General: Patients treated with Perjeta should have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of > 2.0 by in situ hybridization (ISH) assessed by a validated test.
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
For full instructions on assay performance and interpretation, refer to the package inserts of validated HER2 testing assays.
Substitution by any other biological medicinal product requires the consent of the prescribing physician.
In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is Perjeta.
Perjeta therapy should only be administered under the supervision of a healthcare professional experienced in the treatment of cancer patients.
Perjeta must be diluted by a healthcare professional and administered as an intravenous infusion. Do not administer as an IV push or bolus.
Metastatic and Early Breast Cancer: The recommended initial dose of Perjeta is 840 mg administered as a 60 minutes intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered over a period 30 to 60 minutes. An observation period of 30-60 minutes is recommended after completion of each Perjeta infusion. The observation period should be completed prior to any subsequent dose of Herceptin or chemotherapy (see Precautions). Perjeta and Herceptin should be administered sequentially and can be given in any order. When administered with Perjeta, the recommendation is to follow a 3-weekly schedule for Herceptin administered either as: an IV infusion with an initial dose of 8 mg/kg followed every 3 weeks thereafter by a dose of 6 mg/kg body weight;
a fixed dose of Herceptin subcutaneous (SC) injection (600mg) for the initial dose and every 3 weeks thereafter irrespective of the patient's body weight.
In patients receiving a taxane, Perjeta and Herceptin should be administered prior to the taxane. When administered with Perjeta, the recommended initial dose of docetaxel is 75 mg/m2.
In patients receiving an anthracycline-based regimen, Perjeta and Herceptin should be administered following completion of the entire anthracycline regimen.
Metastatic Breast Cancer (MBC): Perjeta should be administered in combination with Herceptin and docetaxel until disease progression or unmanageable toxicity. Treatment with Perjeta and Herceptin may continue even if treatment with docetaxel is discontinued.
Early Breast Cancer (EBC): In the neoadjuvant setting (before surgery), it is recommended that patients are treated with Perjeta for three to six cycles depending on the regimen chosen in combination with Herceptin and chemotherapy (see Pharmacology: Pharmacodynamics: Clinical/ Efficacy Studies under Actions).
In the adjuvant setting (after surgery), Perjeta should be administered in combination with Herceptin for a total of one year (maximum 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for early breast cancer, including standard anthracycline and/ or taxane-based chemotherapy. Perjeta and Herceptin should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Patients who start Perjeta and Herceptin in the neoadjuvant setting should continue to receive adjuvant Perjeta and Herceptin to complete 1 year of treatment.
Delayed or Missed doses: For recommendations on delayed or missed doses, refer to Table 5 as follows. (See Table 5.)
Click on icon to see table/diagram/image
Dose modifications: Perjeta should be discontinued if Herceptin treatment is discontinued.
Dose reductions are not recommended for Perjeta and Herceptin (see Herceptin prescribing information).
For chemotherapy dose modifications, see relevant prescribing information.
Infusion-related reactions: The infusion rate of Perjeta may be slowed or the administration interrupted if the patient develops an infusion-related reaction.
Hypersensitivity reactions/anaphylaxis: The infusion should be discontinued immediately and permanently if the patient experiences a serious hypersensitivity reaction (e.g. anaphylaxis) (see Precautions).
Left ventricular dysfunction: See Precautions for information on dose recommendations in the event of left ventricular dysfunction.
Special dosage instructions: Geriatric use: No dose adjustment is required in the elderly population (≥65 years of age) (see Use in Elderly under Precautions).
Pediatric use: The safety and efficacy of Perjeta in children and adolescents below 18 years of age have not been established.
Renal impairment: Dose adjustments of Perjeta are not needed in patients with mild or moderate renal impairment. No dose recommendations can be made for patients with severe renal impairment because of the limited pharmacokinetic data available (see Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).
Hepatic impairment: The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment.