Xarelto Side Effects

XARELTO^® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO^® is a blood thinner medicine that reduces blood clotting. While you take XARELTO^® you are likely to bruise more easily and it may take longer for bleeding to stop.

increased risk of thrombotic events after Premature Discontinuation
risk of bleeding
spinal/epidural anesthesia or Puncture
Use in Patients with renal impairment
Use in Patients with hepatic impairment
Risk of Pregnancy-related Hemorrhage – ( should only be used if potential benefits outweigh the risks to the fetus and mother.
Prosthetic Heart Valves – This drug should not be used by patients with prosthetic heart valves.

Over Dosage

Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. A specific antidote for rivaroxaban is not available. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.

Warnings & Recalls for Xarelto

BOXED WARNING

Optimal timing between the administration of XARELTO and neuraxial procedures is not known
Premature discontinuation of Xarelto increases the risk of thrombotic events, and spinal/epidural hematoma.

WARNINGS AND PRECAUTIONS

Spinal/Epidural Anesthesia or Puncture

To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Increased Risk of Thrombotic Events after Premature Discontinuation - Premature discontinuation of any oral anticoagulant, including Xarelto, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events…
Patients with Prosthetic Heart Valves - The safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves. Therefore, use of Xarelto is not recommended in these patients.
Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.

Reversal of Anticoagulant Effect:

A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected. The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.
Avoid concomitant use of XARELTO with combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, and conivaptan).
Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).
The safety and efficacy of XARELTO have not been studied in patients with prosthetic heart valves. Therefore, use of XARELTO is not recommended in these patients.
Initiation of XARELTO is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

Use with P-gp and Strong CYP3A4 Inhibitors or Inducers Patients with Prosthetic Heart Valves Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy

Xarelto Treatment and Use

Xarelto® (known generically as Rivaroxaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.

XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

Other Names for Xarelto

rivaroxaban