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SAVAYSA for NVAF Nonvalvular Atrial Fibrillation & DVT/PE Deep Vein Thrombosis/Pulmonary Embolism
Nonvalvular Atrial Fibrillation
Deep Vein Thrombosis/ Pulmonary Embolism
SAVAYSA for NVAF & DVT/PE
SAVAYSA for NVAF
- For the reduction in the risk of stroke and systemic embolism (SE) in NVAF patients with creatinine clearance (CrCl) ≤ 95 mL/min
- The once-daily novel oral anticoagulant (NOAC) that offers: Superiority with less major bleeding vs warfarin1* & convenient once-daily dosing with or without food1
- SAVAYSA demonstrated a 16% relative risk reduction (RRR) in major bleeding* compared to warfarin in patients with CrCl ≤95 mL/min1
- 3.1%/year with SAVAYSA vs 3.7%/year with warfarin (HR [95% CI]: 0.84 [0.73-0.97])
- SAVAYSA also reduced risk of stroke/SE vs well-managed warfarin in patients with CrCl≤95 mL/min1†‡
- 1.2%/year with SAVAYSA vs 1.8%/year with warfarin (HR [95% CI]: 0.68 [0.55-0.84])
SAVAYSA for DVT/PE
- For the treatment of DVT/PE patients initiated with 5 to 10 days of a parenteral anticoagulant
- The once-daily NOAC that offers: Superiority with less clinically relevant bleeding vs warfarin1§ & convenient once-daily dosing with or without food1
- SAVAYSA demonstrated a 19% RRR, 1.8% absolute risk reduction (ARR) in clinically relevant bleeding§ compared to warfarin1
- 8.5% with SAVAYSA vs 10.3% with warfarin (HR [95% CI]: 0.81 [0.71-0.94]); P=0.004
- Savaysa was noninferior vs warfarin in reducing the rate of recurrent DVT/PE1||
- 3.2% with SAVAYSA vs 3.5% with warfarin (HR [95% Cl]: 0.89 [0.70-1.13])
SAVAYSA® (edoxaban) is indicated to reduce the risk of stroke and SE in patients with NVAF. SAVAYSA should not be used in patients with CrCl >95 mL/min because of an increased risk of ischemic stroke compared to warfarin.
SAVAYSA is indicated for the treatment of deep DVT and PE following 5 to 10 days of initial therapy with a parenteral anticoagulant.
*The primary safety endpoint was major bleeding that occurred during or within 2 days of stopping study treatment. Major bleeding was defined as clinically overt bleeding that met 1 of the following criteria: fatal bleeding, symptomatic bleeding in critical area/organ, caused a fall in hemoglobin of at least 2.0 g/dL (or a fall in hematocrit of at least 6.0%), when adjusted for transfusions (1 unit of transfusion=1.0 g/dL drop in hemoglobin).
†The primary efficacy endpoint of the study was the occurrence of first stroke (either ischemic or hemorrhagic) or systemic embolism (SE).
‡Mean time in therapeutic range (INR target 2.0 to 3.0): 65%
ENGAGE AF-TIMI 48 study information: A multinational, randomized, double-blind, noninferiority study comparing the efficacy and safety of SAVAYSA 60 mg (N=7012) and warfarin (N=7012) in NVAF patients with CHADS2 ≥2. Patients randomized to SAVAYSA received 30 mg if 1 or more of the following clinical factors were present: CrCl ≤50 mL/min, low body weight (≤60 kg/132 lb), or concomitant use of specific P-gp inhibitors. According to the approved label for SAVAYSA, no dose reduction is recommended for concomitant P-gp inhibitor use or for low body weight (≤60 kg). The median treatment duration was 2.5 years and the median age was 72 years. Approximately 77% of the patients in the study had CrCl ≤95 mL/min (N=5417 for SAVAYSA, N=5485 for warfarin)1,2
§Clinically relevant bleeding (the study primary safety endpoint) was defined as a composite of major and clinically relevant non-major (CRNM) bleeding. A Major Bleeding event was defined as clinically overt bleeding that met one of the following criteria: associated with a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of 2 or more units of packed red cells or whole blood; occurring in a critical site or organ: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; contributing to death.
CRNM bleeding was defined as overt bleeding not meeting the criteria for a Major Bleeding event but that was associated with a medical intervention, an unscheduled contact (visit or telephone call) with a physician, temporary cessation of study treatment, or associated with discomfort for the subject such as pain, or impairment of activities of daily life.
||The primary efficacy endpoint of the study was the occurrence of symptomatic VTE, defined as the composite of recurrent DVT, new nonfatal symptomatic PE, and fatal PE during the 12-month study period.
Hokusai-VTE Study Information: A multinational, double-blind study that compared the efficacy and safety of SAVAYSA 60 mg (N=4118) once daily to warfarin (N=4122, titrated to INR 2.0 to 3.0) in patients with acute symptomatic VTE. All patients received initial heparin therapy for at least 5 days. Blinded drug treatment in the warfarin arm was started concurrently with initial heparin therapy and in the SAVAYSA arm after discontinuation of initial heparin. Patients in the SAVAYSA arm received 30 mg once daily if they met one or more of the following criteria: CrCl 30 to 50 mL/min, body weight ≤60 kg/132 lb, or concomitant use of specific P-gp inhibitors. The mean age was 56 years. The mean treatment duration was 252 days for SAVAYSA and 250 days for warfarin.1,3
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Important Safery Information
SAVAYSA® (edoxaban) is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). SAVAYSA should not be used in patients with creatinine clearance (CrCl) >95 mL/min because of an increased risk of ischemic stroke compared to warfarin.
SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.
- REDUCED EFFICACY IN NVAF PATIENTS WITH CRCL >95 ML/MIN
SAVAYSA should not be used in patients with CrCl >95 mL/min. In the ENGAGE AF-TIMI 48 study, NVAF patients with CrCl >95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used.
- PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS
Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance in the Prescribing Information.
- SPINAL/EPIDURAL HEMATOMA
- Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures
- Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery
- Optimal timing between the administration of SAVAYSA and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
SAVAYSA is contraindicated in patients with active pathological bleeding.
SAVAYSA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly evaluate any signs or symptoms of blood loss. Discontinue SAVAYSA in patients with active pathological bleeding. Concomitant use of drugs affecting hemostasis may increase the risk of bleeding. These include aspirin and other antiplatelet agents, other antithrombotic agents, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse its anticoagulant activity.
Mechanical Heart Valves or Moderate to Severe Mitral Stenosis
The safety and efficacy of SAVAYSA has not been studied in patients with mechanical heart valves or moderate to severe mitral stenosis. SAVAYSA is not recommended in these patients.
- NVAF: The most common adverse reactions (≥5%) are bleeding and anemia
- DVT/PE: The most common adverse reactions (≥1%) are bleeding, rash, abnormal liver function tests and anemia
Discontinue SAVAYSA at least 24 hours before invasive or surgical procedures because of the risk of bleeding. SAVAYSA can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established.
- Anticoagulants, Antiplatelets, and Thrombolytics: Coadministration of anticoagulants, antiplatelet drugs, and thrombolytics may increase the risk of bleeding
- P-gp Inducers: Avoid concomitant use of SAVAYSA with rifampin
- P-gp Inhibitors (DVT/PE only): Coadministration of certain P-gp inhibitor medications requires a dose reduction of SAVAYSA to 30 mg once daily
- Nursing mothers: Discontinue drug or discontinue nursing
- Impaired renal function (CrCl 15 to 50 mL/min): Reduce SAVAYSA dose to 30 mg once daily
- Moderate or severe hepatic impairment: Not recommended
- Pregnancy Category C
Savings Card Terms & Conditions
SAVAYSA® (edoxaban) Savings Card:
Eligibility Criteria and Terms & Conditions
Eligibility Criteria: Residents of US or Puerto Rico, 18 years of age or older, with valid prescription for SAVAYSA. Not valid if enrolled in state or federally funded prescription benefit program, including but not limited to Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD) or TRICARE programs, or if prohibited by law. Patients who move from commercial to state or federally funded prescription insurance will no longer be eligible.
Terms & Conditions: For patients with commercial insurance, or patients without insurance, this savings card is applied after the following out-of-pocket expenses are met: $4 for a 30-day prescription or $12 for a 90-day prescription. This card is not insurance and does not cover deductibles. The maximum benefit is $270 per 30-day prescription or $810 per 90-day prescription. For patients with commercial insurance or without insurance, card activation must occur by 12/31/17 and program expiration is 12/31/18. This offer is not conditioned on any past, present, or future purchases, including refills. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by patients through this offer. Patient acceptance (use) of this offer constitutes an acknowledgement that it is not prohibited by the patient’s insurance, and that patient will report the value received if required by the insurance provider. This offer is non-transferrable and no substitutions are permissible. Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Reproductions of the card are void.
If your pharmacy does not accept the SAVAYSA Savings Card, visit www.patientrebateonline.com for instructions on how to obtain the savings benefit or call the number below. This is not insurance.
By using this card, you certify you meet the Eligibility Criteria and Terms & Conditions.
Pharmacist & Patient Questions:
Call 1-844-SAVAYSA (1-844-728-2972), 8 AM–8 PM EST, M–F.
Pharmacist Conditions: By using this card, you certify that the Eligibility Criteria are met. Submit transaction to McKesson Corp, using BIN #610524. If primary coverage exists, input card information as secondary coverage and transmit using COB segment of NCPDP transaction. Applicable discounts will be displayed in the transaction response. Acceptance of this card and your submission of claims for the SAVAYSA Savings Card program are subject to SAVAYSA Savings Card program Terms & Conditions posted at www.mckesson.com/mprstnc.
Daiichi Sankyo, Inc., reserves the right to rescind, revoke, or amend this program, at any time, without notice.