Cyclophosphamide for injection, usp rx only description cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Coadministration of irinotecan hydrochloride trihydrate with azole antifungals ketoconazole. Camptosar package insert pdf irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. Late diarrhea can be life threatening and should be treated promptly with loperamide. Vectibix panitumumab for metastatic colorectal cancer. Camptosar irinotecan dosing, indications, interactions, adverse. Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl. Doses of camptosar and 5fu should be modified as necessary to accommodate individual patient tolerance to treatment.
Interrupt camptosar and reduce subsequent doses if severe. For patients and those who care for them how to manage. Irinotecan hydrochloride monograph for professionals. See full prescribing information for complete boxed warning. Folfirinox chemotherapy is not commonly given with the goal of cure.
Camptosar may interact with diuretics water pills, atazanavir, ketoconazole, rifabutin, rifampin, st. Mar 01, 2020 irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracilbased therapy. It is usually given with other cancer medicines in a combination chemotherapy. Late diarrhea generally occurring more than 24 hours after administration of camptosar can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Mar 09, 2020 camptosar is administered as an intravenous infusion over 90 minutes in a weekly or onceevery3week dosage schedule.
Camptosar injection is available in three singledose sizes. But can camptosar be given simultaneously with leucovorin. Dose modifications patients should be carefully monitored for toxicity and assessed prior to each treatment. Camptosar irinotecan hcl highlights pfizer medical information. Irinotecan hydrochloride reference guide for safe and effective use from the.
Folfirinox is most commonly given to decrease symptoms and extend life when the disease is advanced pancreatic cancer or, metastatic, which means. Each milliliter of solution contains 20 mg of irinotecan hydrochloride on the basis of the trihydrate salt, 45 mg of sorbitol, nf, and 0. Camptosar irinotecan injection, intravenous infusion. Irinotecan is a cancer medicine that interferes with the growth and spread of cancer cells in the body irinotecan is used to treat cancers of the colon and rectum.
Irinotecan is fda approved for the following indications. Camptosar irinotecan injection, for intravenous use. Camptosar is approved to treat cancer of the colon or rectum that has spread to other parts of the body. Can camptosar be given simultaneously with leucovorin.
Camptosar irinotecan hydrochloride injection for intravenous. Camptosar irinotecan injection, intravenous infusion initial u. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Camptosar is intended for dilution with 5% dextrose injection, usp d5w, or 0. Correct coding initiative medicare contractor beneficiary and provider communications manual pub. Elitek rasburicase for managing uric acid levels when.
Do not follow the directions on the imodium ad package. Sep 26, 2019 camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Prescribing information hycamtin topotecan hydrochloride for injection for intravenous use warning hycamtin topotecan hydrochloride for injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Irinotecan is a camptothecin analog used as an anticancer drug. Irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these.
Camptosar nda 20571snda 009 final package insert 42000 3 71 versus time curve auc values for sn38 are 2% to 8% of irinotecan and sn38 is 95% bound 72 to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan see 73 pharmacokinetics. Camptosar irinotecan hcl dosage forms and strengths. Irinotecan hydrochloride 20 mgml concentrate for solution for infusion. Contraindications warnings fluorouracil warnings see boxed. The precise contribution of sn38 to the activity of camptosar is thus 74 unknown.
Camptosar injection must be diluted prior to infusion. Jul 07, 2019 camptosar package insert pdf posted on july 7, 2019 by admin irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. Irinotecan hydrochloride injection, usp is supplied as a sterile, pale yellow, clear, aqueous solution and is available in singledose brown glass vials in the following package sizes. Drugs commonly considered to fall under the category of hormonal.
Follow applicable special handling and disposal procedures. Side effects of camptosar injection irinotecan hydrochloride. Monitor patients with diarrhea and give fluid and electrolytes as needed. Irinotecan hydrochloride hcl is an antineoplastic drug that is a semisynthetic derivative of camptothecin, an alkaloid extract from plants. Dailymed irinotecan hydrochloride injection, solution. In patients receiving onivyde5fulv, the incidence of grade 34 neutropenia was higher among asian 1833 55% vs white patients 73 18%. Co administration of irinotecan hydrochloride trihydrate with azole antifungals ketoconazole. Jun 17, 2019 camptosar package insert pdf irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. The dosage is based on your medical condition, body size, and response to treatment.
Irinotecan fda prescribing information, side effects and uses. It can be used along with 2 drugs, called 5fu and lv. This emedtv article presents an overview of this chemotherapy medicine, with details on how it is given, how it works, possible side effects, and more. Unitedhealthcare medicare advantage policy guideline approved 09112019. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Appropriate 7 management of complications is possible only when adequate diagnostic and treatment 8 facilities are readily available. It is used as a first treatment, in combination with leucovorin and 5fluorouracil adrucil, carac, efudex, fluoroplex, also known as 5fu. See prescribing information for detailed recommendations for combination and singleuse.
Highlights of prescribing information these highlights do not include all the information needed to use camptosarsafely and effectively. Camptosar nda 20571snda 009 final package insert 42000. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine see package insert for precautions, general. What drugs, substances, or supplements interact with camptosar. Interrupt camptosar and reduce subsequent doses if necessary. Irinotecan fda prescribing information, side effects and. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as camptotheca acuminata or is. The preferred diluent is 5% dextrose injection, usp. In rare instances, folfirinox can be given to shrink tumors early in treatment with. Highlights of prescribing information platinumresistant. Mar 09, 2020 where can i get more information camptosar. Feb 28, 2020 irinotecan hydrochloride injection, usp is available in singledose amber glass vials in the following package size. This medication is given by injection into a vein by a health care professional. Ndc 6170334916, 40 mg2 ml 20 mgml ndc 6170334909, 100 mg5 ml 20 mgml ndc 6170334936, 500 mg25 ml 20 mgml store at 20 to 25c 68 to 77f.
Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. Pfizer oncology together provides financial assistance resources to help patients access their prescribed oncology medicines. Medscape colorectal cancer dosing for camptosar irinotecan. Product monograph pririnotecan hydrochloride injection usp. Interrupt camptosar and reduce subsequent doses if severe diarrhea. Administer irinotecan hydrochloride injection as a 90minute intravenous. In a phase 3 trial, elitek given prophylactically prior to anticancer therapy maintained normal uric acid levels. Camptosar injection irinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase i inhibitor class. The drug works by causing strand breaks in dna that the cell cannot repair leading to cell death. Formal in vivo or in vitro drug interaction studies to evaluate the influence of irinotecan on the disposition of 5fu and lv. Camptosar is supplied as a sterile, pale yellow, clear, aqueous solution.
Irinotecan hydrochloride was clinically investigated as 28 cpt11. Camptosar irinotecan injection, intravenous infusion fda. Irinotecan package insert highlights of prescribing information. Vectibix panitumumab is for treating patients with wildtype ras metastatic colorectal cancer cancer that has spread outside of the colon and rectum. Starting doses of camptosar in these trials were 100, 125, or 150 mgm 2, but the 150mgm 2 dose was poorly tolerated due to high rates of grade 4 late diarrhea and. May 06, 2020 camptosar package insert pdf irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these.
Highlights of prescribing information these highlights do not include all the information needed to use camptosar safely and effectively. Camptosar irinotecan hcl clinical studies pfizer medical. Information for the user irinotecan hydrochloride 20. Jul 19, 2019 camptosar package insert pdf irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. Nov 07, 2019 camptosar package insert pdf posted on november 7, 2019 by admin irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. Camptosar is approved to treat colon or rectal cancer that is metastatic has spread to other areas of the body. Wildtype ras is a cancer without mutations in the kras and nras genes. Irinotecan is used to treat cancers of the colon and rectum. Camptosar is a drug prescribed in the treatment of certain cancers that affect the colon or rectum. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.