Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - doxorubicin hydrochloride 10 mg/5 ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - doxorubicin hydrochloride 10 mg/5 ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - doxorubicin hydrochloride 10 mg/5 ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 50 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - doxorubicin hydrochloride 2 mg/ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - doxorubicin hydrochloride 2 mg/ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - doxorubicin hydrochloride 2 mg/ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - doxorubicin hydrochloride 2 mg/ml - concentrate for solution for infusion - 2 mg/ml - doxorubicin hydrochloride 2 mg/ml - doxorubicin

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

zydus pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposomal infusion is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposomal infusion can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride liposomal infusion during the 1st trimester. in animal reproduction studies, doxorubicin hydrochloride liposomal infusion was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose (see data) . available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data animal data doxorubicin hydrochloride liposomal infusion was embryotoxic at doses of 1 mg/kg/day in rats and was embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about 0.12 times the recommended dose of 50 mg/m2 human dose on a mg/m2 basis). embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes. risk summary it is not known whether doxorubicin hydrochloride liposomal infusion is present in human milk. because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from doxorubicin hydrochloride liposomal infusion, discontinue breastfeeding during treatment with doxorubicin hydrochloride liposomal infusion. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride liposomal infusion. contraception females doxorubicin hydrochloride liposomal infusion can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposomal infusion. males doxorubicin hydrochloride liposomal infusion may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposomal infusion [see non-clinical toxicology (13.1)]. infertility females in females of reproductive potential, doxorubicin hydrochloride liposomal infusion may cause infertility and result in amenorrhea. premature menopause can occur with doxorubicin hydrochloride. recovery of menses and ovulation is related to age at treatment. males doxorubicin hydrochloride liposomal infusion may result in oligospermia, azoospermia, and permanent loss of fertility. sperm counts have been reported to return to normal levels in some men. this may occur several years after the end of therapy [see non-clinical toxicology (13.1)] . the safety and effectiveness of doxorubicin hydrochloride liposomal infusion in pediatric patients have not been established. clinical studies of doxorubicin hydrochloride liposomal infusion conducted in patients with either epithelial ovarian cancer (trial 4) or with aids-related kaposi's sarcoma (trial 5) did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in trial 6, of 318 patients treated with doxorubicin hydrochloride liposomal infusion in combination with bortezomib for multiple myeloma, 37% were 65 years of age or older and 8% were 75 years of age or older. no overall differences in safety or efficacy were observed between these patients and younger patients. the pharmacokinetics of doxorubicin hydrochloride liposomal infusion has not been adequately evaluated in patients with hepatic impairment. doxorubicin is eliminated in large part by the liver. reduce doxorubicin hydrochloride liposomal infusion for serum bilirubin of 1.2 mg/dl or higher.

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

northstar rxllc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. doxorubicin hydrochloride injection is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - hodgkin lymphoma - non-hodgkin lymphoma (nhl) - metastatic breast cancer - metastatic wilms’ tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma doxorubicin hydrochloride injection is contraindicated in patients with: - severe myocardial insufficiency [see warnings and precautions (5.1)] - recent (occurring within the past 4 to 6 weeks) myocardial infarction [see warnings and precautions (5.1)] - severe persistent drug-induced myelosuppression [see warnings and

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

hikma pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hcl injection, usp is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see clinical studies (14.1)]. doxorubicin is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - hodgkin lymphoma - non-hodgkin lymphoma (nhl) - metastatic breast cancer - metastatic wilms’ tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma doxorubicin is contraindicated in patients with: - severe myocardial insufficiency [see warnings and precautions (5.1)] - recent (occurring within the past 4 to 6 weeks) myocardial infarction [see warnings and precautions (5.1)] - severe persistent drug-induced myelosuppression [see warnings and precautions (5.4)] - severe hepatic impairment (defined as child pugh class c or serum bilirubin level greater than 5 mg/dl) [see warnings and precautions (5.5)] - severe hypersensitivity reaction to doxorubicin including anaphylaxis [see adverse reactions (6.2)] pregnancy category d risk summary doxorubicin can cause fetal harm when administered to a pregnant woman. doxorubicin was teratogenic and embryotoxic in rats and rabbits at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. animal data doxorubicin was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. teratogenicity and embryotoxicity were also seen using discrete periods of treatment. the most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies. doxorubicin was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis. doxorubicin has been detected in the milk of at least one lactating patient [see clinical pharmacology (12.3)] . because of the potential for serious adverse reactions in nursing infants from doxorubicin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. based on postmarketing reports, pediatric patients treated with doxorubicin are at risk for developing late cardiovascular dysfunction. risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin. doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. there are no recommended dose adjustments based on age. doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in children less than 2 years as compared to adults [see clinical pharmacology (12.3)]. clinical experience in patients who were 65 years of age and older who received doxorubicin based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients. contraception females doxorubicin can cause fetal harm when administered during pregnancy. advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin and for 6 months after treatment. advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking doxorubicin [see use in specific populations (8.1)] . males doxorubicin may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment [see nonclinical toxicology (13.1)] . infertility females in females of reproductive potential, doxorubicin may cause infertility and result in amenorrhea. premature menopause can occur. recovery of menses and ovulation is related to age at treatment [see nonclinical toxicology (13.1)] . males doxorubicin may result in oligospermia, azoospermia, and permanent loss of fertility. sperm counts have been reported to return to normal levels in some men. this may occur several years after the end of therapy. the clearance of doxorubicin was reduced in patients with elevated serum bilirubin levels. reduce the dose of doxorubicin in patients with serum bilirubin levels greater than 1.2 mg/dl [see dosage and administration (2.2) and warnings and precautions (5.5)] . doxorubicin is contraindicated in patients with severe hepatic impairment (defined as child pugh class c or serum bilirubin levels greater than 5 mg/dl) [see contraindications (4)] .