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DVT/PE Starter Pack
Dear Pharmacist,
Bayer Healthcare is pleased to announce the launch of the DVT/PE Starter Pack. This convenient format is available
for new VTE patients to facilitate the dosage transition during the first 28 days of treatment.1
Please detail to the patient that the DVT/PE Starter Pack is only for the first 28 days of
Xarelto® treatment and that they will need to schedule a follow-up appointment with
their healthcare provider to renew Xarelto® before the DVT/PE Starter Pack is completed
First 28 days of Xarelto® treatment included, with easy-to-follow
dosing instructions:1
  • 15 mg twice daily with food (42 tablets total) for the first 21 days
  • 20 mg once daily with food (7 tablets total) for days 22-28
A single-agent treatment approach from the time of diagnosis
Helps to facilitate the dosing transition
The only NOAC starter pack available for initiation of DVT/PE treatment*
Available through retail and outpatient pharmacies

Xarelto® is indicated for the treatment of venous thromboembolic events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE.


For the treatment of VTE, Xarelto® is not recommended as an alternative to unfractionated heparin in patients with acute pulmonary embolus who are haemodynamically unstable, or who may receive thrombolysis or pulmonary embolectomy, since the safety and efficacy of Xarelto® have not been established in these clinical situations.


Xarelto® is not recommended for use in children less than 18 years of age.


*Comparative clinical significance is unknown.


Xarelto®: Demonstrated Effective Oral Single Drug Treatment for DVT and PE

Xarelto®: demonstrated efficacy in VTE (DVT and PE) treatment1*†
Xarelto® was comparable to enoxaparin/VKA for symptomatic, recurrent VTE (EINSTEIN DVT trial: 2.1%/year vs. 3.0%/year,
P<0.001 for noninferiority, EINSTEIN PE trial: 2.1%/year vs. 1.8%/year, P<0.0026 for noninferiority)
Xarelto® provided effective treatment and prevention of recurrent DVT and PE with a demonstrated safety profile1‡§
Principal safety outcome (pooled analysis):
The rates of total major and clinically relevant nonmajor bleeding Xarelto® vs. enoxaparin/VKA were not statistically different
(9.4% vs. 10.0%, P=0.27)
Secondary safety outcome:
Significantly lower incidence of major bleeding events compared to enoxaparin/VKA (1.0% vs. 1.7%, P=0.0018)
Other outcome:
The rates of clinically relevant nonmajor bleeding Xarelto® vs. enoxaparin/VKA demonstrated no statistical significant
difference (8.6% vs. 8.7%, P=0.84)


Contraindications:

  • Clinically significant active bleeding, including gastrointestinal bleeding
  • Lesions or conditions at increased risk of clinically significant bleeding, e.g., recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
  • Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein (P-gp), such as ketoconazole, itraconazole, posaconazole, or ritonavir
  • Concomitant treatment with any other anticoagulant, including:
    - unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter,
    - low molecular weight heparins (LMWH), such as enoxaparin and dalteparin,
    - heparin derivatives, such as fondaparinux, and
    - oral anticoagulants, such as warfarin, dabigatran, apixaban, except under circumstances of switching therapy to or from Xarelto.
  • Hepatic disease (including Child-Pugh Class B and C) associated with coagulopathy, and having clinically relevant bleeding risk
  • Pregnancy
  • Nursing women
  • Hypersensitivity to Xarelto® (rivaroxaban) or to any ingredient in the formulation

Most serious warnings and precautions:

PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING Xarelto®, INCREASES THE RISK OF THROMBOTIC EVENTS. To reduce this risk, consider coverage with another anticoagulant if Xarelto® is discontinued for a reason other than pathological bleeding or completion of a course of therapy.

Bleeding: Xarelto® (rivaroxaban), like other anticoagulants, should be used with caution in patients with an increased bleeding risk. Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site. Patients at high risk of bleeding should not be prescribed Xarelto®.

Should severe bleeding occur, treatment with Xarelto® must be discontinued and the source of bleeding investigated promptly. See Other relevant warnings and precautions for concomitant use of drugs affecting hemostasis.

Peri-operative spinal/epidural anesthesia, lumbar puncture: The risk of developing an epidural or spinal hematoma that may result in long-term neurological injury or permanent paralysis is increased by the use of indwelling epidural catheters or the concomitant use of drugs affecting hemostasis. Accordingly, the use of Xarelto®, at doses greater than 10 mg, is not recommended in patients undergoing anesthesia with post-operative indwelling epidural catheters. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, the administration of Xarelto® should be delayed for 24 hours. Patients who have undergone epidural puncture and who are receiving Xarelto® should be frequently monitored for signs and symptoms of neurological impairment. If neurological deficits are noted, urgent diagnosis and treatment is necessary. The physician should consider the potential benefit versus the risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis and use Xarelto® only when the benefits clearly outweigh the possible risks. An epidural catheter should not be withdrawn earlier than 18 hours after the last administration of Xarelto®. Xarelto® should be administered not earlier than 6 hours after the removal of the catheter.

Renal impairment: Xarelto® is not recommended in patients with severe renal impairment. Xarelto® should be used with caution in patients with moderate renal impairment (CrCl 30-49 mL/min), especially in those concomitantly receiving other drugs which increase rivaroxaban plasma concentrations. Determine estimated creatinine clearance (eCrCl) in all patients before instituting Xarelto®.

Monitoring and laboratory tests: Although Xarelto® therapy will lead to an elevated INR, depending on the timing of the measurement, the INR is not a valid measure to assess the anticoagulant activity of Xarelto®. The INR is only calibrated and validated for vitamin K antagonists (VKA) and should not be used for any other anticoagulant, including Xarelto®.

Other relevant warnings and precautions:

  • Fall in hemoglobin or blood pressure
  • Concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA), and platelet aggregation inhibitors
  • Atrial fibrillation and having a condition that warrants single or dual antiplatelet therapy
  • Use of antiplatelet agents, prasugrel and ticagrelor
  • Use of thrombolytics during acute myocardial infarction (AMI) or acute stroke due to expected increased risk of major bleeding
  • Patients with prosthetic heart valves or those with hemodynamically significant rheumatic heart disease, especially mitral stenosis
  • Interaction with strong inhibitors of both CYP 3A4 and P-gp, such as ketaconazole, itraconazole, posaconazole, or ritonavir. These drugs may increase Xarelto® plasma concentrations which increases bleeding risk
  • Patients with mild and moderate renal impairment concomitantly treated with combined P-gp and moderate CYP 3A4 inhibitors such as erythromycin increased exposure to rivaroxaban. Caution is required
  • Interaction with strong CYP 3A4 inducers, such as rifampicin, and the anticonvulsants, phenytoin, carbamazepine, phenobarbital
  • Patients with hepatic impairment
  • Patients who undergo surgery or invasive procedures including fracture-related surgery of the lower limbs (limited clinical data), pre-operative phase (associated with risk of bleeding) and peri-operative phase when neuraxial (epidural/spinal) anesthesia or spinal puncture is performed (associated with risk of epidural or spinal hematoma that may result in long-term neurological injury or permanent paralysis) and post-procedural period (to avoid unnecessary increased risk of thrombosis)
  • Patients with lactose sensitivity


For more information:

Please consult the Xarelto® Product Monograph at http://bayer.ca/xarelto for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.
The product monograph is also available by calling 1-800-265-7382.

Sincerely,

Your Bayer Team


* Duration of administration in the EINSTEIN DVT and PE trials was up to 12 months (i.e., 3, 6 or 12 months). Nearly half of the subjects were treated for 6 to 9 months. Approximately 92% had actual treatment duration of at least 3 months, 68% of subjects had at least 6 months, and around 3% of subjects had at least 12 months in the EINSTEIN DVT trial. Approximately 92% had actual treatment duration of at least 3 months, 73% of subjects had at least 6 months, and around 4% of subjects had at least 12 months in the EINSTEIN PE trial.1
The EINSTEIN DVT and EINSTEIN PE trials were randomized, open label trials evaluating the efficacy and safety profile of oral Xarelto® vs. subcutaneous enoxaparin and VKA treatment of VTE and prevention of recurrent DVT and PE. Xarelto® regimen:
15 mg twice daily for 3 weeks, followed by 20 mg once daily. Enoxaparin + VKA regimen: enoxaparin 1 mg per kg of body weight for at least 5 days and discontinued when the international normalized ratio was 2.0 for 2 consecutive days, and VKA started within 48 hours of randomization. Treatment continued for 3, 6, or 12 months as determined by the treating physician. Results of analysis of the intent-to-treat population.
The studies were designed as event-driven, noninferiority studies.1
Results of the safety population from the pooled analysis of the EINSTEIN DVT and EINSTEIN PE trials, while patients were taking Xarelto® (N=4,130) or enoxaparin/VKA (N=4,116).1
§ Major bleeding event was defined as overt bleeding associated with a fall in hemoglobin of 2 g/dL or more; or leading to a transfusion of 2 or more units of packed red blood cells or whole blood; or that occurred in a critical site: intracranial, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death.1
Reference: 1. Xarelto® Product Monograph. Bayer Inc. July 20, 2015.



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Frank Humada, Director of Publishing, MultiView 289.695.5422
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