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Irinotecan Hydrochloride (Camptosar)

Trade Name : Camptosar

Pharmacia and Upjohn Company LLC

INJECTION, SOLUTION

Strength 20 mg/mL

IRINOTECAN HYDROCHLORIDE Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Irinotecan Hydrochloride (Camptosar) which is also known as Camptosar and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 20 mg/mL per ml. Read more

Irinotecan Hydrochloride (Camptosar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: DIARRHEA and MYELOSUPPRESSION
  • See full prescribing information for complete boxed warning
  • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs. (, )
  • Severe myelosuppression may occur. ()
  • No data
  • CAMPTOSAR is a topoisomerase inhibitor indicated for:
  • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ()
  • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ()
  • No data
  • Colorectal cancer combination regimen 1: CAMPTOSAR 125 mg/m intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks. ()
  • Colorectal cancer combination regimen 2: CAMPTOSAR 180 mg/m intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30. ()
  • Colorectal cancer single agent regimen 1: CAMPTOSAR 125 mg/m intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. ()
  • Colorectal cancer single agent regimen 2: CAMPTOSAR 350 mg/m intravenous infusion over 90 minutes on day 1 every 3 weeks. ()
  • CAMPTOSAR Injection is available in three single-dose sizes:
  • CAMPTOSAR Injection is available in three single-dose sizes:
  • 2 mL-fill vial containing 40 mg irinotecan hydrochloride injection ()
  • 5 mL-fill vial containing 100 mg irinotecan hydrochloride injection ()
  • 15 mL-fill vial containing 300 mg irinotecan hydrochloride injection ()
  • No data
  • Hypersensitivity to CAMPTOSAR or its excipients ()
  • No data
  • Diarrhea and Cholinergic Reactions
  • Myelosuppression
  • Patients with Reduced UGT1A1 Activity:
  • Hypersensitivity:
  • Renal Impairment/Renal Failure:
  • Pulmonary Toxicity:
  • Toxicity of the 5 Day Regimen:
  • Embryo-Fetal Toxicity:
  • Patients with Hepatic Impairment:
  • Common adverse reactions (u226530%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia. ()
  • Common adverse reactions (u226530%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Strong CYP3A4 Inducers:
  • Strong CYP3A4 Inhibitors:
  • No data
  • Lactation:
  • Geriatric Use:
  • Patients with Renal Impairment:
  • Patients with Hepatic Impairment:
  • In U.S. phase 1 trials, single doses of up to 345 mg/m of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg/m 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 CAMPTOSAR. Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.
  • CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class.
  • CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.
  • Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as or is chemically synthesizedn
  • The chemical name is -4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. Its empirical formula is CHNOu2219HClu22193HO and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows:
  • No data
  • Long-term carcinogenicity studies with irinotecan were not conducted. Rats were, however, administered intravenous doses of 2 mg/kg or 25 mg/kg irinotecan once per week for 13 weeks (in separate studies, the 25 mg/kg dose produced an irinotecan Cand AUC that were about 7.0 times and 1.3 times the respective values in patients administered 125 mg/m weekly) and were then allowed to recover for 91 weeks. Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas. Irinotecan was clastogenic both (chromosome aberrations in Chinese hamster ovary cells) and (micronucleus test in mice). Neither irinotecan nor its active metabolite SN-38 was mutagenic in the Ames assay.
  • No significant adverse effects on fertility and general reproductive performance were observed after intravenous administration of irinotecan in doses of up to 6 mg/kg/day to rats and rabbits; however, atrophy of male reproductive organs was observed after multiple daily irinotecan doses both in rodents at 20 mg/kg and in dogs at 0.4 mg/kg. In separate studies in rodents, this dose produced an irinotecan Cand AUC about 5 and 1 times, respectively, of the corresponding values in patients administered 125 mg/m weekly. In dogs this dose produced an irinotecan C and AUC about one-half and 1/15th, respectively, of the corresponding values in patients administered 125 mg/m weekly.
  • Irinotecan has been studied in clinical trials in combination with 5-fluorouracil (5-FU) and leucovorin (LV) and as a single agent . When given as a component of combination-agent treatment, irinotecan was either given with a weekly schedule of bolus 5-FU/LV or with an every-2-week schedule of infusional 5-FU/LV. Weekly and once-every-3-week dosage schedules were used for the single-agent irinotecan studies. Clinical studies of combination and single-agent use are described below.
  • No data
  • CAMPTOSAR Injection is available in single-dose brown glass vials in the following package sizes:
  • CAMPTOSAR Injection is available in single-dose amber colored polypropylene CYTOSAFE vials in the following package sizes:
  • Store at controlled room temperature 15u00b0C to 30u00b0C (59u00b0 to 86u00b0F). Protect from light. Keep the vial in the carton until the time of use.
  • Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package.
  • No data
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0134-23.0
  • PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Label
  • NDC 0009-7529-03Single Use: Discard unused portion
  • Camptosarn
  • 100 mg/5 mL
  • For Intravenous Use OnlyCytosafe Vialn n
  • PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton
  • NDC 0009-7529-03
  • Single Use: Discard unused portionCamptosarn
  • 100 mg/5 mL
  • For Intravenous Use Only
  • Cytosafe VialCaution: Cytotoxic Agent
  • Pfizer Injectables
  • Rx only

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