Names and pronunciation
(per-too′zoo-mab) Perjeta
PDF page 1044
Loading InternPractice…
Drug reference
(per-too′zoo-mab) Perjeta
PDF page 1044
Func. class.: Antineoplastic
PDF page 1044
Chem. class.: HER-2/new antagonist
PDF page 1044
ACTION: Blocks liquid-dependent action of human epidermal growth factor-2 (HER2), inhibiting signal pathways
PDF page 1044
USES: First-line treatment of HER2-positive metastatic breast cancer with trastuzumab and DOCEtaxel
PDF page 1044
CONTRAINDICATIONS Hypersensitivity:
PDF page 1044
Black Box Warning: Pregnancy Precautions: Breastfeeding, children, infants, neonates, cardiac arrhythmias, MI, cardiac disease, heart failure, hyper- tension, infusion-related reactions Black Box Warning: Heart failure, ven- tricular dysfunction Black Box Warning: Pregnancy: de- termine whether pregnancy is planned or suspected; patients who become pregnant during therapy should report exposure to the Genentech Adverse Event line at 888-835-2555 and enroll in the MotHER Pregnancy Registry at 800-690- 6720, women of childbearing age and men with partners of childbearing age must use contraception during and for 7 mo after last dose Black Box Warning: Pregnancy/breast- feeding: counsel women of childbearing age and men with partners of childbear- ing age on the need for contraception during and for 7 mo after therapy; advise patients who suspect pregnancy to con- tact their health care provider immedi- ately; discontinue breastfeeding
PDF pages 1044, 1045
SIDE EFFECTS CNS: Headache, fever, peripheral neu ropathy, chills, fatigue, asthenia CV: Heart failure EENT: Lacrimation, stomatitis GI: Nausea, vomiting, diarrhea, dysgeu- sia, stomatitis, constipation, anorexia HEMA: Anemia, neutropenia MS: Arthralgia RESP: Upper respiratory infection, cough SYST: Anaphylaxis, antibody formation INTEG: Alopecia
PDF page 1045
DOSAGE AND ROUTES • Adult: IV 840 mg over 60 min, then after 3 wk 420 mg over 30-60 min every 3 wk; give with trastuzumab 8 mg/kg IV over 90 min, then after 3 wk 6 mg/kg over 30-90 min every 3 wk and DOCEtaxel 75 mg/m2 IV every 3 wk; dosage may be escalated to 100 mg/m2
PDF page 1044
Available forms: Solution for inj 420 mg/14 mL (single-use vials) (30 mg/mL)
PDF page 1044
Administer: • Visually inspect for particulate matter and discoloration Dilution and preparation • Withdraw the calculated dose from the vial and add to a 250 mL 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag; do not dilute with dextrose 5% solution • Dilute in normal saline only; do not mix or dilute with other drugs or dex- trose solutions • Mix the diluted solution by gentle in- version; do not shake IV infusion • Administer the diluted solution imme- diately • Do not administer as an IV push or bolus • Give the first dose of 840 mg over 60 min and subsequent 420-mg doses over 30-60 min • If the diluted solution is not used im- mediately, store at 2°-8°C for up to 24 hr Delayed or missed doses • If time since previous dose is <6 wk, give 420 mg IV (do not wait for next scheduled dose) • If time since previous dose is ≥6 wk, give 840 mg IV over 60 min, followed 3 wk later by 420 mg IV over 30-60 min repeated every 3 wk • If DOCEtaxel is discontinued, this product and trastuzumab may continue
PDF page 1044
Assess: • HER2 overexpression: testing should be done to identify HER2 overexpression before using this product • Decreased left ventricular ejec- tion fraction (LVEF): can occur and is increased in those with a history of prior anthracycline use or radiotherapy to the chest; evaluate LVEF at baseline and every 3 mo; withhold therapy ×3 wk if LVEF is <40% or LVEF is 40%-45% with a 10% or greater absolute decrease from baseline; resume therapy if the LVEF is recovered to >45% or to 40%-45% with <10% abso- lute decrease at reassessment; if the LVEF has not improved or has declined further, consider permanently discontinuing pertu- zumab and trastuzumab after a risk/ben- efit assessment • Infusion-related reactions/hyper- sensitivity: assess anaphylactoid reac- tion, acute infusion reaction, cytokine- release syndrome 60 min after the first infusion, 30 min after other infusions; monitor for pyrexia, chills, fatigue, head- ache, asthenia, hypersensitivity, and vomiting; if a significant reaction occurs, slow or interrupt the infusion; permanent discontinuation may be needed in severe reactions • Neutropenia: can occur, but occurs more commonly when trastuzumab is also used and in Asian patients, moni- tor CBC with differential baseline and pe- riodically • Upper respiratory infection: monitor for dyspnea, shortness of breath, fever
PDF page 1045
Evaluate: • Decreased size, spread of tumor
PDF page 1045
CLINICAL CONSIDERATIONS
PDF page 1045
Patient and caregiver information: • To notify prescriber immediately of in- fection (cough, fever, chills, sore throat); bleeding (gums, bruising, blood in urine/ stools/sputum); to avoid persons with known infections • To avoid all OTC, prescription, herbal, and supplement products unless ap- proved by prescriber; not to use aspirin, NSAIDs, alcohol • To notify prescriber of peripheral neu- P ropathy • That hair loss is common
PDF page 1045
PHARMACOKINETICS Median half-life 18 days
PDF page 1045
• Adult: IV 840 mg over 60 min, then after 3 wk 420 mg over 30-60 min every 3 wk; give with trastuzumab 8 mg/kg IV over 90 min, then after 3 wk 6 mg/kg over 30-90 min every 3 wk and DOCEtaxel 75 mg/m2 IV every 3 wk; dosage may be escalated to 100 mg/m2
PDF page 1044