Rivaroxaban granules for oral suspension
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Drugs List
Therapeutic Indications
Uses
VTE in children under 18 years: Prevention of recurrence
VTE in children under 18 years: Treatment
Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.
Dosage
Dose and frequency of administration is determined based on bodyweight.
Children
Children aged 18 years or less
Bodyweight equal to or greater than 50kg
20mg once a day. Dose should be taken approximately 24 hours apart.
Bodyweight equal to or greater than 30kg but less than 50kg
15mg once a day. Dose should be taken approximately 24 hours apart.
Bodyweight equal to or greater than 12kg but less than 30kg
5mg twice a day. Dose should be taken approximately 12 hours apart.
Bodyweight equal to or greater than 10kg but less than 12kg
3mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 9kg but less than 10kg
2.8mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 8kg but less than 9kg
2.4mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 7kg but less than 8kg
1.8mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 5kg but less than 7kg
1.6mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 4kg but less than 5kg
1.4mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 3kg but less than 4kg
0.9mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight equal to or greater than 2.6kg but less than 3kg
0.8mg three times a day. Dose should be taken approximately 8 hours apart.
Bodyweight of less than 2.6kg
Rivaroxaban oral granules are contraindicated.
Additional Dosage Information
Each dose should be followed by the intake of one typical serving of liquid immediately. If the patient spits up the dose or vomits within 30 minutes after receiving the dose, a new dose should be given. If the patient vomits more than 30 minutes after the dose, the dose should not be re-administered and the next dose should be taken as scheduled.
All children, except those aged less than 2 years with catheter-related thrombosis
Therapy should be continued for at least 3 months. Treatment can be extended up to 12 months when clinically necessary, continued therapy after 3 months should be assessed on an individual basis taking into account the risk of recurrent thrombosis versus potential risk of bleeding.
Children aged less than 2 years with catheter-related thrombosis
Therapy should be continued for at least 1 month. Treatment can be extended up to 3 months when clinically necessary, continued therapy after 1 month should be assessed on an individual basis taking into account the risk of recurrent thrombosis versus potential risk of bleeding.
Missed doses
Once a day regimen
A missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next prescribed dose. Do not take two doses to make up for the missed dose.
Two times a day regimen
A missed morning dose should be taken immediately when it is noticed, it may be taken together with the evening dose. A missed evening dose can only be taken during the same evening, the patient should not take two doses the next morning.
Three times a day regimen
The administration schedule with approximately 8 hour intervals should be resumed at the next scheduled dose without compensating for the missed dose.
Converting from parenteral anticoagulants to rivaroxaban
Start rivaroxaban treatment 0 to 2 hours before the time of the next scheduled administration of the parenteral product or at the time of discontinuation of a continuously administered parenteral product.
Converting from rivaroxaban to parenteral anticoagulants
Discontinue rivaroxaban and give the first dose of parenteral anticoagulant at the time the next rivaroxaban dose would be taken.
Converting from vitamin K antagonist (VKA) to rivaroxaban
Once the International Normalised Ratio (INR) is less than or equal to 2.5, discontinue VKA treatment and initiate rivaroxaban therapy. When converting from VKAs to rivaroxaban, INR values will be falsely elevated following the intake of rivaroxaban. INR is not a valid measure of the anticoagulant activity of rivaroxaban and should not be used.
Converting from rivaroxaban to vitamin K antagonist (VKA)
During transition from rivaroxaban to VKAs there is the potential for inadequate anticoagulation. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. Rivaroxaban can contribute to elevated INR.
If converting in children, rivaroxaban treatment needs to be continued for 48 hours after the first dose of VKA. Following two days of co-administration an INR should be obtained prior to the next scheduled dose of rivaroxaban. It is advised to continue co-administration of rivaroxaban and VKA until the INR is greater than or equal to 2. Once rivaroxaban is discontinued, INR testing may be done reliably 24 hours after the last dose.
Contraindications
Children aged under 6 months with < 37 weeks gestational age at birth
Children aged under 6 months with less than 10 days of oral feeding
Children weighing less than 2.6kg
Haemorrhage
Arteriovenous malformation
Breastfeeding
Coagulopathy due to hepatic disorder
Gastrointestinal ulcer
History of gastrointestinal ulceration
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 in children < 1 year - CrCl < 97.5th percentile
Renal impairment in children 1 to 18 years - GFR below 50ml/minute/1.73m sq
Vascular disorder
Precautions and Warnings
Predisposition to haemorrhage
Spinal/epidural anaesthesia
Weight below 12kg
Antiphospholipid syndrome
Bronchiectasis
Coagulopathy
Gastrointestinal disorder
Haemorrhagic retinopathy
History of pulmonary haemorrhage
Uncontrolled severe hypertension
Not recommended for anticoagulation with prosthetic heart valves
Advise ability to drive/operate machinery may be affected by side effects
Must be taken with food and water
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 body weight in children and review dose if necessary
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 treatment 24 hours prior to surgery
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.
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.
Rivaroxaban is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of rivaroxaban have not been established in these clinical situations.
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.
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.
If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
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.
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 1mg/ml granules for oral suspension. Bayer Plc. Revised November 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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