ST. LOUIS--(BUSINESS WIRE)--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.
