PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Recommended Doses and Schedules

The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.

When administered with PERJETA, the recommended initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.

When administered with PERJETA, the recommended initial dose of docetaxel is 75 mg/m² administered as an intravenous infusion. The dose may be escalated to 100 mg/m² administered every 3 weeks if the initial dose is well tolerated.

Dose Modification

For delayed or missed doses, if the time between two sequential infusions is less than 6 weeks, the 420 mg dose of PERJETA should be administered. Do not wait until the next planned dose. If the time between two sequential infusions is 6 weeks or more, the initial dose of 840 mg PERJETA should be re-administered as a 60-minute intravenous infusion followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.

The infusion rate of PERJETA may be slowed or interrupted if the patient develops an infusion-associated reaction. The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see WARNINGS AND PRECAUTIONS].

Left Ventricular Ejection Fraction (LVEF)

Withhold PERJETA and trastuzumab dosing for at least 3 weeks for either:

• a drop in LVEF to less than 40% or
• LVEF of 40% to 45% with a 10% or greater absolute decrease below pretreatment values [see WARNINGS AND PRECAUTIONS]

PERJETA may be resumed if the LVEF has recovered to greater than 45% or to 40% to 45% associated with less than a 10% absolute decrease below pretreatment values.

If after a repeat assessment within approximately 3 weeks, the LVEF has not improved, or has declined further, discontinuation of PERJETA and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks [see WARNINGS AND PRECAUTIONS].

PERJETA should be withheld or discontinued if trastuzumab treatment is withheld or discontinued.

If docetaxel is discontinued, treatment with PERJETA and trastuzumab may continue.

Dose reductions are not recommended for PERJETA.

For docetaxel dose modifications, see docetaxel prescribing information.

Preparation for Administration

Administer as an intravenous infusion only. Do not administer as an intravenous push or bolus. Do not mix PERJETA with other drugs.

Preparation

Prepare the solution for infusion, using aseptic technique, as follows:

• Parenteral drug products should be inspected visually for particulates and discoloration prior to administration.
• Withdraw the appropriate volume of PERJETA solution from the vial(s).
• Dilute into a 250 mL 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag.
• Mix diluted solution by gentle inversion. Do not shake.
• Administer immediately once prepared.
• If the diluted infusion solution is not used immediately, it can be stored at 2oC to 8oC for up to 24 hours.
• Dilute with 0.9% Sodium Chloride injection only. Do not use dextrose (5%) solution.

Dosage Forms And Strengths

PERJETA (pertuzumab) 420 mg/14 mL (30 mg/mL) in a single-use vial

Storage And Handling

PERJETA is supplied as a 420 mg/14 mL (30 mg/mL) single-use vial containing preservative-free solution. NDC 50242-145-01.

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.

Keep vial in the outer carton in order to protect from light.

DO NOT FREEZE. DO NOT SHAKE.

Manufactured by: Genentech, Inc., A Member of the Roche Group 1 DNA Way, South San Francisco, CA 94080-4990.

Last reviewed on RxList: 4/26/2013
This monograph has been modified to include the generic and brand name in many instances.