TAVALISSE (fostamatinib disodium hexahydrate) Approved by FDA, Available for Order at Biologics, Inc.

May 29, 2018

CARY, N.C. (May 29, 2018) Biologics, Inc., a McKesson Specialty Health oncology, neurology and complex care pharmacy services company, announced today that it has been selected by Rigel Pharmaceuticals, Inc. to be in the limited distribution network for TAVALISSETM (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase(SYK) inhibitor for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

ITP is an autoimmune disease where the immune system attacks and destroys platelets in the blood, resulting in abnormally low platelet counts. There are approximately 60,000 patients with adult primary ITP in the U.S., and it qualifies as an orphan disease.1

TAVALISSE is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of the disease by impeding platelet destruction, providing an important new treatment option for adult patients with chronic ITP.2

Approval by The U.S. Food and Drug Administration (FDA) on April 17, 2018 was supported by data from the FIT clinical program, which included two randomized placebo-controlled Phase 3 trials (Studies 047 and 048) and an open-label extension (Study 049), as well as an initial proof of concept study.

“Adult patients with chronic immune thrombocytopenic purpura, an orphan disease, need a new therapy option today,” said Brandon Tom, VP, Commercial Services, McKesson Specialty Health. “We are excited to play a role in bringing this new treatment option to patients facing this devastating blood disease.”

Biologics’ oncology specialty pharmacy is committed to providing patient-centric care throughout the patient journey. The company is recognized across the industry for its high level of customer service and its innovative high-touch patient care model that supports patients with a multidisciplinary care team. Each team includes a pharmacist with in-depth knowledge of hematology-oncology pharmaceuticals, an experienced hematology-oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. This highly skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and that streamline communication back to the treating provider, empowering high-quality care and optimal outcomes.

Physicians may submit prescriptions to Biologics via phone (800-850-4306), fax (800-823-4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

For more information including full prescribing information and important safety information, please visit www.TAVALISSE.com

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 (e.g., rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (e.g., 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.

About Biologics

Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payers and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk.

Biologics is part of McKesson Specialty Health, a division of McKesson Corporation empowering the community patient care delivery system by helping community practices advance the science, technology and quality of care. Through innovative clinical research, business and operational solutions, facilitated by integrated technology systems, we focus on improving the financial health of our customers so they may provide the best care to their patients. Our combined organization will help better support patients and expedite access to oncology therapies. For more information, visit www.McKessonspecialtyhealth.com and www.biologicsinc.com.

1 Segal JB, et al. J Thromb Haemost. 2006;4(11):2377-2383

2 https://ir.rigel.com/news-releases/news-release-details/rigel-announces-fda-approval-tavalissetm-fostamatinib-disodium. Accessed 4/28/18.

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