Breast cancer:
Indications for: PERJETA
In combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In combination with trastuzumab and chemotherapy: for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer (EBC); or for the adjuvant treatment of patients with HER2-positive EBC at high risk of recurrence.
Adult Dosage:
Test and confirm for HER2 protein overexpression or HER2 gene amplification using FDA-approved tests. Initially 840mg IV over 60mins, followed every 3 weeks thereafter by a dose of 420mg IV over 30–60mins. Give in combination with trastuzumab 8mg/kg IV over 90mins, followed every 3 weeks by a dose of 6mg/kg IV over 30–90mins. MBC: also give with docetaxel 75mg/m2 IV infusion; may escalate to 100mg/m2 every 3 weeks if tolerated. Neoadjuvant: give every 3 weeks for 3 to 6 cycles as part of one of the treatment regimens for EBC: see full labeling. Adjuvant: give every 3 weeks for a total of 1 year (up to 18 cycles) or until disease recurrence or unacceptable toxicity, whichever occurs first, as part of a complete regimen for EBC: see full labeling. Pertuzumab should be withheld or discontinued if trastuzumab is withheld or discontinued. Dose modifications (missed dose, LVEF, or infusion reactions): see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Left ventricular dysfunction. Embryo-fetal toxicty.
PERJETA Warnings/Precautions:
Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment (eg, every 12wks for MBC or EBC [once for neoadjuvant therapy]); withhold pertuzumab and trastuzumab for LVEF decreases (see full labeling); discontinue if LVEF has not improved or clinically significant decrease in left ventricular function is confirmed. Pretreatment LVEF value of ≤50%, history of CHF, decreases in LVEF to <50% during prior trastuzumab therapy, uncontrolled hypertension, recent MI, serious cardiac arrythmia requiring treatment or a cumulative prior anthracycline exposure to >360mg/m2 of doxorubicin or its equivalent: not studied. Monitor for signs/symptoms of infusion reactions; slow or interrupt infusion and treat if occur; permanently discontinue if severe. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 7 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
PERJETA Classification:
Human epidermal growth factor receptor (HER2) dimerization inhibitor.
Adverse Reactions:
Diarrhea, alopecia, neutropenia, nausea, fatigue, rash, peripheral neuropathy, vomiting, thrombocytopenia, anemia, constipation, headache, asthenia, mucosal inflammation, myalgia; hypersensitivity reactions/anaphylaxis (monitor closely), left ventricular dysfunction; pregnant women: possible oligohydramnios (monitor).
Note:
Encourage women who are exposed to Perjeta during pregnancy and within 7 months prior to conception to enroll in the MotHER Pregnancy Registry: (800) 690-6720.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
