Iritero

Irinotecan HCl trihydrate.

Concentrate for solution for infusion 40 mg/2 mL and 100 mg/5 mL, each mL contains: Irinotecan HCl Trihydrate 20 mg equivalent to Irinotecan 17.32 mg.

Pharmacology: Pharmacodynamics: Therapeutic class: Irinotecan Hydrochloride is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan is a semisynthetic derivative of Camptothecin, an alkaloid extract from plants such as Camptotheca acuminata, or is chemically synthesized.
Mechanism of action: Irinotecan and its active metabolite SN-38 bind to the topoisomerase I - DNA complex and prevent re-ligation 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.
Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from Irinotecan by carboxylesterases-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. The precise contribution of SN-38 to the activity of Irinotecan is thus known. Both Irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form. A pH-dependent equilibrium exist 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.
Pharmacokinetics in special populations: Geriatric: No differences in the pharmacokinetics of Irinotecan, SN-38, and SN-38 glucuronide in patients < 65 years of age compared with patients ≥ 65 years of age.
Gender: The pharmacokinetics of Irinotecan do not appear to be influenced by gender.
Race: The influence of race on the pharmacokinetics of Irinotecan has not been evaluated.
Hepatic insufficiency: Irinotecan clearance is diminished in patients with hepatic dysfunction while relative exposure to the active metabolite SN-38 is increased. The magnitude of these effects is proportional to the degree of liver impairment as measured by elevations in serum total bilirubin and transaminase concentrations.
Renal insufficiency: The influence of renal insufficiency on the pharmacokinetics of Irinotecan has not been evaluated.

IRITERO is indicated for the treatment of patients with advanced colorectal cancer: In combination with 5-fluorouracil and Folinic acid in patients without prior chemotherapy for advanced disease; As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
Irinotecan combination with Cisplatin is indicated for treatment of patients with small cell lung cancer.
Strictly follow the recommended dosage unless directed otherwise by the physician.

For adults only. IRITERO solution for infusion should be infused into a peripheral or central vein.
In monotherapy (for previously treated patients): The recommended dosage of IRITERO is 350 mg/m² administered as an intravenous infusion over a 30- to 90 minute period every three weeks.
In combination therapy (for previously untreated patients): Safety and efficacy of IRITERO in combination with 5-fluorouracil (5-FU) and Folinic acid (FA) have been assessed with the following schedule. The recommended dosage of IRITERO is 180 mg/m² administered once every 2 weeks as an intravenous infusion over a 30- to 90- minute period, followed by infusion with Folinic acid and 5-fluorouracil.
Irinotecan in combination with Cisplatin: The recommended starting dose is 65 mg/m² of Irinotecan and 30 mg/m² of Cisplatin. Cisplatin infused prior to Irinotecan. A lower starting dose of Irinotecan may be considered for patients with any of the following conditions: Age 65 years and older, prior extensive radiotherapy, performance status of 2, increased bilirubin levels, or gastric cancer. Treatment should be given in repeated 6-week cycles, comprising days 1 and 8, every 21 days.
Irinotecan should be administered as an intravenous infusion over 30 to 90 minutes.
Dosage adjustment: IRITERO should be administered after appropriate recovery of all adverse events to grade 0 or 1 NCI-CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of IRITERO, and 5FU when applicable, should be decreased according to the worst grade of adverse events observed in the prior infusion. Treatment should be delayed by 1 to 2 weeks to allow recovery from treatment-related adverse events. With the following adverse events a dose reduction of 15% to 20% should be applied for IRITERO and/or 5FU when applicable: Haematological toxicity (neutropenia grade 4), febrile neutropenia (neutropenia grade 3 - 4 and fever grade 2 - 4), thrombocytopenia and leukopenia (grade 4), non-hematological toxicity (grade 3 - 4).
Duration of treatment: For both single-agent and combination-agent regimens, treatment with additional cycles of Irinotecan may be continued indefinitely in patients who attain a tumor response or in patients whose cancer remains stable. Patients should be carefully monitored for toxicity and should be removed from therapy if unacceptable toxicity occurs that responsive to dose modifications and routine supportive care.
Modification recommendations: Recommended dose modification for Irinotecan and Cisplatin for the start of each cycle of therapy are described in Table 1, while recommended dose modifications during a cycle of therapy are described in Table 2. (See Table 1 and Table 2.)


Click on icon to see table/diagram/image




Click on icon to see table/diagram/image


Special population: Elderly: The dose should be chosen carefully in this population due to their greater frequency of decreased biological functions. These populations should require more intensive surveillance.
Patients with impaired hepatic function: In monotherapy: In patients with hyperbilirubinemia and prothrombin greater than 50%, the clearance of Irinotecan is decreased and therefore, the risk of hematotoxicity is increased. Thus, frequent monitoring of complete blood counts should be conducted in this patient population.
In patients with bilirubin up to 1.5 times the upper limit of the normal range (ULN), the recommended dosage of IRITERO is 350 mg/m².
In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of IRITERO is 200 mg/m².
Patients with bilirubin beyond to 3 times the ULN should not be treated with IRITERO.
No date are available in patients with hepatic impairment treated by IRITERO in combination.
Patients with impaired renal functions: IRITERO is not recommended for use in patients with impaired renal functions.
Preparation and handling: As with other antineoplastic agents, IRITERO must be prepared and handled with caution. The usage of glasses, mask and gloves is required. If IRITERO solution or infusion solution come into contact with the mucus membranes, wash immediately with water.
Preparation for intravenous infusion administration: As with any other injectable drugs, the IRITERO solution must be prepared aseptically. If any precipitate is observed in the vials or after reconstitution, the product should be discarded according to standard procedures for cytotoxic agents. Aseptically withdraw the required amount of IRITERO solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% Sodium chloride solution or 5% Dextrose solution. The infusion is then thoroughly mixed by manual rotation.
Administration: IRITERO solution for infusion should be infused into a peripheral or central wein. IRITERO should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.
Disposal: All material used for dilution and administration should be disposed of according to hospital standard procedure applicable to cytotoxic agents.

Single doses of up to 750 mg/m² Irinotecan have been given to patients with various cancers. The adverse events in these patients were similar to those reported with the recommended dosages and regimens. 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 knowing antidote for Irinotecan. Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.

IRITERO is contraindicated in patients with: A chronic inflammatory bowel disease and/or a bowel obstruction; A history of severe hypersensitivity reactions to Irinotecan Hydrochloride Trihydrate or to one of the excipients of IRITERO; In pregnant or breast feeding women; In patient with bilirubin > 3 times the ULN; In patient with a severe bone marrow failure; In patient presenting a risk factor, particularly those with a WHO performance status > 2.

Administration: Irinotecan should be administered only under the supervision of a physician, who is experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostics and treatment facilities are readily available.
Irinotecan will only be prescribed in the following cases after the expected benefits have been weighed against the possible therapeutic risks: In patients presenting a risk factor, particularly those with a WHO performance status = 2; In the few instances where patients are deemed unlikely to observe recommendations regarding management of adverse events (need for immediate and prolonged antidiarrheal treatment combined with high fluid intake at onset of delayed diarrhea). Strict hospital supervision is recommended for such patients.
Cholinergic symptoms: Patients may have cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing (vasodilation), bradycardia, and intestinal hyperperistalsis that can cause abdominal cramping and early diarrhea (i.e., diarrhea generally occurring during or within 8 hours of administration of Irinotecan). These symptoms may be observed during or shortly after infusion of Irinotecan, are thought to be related to the anticholinesterase activity of the Irinotecan parent compound, and are expected to occur more frequently with higher Irinotecan doses. Therapeutic or prophylactic administration of 0.25 to 1 mg of intravenous or subcutaneous Atropine should be considered (unless contraindicated) in patients experiencing cholinergic symptoms.
Extravasation: While Irinotecan is not a known vesicant, care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occu, flushing the site, and application of ice is recommended.
Hepatic: National Cancer Institute (NCI) Common Toxicity Criteria grade 3 or 4 liver enzyme abnormalities have been observed. These events typically occur in patients with known hepatic metastases and are not clearly related to Irinotecan.
Hematology: Irinotecan causes neutropenia, leukopenia, and anemia, any of which may be severe and therefore should not be used in patients with severe bone marrow failure. Serious thrombocytopenia is uncommon. The frequency of NCI grade 3 and 4 neutropenia has been significantly higher in patients who received previous pelvic/abdominal irradiation than in those who had not received such irradiation. Patients with baseline serum total bilirubin levels of 1.0 mg/dL or more also have had a significantly greater likelihood of experiencing first-cycle grade 3 or 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dL. There were no significant differences in the frequency of grade 3 and 4 neutropenia by age or gender.
Neutropenic fever (concurrent NCI grade 4 neutropenia and ≥ grade 2 fever) occurred in patients; however, deaths due to sepsis following severe neutropenia have been reported in patients treated with Irinotecan. Neutropenic complications should be managed promptly with antibiotic support. Therapy with Irinotecan should be temporarily discontinued if neutropenic fever occurs or if the absolute neutrophil count drops below 1000/mm³. The dose of Irinotecan should be reduced if significant neutropenia occurs.
Patients with reduced UGT1A1 activity: The metabolic conversion of Irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes and primarily occurs in the liver. SN-38 subsequently undergoes conjugation to form the inactive glucuronide metabolite SN-38G. This glucuronidation reaction is mediated primarily by uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1), which is encoded by the UGT1A1 gene. The UGT1A1 gene is highly polymorphic, resulting in variable metabolic capacities among individuals. One specific variation of the UGT1A1 gene includes a polymorphism in the promoter region known as the UGT1A1 variant allele. This variant and other congenital deficiencies in UGT1A1 expression (such as Crigler-Najjar and Gilbert's syndrome) are associated with reduced enzyme activity and increased systemic exposure to SN-38. Higher plasma concentrations of SN-38 are observed in individuals who are homozygous for the UGT1A1*28 allele (also referred to as UGT1A1 7/6 genotype) versus patients who have one or two wild-type alleles.
Patients who are homozygous (UGT1A1*6/6* of UGT1A1*28*28) or heterozygous (UGT1A1*6/*28) in allele UGT1A1*6, UGT1A1*28 of UGT may be at increased risk for serious adverse reactions (especially neutropenia) caused by reduced glucuronidation of SN-38. Added caution should be exercised when administering in such patients. Patients known to be homozygous for UGT1A1*28 should be administered the normally indicated Irinotecan starting dose. However, these patients should be monitored for hematologic toxicities. A reduced Irinotecan starting dose should be considered for patients who have experienced prior hematologic toxicity with previous treatment. The exact reduction in starting dose in this patient population has not been established and any subsequent dose modifications should be based on individual patient tolerance to treatment.
Hypersensitivity reactions: Hypersensitivity reactions, including severe anaphylactic/anaphylactoid reactions, have been reported.
Immunosuppressant effect/increased susceptibility to infections: Administration of live or live attenuated vaccines in patients immunocompromised by chemotherapeutic agents including Irinotecan, may result in serious or fatal infections. Vaccination with a live vaccine should be avoided in patients receiving Irinotecan. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Late diarrhea: Late diarrhea (generally occurring more that 8 hours after administration of Irinotecan) can be prolonged, may lead to dehydration, electrolyte imbalance, or sepsis and may be life-threatening.
Patients ≥ 65 years of age should be closely monitored due to a greater risk of early diarrhea observed. Colonic ulceration, sometimes with bleeding, has been observed in association with Irinotecan-induced diarrhea.
Late diarrhea should be treated promptly with Loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normally expected for the patient.
The recommended dosage regimen for Loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. During the night, the patient may take 4 mg of Loperamide every 4 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus, nor for less than 12 hours. Premedication with Loperamide is not recommended. Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated and should be given antibiotic support if they develop ileus, fever, or severe neutropenia. In addition to the antibiotic treatment, hospitalization is recommended for management of the diarrhea, in the following cases: Diarrhea associated with fever; Severe diarrhea (requiring intravenous hydration); Patients with vomiting associated with delayed (i.e., late) diarrhea; Diarrhea persisting beyond 48 hours following the initiation of high-dose Loperamide therapy.
After the first treatment, subsequent weekly chemotherapy treatments should be delayed in patients until return of pre-treatment bowel function for at least 24 hours without need for antidiarrheal medication. If NCI grade 2, 3, or 4 diarrhea occurs, subsequent doses of Irinotecan should be reduced within the current cycle.
Chronic inflammatory bowel disease and/or bowel obstruction: Patients must not be treated with Irinotecan until resolution of the bowel obstruction.
Nausea & vomiting: Irinotecan is emetogenic. Nausea and vomiting can be severe and usually occurs during or shortly after infusion of Irinotecan. It is recommended that patients receive premedication with antiemetic agents. Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before administration of Irinotecan. Physicians should also consider providing patients with an antiemetic regimen for subsequent use as needed. Patients with vomiting associated with delayed diarrhea should be hospitalized as soon as possible for treatment.
Neurologic: Dizziness has been observed and may sometimes represent symptomatic evidence of orthostatic hypotension in patients with dehydration.
Renal: Increases in serum creatinine or blood urea nitrogen have been observed. There have been cases of acute renal failure. These events have generally been attributed to complications of infection or to dehydration related to nausea, vomiting, or diarrhea. Instances of renal dysfunction due to tumor lysis syndrome have also been reported.
Respiratory: NCI grade 3 or 4 dyspnea has been observed. The extent to which malignant pulmonary involvement or other preexisting lung disease may have contributed to dyspnea is unknown. A potentially life-threatening pulmonary syndrome, consisting of dyspnea, fever, and a reticulonodular pattern on chest X-ray, was observed in a small percentage of patients in early Japanese studies. The contribution of Irinotecan to these preliminary events was difficult to assess because these patients also had lung tumors and some had pre-existing nonmaligmant pulmonary disease.
Interstitial pulmonary disease presenting as pulmonary infiltrates is uncommon during Irinotecan therapy. Interstitial pulmonary disease can be fatal. Risk factors possibly associated with the development of interstitial, pulmonary disease include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors. Patients with risk factors should be closely monitored for respiratory symptoms before and during Irinotecan therapy.
Others: Since this product contains Sorbitol, it is unsuitable in hereditary fructose intolerance.
Hepatic insufficiency: In patients with hyperbilirubinemia, the clearance of Irinotecan is decreased and therefore the risk of hematotoxicity is increased. The use of Irinotecan in patients with a serum total bilirubin concentration of > 3.0 x institutional upper limit of normal (IULN) given as a single-agent on the once-every-3-weeks schedule has not been established. Liver function should be monitored before initiation of treatment and monthly, or as clinically indicated.
Irradiation therapy: Patients who have previously received pelvic/abdominal irradiation are at increased risk of myelosuppression following the administration of Irinotecan. Physicians should use caution in treating patients with extensive prior irradiation. Specific dosing recommendations may apply to this population depending upon the regimen used.
Performance status: Patients with poor performance status are at increased risk of Irinotecan-related adverse events. Specific dosing recommendations for patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 may apply depending upon the regimen used. Patients with performance status of 3 or 4 should not receive Irinotecan. In patients receiving either Irinotecan/5-FU/LV or 5-FU/LV comparing these agents, higher rates of hospitalisation, neutropenic fever, thromboembolism, first-cycle treatment discontinuation, and early deaths were observed in patients with a baseline performance status of 2 than in patients with a baseline performance status of 0 or 1.
Gastric cancer: Patients with gastric cancer appear to experience greater myelosuppression and other toxicities when given Irinotecan. A lower starting dose should be considered in these patients.
Effects on ability to drive and use machines: Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of Irinotecan, and advised not to drive or operate machinery if these symptoms occur.
Use in Pregnancy: Irinotecan may cause fetal harm when administered to a pregnant woman. If the 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 Irinotecan.
Use in Lactation: Because many drugs are excreted in human milk, and because of the potential for adverse reactions in nursing infants, breast-feeding must be discontinued for the duration of Irinotecan therapy.
Use in Elderly: Specific dosing recommendations may apply to this population depending upon the regimen used.

Pregnancy: Irinotecan may cause fetal harm when administered to a pregnant woman. If the 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 Irinotecan.
Lactation: Because many drugs are excreted in human milk, and because of the potential for adverse reactions in nursing infants, breast-feeding must be discontinued for the duration of Irinotecan therapy.

See Table 3.


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The following additional drug related events have been reported with Irinotecan, but do not meet the criteria as defined above as either drug-related NCI grades 1 - 4 or as a NCI grade 3 or 4 drug-related event: Rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, bradycardia, dizziness, extravasation, tumor lysis syndrome, and colonic ulceration.
Cardiac disorders: Myocardial ischemic events have been observed following Irinotecan therapy predominantly in patients with underlying cardiac disease, other known risk factors for cardiac disease or previous cytotoxic chemotherapy.
Gastrointestinal disorder: Intestinal obstruction, ileus, megacolon, or gastrointestinal hemorrhage, and cases of colitis, including typhlitis, ischemic and ulcerative colitis were reported. In some cases, colitis was complicated by ulceration, bleeding, ileus, or infection. Cases of ileus without preceding colitis have also been reported. Cases of intestinal perforation were reported. Cases of symptomatic pancreatitis or asymptomatic elevated pancreatic enzymes have been observed.
Hypovolemia: There have been cases or renal impairment and acute renal failure, generally in patients who became infected and/or volume depleted from severe gastrointestinal toxicities. Renal insufficiency, hypotension or circulatory failure have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting, or sepsis.
Immune system disorders: Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been reported.
Musculoskeletal disorders and connective tissue disorders: Early effects, such as muscular contraction or cramps and paresthesia, have been reported.
Nervous system disorders: Speech disorder, generally transient in nature, have been reported in patients treated with Irinotecan; in some cases, the event was attributed to the cholinergic syndrome observed during or shortly after infusion of Irinotecan.
Respiratory, thoracic and mediastinal disorders: Interstitial pneumonia and pneumonitis presenting as pulmonary infiltrates have been observed. Early effects, such as dyspnea, have been reported.
Investigations: Cases of hyponatremia mostly related with diarrhea and vomiting have been reported. Increases in serum levels of transaminases (i.e., AST and ALT) in the absence of progressive liver metastasis have been reported.

CYP3A4 and/or UGT1A1 inhibitors: Irinotecan and active metabolite SN-38 are metabolized via human cytochrome P450 3A4 isoenzyme (CYP3A4) and uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1). Co-administration of Irinotecan with inhibitors of CYP3A4 and/or UGT1A1 may result in increased systemic exposure to Irinotecan and the active metabolite SN-38. Physicians should take this into consideration when administering Irinotecan with these drugs.
Ketoconazole: Irinotecan clearance is greatly reduced in patients receiving concomitant Ketoconazole, leading to increased exposure to SN-38. Ketoconazole should be discontinued at least 1 week prior to starting Irinotecan therapy and should not be administered during Irinotecan therapy.
Atazanavir sulfate: Co-administration of Atazanavir sulfate, a CYP3A4 and UGT1A1 inhibitor has the potential to increase systemic exposure to SN-38, the active metabolite of Irinotecan. Physicians should take this into consideration when co-administering these drugs.
CYP3A4 inducers: Anticonvulsants: Concomitant administration of CYP3A-inducing anticonvulsant drugs (e.g., Carbamazepine, Phenobarbital or Phenytoin) leads to reduced exposure to the active metabolite SN-38. Consideration should be given to starting or substituting non-enzyme-inducing anticonvulsants at least one week prior to initiation of Irinotecan therapy in patients requiring anticonvulsant treatment.
St. John's wort (Hypericum perforatum): Exposure to the active metabolite SN-38 is reduced in patients taking concomitant St. John's wort. St. John's wort should be discontinued at least 1 week prior to the first cycle of Irinotecan, and should not be administered during Irinotecan therapy.
Other interactions: Neuromuscular blocking agents: Interaction between Irinotecan Hydrochloride and neuromuscular blocking agents cannot be ruled out, since Irinotecan has anticholinesterase activity. Drugs with anticholinesterase activity may prolong the neuromuscular blocking effects of Suxamethonium and the neuromuscular blockade of non-depolarizing drugs may be antagonized.
Antineoplastic agents: The adverse effects of Irinotecan, such as myelosuppression and diarrhea, would be expected to be exacerbated by other antineoplastic agents having a similar adverse effect profile.
Dexamethasone: 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 lymphocytopenia. However, serious opportunistic infections have not been observed and no complications have specifically been attributed to lymphocytopenia.
Hyperglycemia 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.
Laxatives: Laxative use during therapy with Irinotecan is expected to worsen the incidence of severity of diarrhea.
Diuretics: Dehydration secondary to vomiting and/or diarrhea may be induced by Irinotecan. The physician may wish to withhold diuretics during dosing with Irinotecan and during periods of active vomiting or diarrhea.
Bevacizumab: Results from a dedicated drug-drug interaction trial demonstrated no significant effect of Bevacizumab on the pharmacokinetics of Irinotecan and its active metabolite SN-38.

Store below 30°C and protect from light.
Shelf Life After Reconstitution: To reconstitute: IRITERO must be diluted prior to infusion in 5% Dextrose Injection or 0.9% Sodium Chloride Injection to a final concentration range of 0.12 - 2.8 mg/mL.
In 0.9% Sodium Chloride Injection: After reconstitution, the solution is stable within 24 hours at room temperature.
In 5% Dextrose Injection: After reconstitution, the solution is stable within 6 hours at room temperature or within 24 hours at temperature 2 - 8°C.

Cytotoxic Chemotherapy

L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.

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