Camptosar package insert pdf

Camptosar is intended for dilution with 5% dextrose injection, usp d5w, or 0. Sep 26, 2019 camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Camptosar irinotecan hcl clinical studies pfizer medical. The precise contribution of sn38 to the activity of camptosar is thus 74 unknown. Information for the user irinotecan hydrochloride 20. Irinotecan hydrochloride monograph for professionals. Highlights of prescribing information these highlights do not include all the information needed to use camptosarsafely and effectively. In patients receiving onivyde5fulv, the incidence of grade 34 neutropenia was higher among asian 1833 55% vs white patients 73 18%. Camptosar irinotecan hcl dosage forms and strengths.

Vectibix panitumumab for metastatic colorectal cancer. Correct coding initiative medicare contractor beneficiary and provider communications manual pub. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Folfirinox chemotherapy is not commonly given with the goal of cure. The drug works by causing strand breaks in dna that the cell cannot repair leading to cell death. Late diarrhea can be life threatening and should be treated promptly with loperamide. See prescribing information for detailed recommendations for combination and singleuse. 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. It can be used along with 2 drugs, called 5fu and lv. 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. Irinotecan package insert highlights of prescribing information. Co administration of irinotecan hydrochloride trihydrate with azole antifungals ketoconazole. 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.

Irinotecan hydrochloride reference guide for safe and effective use from the. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Camptosar irinotecan injection, intravenous infusion. Mar 09, 2020 camptosar is administered as an intravenous infusion over 90 minutes in a weekly or onceevery3week dosage schedule. Formal in vivo or in vitro drug interaction studies to evaluate the influence of irinotecan on the disposition of 5fu and lv. Monitor patients with diarrhea and give fluid and electrolytes as needed. Irinotecan fda prescribing information, side effects and uses. It is used as a first treatment, in combination with leucovorin and 5fluorouracil adrucil, carac, efudex, fluoroplex, also known as 5fu. Camptosar nda 20571snda 009 final package insert 42000. Highlights of prescribing information these highlights do not include all the information needed to use camptosar safely and effectively.

Dailymed irinotecan hydrochloride injection, solution. 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. See full prescribing information for complete boxed warning. Irinotecan hydrochloride 20 mgml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. In rare instances, folfirinox can be given to shrink tumors early in treatment with. Camptosar irinotecan hcl highlights pfizer medical information. Highlights of prescribing information platinumresistant.

Interrupt camptosar and reduce subsequent doses if severe diarrhea. Irinotecan fda prescribing information, side effects and. 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. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Irinotecan hydrochloride was clinically investigated as 28 cpt11. 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. This medication is given by injection into a vein by a health care professional. Administer irinotecan hydrochloride injection as a 90minute intravenous. The preferred diluent is 5% dextrose injection, usp. In each study, camptosar was administered in repeated 6week cycles consisting of a 90minute intravenous infusion once weekly for 4 weeks, followed by a 2week rest period. Follow applicable special handling and disposal procedures. Pfizer oncology together provides financial assistance resources to help patients access their prescribed oncology medicines.

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. Side effects of camptosar injection irinotecan hydrochloride. Irinotecan hydrochloride 20 mgml concentrate for solution for infusion. Wildtype ras is a cancer without mutations in the kras and nras genes. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. 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. Camptosar injection must be diluted prior to infusion. 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.

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. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Elitek rasburicase for managing uric acid levels when.

Folfirinox is most commonly given to decrease symptoms and extend life when the disease is advanced pancreatic cancer or, metastatic, which means. Unitedhealthcare medicare advantage policy guideline approved 09112019. For patients and those who care for them how to manage. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine see package insert for precautions, general. Irinotecan is fda approved for the following indications. Contraindications warnings fluorouracil warnings see boxed. What drugs, substances, or supplements interact with camptosar. Each milliliter of solution contains 20 mg of irinotecan hydrochloride on the basis of the trihydrate salt, 45 mg of sorbitol, nf, and 0. Dose modifications patients should be carefully monitored for toxicity and assessed prior to each treatment. Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl.

Camptosar irinotecan hydrochloride injection for intravenous. Interrupt camptosar and reduce subsequent doses if severe. 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. Camptosar injection is available in three singledose sizes. Product monograph pririnotecan hydrochloride injection usp. Irinotecan is a camptothecin analog used as an anticancer drug. Do not follow the directions on the imodium ad package. But can camptosar be given simultaneously with leucovorin.

Mar 09, 2020 where can i get more information camptosar. 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. Coadministration of irinotecan hydrochloride trihydrate with azole antifungals ketoconazole. Camptosar may interact with diuretics water pills, atazanavir, ketoconazole, rifabutin, rifampin, st. 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. 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. Camptosar is supplied as a sterile, pale yellow, clear, aqueous solution. Doses of camptosar and 5fu should be modified as necessary to accommodate individual patient tolerance to treatment. It is usually given with other cancer medicines in a combination chemotherapy. Appropriate 7 management of complications is possible only when adequate diagnostic and treatment 8 facilities are readily available. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as camptotheca acuminata or is. The dosage is based on your medical condition, body size, and response to treatment. Interrupt camptosar and reduce subsequent doses if necessary.

Vectibix panitumumab is for treating patients with wildtype ras metastatic colorectal cancer cancer that has spread outside of the colon and rectum. Medscape colorectal cancer dosing for camptosar irinotecan. Camptosar irinotecan dosing, indications, interactions, adverse. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. 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. Camptosar is approved to treat colon or rectal cancer that is metastatic has spread to other areas of the body. Feb 28, 2020 irinotecan hydrochloride injection, usp is available in singledose amber glass vials in the following package size. Camptosar is approved to treat cancer of the colon or rectum that has spread to other parts of the body. 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. Camptosar irinotecan injection, intravenous infusion fda. Camptosar irinotecan injection, intravenous infusion initial u. Irinotecan is used to treat cancers of the colon and rectum. Camptosar irinotecan injection, for intravenous use.

Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Cyclophosphamide for injection, usp rx only description cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Drugs commonly considered to fall under the category of hormonal. Camptosar is a drug prescribed in the treatment of certain cancers that affect the colon or rectum. Irinotecan is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Can camptosar be given simultaneously with leucovorin.