Pertuzumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV HER2-positive metastatic carcinoma of breast Combined with trastuzumab and docetaxel: Initial: 840 mg. Maintenance: 420 mg once every 3 weeks. Neoadjuvant treatment of locally advanced, inflammatory or early stage HER2-positive carcinoma of breast Combined with trastuzumab and chemotherapy prior to surgery: Initial: 840 mg. Maintenance: 420 mg once every 3 weeks for 3-6 cycles. Adjuvant treatment of HER2-positive early carcinoma of breast Combined with trastuzumab and chemotherapy following surgery: Initial: 840 mg. Maintenance: 420 mg once every 3 weeks for 1 year (up to 18 cycles). Dose interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Dosage Details
Intravenous
HER2-positive metastatic carcinoma of breast
Adult: In combination with trastuzumab and docetaxel: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg over 30-60 minutes once every 3 weeks. Missed dose: <6 weeks: Administer as soon as possible. ≥6 weeks: Restart from initial dosing followed by maintenance doses. Dose interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).

Intravenous
Neoadjuvant treatment of early stage HER2-positive carcinoma of breast, Neoadjuvant treatment of inflammatory HER2-positive carcinoma of breast, Neoadjuvant treatment of locally advanced HER2-positive carcinoma of breast
Adult: In combination with trastuzumab and chemotherapy prior to surgery: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg over 30-60 minutes once every 3 weeks for 3-6 cycles. Missed dose: <6 weeks: Administer as soon as possible. ≥6 weeks: Restart from initial dosing followed by maintenance doses. Dose interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).

Intravenous
Adjuvant treatment of HER2-positive early carcinoma of breast
Adult: In combination with trastuzumab and chemotherapy following surgery: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg over 30-60 minutes once every 3 weeks for 1 year (up to 18 cycles). Missed dose: <6 weeks: Administer as soon as possible. ≥6 weeks: Restart from initial dosing followed by maintenance doses. Dose interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Reconstitution
Withdraw appropriate volume of solution from a vial and dilute into 250 mL NaCl 0.9% infusion bag. Gently invert to mix. Avoid foaming. Do not shake.
Incompatibility
Incompatible with glucose solutions.
Contraindications
Pregnancy.
Special Precautions
Patient with heart failure. Lactation.
Adverse Reactions
Significant: Decreased LVEF, heart failure, diarrhoea, infusion reactions (e.g. fever, chills, fatigue, headache, weakness, myalgia, abnormal taste, vomiting), anaphylaxis, febrile neutropenia.
Blood and lymphatic system disorders: Neutropenia, anaemia, leucopenia.
Eye disorders: Increased lacrimation.
Gastrointestinal disorders: Constipation, mucositis, stomatitis, dysgeusia, abdominal pain, dyspepsia.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness, peripheral sensory neuropathy.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, epistaxis, dyspnoea, nasopharyngitis, oropharyngeal pain, cough, pleural effusion.
Skin and subcutaneous tissue disorders: Alopecia, rash, pruritus, palmar-plantar erythrodysaesthesia, xeroderma, nail disease, paronychia.
MonitoringParameters
Determine HER2 expression status and perform pregnancy test prior to initiation of therapy. Monitor cardiac function (including ECG, echocardiogram and LVEF) at baseline and regularly during treatment. Monitor for infusion-related reactions and hypersensitivity.
Drug Interactions
May enhance the adverse effects of belimumab.
Action
Description: Pertuzumab is a monoclonal antibody that targets extracellular dimerisation of human epidermal growth factor receptor 2 protein (HER2). It prevents heterodimerisation of HER2 with other HER family receptors, thereby preventing activation of HER signalling pathways. This results in cell growth arrest and apoptosis. It also activates an immune response that lyses tumour cells.
Pharmacokinetics:
Distribution: Volume of distribution: 5.12 L.
Excretion: Terminal elimination half-life: Approx 18 days.
Storage
Store between 2-8°C. Protect form light. Do not freeze.
This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
ATC Classification
L01XC13 - pertuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by MIMS based on Pertuzumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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