Perjeta

Perjeta Manufacturers

• Genentech, Inc.
  

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  Perjeta | Genentech, Inc.

  

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  2.1 Recommended Doses and Schedules

  The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks 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 by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.

  PERJETA, trastuzumab, and docetaxel should be administered sequentially. PERJETA and trastuzumab can be given in any order. Docetaxel should be administered after PERJETA and trastuzumab. An observation period of 30 to 60 minutes is recommended after each PERJETA infusion and before commencement of any subsequent infusion of trastuzumab or docetaxel [see Warnings and Precautions (5.3)].

  Metastatic Breast Cancer (MBC)

  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.

  Neoadjuvant Treatment of Breast Cancer

  PERJETA should be administered every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer [see Clinical Studies (14.2)]:

  Four preoperative cycles of PERJETA in combination with trastuzumab and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) as given in Study 2 Three preoperative cycles of FEC alone followed by 3 preoperative cycles of PERJETA in combination with docetaxel and trastuzumab as given in Study 3 Six preoperative cycles of PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) (escalation of docetaxel above 75 mg/m2 is not recommended) as given in Study 3

  Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment. There is insufficient evidence to recommend continued use of PERJETA for greater than 6 cycles for early breast cancer. There is insufficient evidence to recommend concomitant administration of an anthracycline with PERJETA, and there are no safety data to support sequential use of doxorubicin with PERJETA.

  2.2 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.

  PERJETA should be discontinued if trastuzumab treatment is discontinued.

  Dose reductions are not recommended for PERJETA.

  For docetaxel dose modifications, see relevant prescribing information.

  Left Ventricular Ejection Fraction (LVEF):

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

  a drop in LVEF to less than 45% or LVEF of 45% to 49% with a 10% or greater absolute decrease below pretreatment values [see Warnings and Precautions (5.1)]

  PERJETA may be resumed if the LVEF has recovered to greater than 49% or to 45% to 49% 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, PERJETA and trastuzumab should be discontinued, unless the benefits for the individual patient are deemed to outweigh the risks [see Warnings and Precautions (5.1)].

  Infusion-Related Reactions

  The infusion rate of PERJETA may be slowed or interrupted if the patient develops an infusion-related reaction [see Warnings and Precautions (5.3)].

  Hypersensitivity Reactions/Anaphylaxis

  The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Warnings and Precautions (5.4)].

  2.3 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 2°C to 8°C for up to 24 hours. Dilute with 0.9% Sodium Chloride injection only. Do not use dextrose (5%) solution.

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