On November 30, 2017 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that new data on the Company’s first FDA-approved anticoagulant, betrixaban, and its two investigational hematologic compounds – the anticoagulant reversal agent andexanet alfa and the oral, dual Syk/JAK kinase inhibitor cerdulatinib – will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 9-12 in Atlanta, Georgia (Press release, Portola Pharmaceuticals, NOV 30, 2017, View Source;p=RssLanding&cat=news&id=2319373 [SID1234522319]). The Company also will present outcomes-based research on prophylaxis of venous thromboembolism in two real-world settings.
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Oral Presentation Details:
• Presentation Title: Effect of Andexanet-TFPI Interaction on in Vitro Thrombin Formation and Coagulation Markers in the TF-Pathway
Session: 332 (Antithrombotic Therapy: Anticoagulation in Cancer and Beyond)
Presenter: Genmin Lu, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 at 11:30 a.m. ET
Location: Building B, Level 2, B207-B208 (Georgia World Congress Center)
Poster Presentation Details:
• Poster Title: Physiologically-Based Pharmacokinetic (PBPK) Modeling for Betrixaban and the Impact of P-glycoprotein Inhibition on Betrixaban Pharmacokinetics
Poster Session: 321 (Blood Coagulation and Fibrinolytic Factors: Poster III)
Presenter: Janet M. Leeds, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Impact of D-Dimer Assays Performed at Local Labs vs. Central Laboratory in the Evaluation of APEX Trial Outcomes
Poster Session: 332 (Antithrombotic Therapy: Poster II)
Presenter: Lisa Jennings, Ph.D., CirQuest Labs, Memphis, Tennessee
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Did Patients with Renal Disease Receive Sufficient Prophylaxis for Venous Thromboembolism in the Real-World Settings?: A Study Among Hospitalized Acutely Medically Ill Patients
Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster II)
Presenter: Donna Hesari, R.N., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: The Frequency of Venous Thromboembolism (VTE) Prophylaxis Among Patients Hospitalized for Cancer in the US
Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster III)
Presenter: Andrea Hafeman, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B Cell Malignancies: Results from a Phase I Dose Escalation Study
Poster Session: 623 (Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II)
Presenter: Greg Coffey, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
Important U.S. Safety Information for Bevyxxa (betrixaban) capsules
INDICATION
Bevyxxa is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
LIMITATIONS OF USE
The safety and effectiveness of Bevyxxa have not been established in patients with prosthetic heart valves because this population has not been studied.
SELECT IMPORTANT SAFETY INFORMATION
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WARNING: SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH BEVYXXA WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE RISK OF THESE EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING EPIDURAL CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS AFFECTING HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
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CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to Bevyxxa
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Bevyxxa increases the risk of bleeding and can cause serious and potentially fatal bleeding
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs)
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room
Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement
Discontinue Bevyxxa in patients with active pathological bleeding
There is no established way to reverse the anticoagulant effect of Bevyxxa, which can be expected to persist for at least 72hours after the last dose
It is unknown whether hemodialysis removes Bevyxxa
Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of Bevyxxa
Spinal/Epidural Anesthesia or Puncture
When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis
Do not remove an epidural catheter earlier than 72hours after the last administration of Bevyxxa. The next Bevyxxa dose is not to be administered earlier than 5hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Bevyxxa for 72hours
Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary
Prior to neuraxial intervention, consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis
Use in Patients with Severe Renal Impairment
Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking Bevyxxa may have anincreased risk of bleeding events
Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients
Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors
Patients on concomitant P-gp inhibitors with Bevyxxa may have an increased risk of bleeding
Reduce dose of Bevyxxa in patients receiving or starting concomitant P-gp inhibitors, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients
Avoid use of Bevyxxa in patients with severe renal impairment receiving concomitant P‑gp inhibitors
ADVERSE REACTIONS
The most common adverse reactions with Bevyxxa were related to bleeding (> 5%)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment
Bevyxxa has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities
Bevyxxa is not recommended in patients with hepatic impairment