Generic Name and Formulations:
Pertuzumab 420mg/14mL (30mg/mL); soln for IV infusion; preservative-free.
Company:
Genentech, Inc.
In combination with trastuzumab and docetaxel: to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
In combination with trastuzumab and docetaxel: initially 840mg IV over 60 minutes, followed every 3 weeks thereafter by a dose of 420mg IV over 30–60 minutes. Pertuzumab should be withheld or discontinued if trastuzumab is withheld or discontinued. If docetaxel is discontinued, treatment with pertuzumab and trastuzumab may continue. Dose modification (missed dose, LVEF, or infusion reactions): see literature.
Not established.
Human epidermal growth factor receptor (HER2) dimerization inhibitor.
Risk of embryo-fetal toxicity. 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. Assess LVEF at baseline and every 3 months during treatment; if LVEF is <40%, or is 40% to 45% with a ≥10% absolute decrease below the pretreatment value, withhold and repeat LVEF within 3 weeks; discontinue if LVEF has not improved. Monitor for signs/symptoms of infusion reactions; slow or interrupt infusion and treat if occurs; discontinue if severe. Test for HER2 protein overexpression using FDA-approved tests by labs with demonstrated proficiency. Pregnancy (Cat.D); use adequate contraception during and at least 6 months after therapy. Nursing mothers: not recommended.
Diarrhea, alopecia, neutropenia, nausea, fatigue, rash, peripheral neuropathy; decreases in LVEF; pregnant women: possible oligohydramnios (monitor).
Encourage women who are exposed to Perjeta during pregnancy to enroll in the MotHER Pregnancy Registry: (800) 690-6720.
NO
Single-use vial—1