Targeted Therapy Agents
Bevacizumab (Avastin)
PHARMACOKINETICS
• Estimated half-life is approximately 20 days (range 11-50 days).
• Predicted time to reach steady state is 100 days. Drug excreted through kidneys.
• Clearance varies by body weight, sex, and tumor burden.
• No studies have been conducted to examine pharmacokinetics of bevacizumab in patients with renal or hepatic impairment.
USUAL DOSE AND SCHEDULE
• First-line treatment for metastatic colorectal cancer: adults: 5 mg/kg IV every 14 days until disease progression. There are no recommended dose reductions.
• Treatment of advanced and metastatic non–small cell lung cancer: adults: 15 mg/kg IV given on day 1 every 3 weeks in combination with paclitaxel 200 mg/m2 and carboplatin AUC = 6 (each given on day 1)
• Treatment of metastatic renal cell cancer: adults: 10 mg/kg IV given every 2 weeks
• Treatment for malignant glioma in a phase II clinical trial is a 6-week cycle of 5 mg/kg every other week × 2, in combination with CPT-11 125 mg/m2 every week × 4 followed by a 2-week rest period
• Efficacy as a single agent in colorectal cancer has not been established.
MIXING INSTRUCTIONS
• Visually inspect vial for particulate matter and discoloration before mixing.
• Withdraw the appropriate amount of bevacizumab from vial(s).
• Dilute in a total volume of 100 mL of 0.9% sodium chloride injection.
• Do not mix or administer with dextrose solutions.
• Discard any unused portion left in vial because product contains no preservative.
PREGNANCY
• Angiogenesis is critical to fetal development and the inhibition of angiogenesis after the administration of drug is likely to result in adverse effects on pregnancy. Before beginning therapy, patients should be counseled regarding the potential risk to the developing fetus. Adequate contraception should be used.
• It is not known whether drug is secreted in human milk. Because human immunoglobulin G1 is secreted into human milk, the potential for absorption and harm to the infant after ingestion is unknown. Women should be advised to discontinue nursing during treatment and for a prolonged period of time after use, taking into account the estimated half-life of 20 days with a range between 11 and 50 days.
SPECIAL CONSIDERATIONS
• Use with caution in patients with known hypersensitivity to drug or any component of drug product.
• Therapy should NOT be initiated for at least 28 days after major surgery. The surgical incision should be fully healed before initiation of therapy.
• Because of the potential for impaired wound healing, suspend use before elective surgery. Although the appropriate interval between the last dose and elective surgery is unknown, the estimated half-life of 20 days should be taken into consideration when planning surgery.
PATIENT EDUCATION
• Teach patients about the role of angiogenesis in cancer development.
• Advise patients of side effects related to infusion reaction.
• Advise patients of life-threatening side effects, such as gastrointestinal perforation, severe bleeding, wound healing complications, congestive heart failure, pulmonary embolus and blood clots.
• Advise patients to check with health care professional before stopping or starting any medications.
• Advise patients to inform health care professional of recent surgery, the consideration of surgery, or if wound has not healed.
Frankel, C. (2004). Anti-VEGF therapy: Clinical perspective, nursing implications, and patient management strategies. clinical implications of targeting VEGF in solid tumors. Meniscus Educational Institute. Continuing Education presentation. Oncology Nursing Society Congress, Anaheim, CA. Sponsored by Genentech Bio-Oncology, April 30, 2004.
Genentech, Inc. Avastin (bevacizumab) package insert. Retrieved September 24, 2007, from http://www.gen.com/gen/products/information/pdf/avastin-prescribing.pdf, 2006.
Knopp T. Nursing management of patients receiving angiogenesis inhibitors: current topics in colorectal cancer: targeting VEGF. Retrieved February 1, 2007 from www.imeronline.com, 2005.
U.S. BL 125085 Supplement Amendment: AVASTIN. Genentech, Inc. 17 of 28/1048: 125085s45lbl.doc.
Cetuximab (Erbitux)
HOW TO ADMINISTER
SIDE EFFECTS
Severe
• Infusion reactions may occur. Caution must be exercised with every infusion because a severe reaction may occur during any infusion.
• Severe reaction includes rapid onset of airway obstruction; bronchospasm, stridor, hoarseness, urticaria, or hypotension.
• Interstitial lung disease has been reported. Onset of symptoms has occurred between the fourth and eleventh doses in all reported cases.
• Dermatological toxicity—acneiform rash, dry skin, or exfoliative dermatitis occurred in 88% of patients as well as paronychial inflammation—associated swelling of the lateral nail folds of the toes and fingers.
STORAGE
• Store vials under refrigeration at 2° to 8° C (36° to 46° F).
• Preparations are chemically and physically stable for up to 12 hours at 2° to 8° C (36° to 46° F) and up to 8 hours at controlled room temperatures 20° to 25° C (68° to 77° F).
• Discard any unused portion of the solutions after either 8 hours at controlled room temperatures or 12 hours at 2° to 8° C (36° to 46° F).
PREGNANCY
• There are no adequate or well-controlled studies in pregnant women. Drug should only be given to a pregnant woman or any woman not using adequate contraception if the potential benefit justifies the potential risk to the fetus.
• All patients should be counseled before initiation of therapy regarding the potential risk to the developing fetus.
• If the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus or the potential risk for loss of the pregnancy.
PATIENT EDUCATION
• Recommend that patients wear sunscreen and hats and limit sun exposure because sunlight can exacerbate any skin reactions that may occur.
• Women of childbearing age should be advised to avoid pregnancy and use contraception during treatment.
• Women should not breast-feed during treatment or for 60 days after the last dose.
• Tell your doctor or health care professional if you have any lung disease, especially lung fibrosis, any unusual reaction to drug, mouse proteins, other medications, foods, dyes, or preservatives.
• It is important not to miss a dose. Notify your doctor or health care professional if you are unable to keep an appointment.
• Tell your doctor or health care professional if you frequently drink beverages that contain caffeine or alcohol or if you smoke or use recreational drugs because these may affect the way your medicine works.
• Tell your doctor or health care professional before you start or stop any of your medicines.
• Tell your doctor or health care professional as soon as possible if you have any of the following:
ERLOTINIB (TARCEVA)
DRUG INTERACTIONS
• Caution should be used when taking erlotinib in co-treatment with ketoconazole and other strong CYP3A4 enzyme inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TOA), and voriconazole. These medications may increase the effect of erlotinib.
• Pre-treatment with CYP3A4 inducers such as rifampicin, rifabutin, rifapentine, Phenytoin, carbamazepine, Phenobarbital and St. John’s Wort decrease the effectiveness of erlotinib. Use of alternate drugs is recommended otherwise dosing of erlotinib should be adjusted per dose modification schedule.
PREGNANCY
• There are no adequate and well controlled studies in pregnant women.
• Women of childbearing potential should be advised to avoid pregnancy while on therapy.
• Adequate contraceptive methods should be used during therapy, and for at least 2 months after completing therapy.
• Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the fetus.
• If used during pregnancy, the patient should be apprised of the potential hazard to the fetus or potential risk for the loss of the pregnancy.
PATIENT EDUCATION
• Take every day as prescribed
• Take at the same time every day at least one hour before or 2 hours after food. Taking with food may increase risk of side effects.
• If you miss a day, take your normal dose the next day. DO NOT take a double dose. Tell your doctor if you miss a dose.
• Avoid grapefruit or grapefruit juice. It may affect the way the drug works.
• Tell your doctor or nurse if you are taking any other medications including vitamins and herbals. Tell your doctor is you are taking a blood thinner such as Coumadin, as it may increase your risk of bleeding.
• Follow all instructions on how to take the drug.
• Do not stop taking the drug unless your doctor tells you.
• Call your doctor if you experience any of the following symptoms:
McKorkle, M. (2005). Oncology Education Service, Inc. Targeted Therapies in Non-Small Cell Lung Cancer. A Continuing Educational Monograph for Oncology Nurses.
New Product Bulletin-Tarceva™. Washington, DC: American Pharmacy Association, 2004. (erlotinib)
Tarceva (erlotinib) Tablets. Retrieved January 31, 2007, from http://www.tarceva.com.
Tarceva package insert. Retrieved January 30, 2007, from http://www.gen.com/gen/products/information/pdf/tarceva-prescribing.pdf.
Tarceva Monograph (2006). Henry Ford Clinical Pharmacy. Retrieved January 30, 2007, from http://hfhs.org.
Gefitinib (Iressa)
MIXING INSTRUCTIONS
• Oral medication; therefore no mixing instructions are necessary.
• For patients who have difficulty swallowing, tablets may be dispersed in a half a glass of noncarbonated drinking water. NO other liquids should be used. Drop the tablet into the water without crushing it. Stir until tablet is dispersed (approximately 10 minutes) and drink liquid immediately. Rinse glass immediately.
• The liquid may also be administered via a nasogastric (NG) tube.
DRUG INTERACTIONS
• Metabolized by cytochrome P450 (CYP3A4) and CYP2D6. Caution should be used when administering CYP3A4 or CYP2D6 drugs with gefitinib.
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