01.12.2018 20:29:54
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Press Release: Novartis announces longer-term -2-
agitation, anxiety, seizures, difficulty speaking and understanding, or
loss of balance. Patients should be advised to call their healthcare
provider or get emergency help right away if they experience any of
these signs and symptoms of CRS or neurological toxicities.
Because of the risk of CRS and neurological toxicities, Kymriah is only
available through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS) called Kymriah REMS.
Serious allergic reactions, including anaphylaxis, may occur after
Kymriah infusion. Kymriah can increase the risk of life-threatening
infections that may lead to death. Patients should be advised to tell
their healthcare provider right away if they develop fever, chills, or
any signs or symptoms of an infection.
Patients may experience prolonged low blood cell counts (cytopenia),
where one or more types of blood cells (red blood cells, white blood
cells, or platelets) are decreased. The patient's healthcare provider
will do blood tests to check all of their blood cell counts after
treatment with Kymriah. Patients should be advised to tell their
healthcare provider right away if they get a fever, are feeling tired,
or have bruising or bleeding.
Patients may experience hypogammaglobulinemia, a condition in which the
level of immunoglobulins (antibodies) in the blood is low and the risk
of infection is increased. It is expected that patients may develop
hypogammaglobulinemia with Kymriah, and may need to receive
immunoglobulin replacement for an indefinite amount of time following
treatment with Kymriah. Patients should tell their healthcare provider
about their treatment with Kymriah before receiving a live virus
vaccine.
After treatment with Kymriah, patients will be monitored lifelong by
their healthcare provider, as they may develop secondary cancers or
recurrence of their cancer.
Patients should not drive, operate heavy machinery, or do other
dangerous activities for eight weeks after receiving Kymriah because the
treatment can cause temporary memory and coordination problems,
including sleepiness, confusion, weakness, dizziness, and seizures.
Some of the most common side effects of Kymriah are difficulty breathing,
fever (100.4degF/38degC or higher), chills/shaking chills, confusion,
severe nausea, vomiting and diarrhea, severe muscle or joint pain, very
low blood pressure, dizziness/lightheadedness, and headache. However,
these are not all of the possible side effects of Kymriah. Patients
should talk to their healthcare provider for medical advice about side
effects.
Prior to a female patient starting treatment with Kymriah, their
healthcare provider may do a pregnancy test. There is no information
available for Kymriah use in pregnant or breast-feeding women. Therefore,
Kymriah is not recommended for women who are pregnant or breast feeding.
Patients should talk to their healthcare provider about birth control
and pregnancy.
Patients should tell their healthcare provider about all the medicines
they take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
After receiving Kymriah, patients should be advised that some commercial
HIV tests may cause a false-positive test result. Patients should also
be advised not to donate blood, organs, or tissues and cells for
transplantation after receiving Kymriah.
Please see the full Prescribing Information for Kymriah, including Boxed
WARNING, and Medication Guide at www.Kymriah.com
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform Act of
1995. Forward-looking statements can generally be identified by words
such as "potential," "can," "will," "plan," "expect," "anticipate,"
"look forward," "believe," "committed," "investigational," "pipeline,"
"launch," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for
the investigational or approved products described in this press release,
or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking
statements are based on our current beliefs and expectations regarding
future events, and are subject to significant known and unknown risks
and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that the investigational or
approved products described in this press release will be submitted or
approved for sale or for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that
such products will be commercially successful in the future. In
particular, our expectations regarding such products could be affected
by, among other things, the uncertainties inherent in research and
development, including clinical trial results and additional analysis of
existing clinical data; regulatory actions or delays or government
regulation generally; global trends toward health care cost containment,
including government, payor and general public pricing and reimbursement
pressures; our ability to obtain or maintain proprietary intellectual
property protection; the particular prescribing preferences of
physicians and patients; general political and economic conditions;
safety, quality or manufacturing issues; potential or actual data
security and data privacy breaches, or disruptions of our information
technology systems, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press release
as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result
of new information, future events or otherwise.
About Novartis
Novartis is reimagining medicine to improve and extend people's lives.
As a leading global medicines company, we use innovative science and
digital technologies to create transformative treatments in areas of
great medical need. In our quest to find new medicines, we consistently
rank among the world's top companies investing in research and
development. Novartis products reach nearly 1 billion people globally
and we are finding innovative ways to expand access to our latest
treatments. About 125 000 people of more than 140 nationalities work at
Novartis around the world. Find out more at www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit
www.novartis.com/news/media-library
For questions about the site or required registration, please contact
media.relations@novartis.com
References
[1] Grupp S., et al. Updated Analysis of the Efficacy and Safety of
Tisagenlecleucel in Pediatric and Young Adult Patients with
Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60(th) American
Society of Hematology Annual Meeting and Exposition. Abstract #112599.
[2] Schuster S., et al. Sustained Disease Control for Adult Patients
with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated
Analysis of Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel,
Acute Lymphoblastic Leukemia. 60(th) American Society of Hematology
Annual Meeting and Exposition. Abstract #11525.
[3] Schuster S., et al. Tisagenlecleucel in Adult Relapsed/Refractory
Diffuse Large B-Cell Lymphoma. N Engl J Med. December 2018.
[4] Van Den Neste E., et al. Outcome of patients with relapsed
diffuse large B-cell lymphoma who fail second-line salvage regimens in
the International CORAL study. Bone Marrow Transplant. January 2016.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff Fiona Phillips
Novartis Global Media Relations Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862-778-7705 (direct)
+41 79 593 4202 (mobile) +1 862-217-9396 (mobile)
eric.althoff@novartis.com fiona.phillips@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF): http://hugin.info/134323/R/2227522/874527.pdf
This announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Novartis International AG via Globenewswire
--- End of Message ---
Novartis International AG
P.O. Box Basel Switzerland
WKN: 904278;ISIN: CH0012005267;
http://www.novartis.com
(END) Dow Jones Newswires
December 01, 2018 14:30 ET (19:30 GMT)
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