Apixaban - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Apixaban. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
BOXED WARNING WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration , Warnings and Precautions , and Clinical Studies ] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of apixaban and neuraxial procedures is not known [see Warnings and Precautions ] Monitor patients frequently for signs and symptoms of neurolog
5 WARNINGS AND PRECAUTIONS Apixaban can cause serious, potentially fatal, bleeding.
Promptly evaluate signs and symptoms of blood loss.
An agent to reverse the anti-factor Xa activity of apixaban is available Prosthetic heart valves: Apixaban use not recommended.
Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholid Syndrome: Apixaban Tablets are use not recommended.
5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including apixaban tablets, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events.
An increased rate of stroke was observed during the transition from apixaban tablets to warfarin in clinical trials in atrial fibrillation patients.
If apixaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration and Clinical Studies ].
5.2 Bleeding Apixaban tablets increases the risk of bleeding and can cause serious, potentially fatal, bleeding [see Dosage and Administration and Adverse Reactions ].
Concomitant use of drugs affecting hemostasis increases the risk of bleeding.
These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions ].
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room.
Discontinue apixaban tablets in patients with active pathological hemorrhage.
Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of apixaban is available.
The pharmacodynamic effect of apixaban tablets can be expected to persist for at least 24 hours after the last dose, i.e., for about two drug half-lives.
Prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa may be considered, but have not been evaluated in clinical studies [see Clinical Pharmacology ].
When PCCs are used, monitoring for the anticoagulation effect of apixaban using a clotting test (PT, INR, or aPTT) or anti-factor Xa (FXa) activity is not useful and is not recommended.
Activated oral charcoal reduces absorption of apixaban, thereby lowering apixaban plasma concentration [see Overdosage ].
Hemodialysis does not appear to have a substantial impact on apixaban exposure [see Clinical Pharmacology ].
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of apixaban.
There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban.
There is no experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban and they are not expected to be effective as a reversal agent.
5.3 Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis.
Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of apixaban tablets.
The next dose of apixaban tablets should not be administered earlier than 5 hours after the removal of the catheter.
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