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SAVAYSA
Thromboembolic disorders
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Drug Name:

SAVAYSA Rx

Generic Name and Formulations:
Edoxaban 15mg, 30mg, 60mg; tabs.

Company:
Daiichi Sankyo

Therapeutic Use:

Indications for SAVAYSA:

To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.

Limitations Of use:

Not for use in NVAF patients with CrCl >95mL/min.

Adult:

Assess CrCl prior to initiation. NVAF: CrCl >50mL/min: 60mg once daily; CrCl 15–50mL/min: 30mg once daily. DVT/PE: CrCl >50mL/min: 60mg once daily following initial parenteral anticoagulant; CrCl 15–50mL/min, body wt. ≤60kg, or concomitant P-gp inhibitors: 30mg once daily. Transition to or from Savaysa: see full labeling.

Children:

Not established.

Contraindications:

Active pathological bleeding.

Warnings/Precautions:

Reduced efficacy in NVAF patients with CrCl >95mL/min; use another anticoagulant. Premature dis­con­tin­uation increases risk of ischemic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture (eg, use of indwelling epidural catheters); monitor for signs/symptoms of neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Patients with mechanical heart valves or moderate-to-severe mitral stenosis: not recommended. Discontinue at least 24hrs before surgery. Renal impairment (CrCl <15mL/min), moderate or severe hepatic impairment (Child-Pugh B and C): not recommended. Labor & delivery. Pregnancy. Nursing ­mothers: not recommended.

Interactions:

Increased risk of bleeding with concomitant aspirin, other antiplatelets or antithrombotic agents, fibrinolytic therapy, chronic NSAIDs, SSRIs, and SNRIs; monitor. Concomitant other anticoagulants in long term therapy: not recommended. Avoid concomitant P-gp inducers (eg, rifampin).

Pharmacological Class:

Factor Xa inhibitor.

Adverse Reactions:

Bleeding (may be serious or fatal), anemia, rash, abnormal LFTs.

Generic Availability:

NO

How Supplied:

Tabs 15mg—30; 30mg, 60mg—30, 90, 500

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