                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    {"id":6766,"date":"2020-04-28T09:20:54","date_gmt":"2020-04-28T09:20:54","guid":{"rendered":"https:\/\/zuviuslifesciences.in\/old\/?post_type=product&#038;p=6766"},"modified":"2020-07-14T07:00:44","modified_gmt":"2020-07-14T07:00:44","slug":"zaxotein-inj","status":"publish","type":"product","link":"https:\/\/zuviuslifesciences.in\/old\/product\/zaxotein-inj\/","title":{"rendered":"Zaxotein Inj"},"content":{"rendered":"<p>[vc_row][vc_column][vc_tta_tour color=&#8221;peacoc&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Description&#8221; tab_id=&#8221;1588004385633-ad9771ae-2161&#8243;][vc_column_text]<span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for Injectable suspension is an albumin-bound form of Paclitaxel with a mean particle size of approximately 130 nanometers. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. This product is available as lyophilized powder which needs to be reconstituted as described below in this pack insert.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The active agent in Paclitaxel protein-bound particles for injectable suspension is paclitaxel, a natural product with antitumor activity. Paclitaxel is obtained from Taxus media. The chemical name for paclitaxel is 5\u03b2,20-Epoxy-1,2\u03b1,4,7\u03b2,10\u03b2,13\u03b1hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2<\/span><i><span style=\"font-weight: 400;\">R<\/span><\/i><span style=\"font-weight: 400;\">,3<\/span><i><span style=\"font-weight: 400;\">S<\/span><\/i><span style=\"font-weight: 400;\">)-<\/span><i><span style=\"font-weight: 400;\">N<\/span><\/i><span style=\"font-weight: 400;\">-benzoyl-3phenylisoserine.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Paclitaxel is a white to off-white crystalline powder with the empirical formula C<\/span><span style=\"font-weight: 400;\">47<\/span><span style=\"font-weight: 400;\">H<\/span><span style=\"font-weight: 400;\">51<\/span><span style=\"font-weight: 400;\">NO<\/span><span style=\"font-weight: 400;\">14 <\/span><span style=\"font-weight: 400;\">and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216\u00b0C to 217\u00b0C.<\/span><\/p>\n<p><img loading=\"lazy\" class=\"alignnone wp-image-6774\" src=\"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled1.jpg?resize=530%2C332&#038;ssl=1\" alt=\"Untitled1\" width=\"530\" height=\"332\" srcset=\"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled1.jpg?resize=300%2C188&amp;ssl=1 300w, https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled1.jpg?w=391&amp;ssl=1 391w\" sizes=\"(max-width: 530px) 100vw, 530px\" data-recalc-dims=\"1\" \/>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Composition&#8221; tab_id=&#8221;1593177811575-7a18e79a-75c1&#8243;][vc_column_text]<\/p>\n<h3>Composition<\/h3>\n<p><span style=\"font-weight: 400;\">Paclitaxel Protein-bound particles for Injectable suspension 100 mg<\/span><\/p>\n<p><b>ZAXOTEIN<\/b><b>TM<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Each lyophilized vial contains:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">PaclitaxelUSP\u00a0 \u00a0 \u00a0 100mg<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Albumin Human\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 USP<\/span> <span style=\"font-weight: 400;\"> 900mg per 20mL<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Excipients q.s<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Mechanism of Action&#8221; tab_id=&#8221;1584624217032-a15849ed-97bb&#8221;][vc_column_text]<\/p>\n<p style=\"text-align: left;\"><span style=\"font-weight: 400;\">\u00a0A Paclitaxel protein-bound particle for injectable suspension is an anti-microtubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or \u201cbundles\u201d of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Pharmacokinetics&#8221; tab_id=&#8221;1584624217050-ebb8ae5e-43a6&#8243;][vc_column_text]<span style=\"font-weight: 400;\">The pharmacokinetics of total Paclitaxel following 30 and 180-minute infusions of Paclitaxel protein-bound particles for injectable suspension at dose levels of 80 to 375 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">were determined in clinical studies. Dose levels of mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">refer to mg of Paclitaxel in Paclitaxel protein-bound particles for injectable suspension. Following intravenous administration of Paclitaxel protein-bound particles for injectable suspension, Paclitaxel plasma concentrations declined in a biphasic manner, the initial rapid decline representing distribution to the peripheral compartment and the slower second phase representing drug elimination. The terminal half-life was about 27 hours.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">The drug exposure (AUCs) was dose proportional over 80 to 375 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">and the pharmacokinetics of Paclitaxel protein-bound particles for injectable suspensionwereindependent of the duration of administration. At the recommended Paclitaxel protein-bound particles for injectable suspension clinical dose, 260 mg\/m<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">, the mean maximum concentration of Paclitaxel, which occurred at the end of the infusion, was 18,741 ng\/mL. The mean total clearance was 15 L\/hr\/m<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">. The mean volume of distribution was 632 L\/m<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">; the large volume of distribution indicates extensive extravascular distribution and\/or tissue binding of Paclitaxel.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">The pharmacokinetic data of 260 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension administered over 30 minutes was compared to the pharmacokinetics of 175 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">paclitaxel injection over 3 hours. The clearance of Paclitaxel protein-bound particles for injectable suspension was larger (43%) than for the clearance of paclitaxel injection and the volume of distribution of Paclitaxel protein-bound particles for injectable suspension was also higher (53%). Differences in Cmax and Cmax corrected for dose reflected differences in total dose and rate of infusion. There were no differences in terminal half-lives.\u00a0<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Indications&#8221; tab_id=&#8221;1584624459062-96fb7e5b-0e23&#8243;][vc_column_text]<b>Metastatic Breast Cancer:<\/b><span style=\"font-weight: 400;\"> A Paclitaxel protein-bound particle for injectable suspension 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.\u00a0<\/span><\/p>\n<p><b>Non-Small Cell Lung Cancer:<\/b><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension 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.\u00a0<\/span><\/p>\n<p><b>Adenocarcinoma of the Pancreas:<\/b><span style=\"font-weight: 400;\"> Paclitaxel protein-bound particles for injectable suspension is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Dosage And Administration&#8221; tab_id=&#8221;1584624839401-59481bbb-bdc7&#8243;][vc_column_text]<span style=\"font-weight: 400;\">After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Paclitaxel protein-bound particles for injectable suspension is 260 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">administered intravenously over 30 minutes every 3 weeks.<\/span><\/p>\n<p><b>Hepatic Impairment: <\/b><span style=\"font-weight: 400;\">No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate and severe hepatic impairment treated with Paclitaxel protein-bound particles for injectable suspension may be at increased risk of toxicities known to paclitaxel. Patients should not receive Paclitaxel protein-bound particles for injectable suspension if AST &gt; 10 x ULN or bilirubin &gt; 5.0 x ULN<\/span><b>. <\/b><span style=\"font-weight: 400;\">Recommendations for dosage adjustment for the first course of therapy are shown in Table 1. The dose of Paclitaxel protein-bound particles for injectable suspension can be increased up to 200 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">in patients with severe hepatic impairment in subsequent cycles based on individual tolerance.<\/span><\/p>\n<p><b>Table 1: Recommendations for Starting Dose in Patients with Hepatic Impairment<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td><\/td>\n<td><b>SGOT (AST) Levels<\/b><\/td>\n<td><b>Bilirubin Levels<\/b><\/td>\n<td><b>PARTICLE BOUND PACLITAXEL<\/b><b>a<\/b><\/td>\n<\/tr>\n<tr>\n<td><b>Mild<\/b><\/td>\n<td><span style=\"font-weight: 400;\">&lt;10 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">&gt;ULN to \u2264 1.25 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">260 mg\/m<\/span><span style=\"font-weight: 400;\">2<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Moderate<\/b><\/td>\n<td><span style=\"font-weight: 400;\">&lt;10 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">1.26 to 2.0 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">200 mg\/m<\/span><span style=\"font-weight: 400;\">2<\/span><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\"><b>Severe<\/b><\/td>\n<td><span style=\"font-weight: 400;\">&lt;10 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2.01 to 5.0 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">130 mg\/m<\/span><span style=\"font-weight: 400;\">2b<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&gt; 10 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">&gt; 5.0 x ULN<\/span><\/td>\n<td><span style=\"font-weight: 400;\">not eligible<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">A. Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">b. A dose increase to 200 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">in subsequent courses should be considered based on individual tolerance.<\/span><\/p>\n<p><b>Dose Reduction: <\/b><span style=\"font-weight: 400;\">Patients who experience severe neutropenia (neutrophil &lt;500 cells\/mm<\/span><span style=\"font-weight: 400;\">3 <\/span><span style=\"font-weight: 400;\">for a week or longer) or severe sensory neuropathy during Paclitaxel protein-bound particles for injectable suspension therapy should have dosage reduced to 220 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">for subsequent courses of Paclitaxel protein-bound particles for injectable suspension. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg\/m<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">. For grade 3 sensory neuropathy hold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses of Paclitaxel protein-bound particles for injectable suspension.<\/span><\/p>\n<p><b>Preparation for Intravenous Administration: <\/b><span style=\"font-weight: 400;\">A Paclitaxel protein-bound particle for injectable suspension is supplied as a sterile lyophilized powder for reconstitution before use. AVOID ERRORS, READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP. Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this will result in foaming. Once the injection is complete, allow the vial to stand for a minimum of 5 minutes to ensure proper wetting of the lyophilized cake\/powder. Gently swirl and\/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake\/powder occurs. Avoid generation of foam. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section tab_id=&#8221;1584625017135-3ffdd9c5-1bd6&#8243; title=&#8221;Warnings&#8221;][vc_column_text]<strong>Bone marrow suppression:<\/strong> Primarily neutropenia is dose dependent and a dose limiting toxicity. Paclitaxel protein-bound particles for injectable suspension should not be administered to patients with baseline neutrophil counts of &lt; 1,500 cells\/mm3. Frequent monitoring of blood counts should be instituted during Paclitaxel protein-bound particles for injectable suspension treatment. Patients should not be retreated with subsequent cycles of Paclitaxel protein-bound particles for injectable suspension until neutrophils recover to a level &gt;1,500 cells\/mm3 and platelets recover to a level &gt;100,000 cells\/mm3.<br \/>\nThe use of Paclitaxel protein-bound particles for injectable suspension has not been studied in patients with renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin &gt;1.5 mg\/dL or baseline serum creatinine &gt;2 mg\/dL.<\/p>\n<p><strong>Pregnancy \u2013 Teratogenic Effects: Pregnancy Category D:<\/strong> There are no adequate and well-controlled studies in pregnant women using Paclitaxel protein-bound particles for injectable suspension. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Paclitaxel protein-bound particles for injectable suspension.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Precautions&#8221; tab_id=&#8221;1588004155234-9eb27d85-6ba1&#8243;][vc_column_text]<b>Carcinogenesis, Mutagenesis, Impairment of Fertility: <\/b><span style=\"font-weight: 400;\">The carcinogenic potential of Paclitaxel protein-bound particles for injectable suspension has not been studied. Paclitaxel has been shown to be clastogenicin vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice). A Paclitaxel protein-bound particle for injectable suspension was not mutagenic in the Ames test or the CHO\/HGPRT gene mutation assay.\u00a0<\/span><\/p>\n<p><b>Hematology: <\/b><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension therapy should not be administered to patients with baseline neutrophil counts of less than 1,500 cells\/mm<\/span><span style=\"font-weight: 400;\">3<\/span><span style=\"font-weight: 400;\">. In order to monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Paclitaxel protein-bound particles for injectable suspension. Patients should not be retreated with subsequent cycles of Paclitaxel protein-bound particles for injectable suspension until neutrophils recover to a level &gt;1,500 cells\/mm<\/span><span style=\"font-weight: 400;\">3 <\/span><span style=\"font-weight: 400;\">and platelets recover to a level &gt;100,000 cells\/mm<\/span><span style=\"font-weight: 400;\">3<\/span><span style=\"font-weight: 400;\">. In the case of severe neutropenia (&lt;500 cells\/mm<\/span><span style=\"font-weight: 400;\">3 <\/span><span style=\"font-weight: 400;\">for seven days or more) during a course of Paclitaxel protein-bound particles for injectable suspension therapy, a dose reduction for subsequent courses of therapy is recommended.<\/span><\/p>\n<p><b>Nervous System: <\/b><span style=\"font-weight: 400;\">Sensory neuropathy occurs frequently with Paclitaxel protein-bound particles for injectable suspension. The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose modification. If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of Paclitaxel protein-bound particles for injectable suspension.<\/span><\/p>\n<p><b>Hepatic Impairment: <\/b><span style=\"font-weight: 400;\">Because the exposure and toxicity of Paclitaxel can be increased with hepatic impairment, administration of Paclitaxel protein-bound particles for injectable suspension in patients with hepatic impairment should be performed with caution. The starting dose should be reduced for patients with moderate and severe hepatic impairment.\u00a0<\/span><\/p>\n<p><b>Pregnancy: Teratogenic Effects: Pregnancy Category D:\u00a0<\/b><\/p>\n<p><b>Nursing Mothers: <\/b><span style=\"font-weight: 400;\">It is not known whether Paclitaxel is excreted in human milk. Following intravenous administration of carbon-14 labeled 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. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving Paclitaxel protein-bound particles for injectable suspensiontherapy.<\/span><\/p>\n<p><b>Pediatric Use: <\/b><span style=\"font-weight: 400;\">The safety and effectiveness of Paclitaxel protein-bound particles for injectable suspension in pediatric patients have not been evaluated.<\/span><\/p>\n<p><b>Geriatric use: <\/b><span style=\"font-weight: 400;\">Of the 229 patients in the randomized study who received Paclitaxel protein-bound particles for injectable suspension, 11% were at least 65 years of age and &lt; 2% were 75 years or older. No toxicities occurred notably more frequently among elderly patients who received Paclitaxel protein-bound particles for injectable suspension.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Adverse Reactions (Side Effects)&#8221; tab_id=&#8221;1588004219145-c96da97e-bf1f&#8221;][vc_column_text]<span style=\"font-weight: 400;\">The following table shows the frequency of important adverse events in the randomized comparative trial for the patients who received either single-agent Paclitaxel protein-bound particles for injectable suspensionorPaclitaxel injection for the treatment of metastatic breast cancer.<\/span><\/p>\n<p><b>Table 2: Frequency<\/b><b>a<\/b><b>of Important Treatment Emergent Adverse Events in the Randomized Study on an Every-3-Weeks Schedule<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td><\/td>\n<td colspan=\"2\"><b>Percent of Patients<\/b><\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><b>Particle bound Paclitaxel<\/b><\/p>\n<p><b>260 mg\/m<\/b><b>2<\/b><b>\u00a0over 30 min<\/b><\/p>\n<p><b>(n=229)<\/b><\/td>\n<td><b>Paclitaxel Injection<\/b><\/p>\n<p><b>175 mg\/m<\/b><b>2<\/b><b>\u00a0over 3 hr<\/b><\/p>\n<p><b>(n=225)<\/b><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><b>Bone Marrow\u00a0<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Neutropenia<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 2.0 x 10<\/span><span style=\"font-weight: 400;\">9<\/span><span style=\"font-weight: 400;\">\/L\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 0.5 x 10<\/span><span style=\"font-weight: 400;\">9<\/span><span style=\"font-weight: 400;\">\/L\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">80<\/span><\/p>\n<p><span style=\"font-weight: 400;\">9<\/span><\/td>\n<td><span style=\"font-weight: 400;\">82\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">22\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Thrombocytopenia<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 100 x 10<\/span><span style=\"font-weight: 400;\">9<\/span><span style=\"font-weight: 400;\">\/L\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 50 x 10<\/span><span style=\"font-weight: 400;\">9<\/span><span style=\"font-weight: 400;\">\/L\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt;1<\/span><\/td>\n<td><span style=\"font-weight: 400;\">3\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt;1\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Anemia\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 11 g\/dL\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&lt; 8 g\/dL\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">33<\/span><span style=\"font-weight: 400;\">1<\/span><\/td>\n<td><span style=\"font-weight: 400;\">25\u00a0<\/span><span style=\"font-weight: 400;\">&lt;1\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><b>Hypersensitivity Reaction<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">All<\/span><\/td>\n<td><span style=\"font-weight: 400;\">4<\/span><\/td>\n<td><span style=\"font-weight: 400;\">12<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Severe<\/span><\/td>\n<td><span style=\"font-weight: 400;\">0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><b>Cardiovascular<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Bradycardia<\/span><\/td>\n<td><span style=\"font-weight: 400;\">&lt;1<\/span><\/td>\n<td><span style=\"font-weight: 400;\">&lt;1<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Hypotension<\/span><\/td>\n<td><span style=\"font-weight: 400;\">5<\/span><\/td>\n<td><span style=\"font-weight: 400;\">5<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Severe cardiovascular events<\/span><\/td>\n<td><span style=\"font-weight: 400;\">3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">4<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><b>Abnormal ECG<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">All patients<\/span><\/td>\n<td><span style=\"font-weight: 400;\">60<\/span><\/td>\n<td><span style=\"font-weight: 400;\">52<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Patients with normal baseline<\/span><\/td>\n<td><span style=\"font-weight: 400;\">35<\/span><\/td>\n<td><span style=\"font-weight: 400;\">30<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><b>Respiratory<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Cough\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">7<\/span><\/td>\n<td><span style=\"font-weight: 400;\">6<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">dyspnea<\/span><\/td>\n<td><span style=\"font-weight: 400;\">12<\/span><\/td>\n<td><span style=\"font-weight: 400;\">9<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">\u00a0 a Based on worst grade<\/span><\/p>\n<p><b>Hematologic:<\/b><span style=\"font-weight: 400;\"> Neutropenia, the most important hematologic toxicity, was dose dependent and reversible. Among patients with metastatic breast cancer in the randomized trial, neutrophil counts declined below 500 cells\/mm<\/span><span style=\"font-weight: 400;\">3 <\/span><span style=\"font-weight: 400;\">(Grade 4) in 9% of the patients treated with a dose of 260 mg\/m<\/span><span style=\"font-weight: 400;\">2 <\/span><span style=\"font-weight: 400;\">compared to 22% in patients receiving paclitaxel injection at a dose of 175 mg\/m<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Anemia:<\/b><span style=\"font-weight: 400;\"> Anemia (Hb &lt;11 g\/dL) was observed in 33% of patients treated with Paclitaxel protein-bound particles for injectable suspension in the randomized trial and was severe (Hb &lt;8 g\/dL) in 1% of the cases. Among all patients with normal baseline hemoglobin, 31% became anemic on study and 1% had severe anemia.<\/span><\/p>\n<p><b>Cardiovascular:<\/b><span style=\"font-weight: 400;\"> Hypotension, during the 30-minute infusion, occurred in 5% of patients in the randomized metastatic breast cancer trial. Bradycardia, during the 30-minute infusion, occurred in &lt;1% of patients. These vital sign changes most often caused no symptoms and required neither specific therapy nor treatment discontinuation.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Severe cardiovascular events possibly related to single-agent Paclitaxel protein-bound particles for injectable suspension occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension. Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported rarely.<\/span><\/p>\n<p><b>Respiratory:<\/b><span style=\"font-weight: 400;\"> Reports of dyspnea (12%) and cough (6%) were reported after treatment with Paclitaxel protein-bound particles for injectable suspension in the randomized trial. Rare reports (&lt;1%) of pneumothorax were reported after treatment with Paclitaxel protein-bound particles for injectable suspension. Rare reports of interstitial pneumonia, lung fibrosis, and pulmonary embolism have been received as part of the continuing surveillance of paclitaxel injection safety and may occur following Paclitaxel protein-bound particles for injectable suspension treatment. Rare reports of radiation pneumonitis have been received in paclitaxel injection patients receiving concurrent radiotherapy. There is no experience with the use of Paclitaxel protein-bound particles for injectable suspension with concurrent radiotherapy.\u00a0<\/span><\/p>\n<p><b>Renal:<\/b><span style=\"font-weight: 400;\"> Overall 11% of patients experienced creatinine elevation, 1% severe. No discontinuations, dose reductions, or dose delays were caused by renal toxicities.\u00a0<\/span><\/p>\n<p><b>Other Clinical Events:<\/b><span style=\"font-weight: 400;\"> Rare cases of cardiac ischemia\/infarction and thrombosis\/embolism possibly related to Paclitaxel protein-bound particles for injectable suspension treatment have been reported. Alopecia was observed in almost all of the patients. Nail changes (changes in pigmentation or discoloration of nail bed) were uncommon. Edema (fluid retention) was infrequent (10% of randomized trial patients); no patients had severe edema.<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Drug Interactions&#8221; tab_id=&#8221;1588004246143-da131a40-78a3&#8243;][vc_column_text]<span style=\"font-weight: 400;\">The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering Protein boundPaclitaxelconcomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Overdose And Contradiction&#8221; tab_id=&#8221;1588004284140-0d63f957-72bf&#8221;][vc_column_text]<span style=\"font-weight: 400;\">There is no known antidote for <\/span><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension<\/span><span style=\"font-weight: 400;\"> overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.<\/span><\/p>\n<p><b>CONTRAINDICATIONS<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension should not be used in patients who have baseline neutrophil counts of &lt; 1,500 cells\/mm<\/span><span style=\"font-weight: 400;\">3<\/span><span style=\"font-weight: 400;\">.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Storage&#8221; tab_id=&#8221;1588004331495-1ab925f1-7cf0&#8243;][vc_column_text]<span style=\"font-weight: 400;\">Store between 20\u00b0C to 25\u00b0C.Protect from light.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Presentation&#8221; tab_id=&#8221;1588004354380-1368228c-d47c&#8221;][vc_column_text]I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong>\u00a0Paclitaxel protein-bound particles Inj &#8211; 100MG<\/strong><\/p>\n<p><b>Metastatic Breast Cancer:<\/b><span style=\"font-weight: 400;\"> A Paclitaxel protein-bound particle for injectable suspension 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.\u00a0<\/span><\/p>\n<p><b>Non-Small Cell Lung Cancer: <\/b><span style=\"font-weight: 400;\">Paclitaxel protein-bound particles for injectable suspension 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.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/zuviuslifesciences.in\/old\/product\/zaxotein-inj\/#1584624459062-96fb7e5b-0e23\">Read More<\/a><\/p>\n","protected":false},"featured_media":7345,"template":"","meta":{"spay_email":""},"product_cat":[66,176,67],"product_tag":[175,174],"jetpack-related-posts":[{"id":6694,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zaxol-inj\/","url_meta":{"origin":6766,"position":0},"title":"Zaxol Inj","date":"April 25, 2020","format":false,"excerpt":"Paclitaxel Inj - 30MG, 100MG, 260MG, 300MG ZAXOL (Paclitaxel) is indicated for the treatment of metastatic carcinoma of the ovary or breast after failure of standard therapy. The standard therapy means anthracycline containing regimen for ovarian cancer unless clinically contraindicated.","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zaxol-Group_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6712,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/capcetaz-tab\/","url_meta":{"origin":6766,"position":1},"title":"Capetaz Tab","date":"April 27, 2020","format":false,"excerpt":"Capecitabine Tab - 500MG Capecitabine is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated..","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Capetaz-500mg_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6750,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zemecon-inj\/","url_meta":{"origin":6766,"position":2},"title":"Zemecon Inj","date":"April 27, 2020","format":false,"excerpt":"Fosaprepitant Inj - 150 MG Fosaprepitant for Injection is a substance P\/neurokinin-1 (NK,) receptor antagonist indicated in adults for use in combination with other antiemetic agents for the: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose\u2026","rel":"","context":"Similar post","img":{"alt_text":"Zemecon","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zemecon-150mg_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6696,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zuvitop-inj\/","url_meta":{"origin":6766,"position":3},"title":"Zuvitop Inj","date":"April 25, 2020","format":false,"excerpt":"\u00a0Etoposide\u00a0 Inj -\u00a0 100MG Etoposide Injection is indicated in the management of the following neoplasms. Small cell lung cancer, \u00a0malignant lymphomas Acute leukemia\u2019s... Testicular tumors. Bladder Cancer. Trophoblastic \u00a0diseases Etoposide Injection are indicated in the management of the following neoplasms. Small cell lung cancer. \u00a0Malignant lymphomas.","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zuvitop-Group_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6753,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/aprepet-z-combi-pack-caps\/","url_meta":{"origin":6766,"position":4},"title":"Aprepet-z Combi Pack Caps","date":"April 27, 2020","format":false,"excerpt":"Aprepitant Combi Pack - 125MG , 80MG Aprepitant, for the treatment of adult patients with chemotherapy-induced nausea and vomiting.","rel":"","context":"Similar post","img":{"alt_text":"Aprepet-Z_1_1000 x 1000px","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Aprepet-Z_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":7379,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zuvisor-tab\/","url_meta":{"origin":6766,"position":5},"title":"Zuvisor Tab","date":"July 3, 2020","format":false,"excerpt":"Sorafenib Tab - 200MG Sorafenib is indicated for the treatment of Hepatocellular carcinoma Advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy Progressive, locally advanced or metastatic, differentiated (papillary\/follicular\/H\u00fcrthle cell) thyroid carcinoma, refractory to radioactive iodine. Read More","rel":"","context":"Similar post","img":{"alt_text":"Zuvisor 200mg_1_1000 x 1000px","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/07\/Zuvisor-200mg_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product\/6766"}],"collection":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/media\/7345"}],"wp:attachment":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/media?parent=6766"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_cat?post=6766"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_tag?post=6766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}