trastuzumab

[tras-tuz´u-mab] a monoclonal antibody that binds to a protein overexpressed in some breast cancers; used as an antineoplastic agent in treatment of metastatic breast cancer with such overexpression.

trastuzumab

Herceptin

Pharmacologic class: Recombinant DNA-derived monoclonal antibody

Therapeutic class: Antineoplastic

Pregnancy risk category B

FDA Box Warning

Drug can result in subclinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction.

Incidence and severity of left ventricular dysfunction were highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens.

Discontinue trastuzumab in patients receiving adjuvant therapy and strongly consider discontinuing in patients with metastatic breast cancer who develop clinically significant decrease in left ventricular function.

Monitor patients for decreased left ventricular function before starting trastuzumab and frequently during and after treatment. Monitor more frequently if drug is withheld in patients who develop significant left ventricular dysfunction.

Serious infusion reactions, some fatal, and pulmonary toxicity have occurred. In most cases, signs and symptoms occurred during or within 24 hours of administration. Interrupt infusion for patients experiencing dyspnea or clinically significant hypotension.

Discontinue drug for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Exacerbation of chemotherapy-induced neutropenia has also occurred.

Action

Selectively binds to human epidermal growth factor receptor 2 (HER2), inhibiting proliferation of human tumor cells that overexpress HER2

Availability

Lyophilized powder: 440-mg vial (each vial contains 20 ml bacteriostatic water for injection, 1.1% benzyl alcohol)

Indications and dosages

➣ Metastatic breast cancer in patients whose tumors overexpress HER2

Adults: As monotherapy, loading dose of 4 mg/kg I.V. infusion over 90 minutes, followed by weekly maintenance dose of 2 mg/kg I.V. infusion given over 30 minutes if loading dose was tolerated. Don't give by I.V. push.

Contraindications

None

Precautions

Use cautiously in:

• hypersensitivity to Chinese hamster ovary cell protein or to benzyl alcohol

• cardiac disease, anemia, leukopenia

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).

Administration

• Be aware that baseline left ventricular ejection fraction (LVEF) measurement should be performed immediately before starting drug.

• Follow facility policy for handling, administering, and disposal of carcinogenic, mutagenic, and teratogenic agents.

• Give antiemetic, as prescribed, before administering trastuzumab.

Administer by I.V. infusion only. Don't give by I.V. push or bolus.

• To reconstitute, add 20 ml of bacteriostatic water for injection to vial, pointing diluent stream at lyophilized cake. Swirl vial gently; don't shake. Withdraw prescribed dose and add it to 250 ml of normal saline solution. (Don't use dextrose 5% in water.)

• Infuse loading dose I.V. over 90 minutes. Infuse weekly doses I.V. over 30 minutes.

• Immediately after reconstituting, write a date that is 28 days from reconstitution date in the space after "Do not use after" on vial label.

• If patient has benzyl alcohol hypersensitivity, reconstitute with sterile water for injection. Use immediately after reconstitution; discard unused portion.

Never administer intrathecally; doing so causes death.

• Know that for patient who hasn't previously received chemotherapy for metastatic disease, drug is given at same dosage but in combination with paclitaxel.

Adverse reactions

CNS: dizziness, headache, depression, paresthesia, insomnia, ataxia, confusion, manic reaction, seizures

CV: peripheral edema, hypotension, tachycardia, syncope, arrhythmias, shock, pericardial effusion, vascular thrombosis, heart failure, cardiotoxicity, cardiac arrest, cardiomyopathy

EENT: amblyopia, hearing loss

GI: nausea, vomiting, diarrhea, gastroenteritis, hematemesis, colitis, esophageal ulcer, stomatitis, ileus, anorexia, intestinal obstruction, pancreatitis

GU: urinary tract infection, hematuria, hemorrhagic cystitis, hydronephrosis, pyelonephritis, renal failure

Hematologic: coagulation disorder, pancytopenia, leukemia, exacerbation of chemotherapy-induced neutropenia

Hepatic: ascites, hepatitis, hepatic failure

Metabolic: hypothyroidism, hypercalcemia, hyponatremia

Musculoskeletal: back, bone, or joint pain; myopathy; fractures; bone necrosis

Respiratory: upper respiratory infection, dyspnea, pulmonary toxicity (dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis)

Skin: cellulitis, rash, acne, herpes simplex, herpes zoster, skin ulcers

Other: weight loss, edema, infection, fever, chills, flulike syndrome, lymphangitis, hypersensitivity reactions including anaphylaxis, infusion reaction

Interactions

Drug-drug. Anthracyclines, cyclophosphamide: cardiotoxicity

Patient monitoring

Monitor closely for signs and symptoms of infusion reaction (including respiratory distress). Halt infusion if these occur.

• Monitor vital signs, especially for hypotension and bradycardia.

Use with extreme caution in patients with cardiac dysfunction. Assess cardiovascular status carefully; stay alert for heart failure, cardiomyopathy, and peripheral edema.

• Assess neurologic status for depression and paresthesia.

• Monitor respiratory status. Report increased dyspnea or flulike symptoms.

• Watch closely for signs and symptoms of infection, including herpes simplex.

• Monitor electrolyte levels and CBC with white cell differential.

• Monitor LVEF measurement every 3 months during and at completion of therapy; measure LVEF at 4-week intervals if drug is withheld for significant left ventricular cardiac dysfunction. Continue LVEF measurement every 6 months for at least 2 years after completion of therapy.

Patient teaching

Instruct patient to immediately report difficulty breathing, flulike symptoms, and fever, chills, and other signs and symptoms of infection.

Advise patient to monitor weight. Tell him to report sudden weight gain as well as swelling and other signs and symptoms of heart failure.

Instruct patient to immediately report abdominal pain, change in bowel habits, yellowing of skin or eyes, and easy bruising or bleeding.

• Tell patient drug may cause depression. Advise him (or significant other as appropriate) to contact prescriber if this occurs.

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

trastuzumab

(trăs-to͞o′zə-măb′)n. A humanized monoclonal antibody used intravenously to treat certain types of breast cancer and gastric cancer.

trastuzumab

Herceptin^® Oncology A bioengineered monoclonal antibody used to manage Pts with breast CA who overexpress HER2, which transmits growth signals to breast CA cells. See HER2.

trastuzumab

A monoclonal antibody drug used to treat breast cancers that over-express the HER2 growth factor receptor. Trastuzumab blocks the receptors on cancer cells thus preventing the growth factor from promoting reproduction and growth of the cancer cells. In May 2005 it was announced that an international trial called Hera involving 5000 women in 39 countries had shown a 46 percent reduction in the risk of recurrence of the early stages of this kind of cancer by the use of trastuzumab. The drug is being tested on a range of other cancers. A brand name is Herceptin.

单词	trastuzumab
释义	trastuzumab tras·tu·zu·mab T5360600 (trăs-to͞o′zə-măb′)n. A humanized monoclonal antibody used intravenously to treat certain types of breast cancer and gastric cancer. [tras-, origin unknown + tu(mor) + -zu- (shortening and alteration of humanized) + m(onoclonal) a(nti)b(ody).] trastuzumab trastuzumab [tras-tuz´u-mab] a monoclonal antibody that binds to a protein overexpressed in some breast cancers; used as an antineoplastic agent in treatment of metastatic breast cancer with such overexpression. trastuzumab Herceptin Pharmacologic class: Recombinant DNA-derived monoclonal antibody Therapeutic class: Antineoplastic *Pregnancy risk category B* FDA Box Warning Drug can result in subclinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction. Incidence and severity of left ventricular dysfunction were highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens. Discontinue trastuzumab in patients receiving adjuvant therapy and strongly consider discontinuing in patients with metastatic breast cancer who develop clinically significant decrease in left ventricular function. Monitor patients for decreased left ventricular function before starting trastuzumab and frequently during and after treatment. Monitor more frequently if drug is withheld in patients who develop significant left ventricular dysfunction. Serious infusion reactions, some fatal, and pulmonary toxicity have occurred. In most cases, signs and symptoms occurred during or within 24 hours of administration. Interrupt infusion for patients experiencing dyspnea or clinically significant hypotension. Discontinue drug for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Exacerbation of chemotherapy-induced neutropenia has also occurred. Action Selectively binds to human epidermal growth factor receptor 2 (HER2), inhibiting proliferation of human tumor cells that overexpress HER2 Availability Lyophilized powder: 440-mg vial (each vial contains 20 ml bacteriostatic water for injection, 1.1% benzyl alcohol) Indications and dosages ➣ Metastatic breast cancer in patients whose tumors overexpress HER2 Adults: As monotherapy, loading dose of 4 mg/kg I.V. infusion over 90 minutes, followed by weekly maintenance dose of 2 mg/kg I.V. infusion given over 30 minutes if loading dose was tolerated. Don't give by I.V. push. Contraindications None Precautions Use cautiously in: • hypersensitivity to Chinese hamster ovary cell protein or to benzyl alcohol • cardiac disease, anemia, leukopenia • elderly patients • pregnant or breastfeeding patients • children younger than age 18 (safety and efficacy not established). Administration • Be aware that baseline left ventricular ejection fraction (LVEF) measurement should be performed immediately before starting drug. • Follow facility policy for handling, administering, and disposal of carcinogenic, mutagenic, and teratogenic agents. • Give antiemetic, as prescribed, before administering trastuzumab. Administer by I.V. infusion only. Don't give by I.V. push or bolus. • To reconstitute, add 20 ml of bacteriostatic water for injection to vial, pointing diluent stream at lyophilized cake. Swirl vial gently; don't shake. Withdraw prescribed dose and add it to 250 ml of normal saline solution. (Don't use dextrose 5% in water.) • Infuse loading dose I.V. over 90 minutes. Infuse weekly doses I.V. over 30 minutes. • Immediately after reconstituting, write a date that is 28 days from reconstitution date in the space after "Do not use after" on vial label. • If patient has benzyl alcohol hypersensitivity, reconstitute with sterile water for injection. Use immediately after reconstitution; discard unused portion. Never administer intrathecally; doing so causes death. • Know that for patient who hasn't previously received chemotherapy for metastatic disease, drug is given at same dosage but in combination with paclitaxel. Adverse reactions CNS: dizziness, headache, depression, paresthesia, insomnia, ataxia, confusion, manic reaction, seizures CV: peripheral edema, hypotension, tachycardia, syncope, arrhythmias, shock, pericardial effusion, vascular thrombosis, heart failure, cardiotoxicity, cardiac arrest, cardiomyopathy EENT: amblyopia, hearing loss GI: nausea, vomiting, diarrhea, gastroenteritis, hematemesis, colitis, esophageal ulcer, stomatitis, ileus, anorexia, intestinal obstruction, pancreatitis GU: urinary tract infection, hematuria, hemorrhagic cystitis, hydronephrosis, pyelonephritis, renal failure Hematologic: coagulation disorder, pancytopenia, leukemia, exacerbation of chemotherapy-induced neutropenia Hepatic: ascites, hepatitis, hepatic failure Metabolic: hypothyroidism, hypercalcemia, hyponatremia Musculoskeletal: back, bone, or joint pain; myopathy; fractures; bone necrosis Respiratory: upper respiratory infection, dyspnea, pulmonary toxicity (dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis) Skin: cellulitis, rash, acne, herpes simplex, herpes zoster, skin ulcers Other: weight loss, edema, infection, fever, chills, flulike syndrome, lymphangitis, hypersensitivity reactions including anaphylaxis, infusion reaction Interactions Drug-drug. Anthracyclines, cyclophosphamide: cardiotoxicity Patient monitoring Monitor closely for signs and symptoms of infusion reaction (including respiratory distress). Halt infusion if these occur. • Monitor vital signs, especially for hypotension and bradycardia. Use with extreme caution in patients with cardiac dysfunction. Assess cardiovascular status carefully; stay alert for heart failure, cardiomyopathy, and peripheral edema. • Assess neurologic status for depression and paresthesia. • Monitor respiratory status. Report increased dyspnea or flulike symptoms. • Watch closely for signs and symptoms of infection, including herpes simplex. • Monitor electrolyte levels and CBC with white cell differential. • Monitor LVEF measurement every 3 months during and at completion of therapy; measure LVEF at 4-week intervals if drug is withheld for significant left ventricular cardiac dysfunction. Continue LVEF measurement every 6 months for at least 2 years after completion of therapy. Patient teaching Instruct patient to immediately report difficulty breathing, flulike symptoms, and fever, chills, and other signs and symptoms of infection. Advise patient to monitor weight. Tell him to report sudden weight gain as well as swelling and other signs and symptoms of heart failure. Instruct patient to immediately report abdominal pain, change in bowel habits, yellowing of skin or eyes, and easy bruising or bleeding. • Tell patient drug may cause depression. Advise him (or significant other as appropriate) to contact prescriber if this occurs. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above. trastuzumab (trăs-to͞o′zə-măb′)n. A humanized monoclonal antibody used intravenously to treat certain types of breast cancer and gastric cancer. trastuzumab Herceptin^® Oncology A bioengineered monoclonal antibody used to manage Pts with breast CA who overexpress HER2, which transmits growth signals to breast CA cells. See HER2. trastuzumab A monoclonal antibody drug used to treat breast cancers that over-express the HER2 growth factor receptor. Trastuzumab blocks the receptors on cancer cells thus preventing the growth factor from promoting reproduction and growth of the cancer cells. In May 2005 it was announced that an international trial called Hera involving 5000 women in 39 countries had shown a 46 percent reduction in the risk of recurrence of the early stages of this kind of cancer by the use of trastuzumab. The drug is being tested on a range of other cancers. A brand name is Herceptin.
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trastuzumab

tras·tu·zu·mab

trastuzumab

trastuzumab

trastuzumab

FDA Box Warning

Action

Availability

Indications and dosages

Contraindications

Precautions

Administration

Adverse reactions

Interactions

Patient monitoring

Patient teaching

trastuzumab

trastuzumab

trastuzumab