Rivaroxaban 2.5mg oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of rivaroxaban containing 2.5mg.
Drugs List
Therapeutic Indications
Uses
Atherothrombotic events after ACS (with antiplatelet agents): prevention
Prevention of atherothrombotic events in coronary artery disease
Prevention of atherothrombotic events in peripheral arterial disease
Prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers in combination with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Prevention of atherothrombotic events in patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events with acetylsalicylic acid.
Dosage
Adults
The recommended dose is 2.5mg twice daily.
Acute coronary syndrome (ACS)
Patients should also take a daily dose of 75mg to 100mg ASA or a daily dose of 75mg to 100mg ASA in addition to either a daily dose of 75mg clopidogrel or a standard daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited.
Treatment with rivaroxaban should be started as soon as possible after stabilisation of the ACS event (including revascularisation procedures); at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued.
Coronary artery disease (CAD) or Peripheral artery disease (PAD)
Patients should also take a daily dose of 75mg to 100mg ASA.
Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk for thrombotic events versus the bleeding risks.
Patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of rivaroxaban 2.5mg twice daily should be evaluated depending on the type of event or procedure and antiplatelet regimen. Safety and efficacy of rivaroxaban 2.5mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS. Dual antiplatelet therapy has not been studied in combination with rivaroxaban 2.5mg twice daily in patients with CAD/PAD.
Additional Dosage Information
Missed doses
If a dose is missed the patient should continue with the regular dose as recommended at the next scheduled time. The dose should not be doubled to make up for a missed dose.
Converting from vitamin K antagonists (VKA) to rivaroxaban.
When converting patients from VKAs to rivaroxaban, international normalized ratio (INR) values will be falsely elevated after the intake of rivaroxaban. The INR is not valid to measure the anticoagulant activity of rivaroxaban, and therefore should not be used.
Converting from rivaroxaban to vitamin K antagonists (VKA)
In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is 2 or greater. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing guided by INR testing. While patients are on both rivaroxaban and VKA the INR should not be tested earlier than 24 hours after previous dose but prior to the next dose of rivaroxaban. Once rivaroxaban is discontinued INR testing may be done reliably at least 24 hours after the last dose.
Converting from parenteral anticoagulants to rivaroxaban
For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Converting from rivaroxaban to parenteral anticoagulants
Give the first dose of parenteral anticoagulant at the time the next rivaroxaban dose would be taken.
Administration
For oral administration. For patients who are unable to swallow whole tablets, rivaroxaban tablets may be crushed and mixed with water or apple puree immediately prior to use and administered orally.
Contraindications
Children under 18 years
Haemorrhage
Arteriovenous malformation
Breastfeeding
Coagulopathy due to hepatic disorder
Galactosaemia
Gastrointestinal ulcer
History of cerebrovascular accident
History of gastrointestinal ulceration
History of transient ischaemic attack
Neoplasm with increased bleeding risk
Oesophageal varices
Pregnancy
Prosthetic heart valve
Recent central nervous system surgery
Recent central nervous system trauma
Recent intracranial haemorrhage
Recent ocular surgery
Renal impairment - creatinine clearance below 15ml/minute
Vascular disorder
Precautions and Warnings
Patients over 75 years
Predisposition to haemorrhage
Spinal/epidural anaesthesia
Weight below 60kg
Antiphospholipid syndrome
Bronchiectasis
Coagulopathy
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Haemorrhagic retinopathy
History of pulmonary haemorrhage
Lactose intolerance
Renal impairment - creatinine clearance 15-29ml/minute
Uncontrolled severe hypertension
Not recommended for anticoagulation with prosthetic heart valves
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Increased risk of spinal haematoma with post-op insitu epidural catheter
Consider monitoring haemoglobin/haematocrit
Monitor anti-Factor Xa levels in patients at risk of bleeding
Monitor for bleeding during treatment
Monitor patients undergoing spinal or epidural anaesthesia closely
Reversal agent available
Spinal anaesthesia: tell patient-report symptoms of neurological impairment
Discontinue at least 12 hours before surgery or an invasive procedure
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if severe haemorrhage occurs
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Advise patient of risk of bleeding
Remind patient of importance of carrying Alert Card with them at all times
Several subgroups are at increased risk of bleeding, they should be monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment. If an unexplained fall in haemoglobin or blood pressure occurs the patient should be investigated for a bleeding site. The use of rivaroxaban in combination with dual antiplatelet therapy in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events.
Patients undergoing spinal or epidural anaesthesia or puncture while being treated with rivaroxaban are at risk of developing an epidural or spinal haematoma which could result in long term or permanent paralysis. This risk is increased by the use of indwelling epidural catheters or other drugs affecting haemostasis. Traumatic or repeated epidural or spinal puncture will also increase the risk. Urgent diagnosis and treatment is required if neurological compromise is observed. Prior to neuraxial intervention the potential risks should be weighed against the benefits in patients currently anticoagulated or planned to be anticoagulated for thromboprophylaxis.
At the time of writing there is limited clinical experience with 2.5mg rivaroxaban with ASA alone or with ASA plus clopidogrel or ticlopidine in these situations.
To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low.
Increasing age may increase haemorrhagic risk.
Administration of rivaroxaban must be stopped at least 12 hours before invasive procedure or surgical intervention. Rivaroxaban should be restarted as soon as possible provided the clinical situation allows and adequate haemostasis has been established.
Serious skin reactions, including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and DRESS syndrome (Drug rash with eosinophilia and systemic symptoms) have been reported. The highest risk for these reactions occurs early in the course of therapy within the first weeks of treatment. Rivaroxaban should be discontinued at the first appearance of a severe skin rash, or any other sign of hypersensitivity in conjunction with mucosal lesions.
Direct acting Oral Anticoagulants (DOACs) including rivaroxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein 1 antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Pregnancy and Lactation
Pregnancy
Rivaroxaban is contraindicated during pregnancy.
Use of rivaroxaban during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Rivaroxaban is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues rivaroxaban or discontinues breastfeeding. Animal studies show that rivaroxaban is excreted in the breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Abnormal liver function
Acute renal failure
Allergic dermatitis
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Asthenia
Blood urea increased
Cerebral haemorrhage
Cholestasis
Compartment syndrome
Conjunctival haemorrhage
Constipation
Contusion
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dyspepsia
Ecchymosis
Elevated amylase levels
Elevated serum lipase
Eosinophilic pneumonia
Epistaxis
Extremity pain
Fatigue
Fever
Gamma glutamyl transferase (GGT) increased
Gastro-intestinal haemorrhage
Genitourinary bleeding
Gingival bleeding
Haemarthrosis
Haematoma
Haematuria
Haemoptysis
Haemorrhage
Headache
Hepatitis
Hypersensitivity reactions
Hypotension
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase of liver transaminases
Increased platelet count
Intracranial bleeding
Jaundice
Malaise
Menorrhagia
Muscle haemorrhage
Nausea
Ocular haemorrhage
Oedema
Peripheral oedema
Post operative wound haemorrhage
Pruritus
Rash
Rectal bleeding
Renal impairment
Serum bilirubin increased
Serum creatinine increased
Stevens-Johnson syndrome
Syncope
Tachycardia
Thrombocythaemia
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vascular pseudoaneurysm
Vomiting
Wound secretion
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2022
Reference Sources
Summary of Product Characteristics: Xarelto 2.5mg film coated tablets. Bayer Plc. Revised November 2022.
HPRA Saftey Notices October 2018, May 2019.
Available at: https://www.hpra.ie
Last accessed: 06 September 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 September 2019
MHRA Drug Safety Update June 2020
Available at: https://www.mhra.gov.uk
Last accessed: 06 November 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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