irinotecan hydrochloride

irinotecan hydrochloride

Campto (UK), Camptosar

Pharmacologic class: Topoisomerase inhibitor

Therapeutic class: Hormonal antineoplastic

Pregnancy risk category D

Action

Inhibits topoisomerase 1 (an enzyme that allows DNA replication) by binding to it. This action prevents religation of DNA strand, which results in breakage of double-stranded DNA and cell death.

Availability

Injection: 20 mg/ml in 2-ml and 5-ml vials

Indications and dosages

Metastatic colorectal cancer or recurrence or progression of metastatic colorectal cancer after fluorouracil (5-FU) therapy

Adults: 125 mg/m2 I.V. infused over 90 minutes on days 1, 8, 15, and 22, followed by a 2-week rest; given with leucovorin and 5-FU. Or, 180 mg/m2 I.V. infused over 90 minutes on days 1, 15, and 29 with leucovorin, 5-FU bolus, and 5-FU infusion followed by a 2-week rest. Or as monotherapy, 125 mg/m2 I.V. infused over 90 minutes weekly for 4 weeks, followed by a 2-week rest period; or, 350 mg/m2 I.V. infused over 90 minutes q 3 weeks as long as tolerable. Adjust dosage in increments based on tolerance and age.

Off-label uses

• Most cancers

Contraindications

• Hypersensitivity to drug

• Concurrent atazanavir use

• Pregnancy or breastfeeding

Precautions

Use cautiously in:

• bone marrow depression, severe diarrhea

• patients undergoing radiation therapy

• elderly patients

• children.

Administration

Follow facility policy for handling antineoplastics. If skin contact occurs, wash with soap and water immediately and thoroughly. If mucous membrane contact occurs, flush with water.

• Dilute in dextrose 5% in water or normal saline solution, to a concentration of 0.12 to 1.1 mg/ml.

• Infuse within 6 hours if drug is stored at room temperature or within 24 hours if refrigerated.

• Give single dose by I.V. infusion over 90 minutes.

• Administer antiemetic to ease nausea and vomiting, as needed and prescribed.

Adverse reactions

CNS: insomnia, dizziness, asthenia, headache, akathisia

CV: vasodilation, orthostatic hypotension

EENT: rhinitis

GI: nausea, vomiting, constipation, diarrhea, flatulence, dyspepsia, abdominal pain or enlargement, stomatitis, anorexia

Hematologic: anemia, neutropenia, leukopenia, thrombocytopenia

Hepatic: hepatotoxicity

Metabolic: dehydration

Musculoskeletal: back pain

Respiratory: dyspnea, increased cough

Skin: alopecia, diaphoresis, rash

Other: weight loss, edema, fever, pain, chills, minor infections

Interactions

Drug-drug. Dexamethasone: increased risk of lymphocytopenia

Diuretics: increased risk of dehydration

Laxatives: increased risk of diarrhea

Other antineoplastics: additive adverse effects

Drug-diagnostic tests. Alkaline phosphatase: increased level

Hemoglobin, neutrophils, white blood cells: decreased values

Patient monitoring

Assess CBC before each infusion. Withhold dose if neutrophil count is below 1,500 cells/mm3.

• Monitor infusion site for extravasation; if it occurs, flush with sterile water and apply ice.

• Assess fluid intake and output. Keep patient well hydrated.

• Monitor oral intake. Evaluate for nausea and vomiting.

• Assess for diarrhea. In severe diarrhea, expect to decrease dosage or withhold dose.

• Institute infection-control protocols to help prevent infection.

• Monitor liver function test results.

Patient teaching

• Inform patient that blood tests will be done before each dose.

• Instruct patient to report pain at infusion site; severe nausea or vomiting; severe, increased, or bloody diarrhea; infection; or injury.

Instruct patient to immediately report unusual tiredness or yellowing of skin or eyes.

• Tell patient that drug increases his risk of infection. Advise him to avoid crowds and other potential infection sources.

• Caution female patient not to breastfeed or become pregnant during therapy. Recommend barrier contraception.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Mentioned in ?
References in periodicals archive ?
Watanabe et al., "Optimal antidiarrhea treatment for antitumor agent irinotecan hydrochloride (CPT-11)-induced delayed diarrhea," Cancer Chemotherapy and Pharmacology, vol.
Nishikata et al., "Effect of glutamine or alkaline ionized water on late diarrhea induced by irinotecan hydrochloride in Gunn rats," Asian Journal of Pharmaceutical Sciences, vol.
The CHMP recommended approval of ONIVYDE in combination with 5-FU/LV at a dose of 70 mg/m2 irinotecan free base (equivalent to 80 mg/m2 irinotecan hydrochloride salt), every two weeks, is also the FDA-approved dose regimen for pancreatic cancer in the United States.
According to the company, Irinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class.
A case in point, they say, is Pfizer Inc.'s Camptosar (irinotecan hydrochloride), an injectable drug used to treat patients with colorectal cancer.
The antineoplastic agent irinotecan hydrochloride (7-ethyl-10-[4-(1-piperidino)-1-piperidino]-carbonyloxy-camptothecin; CPT-11; Fig.
Led by Hidehiko Saito, the team examined the base sequences in blood samples taken from 108 cancer patients, including people suffering from lung cancer, who had been administered the anticancer drug irinotecan hydrochloride.
Typical side effects of irinotecan hydrochloride are decreased white blood cell counts and diarrhea.
* Adding irinotecan hydrochloride injection (125 mg/m2 Camptosar, Pharmacia & Upjohn) to standard first-line therapy of 5-FU 500 mg/m2 and leucovorin 20 mg/m2 in 225 patients with metastatic colon cancer prevented tumor growth in 52%, versus 35% of 219 patients getting 425 mg/m2/day 5FU and leucovorin 20 mg/m2 alone at six months, according to Leonard Saltz, M.D., of Sloan- Kettering.
Irinotecan (Irinotecan hydrochloride trihydrate) is the generic equivalent of Pfizer's Campto and is a cytostatic, a treatment for advanced colorectal cancer.
Irinotecan Hydrochloride Watson Laboratories Camptosar
WASHINGTON -- The Actavis Group has received approval from the Food and Drug Administration for irinotecan hydrochloride, the first injectable product in the United States for the generic pharmaceutical firm.