TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced that it has updated the VARUBI®
(rolapitant) injectable emulsion package insert in collaboration
with the U.S. Food and Drug Administration (FDA). VARUBI injectable
emulsion is a substance P/neurokinin (NK-1) receptor antagonist
indicated for the prevention of delayed nausea and vomiting
associated with chemotherapy in adults. The changes to the labeling
include modifications to the CONTRAINDICATIONS, WARNINGS and
PRECAUTIONS, and ADVERSE REACTIONS sections.
Following its introduction in late November
2017, TESARO estimates that at least 7,000 doses of VARUBI
injectable emulsion have been administered to patients receiving
emetogenic chemotherapy in the United States. Anaphylaxis,
anaphylactic shock and other serious hypersensitivity reactions
have been reported in the postmarketing setting, some requiring
hospitalization. These reactions have occurred during or soon after
the infusion of VARUBI injectable emulsion. Most reactions have
occurred within the first few minutes of administration.
Patient safety is a paramount priority for
TESARO. In its commitment to ensuring patients and healthcare
professionals are aware of the label update, TESARO has issued a
Dear Healthcare Professional (DHCP) letter. This letter, as well as
the updated full prescribing information, has been posted on the
VARUBI website (www.varubirx.com). Additionally, members of the
TESARO field force will be calling on healthcare professionals to
communicate this important new safety information.
Healthcare providers and patients are encouraged
to report adverse events in patients taking VARUBI injectable
emulsion to TESARO at 1-844-4-TESARO (1-844-483-7276). TESARO’s
medical information department may be reached at 1-844-4-TESARO
(1-844-483-7276) to address any questions from healthcare providers
about the information contained in this release, or the safe and
effective use of VARUBI injectable emulsion.
VARUBI Indication and Important Safety
Information
VARUBI, in combination with other antiemetic
agents, is indicated in adults for the prevention of delayed nausea
and vomiting associated with initial and repeat courses of
emetogenic cancer chemotherapy, including, but not limited to,
highly emetogenic chemotherapy.
VARUBI is contraindicated in patients taking
CYP2D6 substrates with a narrow therapeutic index, such as
thioridazine and pimozide. VARUBI can significantly increase the
plasma concentrations of thioridazine and pimozide, which may
result in QT prolongation and Torsades de Pointes.
VARUBI is a moderate inhibitor of CYP2D6 and
significantly increases the plasma concentrations of CYP2D6
substrates for at least 28 days, with inhibitory effects expected
to persist for an unknown duration. Monitor for adverse
reactions when VARUBI is coadministered with CYP2D6 substrates
without a narrow therapeutic index (avoid coadministration with
CYP2D6 substrates with a narrow therapeutic index, thioridazine and
pimozide; see Contraindication).
In clinical trials, the most common adverse
reactions reported were neutropenia, hiccups, decreased appetite
and dizziness. IV administration of VARUBI was also
associated with infusion-related symptoms (e.g., sensation of
warmth, abdominal pain, dizziness, and paresthesia).
Avoid use of VARUBI in patients who require
chronic administration of strong CYP3A4 inducers (e.g., rifampin),
as significantly reduced plasma concentrations of VARUBI can
decrease the efficacy of VARUBI.
VARUBI given as an oral dose is an inhibitor of
breast cancer resistance protein (BCRP) and P-glycoprotein
(P-gp). Increased plasma concentrations of BCRP substrates
(e.g., methotrexate, topotecan, or irinotecan) and P-gp substrates
(e.g., digoxin) with a narrow therapeutic index may result in
potential adverse reactions. Monitor digoxin concentrations with
concomitant use of VARUBI, and adjust the dosage as needed to
maintain therapeutic concentrations.
Monitor INR and prothrombin time and adjust the
dosage of warfarin, as needed, to maintain target INR.
VARUBI is available by prescription only. Please
see full prescribing information, including additional important
safety information, available at www.varubirx.com.
About TESARO
TESARO is an oncology-focused biopharmaceutical
company devoted to providing transformative therapies to people
bravely facing cancer. For more information, visit
www.tesarobio.com, and follow us on Twitter and LinkedIn.
Investor/Media Contact
Jennifer DavisVice President, Corporate
Communications & Investor Relations+1.781.325.1116 or
jdavis@tesarobio.com
Forward Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
TESARO, they are forward-looking statements reflecting the current
beliefs, estimates and expectations of management made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect,"
"anticipate," "estimate," "intend," and similar expressions (as
well as other words or expressions referencing future events,
conditions, or circumstances) are intended to identify such
forward-looking statements. For example, the information in
this press release relating to the Company’s estimate of the number
of doses of VARUBI® injectable emulsion administered is a
forward-looking statement reflecting the current belief and best
estimate of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. This
statement and other forward-looking statements contained herein
involve substantial risks and uncertainties including, among
others, risks and uncertainties associated with the completion of
the integrated audit of the Company’s financial statements for the
year ended December 31, 2017 and the quarter ending March 31,
2018. Our estimate of the number of doses of VARUBI®
injectable emulsion administered should not be used to extrapolate
or estimate potential revenues from sales of VARUBI injectable
emulsion for such periods, as the determination of such revenues is
subject to a number of risks, uncertainties, and estimates which
are unknown, including estimates of product returns.
Accordingly, any estimates of revenues for such period would be
highly speculative and unreliable. TESARO undertakes no obligation
to update or revise any such forward-looking statements. For a
further description of the risks and uncertainties relating to the
business of the Company in general, see TESARO's Annual Report on
Form 10-K for the year ended December 31, 2016, and its Quarterly
Report on Form 10-Q for the quarter ended September 30, 2017.
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