Pertuzumab


Generic Medicine Info
Indications and Dosage
Intravenous
HER2-positive locally recurrent unresectable carcinoma of breast, HER2-positive metastatic carcinoma of breast
Adult: In combination with trastuzumab and docetaxel, in patients who have not been given prior anti-HER2 therapy or chemotherapy for their metastatic disease: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg once every 3 weeks given via infusion over 30-60 minutes. Continue therapy until disease progression or uncontrollable toxicity occurs. Observe for 30-60 minutes after each infusion. Missed dose: <6 weeks: Administer maintenance dose as soon as possible then return to original planned schedule; ≥6 weeks: Restart from initial loading dose 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 in patients at high risk of recurrence: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg once every 3 weeks given via infusion over 30-60 minutes for 3-6 cycles. Observe for 30-60 minutes after each infusion. Missed dose: <6 weeks: Administer maintenance dose as soon as possible then return to original planned schedule; ≥6 weeks: Restart from initial loading dose 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 in patients at high risk of recurrence: Initially, 840 mg via infusion over 60 minutes. Maintenance: 420 mg once every 3 weeks given via infusion over 30-60 minutes for 1 year (up to 18 cycles) or until disease recurrence or uncontrollable toxicity occurs (whichever comes first). Observe for 30-60 minutes after each infusion. Missed dose: <6 weeks: Administer maintenance dose as soon as possible then return to original planned schedule; ≥6 weeks: Restart from initial loading dose 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 0.9% NaCl infusion bag. Gently invert to mix and to avoid foaming. Do not shake.
Incompatibility
Incompatible with 5% glucose solutions.
Special Precautions
Patient with heart failure; who has received prior anthracycline therapy or prior radiotherapy to the chest area. Pregnancy and lactation.
Adverse Reactions
Significant: Decreased LVEF, heart failure, diarrhoea, infusion reactions (e.g. fever, chills, fatigue, headache, weakness, myalgia, abnormal taste, vomiting), febrile neutropenia.
Blood and lymphatic system disorders: Neutropenia, anaemia, leucopenia, thrombocytopenia.
Eye disorders: Increased lacrimation.
Gastrointestinal disorders: Constipation, mucositis, stomatitis, abdominal pain, dyspepsia, nausea.
Immune system disorders: Angioedema.
Investigations: Increased ALT.
Metabolism and nutrition disorders: Decreased appetite, peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, pain in extremity.
Neoplasms benign, malignant and unspecified: Rarely, tumour lysis syndrome.
Nervous system disorders: Dizziness, peripheral sensory neuropathy, paraesthesia.
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, nail disease, paronychia, dry skin.
Vascular disorders: Hot flush.
Potentially Fatal: Severe hypersensitivity (e.g. anaphylaxis).
MonitoringParameters
Determine HER2 expression status and perform pregnancy test prior to initiation of therapy. Evaluate cardiac function (including LVEF) at baseline and regularly during treatment. Monitor for infusion-related reactions and hypersensitivity after each administration.
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. Additionally, it mediates antibody-dependent cell-mediated cytotoxicity.
Pharmacokinetics:
Distribution: Volume of distribution: 5.12 L.
Excretion: Terminal elimination half-life: Approx 18 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze. Diluted solutions may be stored between 2-8°C for up to 24 hours. 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.
References
Anon. Pertuzumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/11/2020.

Anon. Pertuzumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/11/2020.

Buckingham R (ed). Pertuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/11/2020.

Joint Formulary Committee. Pertuzumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2020.

Perjeta 420 mg Concentrate for Solution for Infusion (Roche). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 11/11/2020.

Perjeta Injection, Solution, Concentrate (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/11/2020.

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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
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