rivaroxaban

Warnings and precautions

Black Box Warning: Active bleeding Precautions: Pregnancy, breastfeeding, neonates, infants, children, adolescents, geriatric patients, moderate or severe hepatic disease (Child-Pugh Class B or C), hepatic disease associated with coagulop- athy, creatinine clearance <30 mL/min for use as DVT prophylaxis and <15 mL/min for stroke and systemic embolism prophy- laxis in nonvalvular atrial fibrillation, den- tal procedures, aneurysm, diabetes reti- nopathy, diverticulitis, endocarditis, GI bleeding, hypertension, obstetric delivery, peptic ulcer disease, stroke, surgery Black Box Warning: Abrupt discontinua- tion, epidermal/spinal anesthesia Patients, especially those with dental dis- ease, should be instructed in proper oral hygiene, including caution in use of regu- lar toothbrushes, dental floss, toothpicks Black Box Warning: Bleeding: monitor for bleeding, including bleeding during dental procedures (easy bruising, blood in urine, stools, emesis, sputum, epistaxis); there is no specific antidote Black Box Warning: Abrupt discontinu- ation: avoid abrupt discontinuation unless an alternative anticoagulant in those with atrial fibrillation; discontinuing puts patients at an increased risk of thrombotic events; if product must be discontinued for reasons other than pathologic bleeding, consider administering another anticoagulant Black Box Warning: Epidural/spinal anesthesia: epidural or spinal hemato- mas that result in long-term or permanent paralysis may occur in patients who have received anticoagulants and are receiv- ing neuraxial anesthesia or undergoing spinal puncture; epidural catheter should not be removed <18 hr after the last dose of rivaroxaban; do not administer the next rivaroxaban dose <6 hr after the catheter removal; delay rivaroxaban administra- tion for 24 hr if traumatic puncture oc- curs; monitor for neuro changes R • Hepatic/renal disease: increase in ef- fect of product in hepatic disease (Child- Pugh class B or C), hepatic disease with coagulopathy; renal failure/severe renal impairment (creatinine clearance <30 mL/min in DVT prophylaxis and <15 mL/ min for stroke or systemic embolism pro- phylaxis in nonvalvular atrial fibrillation); product should be discontinued in acute renal failure; reduce dose in those with atrial fibrillation and CrCl 15-50 mL/min; monitor renal function periodically (cre- atinine clearance, BUN) • Beers: avoid use in older adults with CCr <30 mL/min; reduce dose in CCr 30-50 mL/min • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; do not breastfeed, excretion unknown; preg- nancy-related hemorrhage may occur Black Box Warning: To report bleeding (bruising, blood in urine, stools, sputum, emesis, heavy menstrual flow); use soft toothbrush, electric shaver • To inform all health care providers of use; to report to prescriber all products used; to take all medication for the dura- tion, exactly as prescribed to prevent clots; to notify prescriber if unable to take so that a different anticoagulant may be used Black Box Warning: To avoid abrupt discontinuation without another blood thinner • To report numbness of extremities, weakness, tingling, contact prescriber immediately (neuraxial anesthesia, spi- nal puncture)

Source pages 1171, 1172, 1173, 1174