Dabigatran

Dabigatran is a novel oral anticoagulant (NOAC). It works by preventing the formation of blood clots in the body. It is a competitive, selective, reversible direct inhibitor of thrombin. It inhibits thrombin-induced platelet aggregation and the conversion of fibrinogen to fibrin thus preventing thrombus formation. It is used to reduce the risk of stroke and heart attack. It prevents and treats clot formation in the veins of your legs, lungs, brain and heart.

• Stroke prevention in atrial fibrillation
• Deep Vein Thrombosis (DVT) prevention and treatment
• Pulmonary Embolism (PE) prevention and treatment
• Prevention of venous thromboembolism after knee or hip replacement surgery

Dabigatran is a competitive, selective, reversible direct inhibitor of thrombin. It inhibits thrombin-induced platelet aggregation and the conversion of fibrinogen to fibrin thus preventing thrombus formation. By directly inhibiting thrombin, it prevents the final step of the coagulation cascade.

Dabigatran directly inhibits thrombin, preventing the conversion of fibrinogen to fibrin and platelet aggregation, thereby preventing blood clot formation.

Adult - Atrial Fibrillation: 150 mg twice daily; reduce to 110 mg twice daily if given concurrently with verapamil.

Adult - Postoperative VTE prophylaxis (Knee): 110 mg within 1-4 hours after surgery, then 220 mg once daily for a total of 10 days.

Adult - Postoperative VTE prophylaxis (Hip): 110 mg within 1-4 hours after surgery, then 220 mg once daily for a total of 28-35 days.

Elderly (>75 years) - Atrial Fibrillation: 110 mg twice daily.

Elderly (>75 years) - Postoperative VTE prophylaxis: 75 mg within 1-4 hours after surgery, then 150 mg once daily.

May be taken with or without food, but it is better to take it at a fixed time. Do not chew, crush or break it. Take in the dose and duration as advised by your doctor.

If you miss a dose of Dabigatran, please consult your doctor.

Common Side Effects:

• Bleeding (nosebleeds, easy bruising)
• Nausea
• Stomach pain
• Indigestion
• Headache
• Seizures
• Allergic reactions
• Changes to eyesight
• Tiredness

• Dabigatran increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, using sharp objects or engaging in contact sports.
• If you are going to have a surgery or dental treatment, you may be asked to stop taking Dabigatran temporarily.
• Your doctor may get a blood test done to check kidney function before starting treatment.
• Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
• Unlike other anticoagulants, regular PT-INR blood test is not required.

• Active pathological bleeding or patient at high risk for bleeding
• Patients with prosthetic heart valve
• Severe renal impairment (CrCl <30 ml/min)
• Concomitant use with antiplatelets, other anticoagulants, thrombolytics
• Concomitant use with dronedarone
• Concomitant use with P-glycoprotein inducers (e.g. carbamazepine, rifampicin, phenytoin and St John's wort)
• Concomitant use with P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, and tacrolimus)

NSAIDs: May increase risk of bleeding.

Clarithromycin: May increase serum levels of dabigatran.

Potentially Fatal: P-glycoprotein inducers (e.g. carbamazepine, rifampicin, phenytoin) decrease systemic exposure of dabigatran. P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, tacrolimus) and dronedarone increase systemic exposure of dabigatran. Increased bleeding risk with antiplatelets, other anticoagulants and thrombolytics.

It is unsafe to consume alcohol with Dabigatran. Can be taken with or without food.

Dabigatran may be unsafe during pregnancy. Animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks. Please consult your doctor.

Dabigatran is probably unsafe during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

Safety and effectiveness in pediatric populations have not been established.

Patients over 75 years of age require dose reduction.

Renal impairment: Use not recommended in severe kidney disease (CrCl <30 ml/min). Dose adjustment needed for CrCl 30-50 ml/min. Please consult your doctor.

Hepatic impairment: Use with caution. Dose adjustment may be needed. Please consult your doctor.

Overdose may lead to bleeding complications. Seek immediate medical attention in case of overdose. No specific antidote is available (prothrombin complex concentrate may be used).

Store below 25°C temperature in a dry place. Protect from moisture. Keep out of reach of children.

Dabigatran