Applies to the following strength(s): 420 mg/14 mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer
METASTATIC BREAST CANCER (MBC):
Recommended dose: 840 mg IV administered as an initial dose over 60 minutes, followed every 3 weeks thereafter by 420 mg IV over 30 to 60 minutes
Duration: Until disease progression, withdrawal of consent, or unmanageable toxicity
-Pertuzumab is given in combination with trastuzumab and docetaxel.
-Follow the manufacturer recommended dosing or local protocol for complete dosing information on trastuzumab and docetaxel.
-Pertuzumab, trastuzumab, and docetaxel should be administered sequentially. Pertuzumab and trastuzumab can be given in any order. Docetaxel should be administered after pertuzumab and trastuzumab.
-An observation period of 30 to 60 minutes is recommended after each pertuzumab infusion and before commencement of any subsequent infusion of trastuzumab or docetaxel.
Use: Metastatic breast cancer (MBC): This drug 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 8 therapy or chemotherapy for metastatic disease.
NEOADJUVANT TREATMENT OF BREAST CANCER:
Recommended dose: 840 mg IV administered as an initial dose over 60 minutes, followed every 3 weeks thereafter by 420 mg IV over 30 to 60 minutes. Pertuzumab should be given by IV infusion preoperatively every 3 weeks for 3 to 6 cycles.
Based on studies, the manufacturer recommends 3 different treatment options for early breast cancer:
1) Four preoperative cycles of pertuzumab in combination with trastuzumab and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC).
2) Three preoperative cycles of FEC alone followed by 3 preoperative cycles of pertuzumab in combination with docetaxel and trastuzumab.
3) Six preoperative cycles of pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH).
-Consult the manufacturer recommended dosing or local protocol for complete dosing information on all concomitant medications.
-There is insufficient evidence to recommend continued use of pertuzumab for greater than 6 cycles for early breast cancer.
Use: Neoadjuvant treatment of breast cancer: This drug is indicated for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended
Severe renal dysfunction: Data not available
Liver Dose Adjustments
Data not available
-For delayed or missed doses, if the time between 2 sequential infusions is less than 6 weeks, the 420 mg dose of pertuzumab should be administered. Do not wait until the next planned dose.
-If the time between 2 sequential infusions is 6 weeks or more, the initial dose of 840 mg pertuzumab should be readministered as a 60 minute IV infusion followed every 3 weeks thereafter by a dose of 420 mg IV over 30 to 60 minutes.
-Pertuzumab should be discontinued if trastuzumab is discontinued.
-Dose reductions are not recommended for pertuzumab.
-For docetaxel dose modifications, see relevant prescribing information.
Left Ventricular Ejection Fraction (LVEF):
-Withhold pertuzumab and trastuzumab dosing for at least 3 weeks for either:
1) A drop in LVEF to less than 45% or
2) LVEF of 45% to 49% with a 10% or greater absolute decrease below pretreatment values.
3) Pertuzumab and trastuzumab 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, pertuzumab and trastuzumab should be discontinued, unless the benefits for the individual patient are deemed to outweigh the risks.
-The infusion rate of pertuzumab may be slowed or interrupted if the patient develops an infusion-related reaction. Treatment including oxygen, beta agonists, antihistamines, rapid IV fluids, and antipyretics may also help alleviate symptoms.
-The infusion should be discontinued immediately if the patient experiences a Grade 4 reaction (anaphylaxis), bronchospasm, or acute respiratory distress syndrome.
US BOXED WARNINGS:
-LEFT VENTRICULAR DYSFUNCTION: This drug can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased left ventricular function (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue this drug for a confirmed clinically significant decrease in LVEF.
-EMBRYOFETAL TOXICITY: Exposure to this drug can result in embryofetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Pertuzumab should only be administered under supervision of a healthcare professional experienced in the treatment of cancer patients.
-Pertuzumab should not be administered as an IV push or bolus injection.
-Pertuzumab and trastuzumab may be administered in any order; however, when the patient is receiving docetaxel, the docetaxel dose should be given after both pertuzumab and trastuzumab infusions.
-Patients should be observed for 30 to 60 minutes after each pertuzumab infusion and before any subsequent infusions of trastuzumab or docetaxel.
-Vials should be stored in a refrigerator at 2 C to 8 C, kept in the outer carton to protect from light.
-Do not freeze or shake the vials.
-If storage is necessary upon dilution, the solution may be stored at 2 C to 8 C for up to 24 hours.
-The manufacturer product information should be consulted.
-Pertuzumab is compatible with 0.9% sodium chloride.
-Pertuzumab is incompatible with 5% glucose solution and should not be mixed or diluted with other drugs.
-Pertuzumab may only be used in patients with a HER2-positive tumor status, determined by a specialized laboratory.
-Hematologic: Full blood count
-Hypersensitivity: Close observation of the patient for infusion-related reactions during and following infusions
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- Drug class: HER2 inhibitors
Other brands: Perjeta