Puma Biotechnology, Inc. and ExceleraRx® Corp. have entered into a definitive agreement whereby NERLYNX (neratinib) will be made available through Excelera to health system specialty pharmacies for the treatment of patients with early-stage, HER2-positive breast cancer. This agreement brings together one of the newest therapies for breast cancer and one of the most advanced approach to specialty pharmacy for the benefit of breast cancer patients.
The Excelera network consists of point-of-care specialty pharmacies owned by health systems and academic medical centers. Excelera offers nationally scaled infrastructure and support to help members develop best practices and gain access to limited distribution drugs and biologics and restrictive payer agreements, so they can provide continuity of care for their patients with complex and chronic conditions. The network also serves as a national platform for collaboration to optimize outpatient specialty drug therapy.
“Patients receive better care and more support through Fairview services than when we refer patients out to other specialty pharmacies. Access to NERLYNX means we will now be able to accelerate the time to therapy start, closely monitor these patients as part of our Therapy Management program and provide a seamless connection back to the provider, all within our own health system.” said Timothy Paine, Director of Industry Relations at Fairview Specialty Pharmacy. “Excelera simplified and sped up the process for accessing NERLYNX, and this partnership ensured all the requirements for safety, education, business analysis and operational logistics were all covered for the benefit of patients, providers, Puma and our specialty pharmacy.”
For health system specialty pharmacies interested in accessing NERLYNX via Excelera, email firstname.lastname@example.org or call 612-293-0378.
Breast Cancer Statistics
Breast cancer is the most common form of cancer in the United States. The National Cancer Institute (NCI) estimates approximately 252,710 women will be diagnosed with breast cancer this year, and approximately 15 to 20 percent of patients with breast cancer have tumors that are HER2-positive.
About NERLYNX (neratinib)
NERLYNX™ is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Important Safety Information
There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.
Diarrhea is a common side effect of NERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:
You should start taking loperamide with your first dose of NERLYNX.
Keep taking loperamide during the first 2 cycles (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide.
While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or if you have diarrhea that does not go away.
Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.
Changes in liver function tests are common with NERLYNX. The patient’s doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach area (abdomen), fever, rash, itching, yellowing of your skin or whites of your eyes.
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.
Common side effects in patients treated with NERLYNX
In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood tests results, nail problems, dry skin, abdominal distention, weight loss, and urinary tract infection.
Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch
. Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).
Please see Full Prescribing Information, available at http://www.NERLYNX.com
. NERLYNX is a registered trademark of Puma Biotechnology.
ExceleraRx Corp. supports the Excelera Specialty Pharmacy Network, a national network of specialty pharmacies based at health systems and academic medical centers, enabling member organizations to gain access to limited distribution drugs and restricted payer agreements. The Excelera network provides national-scale efficiency and collaboration to improve quality and value of outpatient specialty drug therapy for population health outcomes. Excelera’s mission is to “provide tools, technology and best practices around high-performing specialty pharmacy capabilities to network members, so that they can provide integrated, coordinated care to complex patients at the point-of-care leading to improved health outcomes and decreased healthcare costs.” For a current list of Excelera specialty pharmacy network members, or for more information about becoming a member of the Excelera national specialty pharmacy network, visit excelerarx.com
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