Black Box Warning

WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including dabigatran etexilate capsules , increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate capsules a re discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.6, 2.7, 2.8) and Warnings and Precautions (5.1)]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate capsules 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 non-steroidal 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 dabigatran etexilate capsules and neuraxial procedures is not known [see Warnings and Precautions (5.3)]. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)]. WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBO

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Dabigatran.

Other warnings & precautions

Premature discontinuation increases risk of stroke — do not stop without medical guidance

Serious and potentially fatal bleeding can occur; no routine reversal agent was available until idarucizumab (Praxbind) approval

Avoid use in patients with mechanical prosthetic heart valves due to increased thromboembolic and bleeding risk

Use with caution or avoid in severe renal impairment (CrCl < 15 mL/min); dose adjustment required for moderate renal impairment

Spinal/epidural hematoma risk with neuraxial anesthesia or spinal puncture — monitor neurological signs

Capsules must be swallowed whole; do not crush, chew, or open capsules

Drug interactions with P-glycoprotein (P-gp) inducers and inhibitors can significantly alter drug exposure

Use caution in elderly patients due to increased bleeding risk and possible renal impairment

Co-administration with other anticoagulants, antiplatelet agents, or NSAIDs increases bleeding risk

Idarucizumab (Praxbind) is the specific reversal agent for dabigatran in emergency situations