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Contraindications for Pradaxa, a new oral anticoagulant


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Pradaxa ( Dabigatran ).

The CHMP adopted a change to a contraindication as follows:

Lesion or condition, if considered a significant risk factor 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.

For information, the full contraindication for Pradaxa will be as follows:

Hypersensitivity to the active substance or to any of the excipients;

Patients with severe renal impairment ( CrCL less than 30 mL/min );

Active clinically significant bleeding;

Lesion or condition, if considered a significant risk factor 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, Rivaroxaban, Apixaban etc ) except under the circumstances of switching therapy to or from Pradaxa or when unfractionated Heparin is given at doses necessary to maintain an open central venous or arterial catheter;

Hepatic impairment or liver disease expected to have any impact on survival;

Concomitant treatment with systemic Ketoconazole, Cyclosporine, Itraconazole, Tacrolimus and Dronedarone;

Prosthetic heart valves requiring anticoagulant treatment. ( Xagena )

Source: European Medicines Agency, 2013

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