Xarelto® (rivaroxaban) funding announcement

Xarelto® (rivaroxaban) funding announcement

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Bayer New Zealand Ltd
Bayer's Xarelto now fully funded without restrictions
Xarelto® (rivaroxaban) 20mg

Xarelto (rivaroxaban) 15mg x 28 tablet packs and 20mg x 28 tablet packs will be fully funded by PHARMAC, without restrictions, from 1 August 2018. In addition, from this date, Special Authority will no longer apply to Xarelto 10mg tablets.1

Xarelto® (rivaroxaban) product information

Xarelto is a non-vitamin K antagonist oral anticoagulant (NOAC) with a different mechanism of action to dabigatran, by selective inhibition of Factor Xa.2

Xarelto is taken once daily (except during the initial phase of treatment for venous thromboembolism when it is taken twice a day) and does not require routine coagulation monitoring.2 There is also no requirement for parenteral anticoagulation prior to initiation of Xarelto when treating venous thromboembolism.2

Xarelto tablets are small – only 6mm across but for patients who have difficulty swallowing whole tablets, Xarelto can be crushed and mixed with water or applesauce immediately prior to use and administered orally.2

Xarelto (rivaroxaban) 15mg x 28 tablet packs and 20mg x 28 tablet packs
Xarelto is approved in New Zealand for use in the following indications:

Prevention of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.2

 

  • The recommended dose for prevention of stroke and SE in patients with NVAF and creatinine clearance (CrCl) of ≥50mL/min is Xarelto 20 mg once daily with food. Xarelto 15mg once daily with food is approved for patients with moderate renal impairment (CrCl 3049mL/min).2*
    • *Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding.2
  • The use of Xarelto 15mg and 20mg tablets is contraindicated in patients with severe renal impairment (CrCl <30 mL/min).2

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE*.2

*Xarelto is not recommended in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy.

 

  • Initial treatment of acute DVT/PE is 15mg twice daily with food for 21 days followed by 20mg once daily with food.2 Duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding.2There is no requirement for treatment initiation with a parenteral anticoagulant.2
  • There is no dose adjustment for patients with moderate renal impairment (CrCl 3049 mL/min).2
  • The use of Xarelto 15mg and 20mg tablets is contraindicated in patients with severe renal impairment (CrCl < 30mL/min).2

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.2

 

  • The recommended dose of Xarelto for VTE prevention in major orthopaedic surgery of the lower limbs (elective total hip or knee replacement) is a 10 mg tablet taken once daily.2
  • The initial dose should be taken 610 hours after surgery provided that haemostasis has been established.2
  • The duration of treatment depends on the type of major orthopaedic surgery.2
    • For patients undergoing hip replacement surgery, a treatment duration of 5 weeks is recommended.2
    • For patients undergoing knee replacement surgery, a treatment duration of 2 weeks is recommended.2
    • The dose of 10 mg once daily and duration specified for each type of surgery is not to be exceeded.2
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References

1. PHARMAC website, accessed 9/7/2018.

2. Xarelto Data Sheet December 2017

Mandatories

XARELTO® (rivaroxaban)

Xarelto is used in anticoagulation. Prescription Medicine. 10 mg, 15 mg, and 20 mg tablets containing rivaroxaban. INDICATIONS: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and pulmonary embolism (see the PRECAUTIONS for haemodynamically unstable PE patients). DOSAGE AND ADMINISTRATION: For VTE prevention in total hip and knee replacement, one 10 mg tablet taken once daily. Initial dose to be taken 6-10 hours after surgery provided haemostasis has been established. Xarelto may be taken with or without food. For stroke prevention in atrial fibrillation, one 20 mg tablet taken once daily. The dose is one 15 mg tablet taken once daily for patients with creatinine clearance 30-49 mL/min. For treatment of acute DVT and PE, the initial dose is one 15 mg tablet taken twice daily for the first 3 weeks followed by one 20 mg tablet taken once daily for the continued treatment and prevention of recurrent DVT and PE. Xarelto 15 mg and 20 mg tablets should be taken with food. Tablets may be crushed and administered orally (mixed with water or applesauce) or given through gastric tubes. CONTRAINDICATIONS: Hypersensitivity to rivaroxaban or to any of the excipients, clinically significant active bleeding, lesions at increased risk of clinically significant bleeding and patients with spontaneous impairment of haemostasis, significant hepatic disease which is associated with coagulopathy, severe renal impairment with a creatinine clearance < 15 mL/min for Xarelto 10 mg (< 30 mL/min for Xarelto 15 mg and 20 mg), concomitant treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein such as HIV protease inhibitors (e.g. ritonavir) or systemically administered azole anti-mycotics (e.g. ketoconazole), pregnancy, lactation. PRECAUTIONS: Should be used with caution in patients with an increased bleeding risk such as congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, active ulcerative gastrointestinal disease, recent gastrointestinal ulcerations, vascular retinopathy, recent intracranial or intracerebral haemorrhage, intraspinal or intracerebral vascular abnormalities, shortly after brain, spinal or ophthalmological surgery, bronchiectasis or history of pulmonary bleeding, renal impairment, hepatic impairment, surgery and interventions, spinal/epidural anaesthesia or puncture, paediatric use under 18 years not recommended, no clinical data in patients with prosthetic valves, haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy, lactose intolerance, driving and machine use. Pregnancy Category C. INTERACTIONS WITH OTHER MEDICINES: Care to be taken if concomitantly used with medicines affecting haemostasis; increased risk of bleeding with concomitant administration with SSRIs, SNRIs, NSAIDs, platelet aggregation inhibitors, other anticoagulants. Strong inhibitors of both CYP3A4 and P-gp. ADVERSE EFFECTS: Please refer to Datasheet for a complete list. Common adverse reactions (≥ 1/100 to < 1/10) include post procedural, eye, GI tract and urogenital tract haemorrhage, haemoptysis, increased transaminases, gingival bleeding, constipation, diarrhoea, dyspepsia, nausea, vomiting, pyrexia, oedema peripheral, confusion, pain in extremity, gastrointestinal and abdominal pain, headache, fever, decreased general strength and energy, contusion, dizziness, epistaxis, haematoma, anaemia, renal impairment and ecchymosis, cutaneous and subcutaneous haemorrhage, hypotension, rash and pruritus. Less frequent but serious adverse reactions include: urticaria, cerebral and intracranial haemorrhage, jaundice, angioedema, allergic oedema, cholestasis, hepatitis and thrombocytopaenia. Based on DS: Dated 11 December 2017

Xarelto will be fully funded from 1st August 2018. Until 1st August 2018, Xarelto is only funded for patients who meet criteria for use after hip or knee replacement. A prescription fee will apply. This medicine has risks and benefits. Before prescribing, please review Data Sheet for further information. Full Data Sheet is available from www.medsafe.govt.nz or Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627. Telephone 0800 233 988. NA 10257. NZ-XAR-00066-07-2018. Prepared July 2018.