XARELTO for ORAL SUSP Rx

Thromboembolic disorders:

Indications for: XARELTO for ORAL SUSP

Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to <18yrs after at least 5 days of initial parenteral anticoagulant treatment. Thromboprophylaxis in pediatric patients aged ≥2yrs with congenital heart disease after undergoing the Fontan procedure.

Adult Dosage:

Not applicable.

Children Dosage:

VTE: <6mos (<37 weeks of gestation at birth); (<10 days of oral feeding); or (<2.6kg): not recommended. Take with feeding or food. May be given via NG or gastric tube. (2.6–2.9kg): 0.8mg oral susp 3 times daily; (3–3.9kg): 0.9mg oral susp 3 times daily; (4–4.9kg): 1.4mg oral susp 3 times daily; (5–6.9kg): 1.6mg oral susp 3 times daily; (7–7.9kg): 1.8mg oral susp 3 times daily; (8–8.9kg): 2.4mg oral susp 3 times daily; (9–9.9kg): 2.8mg oral susp 3 times daily; (10–11.9kg): 3mg oral susp 3 times daily; (12–29.9kg): 5mg oral susp 2 times daily; (30–49.9kg): 15mg oral susp or tab once daily; (≥50kg): 20mg oral susp or tab once daily. Pediatric patients with or without catheter-related thrombosis: see full labeling. Thromboprophylaxis: <2yrs: not established. Take with or without food. ≥2yrs (7–7.9kg): 1.1mg oral susp 2 times daily; (8–9.9kg): 1.6mg oral susp 2 times daily; (10–11.9kg): 1.7mg oral susp 2 times daily; (12–19.9kg): 2mg oral susp 2 times daily; (20–29.9kg): 2.5mg oral susp 2 times daily; (30–49.9kg): 7.5mg oral susp once daily; (≥50kg): 10mg oral susp or tab once daily. Use of 2.5mg tabs are not recommended. If unable to swallow 10, 15, or 20mg whole tabs; may give oral susp. Renal impairment, switching to or from warfarin, or other anticoagulants: see full labeling.

XARELTO for ORAL SUSP Contraindications:

Active pathological bleeding.

Boxed Warning:

Premature discontinuation increases risk of thrombotic events. Spinal/epidural hematoma.

XARELTO for ORAL SUSP Warnings/Precautions:

Premature discontinuation increases risk of thrombotic 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 (see full labeling); monitor for signs/symptoms of neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Do not use for primary VTE prophylaxis in hospitalized, acutely ill medical patients at high risk of bleeding (see full labeling). Patients with prosthetic heart valves, triple-positive antiphospholipid syndrome, pulmonary embolism (presenting hemodynamic instability), or those requiring thrombolysis or pulmonary embolectomy: not recommended. Moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. Assess renal function periodically; consider dose adjustment or discontinue if acute renal failure develops. Renal impairment: see full labeling. Discontinue ≥24hrs before surgery. Elderly. Labor & delivery. Pregnancy: risk of pregnancy-related hemorrhage. Nursing mothers.

See Also:

XARELTO for ORAL SUSP Classification:

Factor Xa inhibitor.

XARELTO for ORAL SUSP Interactions:

Increased risk of bleeding with concomitant aspirin, clopidogrel, enoxaparin, warfarin, chronic NSAIDs. Avoid concomitant aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, NSAIDs, SSRIs, SNRIs, combined P-gp and strong CYP3A inhibitors (eg, ketoconazole, ritonavir). Increased thrombotic events with combined P-gp and strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort); avoid. Renal impairment (CrCl 15–<80mL/min): do not use Xarelto if receiving concomitant combined P-gp and moderate CYP3A inhibitors (eg, erythromycin), unless benefit justifies the risk.

Adverse Reactions:

Bleeding events (may be serious or fatal), back pain, wound secretion, pruritus, pain in extremity, abdominal pain, blister.

Generic Drug Availability:

NO

How Supplied:

Tabs 2.5mg—60, 180, 100 (10×10 blister cards); 10mg, 15mg—30, 90, 100 (10×10 blister cards); 20mg—30, 90, 1000, 100 (10×10 blister cards); Starter Pack (for DVT/PE)—1 (51 tabs); Susp—150mL (w. oral dosing syringes)