United States - English - NLM (National Library of Medicine)

xlcare pharmaceuticals, inc. - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days. dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. pediatric use information is approved for boehringer ingelheim pharmaceuticals, inc.’s pradaxa (dabigatran etexilate) capsules. however, due to boehringer ingelheim pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. dabigatran etexilate capsules are contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.2) and adverse reactions (6.1)] - history of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] - mechanical prosthetic heart valve [see warnings and precautions (5.4)] risk summary the limited available data on dabigatran etexilate capsules use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. there are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see clinical considerations).  in pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. at a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation day 6). dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. however, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reaction use of anticoagulants, including dabigatran etexilate capsules, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.2)]. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. dabigatran etexilate capsules use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.2, 5.3)]. data animal data dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at mrhd of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a mrhd of 300 mg/day based on auc comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation day 7) to weaning (lactation day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at mrhd of 300 mg/day based on auc comparisons). risk summary there are no data on the presence of dabigatran in human milk, the effects on the breastfed child, or on milk production. dabigatran and/or its metabolites were present in rat milk. breastfeeding is not recommended during treatment with dabigatran etexilate capsules. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including dabigatran etexilate capsules should be assessed in females of reproductive potential and those with abnormal uterine bleeding. safety and effectiveness of dabigatran etexilate capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery. pediatric use information is approved for boehringer ingelheim pharmaceuticals, inc.’s pradaxa (dabigatran etexilate) capsules. however, due to boehringer ingelheim pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. of the total number of patients in the re-ly study, 82% were 65 and over, while 40% were 75 and over. the risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see warnings and precautions (5), adverse reactions (6.1), and clinical studies (14.1)]. reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients no dose adjustment of dabigatran etexilate capsules is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3)]. reduce the dose of dabigatran etexilate capsules in patients with severe renal impairment (crcl 15 to 30 ml/min) [see dosage and administration (2.2, 2.4) and clinical pharmacology (12.3)]. dosing recommendations for patients with crcl <15 ml/min or on dialysis cannot be provided. adjust dose appropriately in patients with renal impairment receiving concomitant p-gp inhibitors [see warnings and precautions (5.5), drug interactions (7.1), and clinical pharmacology (12.3)]. treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients patients with severe renal impairment (crcl ≤30 ml/min) were excluded from re-cover. dosing recommendations for patients with crcl ≤30 ml/min or on dialysis cannot be provided. avoid use of dabigatran etexilate capsules with concomitant p-gp inhibitors in patients with crcl <50 ml/min [see warnings and precautions (5.5), drug interactions (7.2), and clinical pharmacology (12.3)]. pediatric use information is approved for boehringer ingelheim pharmaceuticals, inc.’s pradaxa (dabigatran etexilate) capsules. however, due to boehringer ingelheim pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - antithrombotic agents - prevention of venous thromboembolic events

Malta - English - Medicines Authority

galenicum health, s.l. calle sant gabriel, 50 08950 esplugues de llobregat (barcelona) , spain - dabigatran etexilate - hard capsule - dabigatran etexilate 75 mg - antithrombotic agents

Malta - English - Medicines Authority

galenicum health, s.l. calle sant gabriel, 50 08950 esplugues de llobregat (barcelona) , spain - dabigatran etexilate - hard capsule - dabigatran etexilate 110 mg - antithrombotic agents

Malta - English - Medicines Authority

galenicum health, s.l. calle sant gabriel, 50 08950 esplugues de llobregat (barcelona) , spain - dabigatran etexilate - hard capsule - dabigatran etexilate 150 mg - antithrombotic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate