Important Safety Information
Warnings and Precautions
-
Myelosuppression: Patients with chronic phase and accelerated phase
CML who used SYNRIBO® experienced severe and fatal
myelosuppression including thrombocytopenia, neutropenia, and anemia.
Patients with neutropenia are at increased risk for infections, and
should be monitored frequently and advised to contact a physician if
they have symptoms of infection or fever. Monitor complete blood
counts weekly during induction and initial maintenance cycles and
every two weeks during later maintenance cycles, as clinically
indicated
-
Bleeding: SYNRIBO® causes severe thrombocytopenia which
increases the risk of hemorrhage. Fatalities from cerebral hemorrhage
have occurred. Severe, non-fatal gastrointestinal hemorrhages have
also occurred. Monitor platelet counts as part of the complete blood
count (CBC) monitoring as recommended. Avoid anticoagulants, aspirin,
and non-steroidal anti-inflammatory drugs (NSAIDs) when the platelet
count is <50,000/μL as they may increase the risk of bleeding
-
Hyperglycemia: SYNRIBO® can induce glucose intolerance.
Monitor blood glucose levels frequently, especially in patients with
diabetes or risk factors for diabetes. Avoid SYNRIBO® in
patients with poorly controlled diabetes mellitus until good glycemic
control has been established
-
Embryo-Fetal Toxicity: SYNRIBO® can cause fetal harm when
administered to a pregnant woman. Women should be advised to avoid
becoming pregnant while using SYNRIBO®
Adverse Reactions
-
Serious adverse reactions (frequency ≥5%) in chronic phase patients:
bone marrow failure, thrombocytopenia, febrile neutropenia, and
infections
-
Serious adverse reactions (frequency ≥5%) in accelerated phase
patients: febrile neutropenia, thrombocytopenia, anemia, diarrhea, and
infections
-
Most common adverse reactions (frequency ≥20%) in chronic and
accelerated phase patients: thrombocytopenia, anemia, neutropenia,
diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia,
infection, and lymphopenia
-
You are encouraged to report side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
About CML
Chronic myeloid leukemia (also called chronic myelogenous leukemia) is
one of four main types of leukemia and is a cancer of the blood and bone
marrow. In CML, part of the DNA from one chromosome (chromosome 9)
breaks off and trades places with another chromosome (chromosome 22)
called a “translocation”. This forms the Philadelphia chromosome, an
abnormal chromosome 22 that contains the BCR-ABL hybrid gene. This
hybrid gene leads to over-production of the enzyme tyrosine kinase in
the bone marrow, which causes too many stem cells to develop into white
blood cells (granulocytes or blasts). The American Cancer Society
estimates that in 2014, there will be 5,980 new cases of CML diagnosed
in the United States, and 810 deaths from the disease. The prevalence of
CML has grown significantly since 2001 with the development of new
therapies.
About SYNRIBO®
SYNRIBO® is the first protein synthesis inhibitor and was
originally granted an accelerated approval by the FDA in October 2012.
In February of 2014 the FDA granted SYNRIBO a full approval based on the
submission of 24 month update to the safety and efficacy data. While a
detailed understanding of how SYNRIBO works has not been fully defined,
it has been shown in laboratory studies not including patients, to
prevent the production of specific proteins. The proteins affected by
SYNRIBO are known as Bcr-Abl and Mcl-1. These are examples of some of
the proteins that are produced in higher levels by cancerous CML cells
and help drive the disease. As a protein synthesis inhibitor, the way
SYNRIBO® is believed to work does not directly depend on
Bcr-Abl binding.
For Full Prescribing Information, click here: http://www.synribo.com/pdf/synribo_pi.pdf
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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