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

twi pharmaceuticals, inc. - paclitaxel (unii: p88xt4is4d) (paclitaxel - unii:p88xt4is4d) - paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. prior therapy should have included an anthracycline unless clinically contraindicated. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: risk summary based on its mechanism of action and findings in animals, pacli

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

hbt labs, inc. - paclitaxel (unii: p88xt4is4d) (paclitaxel - unii:p88xt4is4d) - paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. prior therapy should have included an anthracycline unless clinically contraindicated. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: - baseline neutrophil counts of < 1,500 cells/mm3 [see warnings and precaut

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

american regent, inc. - paclitaxel (unii: p88xt4is4d) (paclitaxel - unii:p88xt4is4d) - paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. prior therapy should have included an anthracycline unless clinically contraindicated. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: - baseline neutrophil counts of < 1,500 cells/mm3 [see warnings and precautions (5.1)] - a history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see warnings and precautions (5.5)] risk summary based on its mechanism of action and findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data on paclitaxel protein-bound particles for injectable suspension (albumin-bound) use in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m2 basis (see data ). advise females of reproductive potential of the potential risk to a fetus. the background rate of major birth defects and miscarriage is unknown for the indicated population. 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 in embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m2 (approximately 2% of the daily maximum recommended human dose on a mg/m2 basis) caused embryo-fetal toxicities, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight, and increase in fetal anomalies. fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles. risk summary there are no data on the presence of paclitaxel in human milk, or its effect on the breastfed child or on milk production. in animal studies, paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see data ). because of the potential for serious adverse reactions in a breastfed child from paclitaxel protein-bound particles for injectable suspension (albumin-bound), advise lactating women not to breastfeed during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for two weeks after the last dose. data animal data following intravenous administration of radiolabeled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations. based on animal studies and mechanism of action, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to starting treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound). contraception females advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least six months after the last dose. males based on findings in genetic toxicity and animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least three months after the last dose [see use in specific populations (8.1) and nonclinical toxicology (13.1)]. infertility females and males based on findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) may impair fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. pharmacokinetics, safety, and antitumor activity of protein bound paclitaxel were assessed in an open-label, dose escalation, dose expansion study (nct01962103) in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. the maximum tolerated dose (mtd) normalized for body surface area (bsa) was lower in pediatric patients compared to adults. no new safety signals were observed in pediatric patients across these studies. paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients (aged 1.4 to < 17 years) as compared to those in adults. of the 229 patients in the randomized study who received protein bound paclitaxel for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. this study of protein bound paclitaxel did not include a sufficient number of patients with metastatic breast cancer who were 65 years and older to determine whether they respond differently from younger patients. a subsequent pooled analysis was conducted in 981 patients receiving protein bound paclitaxel monotherapy for metastatic breast cancer, of which 15% were 65 years of age or older and 2% were 75 years of age or older. a higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years of age or older. of the 514 patients in the randomized study who received protein bound paclitaxel and carboplatin for the first-line treatment of non-small cell lung cancer, 31% were 65 years or older and 3.5% were 75 years or older. myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years old. no overall difference in effectiveness, as measured by response rates, was observed between patients 65 years or older compared to patients younger than 65 years old. of the 431 patients in the randomized study who received protein bound paclitaxel and gemcitabine for the first-line treatment of pancreatic adenocarcinoma, 41% were 65 years or older and 10% were 75 years or older. no overall differences in effectiveness were observed between patients who were 65 years of age or older and younger patients. diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old. clinical studies of protein bound paclitaxel did not include sufficient number of patients with pancreatic cancer who were 75 years and older to determine whether they respond differently from younger patients. no adjustment of the starting paclitaxel protein-bound particles for injectable suspension (albumin-bound) dose is required for patients with mild to moderate renal impairment (estimated creatinine clearance 30 to <90 ml/min) [see clinical pharmacology (12.3)]. there are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min). no adjustment of the starting paclitaxel protein-bound particles for injectable suspension (albumin-bound) dose is required for patients with mild hepatic impairment (total bilirubin > uln and ≤ 1.5 x uln and aspartate aminotransferase [ast] ≤ 10 x uln). reduce paclitaxel protein-bound particles for injectable suspension (albumin-bound) starting dose in patients with moderate to severe hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)] . paclitaxel protein-bound particles for injectable suspension (albumin-bound) is not recommended for use in patients with total bilirubin > 5 x uln or ast > 10 x uln [see dosage and administration (2.5), warnings and precautions (5.6), and clinical pharmacology (12.3)] . paclitaxel protein-bound particles for injectable suspension (albumin-bound) is not recommended for use in patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment [see dosage and administration (2.5)] .

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

eugia pharma (malta) ltd. - paclitaxel 6 mg/ml - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

eugia pharma (malta) ltd. - paclitaxel 6 mg/ml - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

eugia pharma (malta) ltd. - paclitaxel 6 mg/ml - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

eugia pharma (malta) ltd. - paclitaxel 6 mg/ml - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

accord healthcare b.v. - paclitaxel 30 mg - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

accord healthcare b.v. - paclitaxel 30 mg - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel

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

accord healthcare b.v. - paclitaxel 30 mg - concentrate for solution for infusion - 6 mg/ml - paclitaxel 6 mg/ml - paclitaxel