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

amneal pharmaceuticals llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride for 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 for 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 for 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 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 hydrochloride, including anaphylaxis [see adverse reactions (6.2)] risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride for injection during the 1st trimester. 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. doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data doxorubicin hydrochloride 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 hydrochloride 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. risk summary doxorubicin was measured in the milk of one lactating patient after therapy with 70 mg/m2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. the peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. doxorubicin was detectable in the milk up to 72 hours. there are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with doxorubicin hydrochloride for injection and for 10 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride for injection. contraception females doxorubicin hydrochloride for injection can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin hydrochloride for injection and for 6 months after treatment [see use in specific populations (8.1)] . males doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 3 months after treatment [see nonclinical toxicology (13.1)] . males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see nonclinical toxicology (13.1), use in specific populations (8.1)] . infertility females in females of reproductive potential, doxorubicin hydrochloride 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 hydrochloride 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 nonclinical toxicology (13.1)] . based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride 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 hydrochloride. doxorubicin hydrochloride, 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 infants 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 hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients. the clearance of doxorubicin was reduced in patients with elevated serum total bilirubin levels. doxorubicin hydrochloride for injection 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)] . reduce the dose of doxorubicin hydrochloride for injection in patients with serum total bilirubin levels greater than 1.2 mg/dl [see dosage and administration (2.4), warnings and precautions (5.5)] .

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

fresenius kabi usa, llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride injection, usp has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, wilms'  tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer. patients should not be treated with doxorubicin if they have any of the following conditions: baseline neutrophil count <1,500 cells/mm 3 ; severe hepatic impairment; recent myocardial infarction; severe myocardial insufficiency; severe arrhythmias; previous treatment with complete cumulative doses of doxoru

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

pfizer laboratories div pfizer inc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - 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 4–6 weeks) myocardial infarction [see warnings and precautions (5.1)] - severe persistent drug-induced myelosuppression [see warnings and pre

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

pfizer laboratories div pfizer inc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride injection/for 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/for injection is indicated for the treatment of doxorubicin hydrochloride injection/for injection are contraindicated in patients with: risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride injection/for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride injection/for injection during the 1st trimester. 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. doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data doxorubicin hydrochloride 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 hydrochloride 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. risk summary doxorubicin was measured in the milk of one lactating patient after therapy with 70 mg/m2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. the peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. doxorubicin was detectable in the milk up to 72 hours. there are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with doxorubicin hydrochloride injection/for injection and for 10 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride injection/for injection. contraception females doxorubicin hydrochloride injection/for injection can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin hydrochloride injection/for injection and for 6 months after treatment. [see use in specific populations (8.1)] . males doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride injection/for injection and for 3 months after treatment [see nonclinical toxicology (13.1)] . males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see nonclinical toxicology (13.1), use in specific populations (8.1)] . infertility females in females of reproductive potential, doxorubicin hydrochloride 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 hydrochloride 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 nonclinical toxicology (13.1)] . based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride 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 hydrochloride. doxorubicin hydrochloride, 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 infants 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 hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients. the clearance of doxorubicin was reduced in patients with elevated serum total bilirubin levels. doxorubicin hydrochloride injection/for injection 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)] . reduce the dose of doxorubicin hydrochloride injection/for injection in patients with serum total bilirubin levels greater than 1.2 mg/dl [see dosage and administration (2.4), warnings and precautions (5.5)] .

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

sagent pharmaceuticals - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - 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)

mylan institutional llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride, 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)]. doxorubicin hydrochloride, usp is indicated for the treatment of doxorubicin hydrochloride is contraindicated in patients with: pregnancy category d doxorubicin hydrochloride can cause fetal harm when administered to a pregnant woman. doxorubicin hydrochloride 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. doxorubicin hydrochloride 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. tera

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

sun pharmaceutical industries, inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride injection, usp is indicated as a c omponent of multi-a gent adjuvant chemotherapy for treat ment of wo men with axillary lymph node involve ment following resection of pri mary breast cancer [see clinical studies (14.1 ) ]. doxorubicin hydrochloride injection, usp is indicated for the treat ment of - acute ly mphoblastic leu ke mia - acute m yeloblastic leuke mia - hodgkin lympho ma - non-hodgkin ly mpho ma (nhl) - metastatic breast cancer - metastatic wil ms’ tumor - metastatic neurobla stoma - metastatic s oft tissue sa rco ma - metastatic bone sarco ma - metastatic o varian car cino ma - metastatic t ransitional c ell bladder carcino ma - metastatic t hyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma doxorubicin hydrochloride 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

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

pfizer laboratories div pfizer inc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - 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 doxorubicin hydrochloride injection are contraindicated in patients with: risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride injection during the 1st trimester. 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. doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 (see

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

gland pharma limited - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - 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)

northstar rxllc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection 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 liposome injection, 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 liposome injection 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 liposome injection can cause fetal harm when administered to a pregnant woman; avoid the