1. Introduction
Dabigatran, marketed under the brand name Pradaxa, is a direct oral anticoagulant (DOAC) used for the prevention and treatment of thromboembolic disorders. It works by directly inhibiting thrombin (Factor IIa), thereby preventing the formation of blood clots. Dabigatran is commonly prescribed as an alternative to warfarin due to its predictable anticoagulant effects and lack of routine monitoring requirements.
2. Indications
- Approved Indications:
- Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF).
- Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Thromboprophylaxis after total hip or knee replacement surgery.
- Off-Label Uses:
- Thromboprophylaxis in patients with cancer-associated thrombosis (specific cases).
3. Dosage
- Stroke Prevention in Atrial Fibrillation (NVAF):
- 150 mg twice daily.
- For patients with CrCl 30–50 mL/min: Consider 110 mg twice daily.
- Treatment of DVT/PE:
- Initial treatment with parenteral anticoagulant for 5–10 days, then 150 mg twice daily.
- Prevention of DVT/PE Following Surgery:
- 110 mg 1–4 hours post-surgery, followed by 220 mg once daily for up to 10 days (knee) or 28–35 days (hip).
- Renal Impairment:
- CrCl <30 mL/min: Avoid use.
- CrCl 30–50 mL/min: Use lower doses or consider alternative therapies.
4. Administration
- Swallow capsules whole with a full glass of water; do not chew, break, or open the capsules.
- Take with or without food.
- Maintain consistent timing of doses to ensure stable anticoagulation.
5. Forms Available
- Capsules: 75 mg, 110 mg, 150 mg.
6. Side Effects
6.1. Common Side Effects
- Bleeding (e.g., bruising, nosebleeds, gastrointestinal bleeding).
- Dyspepsia (indigestion).
6.2. Less Common Side Effects
- Nausea.
- Diarrhoea.
- Fatigue.
6.3. Rare but Serious Side Effects
- Severe bleeding (e.g., intracranial haemorrhage, gastrointestinal bleeding).
- Allergic reactions (e.g., rash, swelling, difficulty breathing).
- Liver enzyme abnormalities.
7. Warnings
- Bleeding Risk: Dabigatran significantly increases the risk of bleeding, particularly in patients with renal impairment, advanced age, or taking other anticoagulants/antiplatelets.
- Avoid Abrupt Discontinuation: Stopping dabigatran abruptly increases the risk of thromboembolic events.
- Use cautiously in patients with a history of gastrointestinal ulcers or recent surgeries.
8. Precautions
- Avoid use in patients with mechanical heart valves due to an increased risk of thromboembolic and bleeding complications.
- Dose adjustments or alternative therapies may be required in patients with moderate renal impairment.
- Use cautiously in elderly patients due to an increased bleeding risk.
9. Interactions
- Drug-Drug Interactions:
- Antiplatelets (e.g., aspirin, clopidogrel): Increased bleeding risk.
- NSAIDs: Increased risk of gastrointestinal bleeding.
- P-glycoprotein inhibitors (e.g., amiodarone, verapamil): May increase dabigatran levels.
- Rifampin and other P-glycoprotein inducers: May reduce dabigatran efficacy.
- Drug-Food Interactions:
- No specific food interactions, but take consistently with or without food.
10. Monitoring Parameters
- Signs of bleeding (e.g., bruising, nosebleeds, or dark stools).
- Renal function (e.g., CrCl) prior to and during therapy.
- Liver function tests if clinically indicated.
11. Use in Children
- Approved in specific cases for children ≥12 years with DVT/PE following parenteral anticoagulation.
12. Use in Pregnancy
- Not recommended due to limited safety data; use only if no alternatives are available and the benefit outweighs the risk.
- May increase the risk of bleeding complications in both mother and foetus.
13. Use in Elderly
- Use with caution due to increased bleeding risk, especially in patients aged ≥75 years.
14. Use in Kidney Disease
- Contraindicated in severe renal impairment (CrCl <30 mL/min).
- Adjust doses or avoid in moderate renal impairment (CrCl 30–50 mL/min) depending on the clinical scenario.
15. Use in Liver Disease
- Use cautiously in patients with moderate hepatic impairment.
- Avoid in patients with significant hepatic disease or liver enzyme abnormalities.
16. Patient Counselling Points
- Take dabigatran as prescribed; do not skip doses.
- Inform your doctor immediately if you experience unusual bleeding, such as prolonged bleeding from cuts, dark stools, or coughing up blood.
- Do not stop dabigatran abruptly without consulting your healthcare provider.
- Keep capsules in the original packaging until use to protect from moisture.
- Inform all healthcare providers, including dentists, about dabigatran use before any procedures.
17. Table of Brand Names, Manufacturers, and Prices
Brand Name | Manufacturer | Price (USD) |
---|---|---|
Pradaxa | Boehringer Ingelheim | $400–500 (30 capsules, 150 mg) |
Generic Dabigatran | Various | $250–400 (30 capsules, 150 mg) |
18. FAQs (15 Questions)
- What is dabigatran used for?
It is used to prevent stroke in atrial fibrillation, treat and prevent DVT/PE, and prevent clots after certain surgeries. - How does dabigatran work?
It directly inhibits thrombin (Factor IIa), preventing clot formation. - What are the common side effects of dabigatran?
Bleeding and dyspepsia (indigestion) are common side effects. - How should dabigatran be taken?
Swallow capsules whole with water. Do not crush, chew, or open them. - Can dabigatran be stopped suddenly?
No, abrupt discontinuation increases the risk of blood clots. Consult your doctor before stopping. - Is routine blood monitoring required with dabigatran?
No routine monitoring is needed, but renal function should be checked periodically. - Can dabigatran cause bleeding?
Yes, bleeding is a significant side effect. Contact your doctor if you notice unusual bleeding. - Can dabigatran be used in pregnancy?
It is not recommended in pregnancy unless no alternatives are available. - What should I do if I miss a dose?
Take it as soon as possible unless it’s close to the next dose. Do not double the dose. - Can dabigatran be taken with other blood thinners?
Generally, no, as this increases bleeding risk. Always consult your doctor. - How is dabigatran stored?
Keep capsules in their original packaging to protect from moisture. Store at room temperature. - Can elderly patients take dabigatran?
Yes, but with caution due to a higher bleeding risk. - Does dabigatran interact with other medications?
Yes, it interacts with antiplatelets, NSAIDs, and P-glycoprotein inhibitors or inducers. - Can dabigatran cause stomach upset?
Yes, dyspepsia is a common side effect. Taking it with food may help. - Can dabigatran be reversed in case of bleeding?
Yes, idarucizumab (Praxbind) is an antidote used to reverse its anticoagulant effects.