DABIGATRAN SPC PDF

PRADAXA safely and effectively. See full prescribing information for. PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules, for oral use. Initial U.S. produce dabigatran exposure similar to that observed in severe renal impairment . Consider reducing the dose of PRADAXA to 75 mg twice daily [see Drug. This is a summary of the European public assessment report (EPAR) for Pradaxa. It explains how the Committee for Medicinal Products for Human Use (CHMP).

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Capsules with white, opaque cap and white, opaque body of size 2 filled cabigatran yellowish pellets. Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. The recommended dose of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.

Dose recommendations and duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery. Treatment initiation on the day of surgery hours after completed surgery. For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed.

If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily. It is recommended to continue with the remaining daily doses of Dabkgatran at the same time of dabiagtran next day.

Pradaxa 75 mg hard capsules

Pradaxa treatment should not be discontinued without medical advice. Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia see section 4.

It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant see section 4. The parenteral anticoagulant should be discontinued and Pradaxa should be started start hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment e. Concomitant use of Pradaxa with mild to moderate P – glycoprotein P – gp inhibitors, i. Dosing should be reduced as indicated in table 1 see also sections 4.

In this situation Pradaxa and these medicinal products should be taken at the same time. In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered see sections 4. Given the available clinical and kinetic data no adjustment is necessary see section 5. There is no relevant use of Pradaxa in the paediatric population for the indication of primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

The capsules can be taken with or without food. Pradaxa should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach. Patients should be instructed not to open the capsule as this may increase the risk of bleeding see sections 5. 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.

These are switching anticoagulant therapy see section 4. Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation. Bleeding can occur at any site during therapy with Pradaxa. For situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effect of dabigatran is required, the specific reversal agent Praxbind, idarucizumab is available see section 4.

Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid ASA or non steroidal antiinflammatory drugs NSAIDas well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding. Pharmacodynamic and kinetic factors. Pradaxa should only be given if the benefit outweighs bleeding risks.

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Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined see table 2 above. Particular caution should be exercised when Pradaxa is co-administered with verapamil, amiodarone, quinidine or clarithromycin P-gp inhibitors and particularly in the occurrence of bleeding, notably in patients having a mild to moderate renal impairment see section 4.

Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs see section 4.

When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind idarucizumab may be considered see section 4. Although Pradaxa does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors. Diluted thrombin time dTTecarin clotting time ECT and activated partial thromboplastin time aPTT may provide useful information, but results should be interpreted with caution due to inter-test variability see section 5.

Therefore INR tests should not be performed. Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding see section 5.

Coagulation test thresholds at trough that may be associated with an increased risk of bleeding. Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke.

The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal ULN according to the local reference range. Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding. Therefore, surgical interventions may require the temporary discontinuation of Pradaxa. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.

Clearance of dabigatran in patients with renal insufficiency may take longer see section 5. This should be considered in advance of any procedures. In such cases a coagulation test see sections 4. Pradaxa should be temporarily discontinued.

When rapid reversal of the anticoagulation effect is required the specific reversal agent Praxbind, idarucizumab to Pradaxa is available.

Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind idarucizumabif the patient is clinically stable and adequate haemostasis has been achieved. If surgery cannot be delayed the risk of bleeding may be increased. This risk of bleeding should be weighed against the urgency of intervention.

If possible, Pradaxa should be discontinued at least 24 hours before invasive or surgical procedures. In patients at higher risk of bleeding or in major surgery where complete haemostasis may be required consider stopping Pradaxa days before surgery. The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.

After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa. These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma. Pradaxa should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.

Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution. There is no data on the use of Pradaxa in patients undergoing hip fracture surgery. Therefore treatment is not recommended. No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population.

Hepatic impairment or liver disease expected to have any impact on survival is contraindicated see section 4.

Concomitant administration of P-gp inducers is expected dabigatrwn result in decreased dabigatran plasma concentrations, and should be avoided see sections 4. Dabigatran etexilate is a substrate for the efflux transporter P-gp.

Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)

Concomitant administration of P-gp inhibitors see table 5 is expected to result in increased dabigatran plasma concentrations. If not otherwise specifically described, close clinical surveillance looking for signs of bleeding or anaemia is required when dabigatran is co-administered with strong P-gp inhibitors. Dose reductions dabigaran be required in combination with some P-gp inhibitors see sections 4. Tacrolimus has been found in vitro to have dabiggatran similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine.

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Dabigatran etexilate has not been clinically studied together with tacrolimus. However, limited clinical data with another P-gp substrate everolimus suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors.

When dabigatran spf mg was co-administered with oral verapamil, the C max and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil see sections 4.

The greatest elevation of dabigatran exposure was dabigartan with the first dose of an immediate release formulation of verapamil administered one hour prior to the dabigatran etexilate intake increase of C max dabugatran about 2. The effect was progressively decreased with administration of an extended release formulation increase of C max by about 1.

There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate increase of C max by about 1. This is explained by completed dabigatran absorption after 2 hours. When Pradaxa was co-administered with a single oral dose of mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.

The dabigatran AUC and C max were increased by about 1. In view of the long half-life of spd the potential for an interaction may exist for weeks after discontinuation of amiodarone see sections 4. Quinidine was given as mg dose every 2nd hour up to a total dose of 1, mg.

Dabigatran etexilate was given twice daily over 3 consecutive days, on the 3 rd day either spd or without quinidine.

Dabigatran AUC ,ss and C max,ss were increased on average by 1. When clarithromycin mg twice daily was administered together with dabigatran etexilate in healthy volunteers, increase of AUC by about 1. When a single dose of 75 mg dabigatran etexilate was coadministered simultaneously with a loading dose of mg ticagrelor, the dabigatran AUC and C max were increased by 1. After multiple doses of ticagrelor 90 mg b. Concomitant administration of a loading dose of mg ticagrelor and mg dabigatran etexilate in steady state increased the dabigatran AUC ,ss and C max,ss by 1.

Pradaxa 150 mg hard capsules

When a loading dose of mg ticagrelor was given 2 hours after mg dabigatran etexilate in steady statethe increase of dabigatran AUC ,ss and C max,ss was reduced to 1. This staggered intake is the recommended administration for start of ticagrelor with a loading dose. Concomitant administration of 90 mg ticagrelor b. Posaconazole also inhibits P-gp to some extent but has not been clinically studied.

Caution should be exercised when Pradaxa is co-administered with posaconazole. Pre-dosing of the probe inducer rifampicin at a dose of mg once daily for 7 days decreased total dabigatran peak and total exposure by The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment.

No further increase in bioavailability was observed after another 7 days. These affect P-gp either as inhibitor or as inducer. They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa. In a study performed with 24 healthy subjects, when Pradaxa was co-administered with digoxin, no changes on digoxin and no clinically relevant changes on dabigatran exposure have been observed. There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: