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Rx Item-Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo

Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo item No.:RX370411 NDC No.65597020130 65597-201-30 6559720130 UPC No.:365597201309 NDC No. 65597-0201-30 UPC/GTIN No. 3-65597-20130-9 365597BRAND: SAVAYSA NDC: 65597-0201-30,65597020130 UPC: 3-65597-20130-9,365597201309 Daiichi SankyoOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo

$466.92$424.24

Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo Item No.: RX370411 NDC No.65597020130 65597-201-30 6559720130 UPC No.:365597201309 NDC No. 65597-0201-30 UPC/GTIN No. 3-65597-20130-9 365597-201309 365597201309 MPN 20130 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx370411 Savaysa 1

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For: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism. SAVAYSA- edoxaban tosylate tablet, film coated
Daiichi Sankyo, Inc.
WARNING (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMA

A. REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION 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, nonvalvular atrial fibrillation 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 [see Dosage and Administration (2.1), Warnings and Precautions (5.1), and Clinical Studies (14.1)].

B. 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 [see Dosage and Administration (2.4), Warnings and Precautions (5.2), and Clinical Studies (14.1)].

C. 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

[see Warnings and Precautions (5.4)].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.4)].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.4)].
1 INDICATIONS AND USAGE
1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).

Limitation of Use for NVAF

SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Clinical Studies (14.1)].
1.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism

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.
2 DOSAGE AND ADMINISTRATION
2.1 Nonvalvular Atrial Fibrillation

The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1), Clinical Studies (14.1)]. Assess creatinine clearance, as calculated using the Cockcroft-Gault equation* , before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min.

Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

* Cockcroft-Gault CrCL = (140-age) x (weight in kg) x (0.85 if female) / (72 x creatinine in mg/dL).
2.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism

The recommended dose of SAVAYSA is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2)].

The recommended dose of SAVAYSA is 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications based on clinical study data in this indication [see Clinical Studies (14.2)].
2.3 Administration Information

If a dose of SAVAYSA is missed, the dose should be taken as soon as possible on the same day. Dosing should resume the next day according to the normal dosing schedule. The dose should not be doubled to make up for a missed dose.

SAVAYSA can be taken without regard to food [see Clinical Pharmacology (12.3)].

Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo item No.:RX370411 NDC No.65597020130 65597-201-30 6559720130 UPC No.:365597201309 NDC No. 65597-0201-30 UPC/GTIN No. 3-65597-20130-9 365597
RX ITEM-Savaysa 15Mg Tab 30 By Daiichi S
Savaysa edoxaban tosylate ORAL 15Mg Tab 30 By Daiichi Sankyo item No.:RX370411 NDC No.65597020130 65597-201-30 6559720130 UPC No.:365597201309 NDC No. 65597-0201-30 UPC/GTIN No. 3-65597-20130-9 365597

BRAND: SAVAYSA NDC: 65597-0201-30,65597020130 UPC: 3-65597-20130-9,365597201309 Daiichi Sankyo
Savaysa 15Mg Tab 30 By Daiichi Sankyo
BRAND: SAVAYSA NDC: 65597-0201-30,65597020130 UPC: 3-65597-20130-9,365597201309 Daiichi Sankyo

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
EDOXABAN TOSYLATE ORAL TA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.