Posts Tagged ‘Rivaroxaban’
Stephan Moll, MD writes… Interesting and noteworthy observations published in the last 2 weeks: Heavy menstrual bleeding appears to occur more commonly with Xarelto® than with warfarin [ref 1] and may be also more common with Xarelto® than with Eliquis® [ref 2].
Stephan Moll, MD writes (on Nov 7th, 2014)… A N Engl J Med publication this week [ref 1] reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants. Read the rest of this entry »
Stephan Moll, MD writes… Is there a dose change or limitation for the use of Xarelto® (rivaroxaban) in very obese or underweight patients? Read the rest of this entry »
Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE. Read the rest of this entry »
Stephan Moll, MD writes… Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials. The dose is 150 mg twice daily for patients with a GFR > 30 ml/min. Due to the design of the RECOVER and RECOVER II trials, the drug is approved to be used in the patient with acute DVT or PE only AFTER 5-10 days of a parenteral anticoagulant have been given – not immediately from day zero onwards. The full package insert is here. The press release from Boehringer-Ingelheim is here. The FDA approval status of the four big new oral anticoagulants for the various indications is summarized in this table.
Disclosures: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last updated: April 7th, 2014
Stephan Moll, MD writes… On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE. The press release of BMS is here. The goal date for a decision by the FDA is August 25, 2014. Read the rest of this entry »
Stephan Moll, MD writes…
1. Pradaxa (Dabigatran)
- Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here.
- At present, in the US, Pradaxa is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
2. Eliquis (Apixaban)
- On July 11th , 2013 the company making Eliquis applied for FDA approval of their drug for DVT and PE prevention after hip and knee replacement surgery – details here.
- The company has not yet filed for approval of the drug for DVT and PE treatment.
- At present, in the US, Eliquis is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
3. Xarelto (Rivaroxaban)
- Xarelto is, at present the only one of the new oral anticoagulants that is FDA-approved for the treatment of DVT and PE. It is also approved for (a) DVT and PE prevention after hip and knee replacement surgery, and (b) for prevention of stroke and other arterial clots in patients with irregular heart beat.
- This new oral anticoagulant by the Japanese company Daiichi is not FDA-approved at this time and no FDA review of data is pending.
Disclosure: I have consulted for Janssen, Daiichi, Boehringer Ingelheim.
Last updated: Sept 1st, 2013
Stephan Moll, MD writes… A major international coagulation conference, the bi-annual meeting of the International Society for Thrombosis and Haemostasis (ISTH; www.isth.org), took place in Amsterdam, Holland, from June 29th to July 4th, 2013. The clinically relevant highlights about thrombosis and anticoagulation are summarized below. Read the rest of this entry »
Stephan Moll, MD writes…
Xarelto® is FDA approved for treatment of venous thromboembolism (VTE), prevention of VTE after hip and knee replacement surgery, and for atrial fibrillation. A number of practical management questions are encountered by physicians, pharmacists, and other health care professional taking care of patients on Xarelto®, such as (a) dosing in renal impairment, (b) conversion of a patient on warfarin to Xarelto®, (c) discontinuation of Xarelto® at times of surgery, dental procedures, colonoscopy, and other procedures, and (d) management of bleeding on Xarelto®. These issues may best be addressed in a health care system by the establishment of a structured treatment algorithm/guide/help for the entire hospital or physician practice. Read the rest of this entry »
Stephan Moll, MD writes…
Today is a very exciting day for patients and health care professionals: the oral anticoagulant Xarelto® (rivaroxaban) was FDA approved today (Nov 2nd, 2012) for the use in patients with DVT and PE – for the acute treatment of DVT and PE, as well as for the secondary long-term prevention of recurrent venous thromboembolism (VTE). The FDA announcement can be read, here. Why is this exciting? Because therapy with Xarelto is much easier for patients and health care professionals than the often cumbersome therapy with warfarin.