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PRADAXA is a brand name for Dabigatran Etexilate, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ............................................................................................ 3 WARNINGS AND PRECAUTIONS............................................................................ 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
The overall safety of PRADAXA (dabigatran etexilate) was evaluated in 23,393 patients who were treated with PRADAXA in 11 clinical trials. Prevention of VTE after THR or TKR surgery Out of the 6,684 patients treated with 150 mg or 220 mg PRADAXA once daily following major elective orthopedic surgery (short-term treatment up to 42 days) in 6 clinical trials, 9% of patients experienced adverse reactions; about 10% of patients treated with enoxaparin experienced adverse reactions.
Treatment of VTE and Prevention of Recurrent DVT and PE Out of the 2,553 patients treated with PRADAXA 150 mg bid in the acute DVT/PE treatment trials (RE-COVER, RE-COVER II) (long-term treatment of up to 6 months), 14% of patients experienced adverse reactions.
Out of the 2,114 patients treated with PRADAXA 150mg bid in the recurrent DVT/PE prevention trials (RE-MEDY, RE-SONATE) (long-term treatment up to 36 months), 15% of patients experienced adverse reactions. A total of 552 were rolled over from the RE-COVER trial (acute DVT/PE treatment) into the RE-MEDY trial and were counted in both the acute and recurrent patient totals.
Prevention of stroke and systemic embolism in AF patients – RE-LY trial:
Out of the 12,042 patients exposed to PRADAXA in RE-LY, 6,059 were treated with PRADAXA 150 mg bid, while 5,983 received doses of 110 mg bid. About 21% of AF patients treated with PRADAXA and about 16% of patients treated with warfarin (long-term treatment up to 3 years) experienced adverse events (AEs) considered related to treatment.
Bleeding Bleeding is the most relevant adverse reaction of PRADAXA. 4% of patients with acute DVT and/or PE. 5% (RE-SONATE) of patients experienced any bleeding. Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Since the patient populations treated with PRADAXA for different indications are not interchangeable, a summary description of major and total bleeding is provided by indication and/or trial in Table 3, Table 4, Table 5, Table 6, Table 7 and Table 8.
7) *Major Bleeding Events: Major bleeding was defined as clinically overt bleeding associated with ≥ 20 g/L fall in hemoglobin; clinically overt bleeding leading to transfusion of ≥ 2 units packed cells or whole blood; fatal, retroperitoneal, intracrani al, intraocular or intraspinal bleeding; bleeding warranting treatment cessation or leading to reoperation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dabigatran Etexilate in Canada.
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Major bleeding included those events occurring at the surgical site.
Treatment of VTE and Prevention of Recurrent DVT and PE Table 5:
Frequency of MBEs*, MBEs or CRBE(s) # and any bleeding event(s) in patients with acute DVT/PE in the RE-COVER and RE-COVER II (pooled data) Dabigatran etexilate 150 mg bid N (%) Warfarin N (%) Hazard ratio vs. 54) *The definition of major bleeding events (MBEs) in RE-COVER, RE-COVER II, RE-MEDY and RE-SONATE followed the recommendations of the International Society on Thrombosis and Hemostasis.
A bleeding event was categorised as an MBE if it fulfilled at least 1 of the following criteria: • Fatal bleeding • Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra -articular, or pericardial, or intramuscular with compartment syndrome.
24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells #the definition of Clinically Relevant Bleeding Event (CRBE): In Studies RE-COVER II, RE-COVER, and RE-MEDY, a minor bleeding event was categorized as a CRBE if it fulfilled at least 1 of the following criteria: • Spontaneous skin hematoma ≥25 cm2 • Spontaneous nose bleed >5 minutes duration PRADAXA Product Monograph Page 14 of 68 • Macroscopic hematuria, either spontaneous or, if associated with an intervention, lasting >24 hours • Spontaneous rectal bleeding (more than spotting on toilet paper) • Gingival bleeding >5 minutes • Bleeding leading to hospitalization and/or requiring surgical treatment • Bleeding leading to a transfusion of <2 units of whole blood or red cells • Any other bleeding […]