Which Anticoagulant?

The information below is based on European or United Kingdom Summaries of Product Characteristics documents, and the other references cited – approved uses and recommendations for drugs vary by region/country

This table is intended as a quick reference guide only and is not an exhaustive list; refer to local prescribing information for full drug information and use clinical judgement before prescribing

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Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Direct Factor Xa inhibitor
Direct Factor Xa inhibitor
Direct Factor Xa inhibitor
Direct Factor IIa (thrombin) inhibitor
Vitamin K antagonist
UFH
LMWH
LMWH
LMWH
Indirect Factor Xa inhibitor

Prevention of VTE

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Approved to use in this indication in EU/UK
Indication

Indication

Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery

Indication

Indication

Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery

Indication

Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery

Indication

Prophylaxis of venous thrombosis and PE

Indication

Indication

Prevention of VTE, in particular VTE associated with orthopaedic or general surgery and in medical patients bedridden due to acute illness

Indication

Peri- and post-operative surgical thromboprophylaxis, and the prophylaxis of proximal DVT in patients bedridden due to a medical condition

Indication

Prevention of thromboembolic events, including DVT, in adults undergoing general and orthopaedic surgery

Indication

Prevention of VTE in adults undergoing major orthopaedic surgery of the lower limbs (e.g. hip/knee replacement) or abdominal surgery if judged at high risk of thromboembolic complications (e.g. cancer surgery), and patients at high risk for VTE who are immobilized due to acute illness
Dose

Dose

2.5 mg twice daily; initial dose 12–24 hours after surgery

Dose

Dose

10 mg once daily; initial dose 6–10 hours after surgery provided haemostasis has been established

Dose

220 mg once daily; initial half dose 1–4 hours after surgery

Dose

To maintain the INR is in the therapeutic range INR 2.0–3.0 (target 2.5)

Dose

Dose

  • General surgery: 20 mg once daily s.c. started approximately 2 hours pre-operatively
  • Orthopaedic surgery, or abdominal or pelvic surgery for cancer: 40 mg once daily s.c. started 12 hours before surgery
  • Medical patients: 40 mg once daily s.c.

Dose

  • Surgical patients at high risk of thrombosis: 2500 IU s.c. administered 1–2 hours before surgery, then 2500 IU s.c. 8–12 hours later, and on the following days 5000 IU s.c. each morning OR 5000 IU s.c. administered the evening before surgery and 5000 IU s.c. the following evenings
  • After hip replacement surgery: 5000 IU s.c. administered the evening before surgery and 5000 IU s.c. the following evenings
  • Medical patients: 5000 IU once daily

Dose

  • Low-to-moderate VTE risk, e.g. general surgery: 3500 anti-Factor Xa IU 2 hours before surgery and once daily thereafter
  • High VTE risk, e.g. orthopaedic surgery: 4500 anti-Factor Xa IU given 12 hours before surgery followed by a once-daily dose, or 50 anti-Factor Xa IU/kg body weight 2 hours before surgery followed by a once-daily dose

Dose

  • Major orthopaedic surgery or abdominal surgery: 2.5 mg s.c. once-daily; initial dose 6 hours following surgical closure provided that haemostasis has been established
  • Medical patients: 2.5 mg s.c. once daily
Dose adjustments

Dose adjustments

None

Dose adjustments

Dose adjustments

None

Dose adjustments

150 mg once daily in patients: with CrCl 30–50 ml/min; taking concomitant verapamil, amiodarone or quinidine; or aged ≥75 years

Dose adjustments

Depending on INR

Dose adjustments

Dose adjustments

None

Dose adjustments

None

Dose adjustments

None

Dose adjustments

1.5 mg once daily in patients with CrCl 20–50 ml/min
Duration

Duration

32–38 days (hip) or 10–14 days (knee)

Duration

Duration

5 weeks (hip) or 2 weeks (knee)

Duration

28–35 days (hip) or 10 days (knee)

Duration

As required as long as the risk of thrombosis persists

Duration

Duration

  • General surgery: 7–10 days, or until the risk of thromboembolism has diminished
  • Orthopaedic surgery: Not specified
  • Abdominal or pelvic surgery for cancer: 4 weeks
  • Medical patients: 6–14 days, until full ambulation

Duration

  • General surgery: 5–7 days, or until the patient is mobilized
  • Hip replacement surgery: 5 weeks
  • Medical patients: Up to 14 days

Duration

7–10 days

Duration

  • Orthopaedic or abdominal surgery: 5–9 days or up to 24 days after hip fracture surgery
  • Medical patients: 6–14 days

DVT and PE treatment

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Approved to use in this indication in EU/UK
Indication

Indication

Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

Indication

Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

Indication

Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

Indication

Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

Indication

Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

Indication

Indication

Treatment of venous thromboembolic disease presenting with DVT, PE or both

Indication

Treatment of VTE presenting clinically as DVT, PE or both

Indication

Treatment of DVT and of PE in adults

Indication

Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant DVT
Dose

Dose

10 mg twice daily for the first 7 days followed by 5 mg twice daily

Dose

60 mg once daily following initial use of parenteral anticoagulant for at least 5 days

Dose

15 mg twice daily for the first 21 days followed by 20 mg once daily

Dose

150 mg twice daily following initial treatment with a parenteral anticoagulant for at least 5 days

Dose

Start dosing in combination with parenteral anticoagulant therapy; continue the parenteral anticoagulant until the INR is in the therapeutic range INR 2.0–3.0 (target 2.5)

Dose

Dose

1.5 mg/kg

Dose

1.5 mg/kg once daily

Dose

175 anti-Factor Xa IU/kg once daily

Dose

2.5 mg s.c. once daily
Dose adjustments

Dose adjustments

Patients who have completed 6 months of anticoagulant treatment, and for whom therapy for prevention of recurrent VTE is to be continued longer term, should receive 2.5 mg twice daily

Dose adjustments

30 mg once daily in patients with one or more of the following: CrCl 15–50 ml/min; body weight ≤60 kg; concomitant use of the P-gp inhibitors cyclosporine, dronedarone, erythromycin or ketoconazole

Dose adjustments

After day 21, use of 15 mg once daily rather than 20 mg once daily should be considered if the patient’s assessed risk for bleeding outweighs the risk for recurrent DVT and PE

Dose adjustments

110 mg capsule twice daily in patients ≥80 years or receiving concomitant verapamil; consider also for patients aged 75–80 years, patients with moderate renal impairment, gastritis, oesophagitis or gastroesophageal reflux, or patients at increased bleeding risk

Dose adjustments

Depending on INR

Dose adjustments

Dose adjustments

By weight

Dose adjustments

By weight

Dose adjustments

By weight

Dose adjustments

1.5 mg once daily in patients with CrCl 20–50 ml/min
Duration

Duration

At least 3 months, based on risk factors for recurrent VTE

Duration

At least 3 months, based on risk factor for reccurent VTE

Duration

At least 3 months, based on risk factor for reccurent VTE

Duration

At least 3 months, based on risk factor for reccurent VTE

Duration

At least 3 months, based on risk factors for recurrent VTE

Duration

Duration

At least 5 days and until adequate oral anticoagulation is established (may be continued for ≥3 months in certain patients who are not recommended to receive oral anticoagulants, e.g. those with cancer, pregnant women)

Duration

At least 5 days and until adequate oral anticoagulation is established (may be continued for ≥3 months in certain patients who are not recommended to receive oral anticoagulants, e.g. those with cancer, pregnant women)

Duration

At least 6 days and until adequate oral anticoagulation is established (may be continued for ≥3 months in certain patients who are not recommended to receive oral anticoagulants, e.g. those with cancer, pregnant women)

Duration

30–45 days

Prevention of stroke in patients with NVAF

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Approved to use in this indication in EU/UK
Indication

Indication

Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors, such as prior stroke or TIA; age ≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥II)

Indication

Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA

Indication

Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA

Indication

Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors, such as prior stroke or TIA; age ≥75 years; heart failure (NYHA Class ≥II); diabetes mellitus; or hypertension

Indication

Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA

Indication

Indication

Indication

Indication

Indication

Dose

Dose

5 mg twice daily

Dose

60 mg once daily

Dose

20 mg once daily

Dose

150 mg twice daily

Dose

Adjust to maintain INR in the therapeutic range (2.0–3.0, target 2.5)

Dose

Dose

Dose

Dose

Dose

Dose adjustments

Dose adjustments

2.5 mg twice daily in patients with NVAF and CrCl 15–29 ml/min or at least two of the following characteristics: age ≥80 years; body weight ≤60 kg; serum creatinine ≥1.5 mg/dl (133 µmol/l)

Dose adjustments

30 mg once daily in patients with one or more of the following: CrCl 15–50 ml/min; body weight ≤60 kg; concomitant use of the P-gp inhibitors cyclosporine, dronedarone, erythromycin or ketoconazole

Dose adjustments

15 mg once daily in patients with CrCl 15–49 ml/min

Dose adjustments

110 mg capsule twice daily in patients ≥80 years or receiving concomitant verapamil; consider also for patients aged 75–80 years, patients with moderate renal impairment, gastritis, oesophagitis or gastroesophageal reflux, or patients at increased bleeding risk

Dose adjustments

Depending on INR

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Duration

Duration

Long term

Duration

Long term

Duration

Long term

Duration

Long term

Duration

Long term

Duration

Duration

Duration

Duration

Duration

Prevention of stroke in patients with VAF

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Approved to use in this indication in EU/UK
Indication

Indication

Indication

Indication

Indication

Indication

Prevention of systemic embolization in patients with rheumatic heart disease and AF

Indication

Indication

Indication

Indication

Indication

Dose

Dose

Dose

Dose

Dose

Dose

Adjust to maintain INR in the therapeutic range (2.0–3.0, target 2.5)

Dose

Dose

Dose

Dose

Dose

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Depending on INR

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

Duration

Duration

Duration

Duration

Duration

Duration

Long term

Duration

Duration

Duration

Duration

Duration

Prevention/treatment of ACS

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Approved to use in this indication in EU/UK
Indication

Indication

Indication

Indication

Prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers, in combination with ASA alone or with ASA plus clopidogrel/ticlopidine. Patients should have no history of stroke/TIA

Indication

Indication

Indication

Indication

Treatment of unstable angina and non-Q-wave MI, administered concurrently with ASA; treatment of acute STEMI including patients to be managed medically or with subsequent PCI in conjunction with thrombolytic drugs

Indication

Unstable angina and non-Q wave MI (unstable CAD), administered concurrently with ASA

Indication

Indication

Dose

Dose

Dose

Dose

2.5 mg twice daily; initiation as soon as possible after stabilization of the ACS event (including revascularization procedures), at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued

Dose

Dose

Dose

Dose

  • Unstable angina and non-Q-wave MI: 1 mg/kg s.c. every 12 hours with oral ASA (100–325 mg once daily)
  • Acute STEMI: Single i.v. bolus of 30 mg plus 1 mg/kg s.c., then 1 mg/kg s.c. every 12 hours (max 100 mg for the first two doses only), with oral ASA (75–325 mg once daily) unless contraindicated; administer enoxaparin between 15 minutes before and 30 minutes after the start of fibrinolytic therapy, if applicable

Dose

120 IU/kg s.c. every 12 hours (maximum 10,000 IU/12 hours)

Dose

Dose

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

None

Dose adjustments

Dose adjustments

Dose adjustments

Dose adjustments

  • For patients managed with PCI: If the last enoxaparin administration was given <8 hours before balloon inflation, no additional dosing is needed; if >8 hours before balloon inflation, administer a 0.3 mg/kg i.v. bolus
  • For patients aged ≥75 years of age treated for acute STEMI: Omit the initial i.v. bolus and initiate dosing with 0.75 mg/kg s.c. every 12 hours (maximum 75 mg for the first two doses only)
  • Further dose adjustments required in patients with CrCl <30 ml/min (see prescribing information)

Dose adjustments

Patients needing treatment beyond 8 days, while awaiting angiography/
revascularization, should receive a fixed dose of either 5000 IU (women <80 kg and men <70 kg) or 7500 IU (women ≥80 kg and men ≥70 kg) 12 hourly

Dose adjustments

Dose adjustments

Duration

Duration

Duration

Duration

As long as the risk for ischaemic events outweighs the bleeding risk. Treatment beyond 12 months should be considered on an individual patient basis, as data up to 24 months are limited

Duration

Duration

Duration

Duration

  • Unstable angina and non-Q-wave MI: 2–8 days
  • Acute STEMI: 8 days

Duration

Up to 8 days unless patient is to undergo revascularization, in which case treatment is recommended to be given until the day of the revascularization procedure (PTCA or CABG) but not for more than 45 days

Duration

Duration

Practical management

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Routine coagulation monitoring needed?

Specific, rapid reversal agent available?

Specific, rapid reversal agent available?

Specific, rapid reversal agent available?

Specific, rapid reversal agent available?

Specific, rapid reversal agent available?


Idarucizumab

Specific, rapid reversal agent available?

Specific, rapid reversal agent available?


Protamine sulphate

Specific, rapid reversal agent available?

Partial
Protamine sulphate

Specific, rapid reversal agent available?

Partial
Protamine sulphate

Specific, rapid reversal agent available?

Partial
Protamine sulphate

Specific, rapid reversal agent available?

Measure drug level/activity using

Measure drug level/activity using

Rotachrom® anti-Factor Xa assay (quantitative)

Measure drug level/activity using

Calibrated anti-Factor Xa assay (quantitative)

Measure drug level/activity using

  • Calibrated anti-Factor Xa assay (quantitative)
  • PT with Neoplastin® Plus as reagent (qualitative)

Measure drug level/activity using

  • Calibrated dTT (quantitative)
  • ECT, aPTT (qualitative)

Measure drug level/activity using

PT/INR

Measure drug level/activity using

aPPT, TT

Measure drug level/activity using

Anti-Factor Xa assay

Measure drug level/activity using

  • Anti-Factor Xa assay (quantitative)
  • aPTT (overdose)

Measure drug level/activity using

Anti-Factor Xa assay

Measure drug level/activity using

Anti-Factor Xa assay
Onset of full therapeutic effect (h)

Onset of full therapeutic effect (h)

3–4

Onset of full therapeutic effect (h)

1–2

Onset of full therapeutic effect (h)

2–4

Onset of full therapeutic effect (h)

0.5–2

Onset of full therapeutic effect (h)

24–96

Onset of full therapeutic effect (h)

0.5

Onset of full therapeutic effect (h)

1–4

Onset of full therapeutic effect (h)

Rapid

Onset of full therapeutic effect (h)

4–6

Onset of full therapeutic effect (h)

2
Approx. half-life (h)

Approx. half-life (h)

12

Approx. half-life (h)

10–14

Approx. half-life (h)

5–13

Approx. half-life (h)

13–18

Approx. half-life (h)

20–60

Approx. half-life (h)

1–2

Approx. half-life (h)

4–5

Approx. half-life (h)

2–4

Approx. half-life (h)

1.5

Approx. half-life (h)

17–21
Approx. renal excretion (%)

Approx. renal excretion (%)

27

Approx. renal excretion (%)

35

Approx. renal excretion (%)

33

Approx. renal excretion (%)

85

Approx. renal excretion (%)

Negligible

Approx. renal excretion (%)

None

Approx. renal excretion (%)

Mostly

Approx. renal excretion (%)

Mostly

Approx. renal excretion (%)

Mostly

Approx. renal excretion (%)

64–77%
Food and drink

Food and drink

Take with or without food

Food and drink

Take with or without food

Food and drink

Take 15/20 mg doses with food

Food and drink

Take with or without food

Food and drink

  • Food high in vitamin K may lessen the effect of warfarin
  • Avoid large amounts of alcohol

Food and drink

No effects

Food and drink

No effects

Food and drink

No effects

Food and drink

No effects

Food and drink

No effects
Missed dose

Missed dose

Take dose immediately and continue with twice-daily intake thereafter

Missed dose

Take dose immediately and continue with usual once-daily dosing the next day; the dose should not be doubled

Missed dose

  • Secondary prevention of ACS (2.5 mg twice daily): continue with the regular dose at the next scheduled time
  • VTE prevention (10 mg once daily): take dose immediately and continue with usual once-daily dosing the next day; the dose should not be doubled
  • Acute phase of VTE treatment (15 mg twice daily): take missed dose immediately to ensure intake of 30 mg per day (two 15 mg tablets may be taken at once); continue with the regular 15 mg twice-daily intake on the following day
  • Secondary prevention of VTE/prevention of stroke in NVAF (15/20 mg once daily): take dose immediately and continue with usual once-daily dosing the next day; the dose should not be doubled

Missed dose

  • VTE prevention: continue with the usual daily doses the next day
  • VTE treatment, NVAF: A forgotten dose may still be taken up to 6 hours prior to the next scheduled dose; thereafter, the missed dose should be omitted
  • In all cases, the dose should not be doubled

Missed dose

No advice in prescribing information

Missed dose

No advice provided

Missed dose

No advice provided

Missed dose

No advice provided

Missed dose

No advice provided

Missed dose

  • Take the dose immediately
  • Do not inject a double dose
Patients needing surgery

Patients needing surgery

  • For minor procedures, perform at trough drug concentration
  • If possible, discontinue at least 24/48 hours before procedures with low/moderate-high bleeding risk
  • Restart as soon as possible once adequate haemostasis is restored
  • Bridging with heparin not required

Patients needing surgery

  • For minor procedures, perform at trough drug concentration
  • If possible, discontinue at least 24 hours before procedure
  • Restart as soon as possible once adequate haemostasis is restored
  • Bridging with heparin not required

Patients needing surgery

  • For minor procedures, perform at trough drug concentration
  • If possible, discontinue at least 24 hours before procedure
  • Restart as soon as possible once adequate haemostasis is restored
  • Bridging with heparin not required

Patients needing surgery

  • For minor procedures, perform at trough drug concentration
  • If possible, discontinue at least 24 hours before procedure and up to 4 days before, depending on renal function and bleeding risk of surgery
  • Restart as soon as possible once adequate haemostasis is restored
  • Bridging with heparin not required

Patients needing surgery

  • Surgery with no bleeding risk can be performed at INR <2.5
  • For surgery where there is a risk of severe bleeding, warfarin should be stopped 3 days prior to surgery if possible
  • If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K
  • Treatment can usually be re-started once the patient can manage an oral intake
  • Heparin bridging should be considered in patients for whom discontinuing anticoagulation presents a high risk of thromboembolism

Patients needing surgery

No advice provided

Patients needing surgery

In patients receiving heparin for treatment (rather than prophylaxis), locoregional anaesthesia in elective surgical procedures is contraindicated

Patients needing surgery

In patients receiving dalteparin for VTE treatment or ACS, local and/or regional anaesthesia in elective surgical procedures

Patients needing surgery

Avoid epidural anaesthesia

Patients needing surgery

  • Stop 24 hours before surgery if possible
  • Re-start no earlier than 6 hours after the procedure and once haemostasis has been achieved

Key interactions and contraindicationsc

Apixaban Eliquis®
Edoxaban Lixiana®
Rivaroxaban Xarelto®
Dabigatran Pradaxa®
Warfarin Coumadin®
Unfractionated heparin Not available
Enoxaparin Clexane®/Lovenox®
Dalteparin Fragmin®
Tinzaparin Innohep®
Fondaparinux Arixtra®
Principal contraindications/recommendations against use

Principal contraindications/recommendations against use

  • Age <18 years
  • CrCl <15 ml/min
  • Pregnancy/lactation
  • Hepatic disease associated with coagulopathy
  • Active bleeding or clinically relevant bleeding risk
  • Prosthetic heart valve/moderate to severe mitral stenosis
  • After hip fracture surgery
  • Patients with haemodynamically unstable PE

Principal contraindications/recommendations against use

  • Age <18 years
  • CrCl <15 ml/min
  • Pregnancy/lactation
  • Hepatic disease associated with coagulopathy
  • Active bleeding or clinically relevant bleeding risk
  • Uncontrolled hypertension
  • Prosthetic heart valve/moderate to severe mitral stenosis
  • Patients with haemodynamically unstable PE

Principal contraindications/recommendations against use

  • Age <18 years
  • CrCl <15 ml/min
  • Pregnancy/lactation
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child–Pugh B/C
  • Active bleeding or clinically relevant bleeding risk
  • Prosthetic heart valve/moderate to severe mitral stenosis
  • Patients with haemodynamically unstable PE

Principal contraindications/recommendations against use

  • Age <18 years
  • CrCl <30 ml/min
  • Pregnancy/lactation
  • Hepatic impairment or liver disease expected to impact on survival
  • Active bleeding or clinically relevant bleeding risk
  • After hip fracture surgery
  • Prosthetic heart valve
  • Patients with haemodynamically unstable PE

Principal contraindications/recommendations against use

  • Haemorrhagic stroke
  • Clinically significant bleeding
  • Within 72 hours of major surgery with risk of severe bleeding
  • Pregnancy or <48 hours postpartum
  • Co-medications where interactions may lead to a significantly increased risk of bleeding

Principal contraindications/recommendations against use

  • Active or high risk of bleeding
  • Severe thrombocytopenia
  • Heparin antibodies

Principal contraindications/recommendations against use

  • Acute bacterial endocarditis
  • Active/high risk of major bleeding including recent haemorrhagic stroke
  • Thrombocytopenia in patients with a positive in vitro aggregation test in the presence of enoxaparin
  • Active gastric or duodenal ulceration
  • Locoregional anaesthesia in elective surgical procedures

Principal contraindications/recommendations against use

  • History of HIT (type II)
  • Acute gastroduodenal ulcer
  • Cerebral haemorrhage
  • Known haemorrhagic diathesis or other active haemorrhage
  • Serious coagulation disorder
  • Acute or sub-acute septic endocarditis
  • Injuries to and operations on the central nervous system, eyes and ears
  • Intramuscular injection of dalteparin and intramuscular injection of other medicines when dalteparin dose >5000 IU/24 hours

Principal contraindications/recommendations against use

  • Current or history of HIT (type II)
  • Active or high risk of major bleeding
  • Septic endocarditis
  • Intramuscular injection of tinzaparin or other agents concurrently with tinzaparin
  • Prosthetic heart valve

Principal contraindications/recommendations against use

  • Age <17 years
  • CrCl <20 ml/min
  • Severe hepatic impairment (VTE treatment)
  • Body weight <50 kg (VTE treatment)
  • Active clinically significant bleeding
  • Acute bacterial endocarditis
  • Pregnancy
Exercise caution

Exercise caution

  • CrCl 15–29 ml/min
  • Mild or moderate hepatic impairment (Child–Pugh A/B)
  • Elevated liver enzymes (ALT/AST >2× ULN or total bilirubin ≥1.5× ULN)
  • Neuraxial blockade
  • Concomitant strong CYP3A4 inducers (e.g. St John’s wort) if used for VTE prevention or in patients with NVAF
  • Concomitant NSAIDs/antiplatelet agents

Exercise caution

  • Mild or moderate hepatic impairment (Child–Pugh A/B)
  • Elevated liver enzymes (ALT/AST >2× ULN or total bilirubin ≥1.5× ULN)
  • Concomitant strong P-gp inducers (e.g. St John’s wort)
  • Concomitant NSAIDs/low-dose ASA/other antiplatelet agents

Exercise caution

  • CrCl 15–29 ml/min
  • Patients with renal impairment receiving co-medications that result in increased rivaroxaban plasma concentrations
  • Neuraxial blockade
  • Concomitant NSAIDs/antiplatelet agents

Exercise caution

  • CrCl 30–50 ml/min
  • Age ≥75 years
  • Concomitant mild to moderate P-gp inhibitors
  • Concomitant posaconazole

Exercise caution

  • Concomitant NSAIDs/antiplatelet agents
  • Recent ischaemic stroke
  • Bacterial endocarditis
  • Previous GI bleeding
  • Excessive alcohol

Exercise caution

Concomitant antiplatelet agents/other anticoagulants

Exercise caution

  • Renal and hepatic impairment
  • Spinal anaesthesia
  • History of HIT
  • Impaired haemostasis
  • History of peptic ulcer
  • Uncontrolled severe arterial hypertension
  • Diabetic retinopathy
  • Recent neurologic or ophthalmologic surgery
  • Co-administration of other anticoagulants and agents affecting haemostasis

Exercise caution

  • Patients with increased bleeding risk
  • Concurrent anticoagulant/
    antiplatelet agents
  • Concomitant antihistamines, cardiac glycosides, tetracycline and ascorbic acid
  • High-dose treatment with dalteparin
  • Rapidly developing thrombocytopenia and severe thrombocytopenia (<100,000/µl) associated with positive or unknown results of in vitro tests for antiplatelet antibody
  • Neuraxial anaesthesia

Exercise caution

  • Neuraxial anaesthesia
  • CrCl <30 ml/min
  • Concurrent anticoagulant/
    antiplatelet agents

Exercise caution

  • Severe hepatic impairment (VTE prevention)
  • Body weight <50 kg (VTE prevention)
  • NSAIDs/antiplatelet agents
  • Spinal/epidural anaesthesia
  • Elderly patients
  • Renal impairment
  • History of HIT
Key co-medications to avoid

Key co-medications to avoid

  • Azole antimycotics
  • HIV protease inhibitors
  • Strong CYP3A4 inducers (e.g. St John’s wort) if used for acute VTE treatment
  • Other anticoagulants

Key co-medications to avoid

  • Other anticoagulants
  • High-dose ASA

Key co-medications to avoid

  • Azole antimycotics
  • HIV protease inhibitors
  • Dronedarone
  • Strong CYP3A4 inducers (e.g. St John’s wort)
  • Other anticoagulants

Key co-medications to avoid

  • Systemic ketoconazole, cyclosporine, itraconazole and dronedarone
  • Tacrolimus
  • Concomitant strong P-gp inducers (e.g. St John’s wort)

Key co-medications to avoid

  • Allopurinol, capecitabine, erlotinib, disulfiram, azole antimycotics
  • Omeprazole, paracetamol (prolonged use), propafenone, amiodarone, tamoxifen, methylphenidate
  • Zafirlukast fibrates, some statins
  • Erythromycin, sulfamethoxazole, metronidazole
  • Barbiturates, primidone, carbamazepine, griseofulvin, oral contraceptives, rifampicin, azathioprine, phenytoin
  • Corticosteroids, nevirapine, ritonavir
  • Glucosamine
  • St John’s wort

Key co-medications to avoid

None specified

Key co-medications to avoid

None specified

Key co-medications to avoid

None specified

Key co-medications to avoid

None specified

Key co-medications to avoid

  • Desirudin
  • Fibrinolytic agents
  • GP IIb/IIIa receptor antagonists
  • Heparins/heparinoids

Approved for use in this indication in EU/UK

Approved for use in this indication in EU/UK
Not approved for use in this indication in EU/UK

aSome drugs may have other indications beyond those listed – refer to full local prescribing information; bapproved for VTE prevention after orthopaedic surgery in Japan; cnot an exhaustive list – refer to full prescribing information.

ALT, alanine transaminase; aPTT, activated partial thromboplastin time; AST, aspartate transaminase; CYP3A4, cytochrome P450 3A4; dTT, dilute thrombin time; ECT, ecarin clotting time; GI, gastrointestinal; GP IIb/IIIa, glycoprotein IIb/IIIa; HIV, human immunodeficiency virus; i.v., intravenous; NSAID, non-steroidal anti-inflammatory drug; NYHA, New York Heart Association; P-gp, P-glycoprotein; PT, prothrombin time; PTCA, percutaneous transluminal coronary angioplasty; s.c., subcutaneous; TT, thrombin time; ULN, upper limit of normal.