Stroke Prevention in Atrial Fibrillation (SPAF)

Patient data

Please specify the type of atrial fibrillation (AF):


Further relevant conditions:


You may provide optional data about your patient:

Please enter the date in the correct format (MM/DD/YYYY) Please review the patient’s age Please review the patient’s age

Please indicate if any of the following stroke risk factors apply:

Please indicate if any of the following contraindications apply:

Please indicate if any of the following haemorrhagic risk factors exist:

Please provide some information about the patient’s renal function:

The patient’s renal function is known:

  • Please enter the patient’s creatinine clearance

ml/min

or

Normal renal function or mild renal impairment i.e. creatinine clearance > 50 ml/min is anticipated:

  • Please review the patient’s serum creatinine
  • Please enter the patient’s serum creatinine
  • Xarelto® is not indicated for use under the age of 18
  • Please review the patient’s age
  • Please enter the patient’s age
  • Please review the patient’s weight
  • Please enter the patient’s weight
  • Please select the patient’s sex

Please calculate the patient’s creatinine clearance based on Cockroft-Gault formula by inserting the respective data:

Sex

Creatinine clearance ml/min

Please indicate if the patient is taking any of the concomitant medications:

Patient assessment summary:

  • You provided the following additional data about your patient:

    Type of atrial fibrillation (AF): %af-type%

    Further relevant conditions: %conditions%
    Last name: %lastname%
    First name: %firstname%
    Date of birth (MM/DD/YYYY): %birth%
    Patient identification number: %number%
  • 1) You have indicated the following stroke risk factors:

  • 2) You have indicated the following contraindications where use of Xarelto® is not recommended:

  • 3) You have indicated the following haemorrhagic risk factors:

  • 4) You have indicated a creatinine clearance of ml/min

  • 5) You have indicated these concomitant medications:

  • 6) Additional comments:

Result: Based on your assessment, Xarelto® is not indicated for this patient.

Do not prescribe Xarelto®

Result: Based on your assessment, you may prescribe Xarelto® 20 mg once-daily taken with food for your patient with atrial fibrillation.

Xarelto® 20 mg once-daily

Result: Based on your assessment, you may prescribe Xarelto® 15 mg once-daily taken with food for your patient with atrial fibrillation.

Xarelto® 15 mg once-daily

Result: Based on your assessment, you may prescribe Xarelto® 15 mg once-daily taken with food for your patient with atrial fibrillation. Please use with caution.

Xarelto® 15 mg once-daily

Result: Based on your assessment, you may prescribe Xarelto® 20 mg once-daily taken with food for your patient with atrial fibrillation. Please use with caution.

Xarelto® 20 mg once-daily

Result: Based on your assessment, you may prescribe Xarelto® 15 mg once-daily taken with food for your patient with atrial fibrillation. Please use with caution.

Xarelto® 15 mg once-daily
for patients with severe renal impairment, to be used with caution

Result: Based on your assessment, you may prescribe Xarelto® 15 mg once-daily taken with food for your patient with atrial fibrillation.

Xarelto® 15 mg once-daily
for patients with moderate renal impairment

Result: Based on your assessment, you may prescribe Xarelto® 15 mg once-daily taken with food for your patient with atrial fibrillation. Please use with caution.

Xarelto® 15 mg once-daily
for patients with moderate renal impairment

Based on your anticipated renal function of your patient, you may prescribe:
- Xarelto® 20 mg once-daily anticipating normal renal function (CrCl > 80 ml/min) or mild renal impairment (CrCl 50-80 ml/min)
- Xarelto® 15 mg once-daily anticipating moderate renal impairment (CrCl 30-49 ml/min) or, with caution in severe renal impairment (CrCl 15-29 ml/min)
Use of Xarelto® is not recommended in patients with CrCl < 15 ml/min.

If abnormal renal function is anticipated, patient’s creatinine clearance should be measured before prescribing Xarelto®.
Xarelto® is not recommended in patients with creatinine clearance < 15 ml/min.

Xarelto® is not recommended in patients with creatinine clearance < 15 ml/min (severe renal impairment)

Xarelto® is to be used with caution in patients with creatinine clearance 15-29 ml/min (severe renal impairment). The recommended dose for these patients is Xarelto® 15 mg once-daily.

The recommended dose for patients with moderate renal impairment is Xarelto® 15 mg once-daily.
Xarelto® is to be used with caution in patients with creatinine clearance 30-49 ml/min (moderate renal impairment) concomitantly receiving other medicinal products which increase Xarelto® plasma concentrations.

When prescribing Xarelto®, VKA treatment should be stopped and Xarelto® therapy should be initiated once the INR is ≤ 3.0

When prescribing Xarelto®, i.v. administered Heparin treatment should be stopped and Xarelto® therapy should be started at the time of discontinuation.

When prescribing Xarelto®, s.c. administered Heparin/LMWH treatment should be stopped and Xarelto® therapy should be started 0–2 hours before the next scheduled dose of Heparin/LMWH.

Based on your assessment, the patient has an increased risk of bleeding. Please use with caution.

No clinical data available, therefore co-administration should be avoided

Strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis

Based on your assessment, the patient has an increased risk of bleeding. Please use with caution.

No dose adjustment is necessary in patients with mild renal impairment. The recommended dose is Xarelto® 20 mg once-daily, which is also the recommended maximum dose.

Based on your assessment, Xarelto® is not indicated for this patient.

Would you still like to continue the assessment?

Based on your assessment, Xarelto® is not recommended for this patient.

Would you still like to continue the assessment?

Based on your assessment, Xarelto® is not recommended for this patient.

Would you still like to continue the assessment?

Based on your assessment, Xarelto® is not recommended for this patient.

Would you still like to continue the assessment?

Based on your assessment, Xarelto® is not indicated for this patient.

Would you still like to continue the assessment?

Based on your assessment, Xarelto® is contraindicated for this patient.

Would you still like to continue the assessment?

Are you considering switching your patient to Xarelto®? or Is your patient receiving UFH at doses necessary to maintain an open central venous or arterial catheter?

TABLET CORE

Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate

FILM-COAT

Macrogol 3350, hypromellose, titanium dioxide (E171), iron oxide red (E172)

Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under the circumstances of switching therapy to or from Xarelto® or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.

Based on your assessment, the patient has an increased risk of bleeding. Please use with caution.

Xarelto® is not recommended for patients with creatinine clearance < 15 ml/min (severe renal impairment)

Would you still like to continue the assessment?

The recommended dose for patients with moderate renal impairment is Xarelto® 15 mg once-daily.
Xarelto® is to be used with caution in patients with creatinine clearance 30-49 ml/min (moderate renal impairment) concomitantly receiving other medicinal products which increase Xarelto® plasma concentrations (see 5 Medications).

%spaf.renalFunction.alert.advice%

Xarelto® is to be used with caution in patients with creatinine clearance 15-29 ml/min (severe renal impairment). The recommended dose for these patients is Xarelto® 15 mg once-daily.

Your patient may receive Xarelto® 20 mg once-daily assuming:
- normal renal function (CrCl > 80 ml/min) or
- mild renal impairment (CrCl 50-80 ml/min)
Xarelto® 15 mg once-daily can be given to patients with:
- moderate renal impairment (CrCl 30-49 ml/min) or
- severe renal impairment (CrCl 15-29 ml/min) with caution
Use of Xarelto® is not recommended in patients with CrCl < 15 ml/min.

Please check patient‘s renal function

You have anticipated a normal renal function or mild renal impairment i.e. creatinine clearance > 50 ml/min

You have not anticipated a normal renal function or mild renal impairment i.e. creatinine clearance > 50 ml/min

Based on your assessment, it is not recommended to use Xarelto® with the concomitant medications indicated.

Would you still like to continue the assessment?

When prescribing Xarelto®, VKA treatment should be stopped and Xarelto® therapy should be initiated once the INR is ≤ 3.0

Concomitant treatment with any other anticoagulant agent is contraindicated except under the circumstances of switching therapy.
When prescribing Xarelto®, VKA treatment should be stopped and Xarelto® therapy should be initiated once the INR is ≤ 3.0

Strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis

Please use with caution.

No clinical data available, therefore co-administration should be avoided

Would you still like to continue the assessment?

Based on your assessment, the patient has an increased risk of bleeding. Please use with caution.

When prescribing Xarelto®, i.v. administered Heparin treatment should be stopped and Xarelto® therapy should be started at the time of discontinuation.

Concomitant treatment with any other anticoagulant agent is contraindicated except under the circumstances of switching therapy.
When prescribing Xarelto®, i.v. administered Heparin treatment should be stopped and Xarelto® therapy should be started at the time of discontinuation.

When prescribing Xarelto®, s.c. administered Heparin/LMWH treatment should be stopped and Xarelto® therapy should be started 0–2 hours before the next scheduled dose of Heparin/LMWH.

Concomitant treatment with any other anticoagulant agent is contraindicated except under the circumstances of switching therapy.
When prescribing Xarelto®, s.c. administered Heparin/LMWH treatment should be stopped and Xarelto® therapy should be started 0–2 hours before the next scheduled dose of Heparin/LMWH.

close

OAC=oral anticoagulant; VKA=vitamin K antagonist

Xarelto® should be continued, provided the benefit of stroke prevention therapy outweights the potential risk bleeding

a INR values should not be used as they are not a dependable measure of the anticoagulant activity of Xarelto®

b Duration according to individual decrease of VKA plasma levels

1 Xarelto® [summary of product characteristics]. Berlin, Germany: Bayer Pharma AG; 2013

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