Streamlined authority code 4269
PBS Information: Authority required (STREAMLINED) for the prevention of stroke or
systemic embolism in patients with non-vascular atrial fibrillation and one or more
risk factors for developing stroke or systemic embolism.
Authority required (STREAMLINED) for prevention of venous thromboembolism in a
patient undergoing total hip replacement or total knee replacement. Refer to PBS
Schedule for full authority information.
Pradaxa® (dabigatran etexilate) 110mg and 150mg capsules
Before prescribing, please review the full Product Information available from Boehringer Ingelheim at
INDICATION: Prevention of stroke and systemic embolism in patients with non- valvular atrial fibrillation and at least one
additional risk factor for stroke (SPAF).
CONTRAINDICATIONS:Known hypersensitivity to dabigatran, dabigatran etexilate or excipient; severe renal impairment
(CrCL < 30mL/min); haemorrhagic manifestations, bleeding diathesis, spontaneous or pharmacological impairment of
haemostasis; lesion or condition if considered significant risk factor for major bleeding (including current or recent
gastrointestinal ulceration, 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 except when switching anticoagulant therapy or when unfractionated heparin is given at doses
necessary to maintain an open central venous or arterial catheter or when unfractionated heparin is given during catheter
ablation for atrial fibrillation; indwelling spinal or epidural catheter and during the first two hours after removal; hepatic
impairment or liver disease expected to have any impact on survival; history of intracranial, intraocular, spinal,
retroperitoneal or atraumatic intra-articular bleeding; gastrointestinal haemorrhage within the past year unless the cause has
been permanently eliminated; conditions associated with increased risk of bleeding; concomitant treatment with systemic
ketoconazole, ciclosporin, itraconazole, dronedarone or the fixed-dose combination glecaprevir/pibrentasvir; simultaneous
initiation of treatment with dabigatran etexilate and oral verapamil; prosthetic heart valve replacement.
PRECAUTIONS: Haemorrhagic risk#: moderate renal impairment (CrCL 30-50 mL/min), congenital or acquired coagulation
disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent gastrointestinal
bleeding, recent biopsy or major trauma, brain, spinal or ophthalmic surgery, bacterial endocarditis, age ≥ 75 years,
fibrinolytic agents. Myocardial infarction. Concomitant administration with: acetylsalicylic acid, NSAIDs, clopidogrel,
unfractionated heparins and heparin derivatives, low molecular weight heparins, fondaparinux, desirudin, thrombolytic
agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, rivaroxaban, prasugrel, ticagrelor, vitamin K
antagonists, selective serotonin re-uptake inhibitors, selective serotonin norepinephrine re-uptake inhibitors, P-gp inhibitors:
amiodarone, verapamil, tacrolimus, ritonavir, tipranavir, nelfinavir, saquinavir, quinidine, clarithromycin,
glecaprevir/pibrentasvir fixed-dose combination. P-gp inducers. Patients with antiphospholipid syndrome. Surgical
interventions may require temporary discontinuation and anticoagulant monitoring is warranted#; clearance in patients with
renal impairment may take longer. Not recommended in patients undergoing hip fracture surgery. Pregnancy (Category C).
Lactation. Children. Patients < 50 kg. See full PI.

# For situations of life-threatening/uncontrolled bleeding, and in case of emergency surgery/urgent procedures when rapid reversal of the anticoagulation effects of PRADAXA is required, the specific reversal agent (PRAXBIND, idarucizumab) is available.

ADVERSE EFFECTS: Bleeding and signs of bleeding, dyspepsia, gastritis-like symptoms, diarrhoea, nausea, vomiting,
constipation, flatulence, dysphagia, nasopharyngitis, dyspnoea, cough, dyspnoea exertional, upper respiratory tract
infection, bronchitis, pneumonia, influenza, sinusitis, urinary tract infection, dizziness, headache, syncope, insomnia, atrial
fibrillation, cardiac failure congestive, cardiac failure, palpitations, angina pectoris, hypertension, hypotension, rash, gout,
arthralgia, back pain, pain in extremity, osteoarthritis, musculoskeletal pain, muscle spasms, oedema peripheral, fatigue,
asthenia, chest pain, chest discomfort, fall, abnormal liver function tests. Less common adverse reactions see full PI.
DOSAGE AND ADMINISTRATION for SPAF: Assess renal function (Cockcroft-Gault method) prior to treatment initiation,
in clinical situations that could lead to renal function decline and at least once a year in patients ≥ 75 years or with moderate
renal impairment. Swallow capsule whole with water, with or without food. Recommended dose: 300 mg (one 150 mg
capsule twice daily). Age ≥ 75 years: reduced dose of 220 mg (one 110 mg capsule twice daily). Moderate renal
impairment, higher risk of bleeding: reduced dose of 220 mg (one 110 mg capsule twice daily) may be considered. Special
populations see full PI.
ABN 52 000 452 308
March 2020
Notification Title