Generic Name and Formulations:
Pertuzumab 420mg/14mL (30mg/mL); soln for IV infusion; preservative-free.
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.
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.
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. Pregnancy; exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for 7 months after last dose. Nursing mothers.
Human epidermal growth factor receptor (HER2) dimerization inhibitor.
Diarrhea, alopecia, neutropenia, nausea, fatigue, rash, peripheral neuropathy, vomiting, thrombocytopenia, anemia, constipation, headache, asthenia, mucosal inflammation, myalgia; hypersensitivity reactions (monitor), left ventricular dysfunction; pregnant women: possible oligohydramnios (monitor).
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.
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