Optime Care, a nationally recognized specialty pharmacy and an
AscellaHealth Company, today announces a contractual partnership
with Rigel Pharmaceuticals, Inc., effective July 1, 2024, bringing
its comprehensive suite of services to support patients using
GAVRETO® (pralsetinib). GAVRETO® is a targeted therapy that is
taken by mouth once daily and is used to treat certain cancers
caused by abnormal RET genes.
Optime Care’s offerings for life sciences manufacturers
encompass pre-commercialization and market access expertise,
exclusive distribution partnerships and national medication
fulfillment. Seamless treatment is ensured through high-touch
patient support and HUB services designed to enhance patient
outcomes.
“Our dedicated team at Optime Care is excited to expand our
long-standing partnership with Rigel Pharmaceuticals and support
GAVRETO® patients,” says Stephanie Wasilewski, PharmD, General
Manager, Optime Care. “Our comprehensive suite of services and deep
commitment to personalized care optimize therapeutic outcomes
throughout the treatment journey,” says Stephanie Wasilewski,
PharmD, General Manager, Optime Care.
Optime Care specialists excel in communication, optimizing the
patient journey through personalized clinical guidance and ongoing
support for patients and their families. Professionals with deep
understanding of complex, chronic disease have specialized
experience that enhances patient access to essential therapies,
streamlines care coordination, assists with insurance coverage to
address financial needs and identifies financial assistance
programs.
Rigel Pharmaceuticals, Inc. has an established relationship with
Optime Care and based this selection for the management of GAVRETO®
patients on the Company’s expertise with specialized, complex
diseases and comprehensive suite of integrated patient management
and HUB services. This includes distribution, patient intake,
prescription fulfillment, prior authorization support, custom
clinical programs, reimbursement services and financial
assistance.
"Optime Care has consistently demonstrated exceptional expertise
and commitment to patient care, making them an ideal partner for
managing GAVRETO® patients,” says Scott Yohe, VP of market access,
Rigel Pharmaceuticals. "Their comprehensive services ensure that
patients have access to the necessary resources and guidance,
support that leads to improved therapeutic outcomes. We are excited
to strengthen our collaboration and continue to make a positive
impact on the lives of those affected by cancers caused by abnormal
RET genes."
About Optime Care Optime Care, Inc., an AscellaHealth
Company, is a nationally recognized specialty pharmacy,
distribution and patient management organization offering a suite
of comprehensive services tailored to maximize therapeutic
opportunities for the treatment of orphan and rare disorders. The
executive team has partnered in the launch and management of over
40 orphan products and programs while consistently implementing the
best brand services for the community. Optime Care has
dual-accreditation from the Utilization Review Accreditation
Commission (URAC) for compliance with specialty pharmacy and the
Accreditation Commission for Health Care (ACHC) for specialty
pharmacy services that demonstrate a commitment to providing
quality care and services to consumers. Visit
www.ascellahealth.com
About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is
a biotechnology company dedicated to discovering, developing and
providing novel small molecule drugs that significantly improve the
lives of patients with hematologic disorders, cancer, and rare
immune diseases. Founded in 1996, Rigel is based in South San
Francisco, California. For more information on Rigel, the Company's
marketed products and pipeline of potential products, visit
www.rigel.com.
About GAVRETO® (pralsetinib) GAVRETO® is a
prescription medicine used to treat certain cancers caused by
abnormal rearranged during transfection (RET) genes in:
- adults with non-small cell lung cancer (NSCLC) that has
spread
- adults and children 12 years of age and older with advanced
thyroid cancer or thyroid cancer that has spread who require a
medicine by mouth or injection (systemic therapy) and who have
received radioactive iodine and it did not work or is no longer
working*
Your healthcare provider will perform a test to make sure that
GAVRETO® is right for you.
It is not known if GAVRETO is safe and effective when used to
treat cancers caused by abnormal RET genes in children for the
treatment of NSCLC or in children younger than 12 years of age for
the treatment of thyroid cancer.
*GAVRETO® was approved based on the percentage of
patients whose tumor size shrank or disappeared after treatment and
how long that response lasted. There are ongoing studies to confirm
the benefit of GAVRETO®.
IMPORTANT SAFETY INFORMATION
GAVRETO® (pralsetinib) may cause serious side effects,
including:
Lung problems: GAVRETO may cause severe or
life-threatening inflammation of the lungs during treatment, that
can lead to death. Tell your healthcare provider right away if you
have any new or worsening symptoms, including shortness of breath,
cough, or fever.
High blood pressure (hypertension): High blood pressure
is common with GAVRETO and may sometimes be severe. You should
check your blood pressure regularly during treatment with GAVRETO.
Tell your healthcare provider if you have increased blood pressure
readings or get any symptoms of high blood pressure, including
confusion, dizziness, headaches, chest pain or shortness of
breath.
Liver problems: Liver problems (increased liver function
blood test results) can happen during treatment with GAVRETO and
may sometimes be serious. Your healthcare provider will do blood
tests before and during treatment with GAVRETO to check you for
liver problems. Tell your healthcare provider right away if you get
any signs or symptoms of liver problem during treatment, including
yellowing of your skin or the white part of your eyes (jaundice),
loss of appetite, nausea or vomiting, dark “tea-colored” urine,
pain on the upper right side of your stomach area, sleepiness,
bleeding or bruising.
Bleeding problems: GAVRETO can cause bleeding which can
be serious and cause death. Tell your healthcare provider if you
have any signs or symptoms of bleeding during treatment, including
vomiting blood or if your vomit looks like coffee grounds, unusual
vaginal bleeding, nose bleeds that happen often, pink or brown
urine, drowsiness or difficulty being awakened, red or black (looks
like tar) stools, confusion, coughing up blood or blood clots,
headache, unusual bleeding or bruising of your skin, change in
speech, or menstrual bleeding that is heavier than normal.
Tumor lysis syndrome (TLS): TLS is caused by a fast
breakdown of cancer cells. TLS can cause you to have kidney failure
and the need for dialysis treatment, an abnormal heartbeat, and may
sometimes lead to hospitalization. Your healthcare provider may do
blood tests to check you for TLS. You should stay well hydrated
during treatment with GAVRETO. Call your healthcare provider or get
emergency medical help right away if you develop any of these
symptoms during treatment with GAVRETO: nausea, shortness of
breath, vomiting, muscle cramps, weakness, seizures or
swelling.
Risk of wound healing problems: Wounds may not heal
properly during treatment with GAVRETO. Tell your healthcare
provider if you plan to have any surgery before or during treatment
with GAVRETO. You should not take GAVRETO for at least 5 days
before surgery. Your healthcare provider should tell you when you
may start taking GAVRETO again after surgery.
Before taking GAVRETO, tell your healthcare provider about
all of your medical conditions, including if you:
- have lung or breathing problems other than lung cancer
- have high blood pressure
- have bleeding problems
- have liver problems
- plan to have surgery
- are pregnant or plan to become pregnant. GAVRETO can harm your
unborn baby.
Females who are able to become
pregnant:
- Your healthcare provider will do a pregnancy test before you
start GAVRETO.
- Should use an effective form of non-hormonal birth control
(contraception) during treatment with GAVRETO and for 2
weeks after your last dose of GAVRETO.
- Birth control methods that contain hormones (such as birth
control pills, injections or transdermal system patches) may not
work as well during treatment with GAVRETO.
- Talk to your healthcare provider about birth control methods
that may be right for you during this time.
- Tell your healthcare provider right away if you become pregnant
or think you might be pregnant during treatment with GAVRETO.
Males with female partners who are able to
become pregnant should use effective birth control
(contraception) during treatment and for 1 week after your
last dose of GAVRETO.
- are breastfeeding or plan to breastfeed. It is not known if
GAVRETO passes into your breast milk. Do not breastfeed during
treatment and for 1 week after your last dose of
GAVRETO.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Taking GAVRETO with other
medicines may affect how GAVRETO works.
The most common side effects of GAVRETO include: muscle
and joint pain, constipation, diarrhea, tiredness, swelling of your
face, arms, legs, hands, and feet (edema), fever, and cough.
The most common severe abnormal blood test results with
GAVRETO include: decreased white blood cell, red blood cell,
and platelet counts, decreased levels of phosphate, body salt
(sodium), calcium and potassium, abnormal liver function, increased
levels of enzyme called alkaline phosphatase, and increased levels
of potassium.
GAVRETO may affect fertility in males and females, which may
affect your ability to have children. Talk to your healthcare
provider if this is a concern for you.
These are not all of the possible side effects of GAVRETO. Call
your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to
Genentech at 1-888-835-2555.
Please click here to see the full Prescribing
Information and Patient Information for GAVRETO.
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