Names and pronunciation
(tras-tuz′uh-mab) Herceptin Kanjinti Ogivri Ontruzant Trazimera
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Individual generic drug information
Extracted information for trastuzumab only.
(tras-tuz′uh-mab) Herceptin Kanjinti Ogivri Ontruzant Trazimera
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Func. class.: Antineoplastic— miscellaneous
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Chem. class.: Humanized monoclonal antibody
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ACTION: DNA-derived monoclonal antibody selectively binds to extracellular portion of human epidermal growth factor receptor 2; it inhibits the proliferation of cancer cells
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USES: Breast cancer; metastatic with overexpression of HER2, early breast cancer (adjuvant, neoadjuvant), gastric cancer; previously untreated HER2 over- expressing metastatic gastric or gastro- esophageal junction adenocarcinoma with CISplatin, 5-fluorouracil, or capecitabine
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Extracted information for trastuzumab only.
CONTRAINDICATIONS: Hyper- sensitivity to this product, Chinese hamster ovary cell protein Precautions: Breastfeeding, children, geriatric patients, pulmonary disease, anemia, leukopenia
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Black Box Warning: Respiratory dis- tress syndrome, respiratory insufficiency, infusion-related reactions, cardiomyo- pathy, contraception requirement, preg- nancy, pulmonary toxicity Black Box Warning: HF, other cardiac symptoms: dyspnea, coughing; gallop; obtain full cardiac workup, ECG, base- line and q3mo during treatment and q6mo for ≥2 yr after adjuvant treatment (LVEF, MUGA, or ECHO); monitor for de- terioration in those with decreased LVEF • Symptoms of infection; may be masked by product • CNS reaction: LOC, mental status, dizziness, confusion • Hypersensitivity reactions, anaphylaxis Black Box Warning: Infusion reactions that may be fatal: fever, chills, nausea, vomiting, pain, headache, dizziness, hy- potension; discontinue product • Pulmonary toxicity: dyspnea, intersti tial pneumonitis, pulmonary hyperten sion, ARDS; can occur after infusion reac tion, those with lung disease may have more severe toxicity • Benzyl alcohol hypersensitivity: re constitute with Sterile Water for Injection, USP; discard any unused portion • Hamster protein hypersensitivity (Chinese hamster ovary cell hypersen sitivity): increased risk of severe allergic reactions • Pregnancy/breastfeeding: monitor for oligohydramnios. If oligohydram nios occurs, fetal testing should be done. Women should enroll in the MotHER Preg nancy Registry, 1-800-690-6720 or http:// www.motherpregnancyregistry.com. Contraception should be used during and for ≥7 mo after last dose; pregnancy test ing before use. Women who become preg nant while receiving or within 7 mo of the last dose should be apprised of potential hazard to the fetus. Unknown whether product is excreted into breast milk; ad vise women to discontinue breastfeed ing during treatment and for 7 mo after last dose Black Box Warning: Pregnancy/breast- feeding: to use contraception while tak- ing this product and for 7 mo after last dose; breastfeed during and for 7 mo after treatment Black Box Warning: To report pain at in- fusion site, usually with first dose Black Box Warning: Cardiomyopathy: to report cough, swelling in extremities, shortness of breath; may occur during or after completion of treatment HIGH ALERT
Source pages 1323, 1324, 1325
SIDE EFFECTS CNS: Dizziness, numbness, paresthe- sias, depression, insomnia, neuropathy, peripheral neuritis CV: Tachycardia, heart failure GI: Nausea, vomiting, anorexia, diar- rhea, abdominal pain, hepatotoxicity, dysgeusia HEMA: Anemia, leukopenia INTEG: Rash, acne, herpes simplex META: Edema, peripheral edema MISC: Flulike symptoms; fever, head- ache, chills MS: Arthralgia, bone pain RESP: Cough, dyspnea, pharyngitis, rhinitis, sinusitis, pneumonia, pulmonary edema/fibrosis, acute respiratory distress syndrome (ARDS) SYST: Anaphylaxis, angioedema
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INTERACTIONS Increase: bleeding risk—warfarin Increase: cardiomyopathy—anthracy- clines, cyclophosphamide; avoid use Decrease: immune response—vaccines, toxoids
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Extracted information for trastuzumab only.
DOSAGE AND ROUTES HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH) • Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly for a total of 12 wk, with PACLitaxel (either 80 mg/m2 IV wk or 175 mg/m2 q3wk) be- ginning on day 1 for a total of 4 cycles (12 wk). On week 13, begin trastuzumab 6 mg/kg over 30-90 min q3wk as mono- therapy for a total of 52 wk of trastu- zumab therapy; begin PACLitaxel plus trastuzumab after the completion of 4 cycles of AC chemotherapy (doxorubicin 60 mg/m2 IV and cyclophosphamide 600 mg/m2 IV q21days) HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH) • Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly (to- tal of 12 wk), with DOCEtaxel 100 mg/ m2 IV q21days beginning on day 1 for a total of 4 cycles (12 wk). On week 13, begin trastuzumab 6 mg/kg IV over 30- 90 min q3wk as monotherapy for a total of 52 wk of trastuzumab therapy. Begin DOCEtaxel plus trastuzumab after the completion of 4 cycles of AC chemother- apy (doxorubicin 60 mg/m2 IV and cy- clophosphamide 600 mg/m2 IV q21days) HER2-positive, node-positive or node-negative (ER/PR negative) in combination (TCH) • Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly (total of 18 wk), with DOCEtaxel 75 mg/m2 IV fol- lowed by CARBOplatin AUC 6 IV over 30-60 min beginning on day 1, q3wk, for a total of 6 cycles (18 wk). On week 19, begin trastu- zumab 6 mg/kg IV over 30-90 min q3wk as monotherapy (52 wk of trastuzumab) HER2-positive, node-positive or node-negative (ER/PR negative) monotherapy • Adult: IV 8 mg/kg over 90 min on day 1, followed by 6 mg/kg IV over 30-90 min q21days (total of 52 wk)
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Available forms: Lyophilized powder 150, 440 mg
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Administer: • Check vial labels carefully, medication errors have occurred between Herceptin A and Kadeyla • Acetaminophen as ordered to alleviate fever and headache Intermittent IV INFUSION route T • Use cytotoxic handling procedures; avoid treatment >1 yr • After reconstituting vial with 20 mL bacteriostatic water for inj, 1.1% benzyl al- cohol preserved (supplied) to yield 21 mg/ mL; mark date on vial 28 days from recon- stitution date; if patient is allergic to benzyl alcohol, reconstitute with sterile water for inj; Dilute: withdraw amount of solution and add to 250 mL of 0.9% NaCl immedi- ately; infuse over 90 min; subsequent 6 mg/ kg dose may be given over 30-60 min • Do not mix or dilute with other prod- ucts or dextrose sol
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Extracted information for trastuzumab only.
Assess: • Labs: CBC, HER2 overexpression
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Evaluate: • Therapeutic response: decrease in size of tumors
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To take acetaminophen for fever • To avoid hazardous tasks because con- fusion, dizziness may occur • To report signs of infection: sore throat, fever, diarrhea, vomiting • That emotional lability is common; to notify prescriber if severe or incapaci- tating
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Extracted information for trastuzumab only.
PHARMACOKINETICS Half-life 1-32 days, 97% washout by 7 mo after end of treatment Drug/Lab Decrease: WBCs
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Filter the extracted dose blocks for this individual drug.
HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH)
• Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly for a total of 12 wk, with PACLitaxel (either 80 mg/m2 IV wk or 175 mg/m2 q3wk) be- ginning on day 1 for a total of 4 cycles (12 wk). On week 13, begin trastuzumab 6 mg/kg over 30-90 min q3wk as mono- therapy for a total of 52 wk of trastu- zumab therapy; begin PACLitaxel plus trastuzumab after the completion of 4 cycles of AC chemotherapy (doxorubicin 60 mg/m2 IV and cyclophosphamide 600 mg/m2 IV q21days) HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH)
Candidate age grouping · source page 1323
HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH)
• Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly (to- tal of 12 wk), with DOCEtaxel 100 mg/ m2 IV q21days beginning on day 1 for a total of 4 cycles (12 wk). On week 13, begin trastuzumab 6 mg/kg IV over 30- 90 min q3wk as monotherapy for a total of 52 wk of trastuzumab therapy. Begin DOCEtaxel plus trastuzumab after the completion of 4 cycles of AC chemother- apy (doxorubicin 60 mg/m2 IV and cy- clophosphamide 600 mg/m2 IV q21days) HER2-positive, node-positive or node-negative (ER/PR negative) in combination (TCH)
Candidate age grouping · source page 1323
HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH)
• Adult: IV 4 mg/kg over 90 min on day 1, then 2 mg/kg over 30 min weekly (total of 18 wk), with DOCEtaxel 75 mg/m2 IV fol- lowed by CARBOplatin AUC 6 IV over 30-60 min beginning on day 1, q3wk, for a total of 6 cycles (18 wk). On week 19, begin trastu- zumab 6 mg/kg IV over 30-90 min q3wk as monotherapy (52 wk of trastuzumab) HER2-positive, node-positive or node-negative (ER/PR negative) monotherapy
Candidate age grouping · source page 1323
HER2-positive, node-positive or node-negative (ER/PR negative) in combination (AC-TH)
• Adult: IV 8 mg/kg over 90 min on day 1, followed by 6 mg/kg IV over 30-90 min q21days (total of 52 wk)
Candidate age grouping · source page 1323