Pertuzumab + Trastuzumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Adjuvant treatment of HER2-positive early carcinoma of breast
Adult: Available preparations:
Pertuzumab 600 mg and trastuzumab 600 mg per 10 mL of solution for inj
Pertuzumab 1,200 mg and trastuzumab 600 mg per 15 mL of solution for inj

In combination with chemotherapy, in patients at high risk of recurrence: Loading dose: 1,200 mg pertuzumab/600 mg trastuzumab, via inj in the thigh over approx 8 minutes. Maintenance dose: 600 mg pertuzumab/600 mg trastuzumab every 3 weeks, given via inj in the thigh over approx 5 minutes for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity occurs (whichever comes first). Missed dose: <6 weeks (time between 2 sequential inj): Administer maintenance dose as soon as possible then continue with the every 3 weeks schedule; ≥6 weeks (time between 2 sequential inj): Readminister loading dose followed by maintenance doses of every 3 weeks thereafter. Switching from IV pertuzumab and trastuzumab: <6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC maintenance dose and every 3 weeks for subsequent administrations; ≥6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC loading dose followed by SC maintenance doses of every 3 weeks for subsequent administrations. Dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).

Subcutaneous
HER2-positive locally recurrent unresectable carcinoma of breast, HER2-positive metastatic carcinoma of breast
Adult: Available preparations:
Pertuzumab 600 mg and trastuzumab 600 mg per 10 mL of solution for inj
Pertuzumab 1,200 mg and trastuzumab 600 mg per 15 mL of solution for inj

In combination with docetaxel, in patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease: Loading dose: 1,200 mg pertuzumab/600 mg trastuzumab, via inj in the thigh over approx 8 minutes. Maintenance dose: 600 mg pertuzumab/600 mg trastuzumab every 3 weeks, given via inj in the thigh over approx 5 minutes. Continue treatment until disease progression or unacceptable toxicity occurs. Missed dose: <6 weeks (time between 2 sequential inj): Administer maintenance dose as soon as possible then continue with the every 3 weeks schedule; ≥6 weeks (time between 2 sequential inj): Readminister loading dose followed by maintenance doses of every 3 weeks thereafter. Switching from IV pertuzumab and trastuzumab: <6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC maintenance dose and every 3 weeks for subsequent administrations; ≥6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC loading dose followed by SC maintenance doses of every 3 weeks for subsequent administrations. Dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).

Subcutaneous
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: Available preparations:
Pertuzumab 600 mg and trastuzumab 600 mg per 10 mL of solution for inj
Pertuzumab 1,200 mg and trastuzumab 600 mg per 15 mL of solution for inj

In combination with chemotherapy, in patients at high risk of recurrence: Loading dose: 1,200 mg pertuzumab/600 mg trastuzumab, via inj in the thigh over approx 8 minutes. Maintenance dose: 600 mg pertuzumab/600 mg trastuzumab every 3 weeks, given via inj in the thigh over approx 5 minutes for 3-6 cycles, depending on the chosen regimen. Missed dose: <6 weeks (time between 2 sequential inj): Administer maintenance dose as soon as possible then continue with the every 3 weeks schedule; ≥6 weeks (time between 2 sequential inj): Readminister loading dose followed by maintenance doses of every 3 weeks thereafter. Switching from IV pertuzumab and trastuzumab: <6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC maintenance dose and every 3 weeks for subsequent administrations; ≥6 weeks since last IV pertuzumab and trastuzumab dose: Administer SC loading dose followed by SC maintenance doses of every 3 weeks for subsequent administrations. Dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Contraindications
Hypersensitivity.
Special Precautions
Patient with cardiac illness; symptomatic intrinsic lung disease or extensive pulmonary tumour involvement resulting in dyspnoea at rest. Patient who have received prior anthracyclines or prior radiotherapy to the chest area. Inj site should be alternated between the left and right thigh only. Pregnancy and lactation.
Adverse Reactions
Significant: Decreased LVEF, heart failure; inj-related reactions (e.g. fever, chills, headache), diarrhoea.
Blood and lymphatic system disorders: Anaemia, neutropenia, leucopenia.
Eye disorders: Increased lacrimation.
Gastrointestinal disorders: Constipation, dysgeusia, dyspepsia, nausea, stomatitis, vomiting, abdominal pain.
General disorders and administration site conditions: Mucosal inflammation, fatigue, asthenia, inj-site reaction.
Metabolism and nutrition disorders: Decreased appetite, peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, pain in extremity.
Nervous system disorders: Dizziness, peripheral neuropathy, peripheral sensory neuropathy, paraesthesia.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Cough, epistaxis, upper respiratory tract infection, nasopharyngitis, dyspnoea, rhinorrhoea.
Skin and subcutaneous tissue disorders: Alopecia, paronychia, rash, pruritus, dry skin, nail disorder.
Vascular disorders: Hot flush.
Potentially Fatal: Severe pulmonary events (e.g. acute respiratory distress syndrome, pneumonia, pneumonitis, acute pulmonary oedema, pleural effusion, respiratory insufficiency, lung infiltrates); severe hypersensitivity reactions (including anaphylaxis); febrile neutropenia.
Patient Counseling Information
This drug may cause dizziness or inj-related reactions, if affected, do not drive or operate machinery.
Monitoring Parameters
Assess for HER2 overexpression and pregnancy status prior to initiation of treatment. Evaluate cardiac function (including LVEF) at baseline and at regular intervals during therapy. Monitor for signs and symptoms of cardio and pulmonary toxicity. Observe for signs and symptoms of hypersensitivity and/or inj-related reactions during administration and for at least 30 minutes after the completion of loading dose and 15 minutes after the completion of maintenance doses.
Drug Interactions
Trastuzumab: May increase the cardiotoxic effect of anthracyclines.
Action
Description: Pertuzumab is a recombinant humanised monoclonal antibody that targets extracellular dimerization domain 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.
Trastuzumab is a monoclonal antibody that binds to the extracellular domain of human epidermal growth factor receptor 2 (HER2) protein. It inhibits proliferation of tumour cells that overexpress HER2 protein thereby mediating antibody-dependent cellular cytotoxicity.
Pharmacokinetics:
Absorption: Pertuzumab: Absolute bioavailability: 0.712. Time to peak plasma concentration: 3.82 days.
Trastuzumab: Absolute bioavailability: 0.771. Time to peak plasma concentration: 3.84 days.
Distribution: Pertuzumab: Volume of distribution: Central compartment: 2.77 L.
Trastuzumab: Volume of distribution: Central compartment: 2.91 L.
Excretion: Pertuzumab: Elimination half-life: Approx 24.3 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XY02 - pertuzumab and trastuzumab ; Belongs to the class of combinations of antineoplastic agents. Used in the treatment of cancer.
References
Anon. Pertuzumab, Trastuzumab, and Hyaluronidase. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/08/2021.

Anon. Pertuzumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/08/2021.

Anon. Trastuzumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/08/2021.

Buckingham R (ed). Pertuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.

Buckingham R (ed). Trastuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.

Joint Formulary Committee. Pertuzumab with Trastuzumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.

Pertuzumab. Drugs and Lactation Database (LactMed) [Internet]. Bethesda, MD. U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501922. Accessed 16/11/2021.

Phesgo 600 mg/600 mg Solution for Injection (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2021.

Phesgo 600 mg/600 mg Solution for Injection; Phesgo 1,200 mg/600 mg Solution for Injection (Roche Pharma AG). European Medicines Agency [online]. Accessed 16/11/2021.

Phesgo Injection Solution (Genetech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2021.

Phesgo Solution for Injection (Roche). MIMS Thailand. http://www.mims.com/thailand. Accessed 16/11/2021.

Trastuzumab. Drugs and Lactation Database (LactMed) [Internet]. Bethesda, MD. U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501922. Accessed 16/11/2021.

Disclaimer: This information is independently developed by MIMS based on Pertuzumab + Trastuzumab 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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