TSRO Announces Availability of VARUBI for Delayed Nausea
Nov 28, 2017 13:13:42 GMT
stcks, icemandios, and 5 more like this
Post by gutset on Nov 28, 2017 13:13:42 GMT
TESARO Announces Availability of VARUBI® (rolapitant) IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy in the United States
8:00 AM ET, 11/28/2017 - GlobeNewswire
VARUBI injectable emulsion features ready-to-use, single-dose vialNo saline, reconstitution or mixing is required to utilize VARUBI IVNew formulation offers healthcare providers flexibility in their choice of antiemetic regimenMajority of NK-1 receptor antagonist doses are administered intravenously in the U.S.
WALTHAM, Mass., Nov. 28, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that VARUBI® (rolapitant) IV, is now available in the United States. The U.S. Food and Drug Administration (FDA) approved VARUBI injectable emulsion on October 25, 2017, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Speaking Up About CINV
“The U.S. launch of VARUBI IV reinforces TESARO’s ongoing commitment to developing and commercializing therapies for people facing cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “VARUBI IV offers healthcare providers an easy-to-use option for the prevention of delayed CINV. The ready-to-use, single-dose vial does not require saline and eliminates the need for reconstitution and mixing, and can be easily adopted into existing practice patterns. We are confident that we have the right team and strategy in place to ensure this product is made available in the clinic or hospital to all patients in need.”
VARUBI is a highly selective and potent antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy-induced nausea and vomiting (CINV). With a long plasma half-life of approximately seven days, a single dose of VARUBI, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV. Results from three Phase 3 trials of VARUBI oral tablets demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. As a result, patients may be protected from nausea and vomiting during their most vulnerable time, in the days following chemotherapy. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. Results from a bioequivalence trial demonstrated comparability of the IV and oral formulations of VARUBI.
VARUBI IV is supplied in ready-to-use vials and does not require refrigerated storage or mixing. As a result, utilization in busy chemotherapy clinics is straightforward and easily adopted into existing practice patterns for administration of antiemetic regimens associated with emetogenic chemotherapy. VARUBI IV is to be administered up to two hours before chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone. No dosage adjustment is required for dexamethasone, a CYP3A4 substrate, and VARUBI is the first intravenously administered NK-1 receptor antagonist approved by the FDA that does not contain polysorbate 80.
“As an oncology nurse, I see the pressing need for a product like VARUBI IV for our patients,” said Robin Wachsman, RN, BSN, CCRN, OCN, BCN, Director of Women’s Oncology Services, Baptist Medical Group, Memphis, TN. “With a polysorbate 80-free formulation and a long half-life, provided in a ready-to-use vial that does not require refrigeration, VARUBI IV will be a very welcomed addition to our anti-emetic regimen.”
“Severe shortages of intravenous fluids continue to plague practices across the country,” said Erin R. Fox, PharmD, BCPS, Senior Director, Drug Information at University of Utah Health. “Medications that are available in ready-to-use vials offer organizations a potential option to overcome this challenge and meet the needs of their patients.”
The full prescribing information for VARUBI IV will be available at www.VarubiRx.com.
TOGETHER with TESARO™TOGETHER with TESARO™ is a patient resource program dedicated to supporting people living with cancer. The program assists with access issues, so that patients with cancer can be free to focus on treatment goals and simply living life. It provides a full suite of services to meet each patient’s needs and individual experience. A team of access and affordability experts is available to help oncology practices and patients gain access to the medication they require. TOGETHER with TESARO will continue to evolve and grow to meet provider and patient needs.
For more information, please visit www.togetherwithtesaro.com or call 1-844-2TESARO (1-844-283-7276).
About Chemotherapy-Induced Nausea and Vomiting (CINV)Chemotherapy-induced nausea and vomiting is a debilitating, yet often preventable side effect of chemotherapy. Up to 50% of patients undergoing highly or moderately emetogenic chemotherapy experience delayed CINV (25 to 120 hours post chemotherapy) — even when prescribed a 5-HT3 receptor antagonist and corticosteroid. Blocking both 5-HT3 and NK-1 receptors has been shown to offer better control of nausea and vomiting than inhibiting 5-HT3 receptors alone. Adding a single dose of VARUBI to an antiemetic regimen, including a 5-HT3 receptor antagonist and corticosteroid, further improves prevention of CINV in the delayed phase following chemotherapy.
8:00 AM ET, 11/28/2017 - GlobeNewswire
VARUBI injectable emulsion features ready-to-use, single-dose vialNo saline, reconstitution or mixing is required to utilize VARUBI IVNew formulation offers healthcare providers flexibility in their choice of antiemetic regimenMajority of NK-1 receptor antagonist doses are administered intravenously in the U.S.
WALTHAM, Mass., Nov. 28, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that VARUBI® (rolapitant) IV, is now available in the United States. The U.S. Food and Drug Administration (FDA) approved VARUBI injectable emulsion on October 25, 2017, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Speaking Up About CINV
“The U.S. launch of VARUBI IV reinforces TESARO’s ongoing commitment to developing and commercializing therapies for people facing cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “VARUBI IV offers healthcare providers an easy-to-use option for the prevention of delayed CINV. The ready-to-use, single-dose vial does not require saline and eliminates the need for reconstitution and mixing, and can be easily adopted into existing practice patterns. We are confident that we have the right team and strategy in place to ensure this product is made available in the clinic or hospital to all patients in need.”
VARUBI is a highly selective and potent antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy-induced nausea and vomiting (CINV). With a long plasma half-life of approximately seven days, a single dose of VARUBI, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV. Results from three Phase 3 trials of VARUBI oral tablets demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. As a result, patients may be protected from nausea and vomiting during their most vulnerable time, in the days following chemotherapy. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. Results from a bioequivalence trial demonstrated comparability of the IV and oral formulations of VARUBI.
VARUBI IV is supplied in ready-to-use vials and does not require refrigerated storage or mixing. As a result, utilization in busy chemotherapy clinics is straightforward and easily adopted into existing practice patterns for administration of antiemetic regimens associated with emetogenic chemotherapy. VARUBI IV is to be administered up to two hours before chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone. No dosage adjustment is required for dexamethasone, a CYP3A4 substrate, and VARUBI is the first intravenously administered NK-1 receptor antagonist approved by the FDA that does not contain polysorbate 80.
“As an oncology nurse, I see the pressing need for a product like VARUBI IV for our patients,” said Robin Wachsman, RN, BSN, CCRN, OCN, BCN, Director of Women’s Oncology Services, Baptist Medical Group, Memphis, TN. “With a polysorbate 80-free formulation and a long half-life, provided in a ready-to-use vial that does not require refrigeration, VARUBI IV will be a very welcomed addition to our anti-emetic regimen.”
“Severe shortages of intravenous fluids continue to plague practices across the country,” said Erin R. Fox, PharmD, BCPS, Senior Director, Drug Information at University of Utah Health. “Medications that are available in ready-to-use vials offer organizations a potential option to overcome this challenge and meet the needs of their patients.”
The full prescribing information for VARUBI IV will be available at www.VarubiRx.com.
TOGETHER with TESARO™TOGETHER with TESARO™ is a patient resource program dedicated to supporting people living with cancer. The program assists with access issues, so that patients with cancer can be free to focus on treatment goals and simply living life. It provides a full suite of services to meet each patient’s needs and individual experience. A team of access and affordability experts is available to help oncology practices and patients gain access to the medication they require. TOGETHER with TESARO will continue to evolve and grow to meet provider and patient needs.
For more information, please visit www.togetherwithtesaro.com or call 1-844-2TESARO (1-844-283-7276).
About Chemotherapy-Induced Nausea and Vomiting (CINV)Chemotherapy-induced nausea and vomiting is a debilitating, yet often preventable side effect of chemotherapy. Up to 50% of patients undergoing highly or moderately emetogenic chemotherapy experience delayed CINV (25 to 120 hours post chemotherapy) — even when prescribed a 5-HT3 receptor antagonist and corticosteroid. Blocking both 5-HT3 and NK-1 receptors has been shown to offer better control of nausea and vomiting than inhibiting 5-HT3 receptors alone. Adding a single dose of VARUBI to an antiemetic regimen, including a 5-HT3 receptor antagonist and corticosteroid, further improves prevention of CINV in the delayed phase following chemotherapy.