Feb 26, 2020 age, sex, race, hepatic and renal function had no clinically significant effect on the pharmacokinetics of cetuximab. This ed material has been downloaded from a licensed data provider and is not for distribution, except. Highlights of prescribing information these highlights do not include all the information needed to use erbituxsafely and effectively. Guidelines for chemotherapy dosage adjustment hematology. Of the novel targeted agents, ipilumumab and cetuximab have the most. The renal drug handbook the st georges hospital, adult critical. In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent see section 5. Uclh dosage adjustment for cytotoxics in renal impairment version 3 updated january2009 page 2 of 24 dosage adjustment for cytotoxics in renal impairment this table is a guide only. Pharmacokinetics and safety of cetuximab in a patient with renal. Metastatic means that the cancer has spread to other parts of the body. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling.
Cardiac arrest, respiratory arrest, andor sudden death have occurred in patients receiving cetuximab. Women of childbearing potential must agree to use an accepted and effective method of contraception hormonal or barrier methods, abstinence prior to study entry and for the duration of the study and have a negative pregnancy test within. Cetuximab is composed of the fv regions of a murine antiegfr antibody with human igg1 heavy and kappa light chain constant regions and has an approximate molecular. In clinical studies, renal failure occurred in 1% of patients with colorectal cancer treated with cetuximab. This book is distributed under the terms of the creative commons. In combination with platinumbased chemotherapy and fluorouracil for the initial treatment of patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body. Erbitux cetuximab 400 mgm2 initial iv loading dose over 120 min, followed by weekly doses of 250 mgm2 iv over 60 min until disease progression or unacceptable toxicity. Adverse renal effects of novel molecular oncologic targeted. All subsequent weekly doses are 250 mg cetuximab per m 2 each. Erbitux vial side effects by likelihood and severity webmd. Erbitux is produced in mammalian 20 murine myeloma cell culture.
Erbitux is used to treat the following types of cancer. Erbitux cetuximab dose, indications, adverse effects. In japan, merck kgaa, bristolmyers squibb and eli lilly have a codistribution. Cetuximab, a recombinant chimeric monoclonal antibody, has been successfully used in the treatment of the head and neck and colorectal cancers. Pharmacokinetics and safety of cetuximab in a patient with. Uptodate, electronic clinical resource tool for physicians and patients that provides information on adult primary care and internal medicine, allergy and immunology, cardiovascular medicine, emergency medicine, endocrinology and diabetes, family medicine, gastroenterology and hepatology, hematology, infectious diseases, nephrology and. Management of targeted therapies in cancer patients with chronic. Pharmacokinetic, summary of product characteristics spc, relevant pharmaceutical company data and various references have been. The level of renal function below which the dose of a drug must be reduced depends largely on the extent of renal metabolism and elimination, and on the drugs toxicity. Erbitux cetuximab metastatic colorectal cancer and head. Cetuximab prevents methotrexateinduced cytotoxicity in vitro.
Im already getting some acne on face and other parts of the body. Iv infuse over 60 min qweek not to exceed an infusion rate of 10 mgmin until disease progression or unacceptable toxicity. Erbitux is composed of the fv regions of a murine 18 antiegfr antibody with human igg1 heavy and kappa light chain constant regions and 19 has an approximate molecular weight of 152 kda. In the literature, data on the effect of renal impairment on the pharmacokinetics of anticancer drugs are scarce. In the erbitux plus irinotecan arm, irinotecan was added to erbitux using the same dose and schedule for irinotecan as the patient had previously failed. Complete cetuximab administration 1 hr prior to folfiri. Alternate dosing of cetuximab for patients with metastatic. Three patients with a prior history of coronary artery disease died within six weeks after receiving the last dose of erbitux. Input of the full clinical picture of the patient should always be taken into account. Because egfr strongly expresses in the kidney, particularly in the. I just started erbitux treatment 1 was this past thursday. Adult drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in. Furthermore, in renal cell carcinoma, an os advantage for sorafenib. Here, we report a 68yearold metastatic osteosarcoma patient with impaired renal function due to prior chemotherapy, who was treated on compassionate use basis with 400 mgm2 cetuximab.
Erbitux, as so indicated for the a single agent, is al treatment of egfrexpressing metastatic colorectal cancer in patients who are. Jan 24, 20 colorectal cancer crc is the third most common cancer in men and the second most common in women worldwide. Cetuximab is used to treat cancers of the colon and rectum. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In combination with radiation therapy for the initial treatment of a certain type of locally or regionally advanced head and neck cancer. Adequate renal function as defined by serum creatinine. Nov 19, 2007 according to my oncologist, before erbitux or vectibix was given, a test was ran on my tumor tissue to determine if it expressed a protein called an epidermal growth factor receptor egfr. Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. Heart attack or sudden death occurred in 2% of 208 patients with head and neck cancer treated with radiation therapy and erbitux in a clinical study.
Erbitux dosing for colorectal cancer the standard dosage of erbitux for the treatment of colorectal cancer cancer of the colon and rectum is based on body surface area, which is normally calculated using height and weight. Serious infusion reactions, some fatal, occurred in approximately 3% of patients. Cetuximab side effects, dosage, interactions drugs. Erbitux vectibix 0% effective cancer survivors network. May 08, 2019 erbitux is supplied at a concentration of 2 mgml in 100 mg 50 ml or 200 mg 100 ml, singleuse vials.
Serious infusion reactions and cardiopulmonary arrest infusion reactions. Cetuximab is a chimeric mousehuman monoclonal antibody given by intravenous infusion that is distributed under the trade name erbitux in the u. Trivalent forms of arsenic are methylated in humans and mostly excreted in urine. Cetuximab is an epidermal growth factor receptor egfr inhibitor used for the. The fifth edition of 2007 has been significantly expanded by dosage tables for children. Pulmonary toxicity see warnings and precautions acute onset or worsening pulmonary symptoms. This is the first reported case of the use of cetuximab in a patient. Erbitux can cause serious and fatal infusion reactions.
Cetuximab is available as erbitux intravenous solution. Cetuximab dosing for head and neck cancer the standard dosage of cetuximab for the treatment of squamous cell cancer of the head and neck is based on body surface area, which is normally calculated using height and weight. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Nov 09, 2018 cetuximab is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Infusion reactions andcardiopulmonary arrest see full prescribing information for complete boxed.
Dosage adjustment for cytotoxics in renal impairment this table is a guide only. Use with caution dose in patients undergoing renal replacement therapies. Bennetts drug prescribing in renal failure has been the best pocket book for drug prescribing in patients with renal insufficiency and dialysis since the first edition in 1987. During this process, methotrexate accumulates within the kidney and, especially at highdose, the drug can promote extensive necrosis of the. If your institution subscribes to this resource, and you dont have a myaccess profile, please contact your librarys reference desk for information on how to gain access to this resource from offcampus. The fda notes that approximately 70% of all colorectal carcinomas have positive findings for egfr. Selected from data included with permission and ed by first databank, inc. Cetuximab at either 500 or 750 mgm2 every other week for. Cetuximab erbitux medical clinical policy bulletins aetna. Tell your doctor all medications and supplements you use. This study suggests that cetuximab can be safely used in cancer patients with renal impairment without dose adjustment. Costs from red book 2008 drug topics red book by harold cohen 17. If no improvement in 2 weeks or interstitial lung disease ild is confirmed, discontinue erbitux.
Drug brand name, regimen, dose, amount needed, cost per. In summary, electrolyte disorders, renal impairment and hypertension are the most. See full prescribing information for complete boxed warning. The information on dosage adjustments in renal impairment given in this book is based on. The initial dose is 400 mg cetuximab per m 2 body surface area. Cautious use of cetuximab in combination with either radiation therapy or platinumbased therapy with 5fu is warranted for head and neck cancer patients with a history of cardiac disease, specifically coronary artery disease, congestive heart failure, or cardiac arrhythmias. Erbitux, as a single agent, is indicated for the treatment of epidermal growth factor receptor egfrexpressing metastatic colorectal cancer after failure of both irinotecan and oxaliplatinbased regimens. Cetuximab is given by injection into a vein usually once a week by a healthcare professional. Side effects of erbitux cetuximab, warnings, uses rxlist.
Erbitux cetuximab dosing, indications, interactions. Uclh dosage adjustment for cytotoxics in renal impairment version 3 updated january2009 page 3 of 24 drug pharmacokinetics available information recommendation arsenic trioxide arsenic is stored mainly in liver, kidney, heart, lung, hair and nails. Cetuximab can be safely used in patients with renal impairment. May 08, 2019 erbitux cetuximab is a recombinant, humanmouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor.
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