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

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data ). the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone tablets can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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 of miscarriage is 2-4% and 15-20%, respectively. data: human data: post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data: during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations, such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia, and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary: there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone tablets, and for at least 2 weeks after the last dose. pregnancy testing: pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone tablets. contraception: females: deferiprone tablets can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 6 months after the last dose. males: based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information . clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

taro pharmaceuticals u.s.a., inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. pediatric use information is approved for chiesi usa, inc.'s ferriprox ® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data) . the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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 of miscarriage is 2 to 4% and 15 to 20%, respectively. data human data post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone, and for at least 2 weeks after the last dose. pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone. contraception females deferiprone can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone and for at least 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.'s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mor

European Union - English - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - all other therapeutic products - deferiprone lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.deferiprone lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.

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

apopharma usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone 100 mg in 1 ml - ferriprox® is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. approval is based on a reduction in serum ferritin levels. there are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see clinical studies (14)] . limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during or

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

apopharma usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone 500 mg - ferriprox® is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. approval is based on a reduction in serum ferritin levels. there are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see clinical studies (14)] . limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during or

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

chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.       limitation s of use • safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [ see adverse reactions ( 6.2 )] . risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal

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

apopharma usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox® is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. approval is based on a reduction in serum ferritin levels. there are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see clinical studies (14)] . limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during o

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - deferiprone - tablets - deferiprone 500 mg - deferiprone - deferiprone tao 500 mg is indicated for the treatment of iron overload in patients over 6 years old with thalassemia major when deferoxamine therapy is contraindicated or inadequate.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - deferiprone - film coated tablets - deferiprone 1000 mg - deferiprone - deferiprone taro 1000 mg is indicated for the treatment of iron overload in patients over 6 years old with thalassaemia major in whom deferoxamine therapy is contraindicated or inadequate.