                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    {"id":6745,"date":"2020-04-27T11:42:47","date_gmt":"2020-04-27T11:42:47","guid":{"rendered":"https:\/\/zuviuslifesciences.in\/old\/?post_type=product&#038;p=6745"},"modified":"2020-07-20T15:04:43","modified_gmt":"2020-07-20T15:04:43","slug":"zinotecan-inj","status":"publish","type":"product","link":"https:\/\/zuviuslifesciences.in\/old\/product\/zinotecan-inj\/","title":{"rendered":"Zinotecan 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;1584624217032-a15849ed-97bb&#8221;][vc_column_text]Pemetrexed disodium heptahydrate \u00a0has the chemical name L-Glutamine acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-,disodium salt, heptahydrate. It is a white to almost-white solid with a molecular \u00a0formula of C20H19N5Na2O67H2O \u00a0and a molecular weight of 597.49. The Structural formula is as follows:<\/p>\n<p><img loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/i0.wp.com\/www.zuviuslifesciences.in\/media\/125462\/zinotecan-desc.jpg?resize=767%2C323&#038;ssl=1\" alt=\"zinotecan\" width=\"767\" height=\"323\" data-recalc-dims=\"1\" \/><\/p>\n<p>ZINOTECANis a pale yellow to yellow crystalline powder, with the empirical formula C33H38N4O6\u2022HCl\u20223H2O and a molecular weight of 677.19. It is slightly soluble in water and organic solvents.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Composition&#8221; tab_id=&#8221;1593176595038-d6cc74c4-42cd&#8221;][vc_column_text]<strong>Generic Name :<\/strong>\u00a0Irinotecan\u00a0injections<\/p>\n<p><strong>Each ml contains:<\/strong><\/p>\n<p>Irinotecan Trihydrate \u2026\u2026\u2026\u2026\u2026.20mg<\/p>\n<p>Excipients \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026q.s.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Mechanism of Action \/ Pharmcodynamics&#8221; tab_id=&#8221;1584624217050-ebb8ae5e-43a6&#8243;][vc_column_text]Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.<\/p>\n<p>Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN38 is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines. In vitro cytotoxicity assays show that the potency of SN-38 relative to irinotecan varies from 2- to 2000-fold. However, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan (see Pharmacokinetics). The precise contribution of SN-38 to the activity of ZINOTECANis thus unknown. Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form. A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.<\/p>\n<p>Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Pharmacokinetics&#8221; tab_id=&#8221;1584624459062-96fb7e5b-0e23&#8243;][vc_column_text]After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. The mean terminal elimination half-life of the active metabolite SN-38 is about 10 to 20 hours. The half-lives of the lactone (active) forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are in equilibrium.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Indications&#8221; tab_id=&#8221;1584624839401-59481bbb-bdc7&#8243;][vc_column_text]ZINOTECAN Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Dosage &amp; Administration&#8221; tab_id=&#8221;1584625017135-3ffdd9c5-1bd6&#8243;][vc_column_text]Patients should be carefully monitored for toxicity and doses of Irinotecan should be modified as necessary to accommodate individual patient tolerance to treatment. Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity.<\/p>\n<p>A new cycle of therapy should not begin until the toxicity has recovered to NCI grade 1 or less. Treatment may be delayed 1 to 2 weeks to allow for recovery from treatment- related toxicity. If the patient has not recovered, consideration should be given to discontinuing this combination therapy. Provided intolerable toxicity does not develop, treatment with additional cycles of Irinotecan may be continued indefinitely as long as patients continue to experience clinical benefit.<\/p>\n<p>Dosage in Patients with Reduced UGT1A1 Activity<\/p>\n<p>When administered in combination with other agents, or as a single-agent, a reduction in the starting dose by at least one level of Irinotecan should be considered for patients known to be homozygous for the UGT1A1*28 allele (seeCLINICAL PHARMACOLOGYandWARNINGS). However, the precise dose reduction in this patient population is not known and subsequent dose modifications should be considered based on individual patient tolerance to treatment.<\/p>\n<p>Preparation &amp; Administration Precautions<\/p>\n<p>As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from ZINOTECAN Injection. The use of gloves is recommended. If a solution of Irinotecan contacts the skin, wash the skin immediately and thoroughly with soap and water. If Irinotecan contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents are available.1-7[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Warnings&#8221; tab_id=&#8221;1587978464677-818e3c8a-8b36&#8243;][vc_column_text]<\/p>\n<ul>\n<li><strong>General :<\/strong>Outside \u00a0of a well-designed clinical study, ZINOTECAN Injection should not be used in \u00a0combination with the &#8220;Mayo Clinic&#8221; regimen of 5-FU\/LV (administration \u00a0for 4-5 consecutive days every 4 weeks) because of reports of increased \u00a0toxicity, including toxic deaths. Irinotecan should be used as recommended (seeIn \u00a0patients receiving either Irinotecan\/5-FU\/LV or 5-FU\/LV in the clinical trials, \u00a0higher rates of hospitalization, neutropenic fever, thromboembolism, \u00a0first-cycle treatment discontinuation, and early deaths were observed in \u00a0patients with a baseline performance status of 2 than in patients with a \u00a0baseline performance status of 0 or 1.<strong>Diarrhea :<\/strong>Irinotecan \u00a0can induce both early and late forms of diarrhea that appear to be mediated by \u00a0different mechanisms. Early diarrhea (occurring during or shortly after \u00a0infusion of Irinotecan) is cholinergic in nature. It is usually transient and \u00a0only infrequently is severe. It may be accompanied by symptoms of rhinitis, \u00a0increased salivation, meiosis, lacrimation, diaphoresis, flushing, and \u00a0intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea \u00a0and other cholinergic symptoms may be prevented or ameliorated by \u00a0administration of atropine\u00a0(see\u00a0PRECAUTIONS,\u00a0GENERAL, for \u00a0dosing recommendations for atropine).Late diarrhea (generally occurring more \u00a0than 24 hours after administration of Irinotecan) can be life threatening since \u00a0it may be prolonged and may lead to dehydration, electrolyte imbalance, or \u00a0sepsis. Late diarrhea should be treated promptly with loperamide (see\u00a0PRECAUTIONS,\u00a0INFORMATION FOR PATIENTS, for \u00a0dosing recommendations for loperamide). Patients with diarrhea should be \u00a0carefully monitored, should be given fluid and electrolyte replacement if they \u00a0become dehydrated, and should be given antibiotic support if they develop \u00a0ileus, fever, or severe neutropenia. After the first treatment, subsequent \u00a0weekly chemotherapy treatments should be delayed in patients until return of \u00a0pretreatment bowel function for at least 24 hours without need for \u00a0anti-diarrhea medication. If grade 2, 3, or 4 late diarrhea occurs subsequent \u00a0doses of Irinotecan should be decreased within the current cycle\u00a0(see\u00a0DOSAGE AND ADMINISTRATION).<strong>Neutropenia :<\/strong>Deaths \u00a0due to sepsis following severe neutropenia have been reported in patients \u00a0treated with Irinotecan. Neutropenic complications should be managed promptly \u00a0with antibiotic support. Therapy with Irinotecan should be temporarily omitted \u00a0during a cycle of therapy if neutropenic fever occurs or if the absolute \u00a0neutrophil count drops &lt;1000\/mm3. After the \u00a0patient recovers to an absolute neutrophil count \u22651000\/mm3, subsequent doses of Irinotecan should be reduced \u00a0depending upon the level of neutropenia observed\u00a0(see\u00a0DOSAGE AND ADMINISTRATION).\n<p>Routine \u00a0administration of a colony-stimulating factor (CSF) is not necessary, but \u00a0physicians may wish to consider CSF use in individual patients experiencing \u00a0significant neutropenia.<\/p>\n<p><strong>Patients with Reduced UGT1A1 Activity :<\/strong><\/p>\n<p>Individuals \u00a0who are homozygous for the UGT1A1*28 allele \u00a0(UGT1A1 7\/7 genotype) are at increased risk for neutropenia following \u00a0initiation of Irinotecan treatment.<\/p>\n<p>In a \u00a0study of 66 patients who received single-agent Irinotecan (350 mg\/m2\u00a0once-every-3-weeks), \u00a0the incidence of grade 4 neutropenia in patients homozygous for the UGT1A1*28 allele was 50%, and in patients heterozygous for \u00a0this allele (UGT1A1 6\/7 genotype) the incidence was 12.5%. No grade 4 neutropenia \u00a0was observed in patients homozygous for the wild-type allele (UGT1A1 6\/6 \u00a0genotype).<\/p>\n<p>In a \u00a0prospective study (n=250) to investigate the role of UGT1A1*28 polymorphism in the development of toxicity in \u00a0patients treated with Irinotecan (180 mg\/m2) in combination with infusional 5-FU\/LV, the \u00a0incidence of grade 4 neutropenia in patients homozygous for the UGT1A1*28 allele was 4.5%, and in patients heterozygous \u00a0for this allele the incidence was 5.3%. Grade 4 neutropenia was observed in \u00a01.8% of patients homozygous for the wild-type allele.<\/p>\n<p>In \u00a0another study in which 109 patients were treated with Irinotecan (100-125 mg\/m2) in combination with bolus 5-FU\/LV, the incidence \u00a0of grade 4 neutropenia in patients homozygous for the UGT1A1*28 allele was 18.2%, and in patients heterozygous \u00a0for this allele the incidence was 11.1%. Grade 4 neutropenia was observed in \u00a06.8% of patients homozygous for the wild-type allele.<\/p>\n<p>When administered in combination with \u00a0other agents, or as a single-agent, a reduction in the starting dose by at \u00a0least one level of Irinotecan should be considered for patients known to be \u00a0homozygous for the UGT1A1*28 allele. \u00a0However, the precise dose reduction in this patient population is not known and \u00a0subsequent dose modifications should be considered based on individual patient \u00a0tolerance to treatment\u00a0(see\u00a0DOSAGE AND ADMINISTRATION\u00a0and\u00a0PRECAUTIONS,\u00a0LABORATORY TESTS).<\/p>\n<p><strong>Hypersensitivity :<\/strong><\/p>\n<p>Hypersensitivity \u00a0reactions including severe anaphylactic or anaphylactoid reactions have been \u00a0observed.<\/p>\n<p><strong>Colitis\/Ileus :<\/strong><\/p>\n<p>Cases \u00a0of colitis complicated by ulceration, bleeding, ileus, and infection have been \u00a0observed. Patients experiencing ileus should receive prompt antibiotic support \u00a0(see\u00a0PRECAUTIONS).<\/p>\n<p><strong>Renal Impairment\/Renal Failure :<\/strong><\/p>\n<p>Rare \u00a0cases of renal impairment and acute renal failure have been identified, usually \u00a0in patients who became volume depleted from severe vomiting and\/or diarrhea.<\/p>\n<p><strong>Thromboembolism :<\/strong><\/p>\n<p>Thromboembolic \u00a0events have been observed in patients receiving irinotecan-containing regimens; \u00a0the specific cause of these events has not been determined.<\/p>\n<p><strong>Pulmonary Toxicity :<\/strong><\/p>\n<p>Interstitial \u00a0Pulmonary Disease (IPD)-like events, including fatalities, have been reported \u00a0in patients receiving irinotecan (in combination and as monotherapy) for \u00a0treatment of colorectal cancer and other advanced solid tumors. In the event of \u00a0an acute onset of new or progressive, unexplained pulmonary symptoms such as \u00a0dyspnea, cough, and fever, irinotecan and other co-prescribed chemotherapeutic \u00a0agents should be interrupted pending diagnostic evaluation. If IPD is \u00a0diagnosed, irinotecan and other chemotherapy should be discontinued and \u00a0appropriate treatment instituted as needed\u00a0(see\u00a0ADVERSE REACTIONS:\u00a0OVERVIEW OF ADVERSE EVENTS: \u00a0RESPIRATORY).<\/p>\n<p><strong>Pregnancy :<\/strong><\/p>\n<p>Irinotecan \u00a0may cause fetal harm when administered to a pregnant woman. Radioactivity \u00a0related to\u00a014C-irinotecan crosses the placenta of rats \u00a0following intravenous administration of 10 mg\/kg (which in separate studies \u00a0produced an irinotecan Cmax\u00a0and AUC about 3 and 0.5 times, \u00a0respectively, the corresponding values in patients administered 125 mg\/m2). Administration of 6 mg\/kg\/day intravenous \u00a0irinotecan to rats (which in separate studies produced an irinotecan Cmax\u00a0and AUC about 2 and 0.2 times, respectively, \u00a0the corresponding values in patients administered 125 mg\/m2) and rabbits (about one-half the recommended human \u00a0weekly starting dose on a mg\/m2\u00a0basis) during the period of \u00a0organogenesis, is embryotoxic as characterized by increased post-implantation \u00a0loss and decreased numbers of live fetuses. Irinotecan was teratogenic in rats \u00a0at doses greater than 1.2 mg\/kg\/day (which in separate studies produced an \u00a0irinotecan Cmax\u00a0and AUC about 2\/3 and 1\/40th, \u00a0respectively, of the corresponding values in patients administered 125 mg\/m2) and in rabbits at 6.0 mg\/kg\/day (about one-half \u00a0the recommended human weekly starting dose on a mg\/m2\u00a0basis). \u00a0Teratogenic effects included a variety of external, visceral, and skeletal \u00a0abnormalities. Irinotecan administered to rat dams for the period following \u00a0organogenesis through weaning at doses of 6 mg\/kg\/day caused decreased learning \u00a0ability and decreased female body weights in the offspring. There are no \u00a0adequate and well-controlled studies of irinotecan in pregnant women. If the \u00a0drug is used during pregnancy, or if the patient becomes pregnant while \u00a0receiving this drug, the patient should be apprised of the potential hazard to \u00a0the fetus. Women of childbearing potential should be advised to avoid becoming \u00a0pregnant while receiving treatment with Irinotecan.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Precautions&#8221; tab_id=&#8221;1587978466341-e08f7517-4cca&#8221;][vc_column_text]<\/p>\n<ul>\n<li>ZINOTECAN \u00a0Injection is administered by intravenous infusion. Care should be taken to \u00a0avoid extravasation, and the infusion site should be monitored for signs of \u00a0inflammation. Should extravasation occur, flushing the site with sterile water \u00a0and applications of ice are recommended.<strong>Premedication with \u00a0Antiemetics :<\/strong>Irinotecan \u00a0is emetigenic. It is recommended that patients receive premedication with \u00a0antiemetic agents. In clinical studies of the weekly dosage schedule, the \u00a0majority of patients received 10 mg of dexamethasone given in conjunction with \u00a0another type of antiemetic agent, such as a 5-HT3\u00a0blocker \u00a0(e.g., ondansetron or granisetron). Antiemetic agents should be given on the \u00a0day of treatment, starting at least 30 minutes before administration of \u00a0Irinotecan. Physicians should also consider providing patients with an \u00a0antiemetic regimen (e.g., prochlorperazine) for subsequent use as needed.<strong>Treatment of \u00a0Cholinergic Symptoms :<\/strong>Prophylactic \u00a0or therapeutic administration of 0.25 to 1 mg of intravenous or subcutaneous \u00a0atropine should be considered (unless clinically contraindicated) in patients \u00a0experiencing rhinitis, increased salivation, miosis, lacrimation, diaphoresis, \u00a0flushing, abdominal cramping, or diarrhea (occurring during or shortly after \u00a0infusion of Irinotecan). These symptoms are expected to occur more frequently \u00a0with higher irinotecan doses.<strong>Immunosuppressant \u00a0Effects\/Increased Susceptibility \u00a0to \u00a0Infections :<\/strong>Administration \u00a0of live or live-attenuated vaccines in patients immunocompromised by \u00a0chemotherapeutic agents including Irinotecan, may result in serious or fatal \u00a0infections. Avoid vaccination with a live vaccine in patients receiving \u00a0irinotecan. Killed or inactivated vaccines may be administered; however, the \u00a0response to such vaccines may be diminished.<strong>Patients at Particular \u00a0Risk :<\/strong>\n<p>In \u00a0patients receiving either irinotecan\/5-FU\/LV or 5-FU\/LV in the clinical trials, \u00a0higher rates of hospitalization, neutropenic fever, thromboembolism, \u00a0first-cycle treatment discontinuation, and early deaths were observed in \u00a0patients with a baseline performance status of 2 than in patients with a \u00a0baseline performance status of 0 or 1. Patients who had previously received \u00a0pelvic\/abdominal radiation and elderly patients with comorbid conditions should \u00a0be closely monitored.<\/p>\n<p>The use of Irinotecan in patients with \u00a0significant hepatic dysfunction has not been established. In clinical trials of \u00a0either dosing schedule, irinotecan was not administered to patients with serum \u00a0bilirubin &gt;2.0 mg\/dL, or transaminase &gt;3 times the upper limit of normal \u00a0if no liver metastasis, or transaminase &gt;5 times the upper limit of normal \u00a0with liver metastasis. In clinical trials of the weekly dosage schedule, patients \u00a0with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg\/dL) \u00a0had a significantly greater likelihood of experiencing first-cycle, grade 3 or \u00a04 neutropenia than those with bilirubin levels that were less than 1.0 mg\/dL \u00a0(50% [19\/38] versus 18% [47\/226]; p&lt;0.001). (Also see\u00a0CLINICAL PHARMACOLOGY:\u00a0PHARMACOKINETICS IN SPECIAL \u00a0POPULATIONS: Hepatic Insufficiency). Patients with deficient glucuronidation of \u00a0bilirubin, such as those with Gilbert\u2019s syndrome, may be at greater risk of \u00a0myelosuppression when receiving therapy with Irinotecan.<\/p>\n<p>Ketoconazole, enzyme-inducing \u00a0anticonvulsants and St. John\u2019s Wort are known to have drug-drug interactions \u00a0with irinotecan therapy. (See Drug-Drug Interactions sub-section under\u00a0CLINICAL PHARMACOLOGY)<\/p>\n<p>Irinotecan \u00a0commonly causes neutropenia, leucopenia, and anemia, any of which may be severe \u00a0and therefore should not be used in patients with severe bone marrow failure. \u00a0Patients must not be treated with irinotecan until resolution of the bowel \u00a0obstruction. Patients with hereditary fructose intolerance should not be given \u00a0Irinotecan, as this product contains sorbitol.<\/p>\n<p><strong>Information for Patients :<\/strong><\/p>\n<p>Patients \u00a0and patients\u2019 caregivers should be informed of the expected toxic effects of \u00a0Irinotecan, particularly of its gastrointestinal complications, such as nausea, \u00a0vomiting, abdominal cramping, diarrhea, and infection. Each patient should be \u00a0instructed to have loperamide readily available and to begin treatment for late \u00a0diarrhea (generally occurring more than 24 hours after administration of \u00a0Irinotecan) at the first episode of poorly formed or loose stools or the \u00a0earliest onset of bowel movements more frequent than normally expected for the \u00a0patient. One dosage regimen for loperamide used in clinical trials consisted of \u00a0the following (Note: This dosage regimen exceeds the usual dosage \u00a0recommendations for loperamide.): 4 mg at the first onset of late diarrhea and \u00a0then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 \u00a0hours. Loperamide is not recommended to be used for more than 48 consecutive \u00a0hours at these doses, because of the risk of paralytic ileus. During the night, \u00a0the patient may take 4 mg of loperamide every 4 hours. Premedication with \u00a0loperamide is not recommended. The use of drugs with laxative properties should \u00a0be avoided because of the potential for exacerbation of diarrhea. Patients \u00a0should be advised to contact their physician to discuss any laxative use.<\/p>\n<p>Patients \u00a0should be instructed to contact their physician or nurse if any of the \u00a0following occur: diarrhea for the first time during treatment; black or bloody \u00a0stools; symptoms of dehydration such as lightheadedness, dizziness, or \u00a0faintness; inability to take fluids by mouth due to nausea or vomiting; \u00a0inability to get diarrhea under control within 24 hours; or fever or evidence \u00a0of infection.<\/p>\n<p>Patients \u00a0should be warned about the potential for dizziness or visual disturbances which \u00a0may occur within 24 hours following the administration of Irinotecan, and \u00a0advised not to drive or operate machinery if these symptoms occur.<\/p>\n<p>Patients \u00a0should be alerted to the possibility of alopecia.<\/p>\n<p><strong>Laboratory Tests :<\/strong><\/p>\n<p>Careful \u00a0monitoring of the white blood cell count with differential, hemoglobin, and \u00a0platelet count is recommended before each dose of Irinotecan.<\/p>\n<p><strong>UGT1A1 \u00a0Testing :<\/strong><\/p>\n<p>A laboratory test is available to \u00a0determine the UGT1A1 status of patients. Testing can detect the UGT1A1 6\/6, 6\/7 \u00a0and 7\/7 genotypes (See\u00a0WARNINGS).<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Adverse Reactions (Side Effects)&#8221; tab_id=&#8221;1587978467943-190d6254-3b32&#8243;][vc_column_text]<strong>First-Line Combination Therapy<\/strong><\/p>\n<p>A total of 955 patients with metastatic colorectal cancer received the recommended regimens of irinotecan in combination with 5-FU\/LV, 5-FU\/LV alone, or irinotecan alone. In the two phase 3 studies, 370 patients received irinotecan in combination with 5-FU\/LV, 362 patients received 5-FU\/LV alone, and 223 patients received irinotecan alone.<\/p>\n<p>In Study 1, 49 (7.3%) patients died within 30 days of last study treatment: 21 (9.3%) received irinotecan in combination with 5-FU\/LV, 15 (6.8%) received 5-FU\/LV alone, and 13 (5.8%) received irinotecan alone. Deaths potentially related to treatment occurred in 2 (0.9%) patients who received irinotecan in combination with 5-FU\/LV (2 neutropenic fever\/sepsis), 3 (1.4%) patients who received 5-FU\/LV alone (1 neutropenic fever\/sepsis, 1 CNS bleeding during thrombocytopenia, 1 unknown) and 2 (0.9%) patients who received irinotecan alone (2 neutropenic fever). Deaths from any cause within 60 days of first study treatment were reported for 15 (6.7%) patients who received irinotecan in combination with 5-FU\/LV, 16 (7.3%) patients who received 5FU\/ LV alone, and 15 (6.7%) patients who received irinotecan alone. Discontinuations due to adverse events were reported for 17 (7.6%) patients who received irinotecan in combination with 5FU\/LV, 14 (6.4%) patients who received 5-FU\/LV alone, and 26 (11.7%) patients who received irinotecan alone.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Drug Interactions&#8221; tab_id=&#8221;1587978788920-a652582e-1377&#8243;][vc_column_text]<\/p>\n<p class=\"first\">The adverse effects of Irinotecan, such as myelosuppression and diarrhea, would be expected to be exacerbated by other antineoplastic agents having similar adverse effects.<\/p>\n<p>Patients who have previously received pelvic\/ abdominal irradiation are at increased risk of severe myelosuppression following the administration of Irinotecan. The concurrent administration of Irinotecan with irradiation has not been adequately studied and is not recommended.<\/p>\n<p>Lymphocytopenia has been reported in patients receiving Irinotecan, and it is possible that the administration of dexamethasone as antiemetic prophylaxis may have enhanced the likelihood of this effect. However, serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia.<\/p>\n<p>Hyperglycemia has also been reported in patients receiving Irinotecan. Usually, this has been observed in patients with a history of diabetes mellitus or evidence of glucose intolerance prior to administration of Irinotecan. It is probable that dexamethasone, given as antiemetic prophylaxis, contributed to hyperglycemia in some patients.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Overdose &amp; Contradiction&#8221; tab_id=&#8221;1587978790937-0b0c9a9f-418f&#8221;][vc_column_text]<strong>OVERDOSAGE<\/strong><\/p>\n<p>In U.S. phase 1 trials, single doses of up to 345 mg\/m2 of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg\/m2 of irinotecan have been given in non-U.S. trials. The adverse events in these patients were similar to those reported with the recommended dosage and regimen. There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhea. There is no known antidote for overdosage of Irinotecan. Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.<\/p>\n<p><strong>CONTRAINDICATIONS<\/strong><\/p>\n<p>ZINOTECANInjection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Storage&#8221; tab_id=&#8221;1587978793604-7c71901c-62cf&#8221;][vc_column_text]Store protected from light at a temperature not exceeding 25degree Celsius.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Presentation&#8221; tab_id=&#8221;1587978938510-bff2f998-3197&#8243;][vc_column_text]40MG\/2ML (SINGLE USE VIAL)<\/p>\n<p>100MG\/5ML (SINGLE USE VIAL)[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<h3>Irinotecan Inj &#8211; 40MG, 100MG<\/h3>\n<p>ZINOTECAN Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.<\/p>\n","protected":false},"featured_media":7777,"template":"","meta":{"spay_email":""},"product_cat":[66,176,67],"product_tag":[175,174],"jetpack-related-posts":[{"id":6701,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/z-blastin-inj\/","url_meta":{"origin":6745,"position":0},"title":"Z-Blastin Inj","date":"April 26, 2020","format":false,"excerpt":"Vinblastine Inj - 10MG \u00a0","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/image-10-3.jpg?fit=615%2C385&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6717,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zolon-inj\/","url_meta":{"origin":6745,"position":1},"title":"Zolon Inj","date":"April 27, 2020","format":false,"excerpt":"Oxaliplatin Inj - 150MG 100MG 50MG Oxaliplatin is indicated in the treatment of metastatic colorectal cancers after the failure of treatment of fluoropyrimidines, alone by monochemotherapy or along with fluoropyrimidines. \u00a0","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zolon-Group-2_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6667,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/antifol-inj\/","url_meta":{"origin":6745,"position":2},"title":"Antifol Inj","date":"April 25, 2020","format":false,"excerpt":"Pemetrexed Inj - 100MG , 500MG A. Nonsquamous Non-Small Cell \u00a0Lung Cancer-Combination with Cisplatin Pemetrexed is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer. B. Nonsquamous Non-Small Cell \u00a0Lung Cancer-Maintenance Pemetrexed is indicated for the maintenance treatment\u2026","rel":"","context":"Similar post","img":{"alt_text":"Antifol 100mg & 500mg_1000 x 1000px","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Antifol-100mg-500mg_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":6745,"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":6710,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zeflo-inj\/","url_meta":{"origin":6745,"position":4},"title":"Zeflo Inj","date":"April 27, 2020","format":false,"excerpt":"Fluorouracil Inj - 250MG, 500MG Fluorouracil is indicated in the palliative treatment of carcinoma of the colon, rectum, breast, stomach, and pancreas. \u00a0 \u00a0","rel":"","context":"Similar post","img":{"alt_text":"Zeflo 500mg_1_1000 x 1000px","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zeflo-500mg_1_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":6745,"position":5},"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":[]}],"_links":{"self":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product\/6745"}],"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\/7777"}],"wp:attachment":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/media?parent=6745"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_cat?post=6745"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_tag?post=6745"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}