Irrinotecan

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    For more information, please download leaflet.

    • ALVINOTEC® Injection is an antineoplastic agent of the topoisomerase I inhibitor class.
    • ALVINOTEC® injection is supplied as a sterile, yellow to pale yellow, clear, aqueous solution.
    • It is available in three single-dose sizes: 2 mL-fill vials contain 40 mg IRINOTECAN hydrochloride, 5 mL-fill vials contain 100 mg IRINOTECAN hydrochloride and 15 mL-fill vials contain 300 mg IRINOTECAN hydrochloride.
    • Each milliliter of solution contains 20 mg of IRINOTECAN hydrochloride (on the basis of the trihydrate salt.

    1 INDICATIONS AND USAGE

    1.1. Metastatic carcinoma of the colon or rectum: IRINOTECAN Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

    2 DOSAGE AND ADMINISTRATION

    General Dosing Guidelines Single-Agent Dosage Schedules: IRINOTECAN Hydrochloride Injection should be administered as an intravenous infusion over 90 minutes for both the weekly and once-every-3-week dosage schedules.

    3 CONTRAINDICATIONS

    IRINOTECAN Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.

    4 STABILITY

    The solution is physically and chemically stable for up to 24 hours at room temperature (approximately 25°C) and in ambient fluorescent lighting. Freezing IRINOTECAN Hydrochloride Injection and admixtures of IRINOTECAN Hydrochloride Injection may result in precipitation of the drug and should be avoided. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, immediately and discard unused portions. Other drugs should not be added to the infusion solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    5 PREPARATION AND ADMINISTRATION

    As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from IRINOTECAN Hydrochloride Injection. The use of gloves is recommended. If a solution of IRINOTECAN Hydrochloride Injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If IRINOTECAN Hydrochloride Injection contacts the mucous membranes, flush thoroughly with water.

    6 USE IN SPECIAL POPULATIONS

      6.1. Pregnancy:

      Pregnancy Risk Factor: D

      Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman. There are no adequate and well controlled studies of Irinotecan in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Irinotecan Hydrochloride Injection.

      6.2. NURSING MOTHERS:

      Lactation Excretion in breast milk unknown/not recommended. Because of the potential for serious adverse reactions in nursing infants from Irinotecan Hydrochloride Injection, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

  • For more information, please download leaflet.

    • ALVINOTEC® Injection is an antineoplastic agent of the topoisomerase I inhibitor class.
    • ALVINOTEC® injection is supplied as a sterile, yellow to pale yellow, clear, aqueous solution.
    • It is available in three single-dose sizes: 2 mL-fill vials contain 40 mg IRINOTECAN hydrochloride, 5 mL-fill vials contain 100 mg IRINOTECAN hydrochloride and 15 mL-fill vials contain 300 mg IRINOTECAN hydrochloride.
    • Each milliliter of solution contains 20 mg of IRINOTECAN hydrochloride (on the basis of the trihydrate salt.

    1 INDICATIONS AND USAGE

    1.1. Metastatic carcinoma of the colon or rectum: IRINOTECAN Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

    2 DOSAGE AND ADMINISTRATION

    General Dosing Guidelines Single-Agent Dosage Schedules: IRINOTECAN Hydrochloride Injection should be administered as an intravenous infusion over 90 minutes for both the weekly and once-every-3-week dosage schedules.

    3 CONTRAINDICATIONS

    IRINOTECAN Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.

    4 STABILITY

    The solution is physically and chemically stable for up to 24 hours at room temperature (approximately 25°C) and in ambient fluorescent lighting. Freezing IRINOTECAN Hydrochloride Injection and admixtures of IRINOTECAN Hydrochloride Injection may result in precipitation of the drug and should be avoided. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, immediately and discard unused portions. Other drugs should not be added to the infusion solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    5 PREPARATION AND ADMINISTRATION

    As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from IRINOTECAN Hydrochloride Injection. The use of gloves is recommended. If a solution of IRINOTECAN Hydrochloride Injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If IRINOTECAN Hydrochloride Injection contacts the mucous membranes, flush thoroughly with water.

    6 USE IN SPECIAL POPULATIONS

      6.1. Pregnancy:

      Pregnancy Risk Factor: D

      Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman. There are no adequate and well controlled studies of Irinotecan in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Irinotecan Hydrochloride Injection.

      6.2. NURSING MOTHERS:

      Lactation Excretion in breast milk unknown/not recommended. Because of the potential for serious adverse reactions in nursing infants from Irinotecan Hydrochloride Injection, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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