Life

CAMPTOSAR PACKAGE INSERT PDF

Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. CATALOG SHEET · PACKAGE INSERT · SDS SHEET · BAR CODES · WHOLESALER ITEM NUMBERS · STORAGE REQUIREMENTS · RETURN GOODS. In depth information on Camptosar (irinotecan) for treatment of colorectal cancer. spacer. Camptosar (irinotecan) Product Information For Health Care Professionals CAMPTOSAR – Package Insert.

Author: Voodoor Mezigar
Country: Kuwait
Language: English (Spanish)
Genre: Personal Growth
Published (Last): 21 July 2014
Pages: 107
PDF File Size: 10.8 Mb
ePub File Size: 11.91 Mb
ISBN: 335-1-34689-835-3
Downloads: 23219
Price: Free* [*Free Regsitration Required]
Uploader: Juzshura

The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined. This product’s label may have been updated.

Transient dysarthria has been reported in patients treated with CAMPTOSAR; in some cases, the event was attributed to the cholinergic syndrome captosar during or shortly after infusion of irinotecan. Once-EveryWeek Dosage Schedule A total of patients with metastatic colorectal cancer whose disease had recurred or acmptosar following prior 5-FU therapy participated in the two phase 3 studies: The metabolic conversion of irinotecan to the active metabolite SN is mediated by carboxylesterase enzymes and primarily occurs in the liver.

These studies were designed to evaluate tumor response rate and do not provide information on effects on survival and disease-related symptoms.

HIGHLIGHTS OF PRESCRIBING INFORMATION

The recommended treatment regimen one treatment course is once weekly treatment psckage 4 weeks, followed by a 2-week rest period. In Study 2, median survival for patients treated with irinotecan was Guidelines and recommendations for safe handling of antineoplastic agents. Neither irinotecan or SN was mutagenic in the in vitro Ames assay.

  A DICTIONARY OF MODERN FUSEKI THE KOREAN STYLE PDF

Recommendations for handling cytotoxic agents. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

In rats, at exposures approximately 0. Paackage supportive care was provided to patients in both arms of Study 7 and included antibiotics, analgesics, corticosteroids, transfusions, psychotherapy, or any other symptomatic therapy as clinically indicated.

Camptosar Product Information

Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. The influence of renal impairment on the pharmacokinetics of irinotecan has not been evaluated. 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 hydrochloride or SN In Study 2, the multivariate analysis on all camptpsar subscales did not indicate a statistically significant difference between irinotecan and infusional 5-FU.

The results camptosqr the individual studies are shown in Table 2.

Procedures for proper handling and disposal: Asthenia, fever, and abdominal pain are generally the most common events of this type.

Chemotherapy camptisar biotherapy guidelines and recommendations for practice 2nd. During the night, the patient may take 4 mg of loperamide every 4 hours. Cases of megacolon and intestinal perforation have been reported. Patients who had received previous irradiation to the pelvis responded to Isnert at approximately the same rate as those who had not previously received irradiation.

Data from three open-label, single-agent, clinical studies, involving a total of patients in 59 centers, support the use of CAMPTOSAR in the treatment of patients with metastatic cancer of the pacmage or rectum that has recurred or progressed following treatment with 5-FU-based therapy. Am J Hosp Pharm ; Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

  LOVASZ PLUMMER MATCHING THEORY PDF

Patients were to be followed every 3 to 6 weeks for 1 year. The half-lives of the lactone active forms of irinotecan and SN are similar to those of total irinotecan and SN, as the lactone and hydroxy acid forms are in equilibrium. Interstitial Pulmonary Disease IPD -like events, including fatalities, have occurred in patients receiving irinotecan in combination and as monotherapy. Early diarrhea occurring during or shortly after infusion of CAMPTOSAR may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping.

Omit dose until resolved to baseline, then 1 dose level.

Camptosar® (Irinotecan) – GlobalRPH

CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. In three clinical studies evaluating the weekly dosage schedule, patients with metastatic carcinoma of the colon or rectum that had recurred or progressed following 5-FU-based therapy were treated with CAMPTOSAR.

Irinotecan hydrochloride was clinically investigated as CPT Its structural formula is as follows:.