Thromboembolic disorders:

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 Dosage:

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 Dosage:

Not established.

SAVAYSA Contraindications:

Active pathological bleeding.

Boxed Warning:

Reduced efficacy in nonvalvular atrial fibrillation (NVAF) patients with CrCl >95mL/min. Premature discontinuation increases the risk of ischemic events. Spinal/epidural hematoma.

SAVAYSA 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 neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Patients with mechanical heart valves, moderate to severe mitral stenosis, triple(+) antiphospholipid syndrome (increased risk of thrombosis): 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. Females of reproductive potential. Abnormal uterine bleeding. Nursing ­mothers: not recommended.

SAVAYSA Classification:

Factor Xa inhibitor.

SAVAYSA 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. Monitor for bleeding in chronic treatment with low dose aspirin and/or NSAIDs. Avoid concomitant P-gp inducers (eg, rifampin).

Adverse Reactions:

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

Generic Drug Availability:


How Supplied:

Tabs 15mg—30; 30mg, 60mg—30, 90, 500