Dabigatran Etexilate 150 mg Capsule, 60-count
Other active recalls for Dabigatran Etexilate (different manufacturers) — 6 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Direct thrombin inhibitors class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dabigatran is used to prevent or treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE) and to prevent strokes in certain adults who have atrial fibrillation (a condition where the heart beats irregularly, and can lead to blood blots and stroke). Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by stopping blood from clotting.
Read the full MedlinePlus article ↗- It's a blood thinner — its main jobs are to reduce your risk of stroke if you have atrial fibrillation (an irregular heartbeat), to treat or prevent dangerous blood clots in your v...
- What exactly is dabigatran etexilate used for?
- No — please don't. Opening, breaking, or chewing the capsule releases the pellets inside in a way the body absorbs about 75% more drug than it should. That raises your risk of seri...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.97 | $118.43 / 60 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dabigatran Etexilate 150 mg 00378-0266-91 | Mylan | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 00904-7255-10 | Major | 10 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 31722-0622-60 | Camber | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran etexilate 150 mg 43598-0641-60 | Dr.Reddys | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 59651-0975-60 | Aurobindo | 60 capsules | $0.823 | AB | Availability likely | — |
| dabigatran etexilate 150 mg 60505-4348-06 | Apotex | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran 150 mg 60687-0974-32 | American | 20 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 62332-0636-06 | Alembic | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 67877-0475-60 | Ascend | 60 capsules | $0.823 | AB | Availability likely | — |
| Dabigatran Etexilate 150 mg 72603-0239-01 | NorthStar | 60 capsules | $0.823 | AB | Availability likely | — |
| Pradaxa 150 mg 00597-0360-42 | Boehringer | 12 capsules | — | AB | Discontinued | — |
| Dabigatran 150 mg 42291-0034-60 | AvKARE | 60 capsules | — | AB | FDA listed | — |
| Dabigatran Etexilate 150 mgthis 46708-0636-60 | Alembic | 60 capsules | — | AB | FDA listed | — |
| Dabigatran 150 mg 50090-7530-00 | A-S | 60 capsules | — | AB | FDA listed | — |
| Dabigatran Etexilate 150 mg 50090-7657-00 | A-S | 60 capsules | — | AB | FDA listed | — |
| Dabigatran 150 mg 50268-0200-16 | AvPAK | 60 capsules | — | AB | FDA listed | — |
| Dabigatran 150 mg 72205-0204-34 | Novadoz | 60 capsules | — | AB | FDA listed | — |
| Dabigatran Etexilate 150 mg 72865-0273-60 | XLCare | 60 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0636-06 | 10 BLISTER PACK in 1 CARTON (46708-636-06) / 6 CAPSULE in 1 BLISTER PACK | 2024-06-14 | Active |
| 46708-0636-45 | 180 CAPSULE in 1 BOTTLE (46708-636-45) | 2025-10-08 | Active |
| 46708-0636-60 You're viewing this | 60 CAPSULE in 1 BOTTLE (46708-636-60) | 2024-06-14 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed 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 THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (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. To reduce this risk, consider coverage with another anticoagulant if dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy ( 2.6 , 2.7 , 2.8 , 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 ( 5.3 ). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently.
Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5 ) • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6 )
1.1Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
1.2Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
1.3Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated.
1.4Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult PatientsFollowing Hip Replacement Surgery Dabigatran etexilate capsules are indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery.
1.5Treatment of Venous Thromboembolic Events in Pediatric Patients Dabigatran etexilate capsules are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days [see Dosage and Administration (2.3)] .
1.6Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated [see Dosage and Administration (2.3)] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2 ) o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily ( 2.2 ) • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation ( 2.2 ) • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) • Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2 ) • Treatment of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3 ) • Reduction in the Risk of Recurrence of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3 ) • Dabigatran etexilate capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms • Review recommendations for converting to or from other oral or parenteral anticoagulants ( 2.6 , 2.7 ) • Temporarily discontinue dabigatran etexilate capsules before invasive or surgical procedures when possible, then restart promptly ( 2.8 )
2.1Important Dosage Information Dabigatran etexilate is available in different dosage forms and not all dosage forms are approved for the same indications and age groups. In addition, there are differences between the dosage forms with respect to dosing due to differences in bioavailability. Do not substitute different dosage forms on a milligram-to-milligram basis and do not combine more than one dosage form to achieve the total dose [see Clinical Pharmacology (12.3)] .
2.2Recommended Dabigatran Etexilate Capsules Dosage for Adults Indication Dosage Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF CrCl >30 mL/min: 150 mg twice daily CrCl 15 to 30 mL/min: 75 mg twice daily CrCl <15 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dosage to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole. CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration Treatment of DVT and PE Reduction in the Risk of Recurrence of DVT and PE CrCl >30 mL/min: 150 mg twice daily CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration Prophylaxis of DVT and PE Following Hip Replacement Surgery CrCl >30 mL/min: 110 mg for first day, then 220 mg once daily CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 150 mg taken orally, twice daily.
For patients with severe renal impairment (CrCl 15 to 30 mL/min), the recommended dosage of dabigatran etexilate capsules are 75 mg twice daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Dosing recommendations for patients with a CrCl <15 mL/min or on dialysis cannot be provided. Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients For patients with CrCl >30 mL/min, the recommended dosage of dabigatran etexilate capsules are 150 mg taken orally, twice daily, after 5 to 10 days of parenteral anticoagulation.
Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Reduction in the Risk of Recurre…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 75 mg capsules: White opaque cap / white opaque body, size ‘2’ HPMC capsules having imprinting “A” on cap with black ink and “329” on body with black ink filled with off white to yellowish pellets. 110 mg capsules: Light blue opaque cap / light blue opaque body, size ‘1’ HPMC capsules having imprinting “A” on cap with black ink and “192” on body with black ink filled with off white to yellowish pellets. 150 mg capsules: Light blue opaque cap/ white opaque body, size ‘0’ HPMC capsules having imprinting “A” on cap with black ink and “316” on body with black ink filled with off white to yellowish pellets.
Capsules: 75 mg, 110 mg and 150 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Dabigatran etexilate capsules are contraindicated in patients with: • Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] • History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] • Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)] • Active pathological bleeding ( 4 ) • History of serious hypersensitivity reaction to dabigatran etexilate capsules ( 4 ) • Mechanical prosthetic heart valve ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Bleeding: Dabigatran etexilate can cause serious and fatal bleeding ( 5.2 ) Bioprosthetic heart valves: Dabigatran etexilate use not recommended ( 5.4 ) Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: Dabigatran etexilate use not recommended ( 5.6 )
5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including dabigatran etexilate, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart dabigatran etexilate capsules as soon as medically appropriate [see Dosage and Administration (2.6, 2.7, 2.8)].
5.2Risk of Bleeding Dabigatran etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue dabigatran etexilate capsules in patients with active pathological bleeding [see Dosage and Administration (2.4)].
Risk factors for bleeding include the concomitant use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). Dabigatran etexilate’s anticoagulant activity and half-life are increased in patients with renal impairment [see Clinical Pharmacology (12.2)]. Reversal of Anticoagulant Effect: In adults, a specific reversal agent (idarucizumab) for dabigatran etexilate is available when reversal of the anticoagulant effect of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding In pediatric patients, the efficacy and safety of idarucizumab have not been established.
Hemodialysis can remove dabigatran; however the clinical experience supporting the use of hemodialysis as a treatment for bleeding is limited [see Overdosage (10)] . Prothrombin complex concentrates, or recombinant Factor VIIa may be considered but their use has not been evaluated in clinical trials. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of dabigatran.
Consider administration of platelet concentrates in cases where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
5.3Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis [see Boxed Warning] . To reduce the potential risk of bleeding associated with the concurrent use of dabigatran etexilate and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of dabigatran [see Clinical Pharmacology (12.3)] .
Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of dabigatran 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.
5.4 Thromboembolic and Bleeding Ev…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with dabigatran etexilate were related to bleeding [see Warnings and Precautions (5.2)].
Most common adverse reactions (>15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Trials Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the use of two doses of dabigatran etexilate capsules and warfarin [see Clinical Studies (14.1)] .
The numbers of patients and their exposures are described in Table 2. Limited information is presented on the 110 mg dosing arm because this dose is not approved. Table 2: Summary of Treatment Exposure in RE-LY Dabigatran Etexilate Capsules 110 mg twice daily Dabigatran Etexilate Capsules 150 mg twice daily Warfarin Total number treated 5,983 6,059 5,998 Exposure > 12 months 4,936 4,939 5,193 > 24 months 2,387 2,405 2,470 Mean exposure (months) 20.5 20.3
21.3Total patient-years 10,242 10,261 10,659 Drug Discontinuation in RE-LY The rates of adverse reactions leading to treatment discontinuation were 21% for dabigatran etexilate capsules 150 mg and 16% for warfarin. The most frequent adverse reactions leading to discontinuation of dabigatran etexilate capsules were bleeding and gastrointestinal events (i.e., dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea). Bleeding [see Warnings and Precautions (5.2)] Table 3 shows the number of adjudicated major bleeding events during the treatment period in the RE-LY study, with the bleeding rate per 100 subject-years (%).
Major bleeding is defined as bleeding accompanied by one or more of the following: a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells, bleeding at a critical site or with a fatal outcome. Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds. Table 3: Adjudicated Major Bleeding Events in Treated Patients a Event Dabigatran Etexilate Capsules 150 mg N = 6,059 n (%/year b ) Warfarin N = 5,998 n (%/year b ) Dabigatran Etexilate Capsules 150 mg vs.
Warfarin HR (95% CI) Major Bleeding c 350 (3.47) 374 (3.58) 0.97 (0.84, 1.12) Intracranial Hemorrhage (ICH) d 23 (0.22) 82 (0.77) 0.29 (0.18, 0.46) Hemorrhagic Stroke e 6 (0.06) 40 (0.37) 0.16 (0.07, 0.37) Other ICH 17 (0.17) 46 (0.43) 0.38 (0.22, 0.67) Gastrointestinal 162 (1.59) 111 (1.05) 1.51 (1.19, 1.92) Fatal Bleeding f 7 (0.07) 16 (0.15) 0.45 (0.19, 1.1) ICH 3 (0.03) 9 (0.08) 0.35 (0.09, 1.28) Non-intracranial g 4 (0.04) 7 (0.07) 0.59 (0.17, 2.02) a Patients during treatment or within 2 days of stopping study treatment.
Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. b Annual event rate per 100 pt-years = 100 * number of subjects with event/subject-years. Subject-years is defined as cumulative number of days from first drug i…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • P-gp inducers: Avoid coadministration with dabigatran etexilate capsules ( 5.5 ) • P-gp inhibitors in adult patients with CrCl 30 to 50 mL/min: Reduce dosage or avoid ( 7 ) • P-gp inhibitors in adult patients with CrCl <30 mL/min: Not recommended ( 7 )
7.1Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of dabigatran etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)] . P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran [see Clinical Pharmacology (12.3)] . Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone.
In patients with moderate renal impairment (CrCl 30 to 50 mL/min), reduce the dosage of dabigatran etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of dabigatran etexilate. These results should not be extrapolated to other P-gp inhibitors [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)] .
The concomitant use of dabigatran etexilate and P-gp inhibitors in patients with severe renal impairment (CrCl 15 to 30 mL/min) should be avoided [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)] .
7.2Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Avoid use of dabigatran etexilate and P-gp inhibitors in patients with CrCl <50 mL/min [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)] .
7.3Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery In patients with CrCl ≥50 mL/min who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of dabigatran and the P-gp inhibitor by several hours. The concomitant use of dabigatran etexilate and P-gp inhibitors in patients with CrCl <50 mL/min should be avoided [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.2, 12.3)] .
7.4Treatment and Reduction in Risk of Recurrence of VTE in Pediatric Patients The concomitant use of dabigatran etexilate capsules with P-gp inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran [see Warnings and Precautions (5.5)] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended ( 8.2 ) Geriatric Use: Risk of bleeding increases with age ( 8.5 )
8.1Pregnancy Risk Summary The limited available data on dabigatran etexilate use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see Clinical Considerations) . In pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure.
At a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation Day 6). Dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. However, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. Fetal/Neonatal adverse reaction Use of anticoagulants, including dabigatran etexilate, may increase the risk of bleeding in the fetus and neonate.
Monitor neonates for bleeding [see Warnings and Precautions (5.2)]. Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Dabigatran etexilate use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas.
Consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see Warnings and Precautions (5.2, 5.3)] . Data Animal Data Dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3 times the human exposure at MRHD of 300 mg/day based on area under the curve [AUC] comparisons) prior to mating and up to implantation (gestation Day 6). Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition.
Dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a MRHD of 300 mg/day based on AUC comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. Death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation Day 7) to weaning (lactation Day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at MRHD of 300 mg/day based on AUC comparisons).
8.2Lactation Risk Summary There are insufficient data to assess the presence of dabigatran in human milk. There are no data on the effects of dabigatran on the breastfed child or on milk production. Dabigatran and/or its metabolites were present in rat…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on dabigatran etexilate use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see Clinical Considerations) . In pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure.
At a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation Day 6). Dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. However, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. Fetal/Neonatal adverse reaction Use of anticoagulants, including dabigatran etexilate, may increase the risk of bleeding in the fetus and neonate.
Monitor neonates for bleeding [see Warnings and Precautions (5.2)]. Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Dabigatran etexilate use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas.
Consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see Warnings and Precautions (5.2, 5.3)] . Data Animal Data Dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3 times the human exposure at MRHD of 300 mg/day based on area under the curve [AUC] comparisons) prior to mating and up to implantation (gestation Day 6). Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition.
Dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a MRHD of 300 mg/day based on AUC comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. Death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation Day 7) to weaning (lactation Day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at MRHD of 300 mg/day based on AUC comparisons).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dabigatran etexilate capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. Use of dabigatran etexilate capsules for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. These studies included an open-label, randomized, parallel-group study and an open-label, single-arm safety study [see Adverse Reactions (6.1) and Clinical Studies (14.4, 14.5) ].
Other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. Safety and effectiveness of dabigatran etexilate capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see Warnings and Precautions (5), Adverse Reactions (6.1), and Clinical Studies (14.1)] .
🆘 Overdosage ▾
10 OVERDOSAGE Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with dabigatran etexilate, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available for adult patients.
Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours.
At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran’s plasma concentration would be expected to vary based on patient specific characteristics.
Measurement of aPTT or ECT may help guide therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.
12.2Pharmacodynamics At recommended therapeutic doses, dabigatran etexilate prolongs the coagulation markers such as aPTT, ECT, TT, and dTT. INR is relatively insensitive to the exposure to dabigatran and cannot be interpreted the same way as used for warfarin monitoring. Adults The aPTT test provides an approximation of dabigatran etexilate’s anticoagulant effect.
The average time course for effects on aPTT, following approved dosing regimens in patients with various degrees of renal impairment is shown in Figure 2. The curves represent mean levels without confidence intervals; variations should be expected when measuring aPTT. While advice cannot be provided on the level of recovery of aPTT needed in any particular clinical setting, the curves can be used to estimate the time to get to a particular level of recovery, even when the time since the last dose of dabigatran etexilate is not precisely known.
In the RE-LY trial, the median (10 th to 90 th percentile) trough aPTT in patients receiving the 150 mg dose was 52 (40 to 76) seconds. Figure 2: Average Time Course for Effects of Dabigatran on aPTT, Following Approved DABIGATRAN Dosing Regimens in Adult Patients with Various Degrees of Renal Impairment* *Simulations based on PK data from a study in subjects with renal impairment and PK/aPTT relationships derived from the RE-LY study; aPTT prolongation in RE-LY was measured centrally in citrate plasma using PTT Reagent Roche Diagnostics GmbH, Mannheim, Germany.
There may be quantitative differences between various established methods for aPTT assessment. The degree of anticoagulant activity can also be assessed by the ecarin clotting time (ECT). This test is a more specific measure of the effect of dabigatran than activated partial thromboplastin time (aPTT).
In the RE-LY trial, the median (10 th to 90 th percentile) trough ECT in patients receiving the 150 mg dose was 63 (44 to 103) seconds. In orthopedic hip surgery patients, maximum aPTT response (E max ) to dabigatran and baseline aPTT were higher shortly after surgery than at later time points (e.g. ≥3 days after surgery). Pediatrics As in adults, there is a correlation between plasma dabigatran concentrations and the degree of its anticoagulant effect in pediatric patients with venous thromboembolism.
The parameters dTT and ECT increased in direct linear proportion to the plasma concentration of dabigatran, whereas aPTT prolongation increases in a nonlinear fashion with dabigatran plasma concentrations. Similar PK/PD relationships for aPTT, ECT, and dTT were observed across age groups of pediatric patients (ages 26 days to < 18 years) and between pediatric and adult patients with venous thromboembolism. This similarity in PK/PD relationship suggests that similar exposure-response relationship is expected for dabigatran etexilate treatment across the pediatric age groups and adult patients.
Cardiac Electrophysiology No prolongation of the QTc interval was observed with dabigatran etexilate at doses up to 600 mg. dabigatran-figure2.jpg
12.3Pharmacokinetics Dabigatran etexilate mesylate is absorbed as the dabigatran etexilate ester. The ester is then hydrolyzed, forming dabigatran, the active moiety. Dabigatran is metabolized to four different acyl glucuronides and both the glucuronides and dabigatran have similar pharmacological activity.
Pharmacokinetics described here refer to the sum of dabigatran and its glucuronides. Dabigatran displays dose-proportional pharmacokinetics in healthy adult subjects and adult patients in the range of doses from 10 to 400 mg.…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dabigatran etexilate capsules 75 mg are with white opaque cap / white opaque body, size ‘2’ HPMC capsules having imprinting “A” on cap with black ink and “329” on body with black ink, filled with off white to yellowish pellets. The capsules are supplied in the packages listed: Bottle of 60 capsules with child-resistant closure, NDC 46708-634-60 Carton of 60 capsules (10 x 6 unit-dose blister cards), NDC 46708-634-06 Dabigatran etexilate capsules 110 mg are with light blue opaque cap / light blue opaque body, size ‘1’ HPMC capsules having imprinting “A” on cap with black ink and “192” on body with black ink, filled with off white to yellowish pellets.
The capsules are supplied in the packages listed: Bottle of 60 capsules with child-resistant closure, NDC 46708-635-60 Carton of 60 capsules (10 x 6 unit-dose blister cards), NDC 46708-635-06 Dabigatran etexilate capsules 150 mg are with light blue opaque cap / white opaque body, size ‘0’ HPMC capsules having imprinting “A” on cap with black ink and “316” on body with black ink, filled with off white to yellowish pellets. The capsules are supplied in the packages listed: Bottle of 60 capsules with child-resistant closure, NDC 46708-636-60 Bottle of 180 capsules with child-resistant closure, NDC 46708-636-45 Carton of 60 capsules (10 x 6 unit-dose blister cards), NDC 46708-636-06 Bottles Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.
Blisters Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.
📋 Description ▾
11 DESCRIPTION The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 ⋅ CH 4 O 3 S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is off-white to yellowish powder.
It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc.
The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2.
The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac. dabigatran-structure.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Instructions for Patients Tell patients to take dabigatran etexilate capsules exactly as prescribed. Remind patients not to discontinue dabigatran etexilate capsules without talking to the healthcare provider who prescribed it.
Keep dabigatran etexilate capsules in the original bottle to protect from moisture. Do not put dabigatran etexilate capsules in pill boxes or pill organizers. When more than one bottle is dispensed to the patient, instruct them to open only one bottle at a time.
Instruct patient to remove only one capsule from the opened bottle at the time of use. The bottle should be immediately and tightly closed. Advise patients not to chew or break the capsules before swallowing them and not to open the capsules and take the pellets alone.
Advise patients that the capsule should be taken with a full glass of water. [see Boxed Warning, Dosage and Administration (2.5)] Bleeding Inform patients that they may bleed more easily, may bleed longer, and should call their healthcare provider for any signs or symptoms of bleeding [see Warnings and Precautions (5.2)] . Instruct patients to seek emergency care right away if they have any of the following, which may be a sign or symptom of serious bleeding: Unusual bruising (bruises that appear without known cause or that get bigger) Pink or brown urine Red or black, tarry stools Coughing up blood Vomiting blood, or vomit that looks like coffee grounds Instruct patients to call their healthcare provider or to get prompt medical attention if they experience any signs or symptoms of bleeding: Pain, swelling or discomfort in a joint Headaches, dizziness, or weakness Reoccurring nose bleeds Unusual bleeding from gums Bleeding from a cut that takes a long time to stop Menstrual bleeding or vaginal bleeding that is heavier than normal If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence.
If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning] . Gastrointestinal Adverse Reactions Instruct patients to call their healthcare provider if they experience any signs or symptoms of dyspepsia or gastritis: Dyspepsia (upset stomach), burning, or nausea Abdominal pain or discomfort Epigastric discomfort, GERD (gastric indigestion) [see Adverse Reactions (6.1)] Invasive or Surgical Procedures Instruct patients to inform their healthcare provider that they are taking dabigatran etexilate capsules before any invasive procedure (including dental procedures) is scheduled [see Dosage and Administration (2.8)] .
Concomitant Medications Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so their health care provider knows about other treatments that may affect bleeding risk (e.g., aspirin or NSAIDs) or dabigatran exposure (e.g., dronedarone or systemic ketoconazole) [see Warnings and Precautions (5.2, 5.5)] . Prosthetic Heart Valves Instruct patients to inform their healthcare provider if they will have or have had surgery to place a prosthetic heart valve [see Warnings and Precautions (5.4)] .
Allergic Reactions Advise adult patients and caregivers that some adults taking dabigatran etexilate capsules have developed symptoms of an allergic reaction. Advise adult patients or caregivers to inform their healthcare provider if they or their child develop symptoms of an allergic reaction, such as hives, rash, or itching. Advise adult patients or caregivers to seek emergency medical attention if they or their child develop chest pain or tightness, swelling of…
💬 Medication Guide ▾
MEDICATION GUIDE Dabigatran Etexilate ( DA-bi-GAT-ran E-tex-i-late ) Capsules This Medication Guide is for dabigatran etexilate capsules. Read this Medication Guide before you start taking dabigatran etexilate capsules and each time you get a refill. There may be new information.
This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about dabigatran etexilate capsules? • People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Dabigatran etexilate capsule lowers your chance of having a stroke by helping to prevent clots from forming.
If you stop taking dabigatran etexilate capsules, you may have increased risk of forming a clot in your blood. Do not stop taking dabigatran etexilate capsules without talking to the healthcare provider who prescribes it for you. Stopping dabigatran etexilate capsules increases your risk of having a stroke.
Dabigatran etexilate capsules may need to be stopped, if possible, before surgery or a medical or dental procedure. Ask the healthcare provider who prescribed dabigatran etexilate capsules for you when you should stop taking it. Your healthcare provider will tell you when you may start taking dabigatran etexilate capsules again after your surgery or procedure.
If you have to stop taking dabigatran etexilate capsules, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming. • Dabigatran etexilate capsules can cause bleeding which can be serious, and sometimes lead to death. This is because dabigatran etexilate capsule is a blood thinner medicine that lowers the chance of blood clots forming in your body. • You may have a higher risk of bleeding if you take dabigatran etexilate capsules and: o are over 75 years old o have kidney problems o have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer o take other medicines that increase your risk of bleeding, including: ▪ aspirin or aspirin-containing products ▪ long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) ▪ a medicine that contains warfarin sodium ▪ a medicine that contains heparin ▪ a medicine that contains clopidogrel bisulfate ▪ a medicine that contains prasugrel o have certain kidney problems and also take a medicine that contains dronedarone or ketoconazole tablets.
Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above. • Dabigatran etexilate capsules can increase your risk of bleeding because it lessens the ability of your blood to clot. During treatment with dabigatran etexilate capsules: o you may bruise more easily o it may take longer for any bleeding to stop Call your healthcare provider or get medical help right away if you have any of these signs or symptoms of bleeding: o unexpected bleeding or bleeding that lasts a long time, such as: ▪ unusual bleeding from the gums ▪ nose bleeds that happen often ▪ menstrual bleeding or vaginal bleeding that is heavier than normal o bleeding that is severe or you cannot control o pink or brown urine o red or black stools (looks like tar) o bruises that happen without a known cause or get larger o cough up blood or blood clots o vomit blood or your vomit looks like “coffee grounds” o unexpected pain, swelling, or joint pain o headaches, feeling dizzy or weak Take dabigatran etexilate capsules exactly as prescribed.
Do not stop taking dabigatran etexilate capsules without first talking to the healthcare provider who prescribes it for you. Stopping dabigatran etexilate capsules may increase your risk of a stroke. • Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anti…