SOUTH SAN FRANCISCO, Calif.,
May 29, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced
that TAVALISSE™ (fostamatinib disodium hexahydrate) is available by
prescription for the treatment of thrombocytopenia in adult
patients with chronic immune thrombocytopenia (ITP) who have had an
insufficient response to a previous treatment. TAVALISSE, an oral
spleen tyrosine kinase (SYK) inhibitor that targets the underlying
autoimmune cause of the disease by impeding platelet destruction,
was approved by the U.S. Food and Drug Administration in
April 2018.
"Healthcare providers and adults living with chronic ITP have
been in need of a new and different treatment option," said
Raul Rodriguez, president and CEO of
Rigel Pharmaceuticals. "We're excited to bring TAVALISSE to this
patient population, and to have an experienced team in place to
answer questions and help patients and providers to start accessing
TAVALISSE."
To assist with access to TAVALISSE, Rigel is also introducing
RIGEL ONECARE™. This is a comprehensive support center to
help patients and physicians navigate through insurance coverage
requirements and provide financial assistance when needed, along
with other support programs. Every patient will have a personalized
Nurse Navigator to assess a patient's individual case.
For more information, visit www.TAVALISSE.com or contact
Rigel ONECARE at 833-RIGELOC (833-744-3562).
Rigel will be at the ASCO Annual Meeting being held June 1-5, 2018 in Chicago, Booth #24160.
To view the TAVALISSE™ approval press release and multimedia
assets, please visit:
https://www.multivu.com/players/English/8297951-rigel-pharmaceuticals-itp-tavalisse-fda-approval/
About ITP
In patients with ITP, the immune
system attacks and destroys the body's own blood platelets, which
play an active role in blood clotting and healing. Common
symptoms of ITP are excessive bruising and bleeding. People
suffering with chronic ITP may live with an increased risk of
severe bleeding events that can result in serious medical
complications or even death. Current therapies for ITP
include steroids, blood platelet production boosters (TPOs) and
splenectomy. However, not all patients are adequately treated with
existing therapies. As a result, there remains a significant
medical need for additional treatment options for patients with
ITP.
About
TAVALISSE
Indication
TAVALISSE™ (fostamatinib
disodium hexahydrate) tablets is indicated for the treatment of
thrombocytopenia in adult patients with chronic immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment.
Important Safety Information
Warnings and Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the
hypertensive effects. Monitor blood pressure every 2 weeks until
stable, then monthly, and adjust or initiate antihypertensive
therapy for blood pressure control maintenance during therapy. If
increased blood pressure persists, TAVALISSE interruption,
reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can
occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to >3 x upper limit of normal, manage
hepatotoxicity using TAVALISSE interruption, reduction, or
discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea
occurred in 1% of patients treated with TAVALISSE. Monitor patients
for the development of diarrhea and manage using supportive care
measures early after the onset of symptoms. If diarrhea becomes
severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE;
febrile neutropenia occurred in 1% of patients. Monitor the ANC
monthly and for infection during treatment. Manage toxicity with
TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant
women. Advise pregnant women the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment and for at least 1 month after the last dose.
Verify pregnancy status prior to initiating TAVALISSE. It is
unknown if TAVALISSE or its metabolite is present in human milk.
Because of the potential for serious adverse reactions in a
breastfed child, advise a lactating woman not to breastfeed during
TAVALISSE treatment and for at least 1 month after the last
dose.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full
Prescribing Information.
To report side effects of prescription drugs to
the FDA, visit www.fda.gov/medwatch or
call 1-800-FDA-1088 (800-332-1088).
TAVALISSE and RIGEL ONECARE are trademarks of Rigel
Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by Rigel
Pharmaceuticals, Inc.
About Rigel (www.rigel.com)
Rigel
Pharmaceuticals, Inc., is a biotechnology company dedicated to
discovering, developing and providing novel small molecule drugs
that significantly improve the lives of patients with immune and
hematologic disorders, cancer and rare diseases. Rigel's pioneering
research focuses on signaling pathways that are critical to disease
mechanisms. The company's first FDA approved product is
TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen
tyrosine kinase (SYK) inhibitor, for the treatment of adult
patients with chronic immune thrombocytopenia who have had an
insufficient response to a previous treatment. Rigel's current
clinical programs include Phase 2 studies of fostamatinib in
autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel
has product candidates in development with partners BerGenBio
AS, Daiichi Sankyo, and Aclaris Therapeutics.
Forward Looking Statements
This release contains forward-looking statements relating to,
among other things, the availability of TAVALISSE to patients and
Rigel's ability to help patients navigate through issues relating
to access to TAVALISSE. Any statements contained in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. Words such as "planned," "will,"
"may," "should," "expect," and similar expressions are intended to
identify these forward-looking statements. These forward-looking
statements are based on Rigel's current expectations and inherently
involve significant risks and uncertainties. Actual results and the
timing of events could differ materially from those anticipated in
such forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the commercialization of TAVALISSE;
risks that the FDA or other regulatory authorities may
make adverse decisions regarding TAVALISSE; risks that TAVALISSE
clinical trials may not be predictive of real-world results or of
results in subsequent clinical trials; risks that TAVALISSE may
have unintended side effects, adverse reactions or incidents of
misuses; the availability of resources to develop Rigel's product
candidates; market competition; as well as other risks detailed
from time to time in Rigel's reports filed with the Securities
and Exchange Commission, including its quarterly report on Form
10-Q for the period ended March 31, 2018. Rigel does not
undertake any obligation to update forward-looking statements and
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein.
Contact: Raul Rodriguez
Phone: 650.624.1302
Email: ir@rigel.com
Media Contact: David Polk
Phone: 310.309.1029
Cell: 805.428.5775
Email: david.polk@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.