31.01.2018 22:59:59
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Press Release: Novartis announces NEJM -2-
loss of balance. Patients should be advised to call their health care
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) in the US 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 health care
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 health care provider
will do blood tests to check all of their blood cell counts after
treatment with Kymriah. Patients should be advised to tell their health
care 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 health care provider
about their treatment with Kymriah before receiving a live virus
vaccine.
After treatment with Kymriah, patients will be monitored life-long by
their health care provider, as they may develop secondary cancers or
recurrence of their leukemia.
Patients should not drive, operate heavy machinery, or do other
dangerous activities for 8 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, and dizziness/lightheadedness. However, these are
not all of the possible side effects of Kymriah. Patients should talk to
their health care provider for medical advice about side effects.
Prior to a female patient starting treatment with Kymriah, their health
care 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. If
either sex partner has received Kymriah, patients should talk to their
health care provider about birth control and pregnancy.
Patients should tell their health care 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.
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
Kymriah, regarding our ability to scale and sustain commercial
manufacturing for Kymriah, or regarding potential future revenues from
Kymriah. 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
Kymriah will be submitted or approved for sale or for any additional
indications or labeling in any market, or at any particular time.
Neither can there be any guarantee that Novartis will successfully scale
and sustain commercial manufacturing for Kymriah, or successfully
sustain a network of treatment centers to offer Kymriah. Nor can there
be any guarantee that Kymriah will be commercially successful in the
future. In particular, our expectations regarding Kymriah could be
affected by, among other things, our ability to successfully scale and
sustain commercial manufacturing and sustain a network of treatment
centers; 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; our ability to obtain or maintain proprietary intellectual
property protection; the particular prescribing preferences of
physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions,
including the effects of the persistently weak economic and financial
environment in many countries; safety, quality or manufacturing issues,
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 provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, cost-saving generic and biosimilar
pharmaceuticals and eye care. Novartis has leading positions globally in
each of these areas. In 2017, the Group achieved net sales of USD 49.1
billion, while R&D throughout the Group amounted to approximately USD
9.0 billion. Novartis Group companies employ approximately 122,000
full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information,
please visit http://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
# # #
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/2165241/833083.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions 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
January 31, 2018 17:00 ET (22:00 GMT)
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Aktien in diesem Artikel
Novartis AG | 80,10 | -0,27% | |
Novartis AG (Spons. ADRS) | 99,60 | 2,05% |
Indizes in diesem Artikel
NASDAQ Comp. | 19 003,65 | 0,16% |