Safety & Efficacy in Patients | SAVAYSA® (edoxaban) | HCP
banner-dvt/pe-safety-and-efficacy
For DVT/PE patients initiated with a parenteral anticoagulant, give them the only NOAC that offers:
Superiority with less
clinically relevant
bleeding vs warfarin1
& convenient
once-daily dosing with
or without food1
The SAVAYSA Savings Card
Print out a Savings Card for your eligible patients today!
Not valid if enrolled in state or federally funded prescription benefit program (eg, Medicare Part D/Medicaid) or if prohibited by law.
DVT- PE Safety Tab
When considering an OAC for DVT/PE patients initiated with 5 to 10 days of a parenteral anticoagulant
Choose the once-daily NOAC that offers superiority to warfarin with less clinically relevant bleeding1
Rates of CRNM bleeding of once-daily SAVAYSA vs warfarin1
- SAVAYSA (n=298): 7.2% vs warfarin (n=368): 8.9%
CRNM=Clinically Relevant Non-Major; DVT=deep vein thrombosis; NOAC=novel oral anticoagulant; OAC=oral anticoagulant; PE=pulmonary embolism.
DVT- PE Efficacy Tab
Efficacy–effective vs well-managed warfarin (median TTR: 66%)1
Effective regardless of qualifying DVT/PE event1,2
- Entry DVT (60% of patients): SAVAYSA 3.4%, warfarin 3.3% (HR [95% CI]: 1.02 [0.75-1.38])
- Entry PE (40% of patients): SAVAYSA 2.8%, warfarin 3.9% (HR [95% CI]: 0.73 [0.50-1.06])
HOKUSAI-VTE enrolled many patients with NT-ProBNP levels ≥500 pg/mL
- 60% of 8240 patients had DVT only at study entry. 2468 received once-daily SAVAYSA and 2453 received warfarin titrated to INR 2.0 to 3.01
- 40% of 8240 patients had PE (with or without DVT) at study entry. 1650 received once-daily SAVAYSA and 1669 received warfarin titrated to INR 2.0 to 3.01
- 31.4% (930 out of 2960)* of patients with PE had NT-ProBNP ≥500 pg/mL3
*2960 of the 3319 patients with entry PE had an assessable NT-ProBNP measurement at baseline.3
DVT=deep vein thrombosis; INR=international normalized ratio; NOAC=novel oral anticoagulant; NT-proBNP=N-terminal pro-brain natriuretic peptide; PE=pulmonary embolism.
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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.
BOXED WARNINGS
- 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.
Bleeding Risk
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.
Increase Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome
Direct-acting oral anticoagulants (DOACs), including SAVAYSA, are not recommended for use in patients with triple positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies], treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
- 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, Thrombolytics, and SSRIs/SNRIs: Coadministration of anticoagulants, antiplatelet drugs, thrombolytics, and SSRIs or SNRIs 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
- Lactation: Breastfeeding not recommended
- Pregnancy: Insufficient data to determine drug-associated risks for adverse developmental outcomes
- Impaired renal function (CrCl 15 to 50 mL/min): Reduce SAVAYSA dose to 30 mg once daily
- Moderate or severe hepatic impairment: Not recommended
- Females and Males of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including SAVAYSA should be assessed in these patients and those with abnormal uterine bleeding.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
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 (eg, Medicare Part D/Medicaid) or if prohibited by law.
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. 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.
If your pharmacy does not accept the SAVAYSA Savings Card, visit www.patientrebateonline.com for instructions on how to obtain the savings benefit. This is not insurance. By using this card, you certify you meet the Eligibility Criteria and Terms & Conditions.
Pharmacist and Patient Questions: Call (877) 264-2440 (8 AM-8 PM ET, Monday-Friday).
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. The SAVAYSA Savings Card is not valid for use with any other prescription drug discount or cash cards for SAVAYSA. Claims submitted utilizing the program are subject to audit or validation.
Daiichi Sankyo, Inc., reserves the right to rescind, revoke, or amend this program, at any time, without notice.
