Individual generic drug information

trastuzumab

Reference monograph

Part of registered formulation

TRASTUZUMAB

Reference record: Trastuzumab
Source: BNF 80 (2020–2021)
Printed source pages: 957, 958, 959
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Trastuzumab only.

Indications And Dose

Treatment of early breast cancer which overexpresses human epidermal growth factor receptor-2 (HER2) (initiated by a specialist) | Treatment of metastatic breast cancer in patients with HER2-positive tumours who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate (in combination with paclitaxel or docetaxel) (initiated by a specialist) | Treatment of metastatic breast cancer in postmenopausal patients with hormone-receptor positive HER2-positive tumours not previously treated with trastuzumab (in combination with an aromatase inhibitor) (initiated by a specialist) ▶BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION ▶Adult: (consult product literature or local protocols) continued → Monotherapy for metastatic breast cancer in patients with tumours that overexpress HER2 who have received at least 2 chemotherapy regimens including, where appropriate, an anthracycline and a taxane (initiated by a specialist) ▶BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION ▶Adult: Women with oestrogen-receptor-positive breast cancer should also have received hormonal therapy (consult product literature or local protocols) Treatment of metastatic gastric cancer in patients with HER2-positive tumours who have not received treatment for metastatic gastric cancer (in combination with Immune system and malignant disease capecitabine or fluorouracil and cisplatin) (initiated by a specialist) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols)

Source pages 957, 958

Contra Indications

Severe dyspnoea at rest

Source page 958

Cautions

Coronary artery disease. history of hypertension. symptomatic heart failure. uncontrolled arrhythmias

Source page 958

Prescribing And Dispensing Information

When prescribing, dispensing or administering, check that this is the correct preparation—trastuzumab is not interchangeable with trastuzumab emtansine. Trastuzumab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1.

Source page 958

National Funding Access Decisions

NICE decisions ▶Guidance on the use of trastuzumab for the treatment of advanced breast cancer (March 2002) NICE TA34 Trastuzumab in combination with paclitaxel is recommended as an option for patients with tumours expressing human epidermal growth factor receptor 2 (HER2) scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer, and in whom anthracycline treatment is inappropriate. Trastuzumab monotherapy is recommended as an option for patients with tumours expressing HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and a taxane where these treatments are appropriate. It should also have included hormonal therapy in suitable oestrogen-receptor-positive patients. www.nice.org.uk/guidance/ta34 ▶Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer (August 2006) NICE TA107 Trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), is recommended as an option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). www.nice.org.uk/guidance/ta107 ▶Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone- receptor-positive breast cancer that overexpresses HER2 (June 2012) NICE TA257 Lapatinib or trastuzumab in combination with an aromatase inhibitor is not recommended for ﬁrst-line treatment in postmenopausal women of metastatic hormone-receptor-positive breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2). Postmenopausal women currently receiving lapatinib or trastuzumab in combination with an aromatase inhibitor for this indication should have the option to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta257 ▶Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer (March 2018) NICE TA509 Pertuzumab, in combination with trastuzumab and docetaxel, is recommended, within its marketing authorisation, for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti-HER2 therapy or chemotherapy for their metastatic disease, only if the manufacturer provides pertuzumab within the agreed commercial access arrangement. www.nice.org.uk/guidance/ta509 ▶Trastuzumab for the treatment of HER2-positive metastatic gastric cancer (November 2010) NICE TA208 Trastuzumab in combination with cisplatin and capecitabine or ﬂuorouracil is recommended for human epidermal growth factor receptor-2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction in patients who: . have not received treatment for metastatic disease and . have tumours expressing high levels of HER2 as deﬁned by a positive immunohistochemistry score of 3. www.nice.org.uk/guidance/ta208 Scottish Medicines Consortium (SMC) decisions SMC No. 928/13 The Scottish Medicines Consortium has advised (January 2014) that subcutaneous trastuzumab injection (Herceptin ®) is accepted for restricted use within NHS Scotland for the treatment of adults with HER2 positive metastatic breast cancer and early breast cancer, when used within licensed indications excluding use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. SMC No. 623/10 The Scottish Medicines Consortium has advised (October 2015) that trastuzumab solution for infusion (Herceptin ®) is accepted for restricted use within NHS Scotland in combination with capecitabine or ﬂuorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro- oesophageal junction, who have not received prior anti- cancer treatment for their metastatic disease. It is restricted to patients with metastatic gastric cancer whose tumours have HER2 over-expression, as determined by an accurate and validated assay.

Source pages 958, 959

Safety

Extracted information for Trastuzumab only.

Interactions

→Appendix 1: monoclonal antibodies

Source page 958

Side Effects

▶Common or very common Alopecia. anaemia. angioedema . anxiety. appetite decreased. arrhythmias. arthralgia. arthritis. asthenia. asthma. ataxia. breast abnormalities. cardiomyopathy. chest pain. chills. constipation. cough. cystitis. depression. diarrhoea. dizziness. drowsiness. dry eye. dry mouth. dyspnoea. excessive tearing. eye inﬂammation. fever. gastrointestinal discomfort. haemorrhage. haemorrhoids. headache. heart failure. hepatic disorders. hyperhidrosis. hypersensitivity. hypotension. increased risk of infection. inﬂuenza like illness. infusion related reaction (may be delayed). insomnia. leucopenia. malaise. mucositis. muscle complaints. muscle tone increased. nail disorders. nausea . neutropenia. oedema. oral disorders. pain. palpitations. pancreatitis. paraesthesia. peripheral neuropathy. renal disorder. respiratory disorders. rhinorrhoea. sepsis. skin reactions. taste altered. thinking abnormal. thrombocytopenia. tremor. vasodilation. vomiting. weight decreased ▶Uncommon Deafness. pericardial effusion ▶Rare or very rare Paresis ▶Frequency not known Brain oedema. cancer progression. cardiogenic shock. glomerulonephritis. hyperkalaemia. hypoprothrombinaemia. hypoxia. pericarditis. pulmonary ﬁbrosis (may be delayed). pulmonary oedema (may be delayed). renal failure

Source page 958

Conception And Contraception

Manufacturer advises effective contraception in women of childbearing potential during and for 7 months after treatment. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 958

Pregnancy

Manufacturer advises avoid— oligohydramnios reported. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 958

Breast Feeding

Avoid breast-feeding during treatment and for 7 months afterwards.

Source page 958

Monitoring Requirements

▶Cardiotoxicity Monitor cardiac function before and during treatment—for details of monitoring and managing cardiotoxicity, consult product literature.

Source page 958

Dose and formulations

Extracted information for Trastuzumab only.

Directions For Administration

Resuscitation facilities should be available during administration of trastuzumab.

Source page 958

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Herceptin (Roche Products Ltd) Trastuzumab 120 mg per 1 ml Herceptin 600mg/5ml solution for injection vials | 1 vial P £1,222.20 (Hospital only) Powder for solution for infusion ▶Herceptin (Roche Products Ltd) Trastuzumab 150 mg Herceptin 150mg powder for concentrate for solution for infusion vials | 1 vial P £407.40 ▶Herzuma (Napp Pharmaceuticals Ltd) A Trastuzumab 150 mg Herzuma 150mg powder for concentrate for solution for infusion vials | 1 vial P £366.66 (Hospital only) Trastuzumab 420 mg Herzuma 420mg powder for concentrate for solution for infusion vials | 1 vial P £1,026.65 (Hospital only) ▶Kanjinti (Amgen Ltd) A Trastuzumab 150 mg Kanjinti 150mg powder for concentrate for solution for infusion vials | 1 vial P £366.66 Trastuzumab 420 mg Kanjinti 420mg powder for concentrate for solution for infusion vials | 1 vial P £1,026.65 (Hospital only) ▶Ontruzant (Merck Sharp & Dohme Ltd) A Trastuzumab 150 mg Ontruzant 150mg powder for concentrate for solution for infusion vials | 1 vial P £366.66 ▶Trazimera (Pfizer Ltd) A Trastuzumab 150 mg Trazimera 150mg powder for concentrate for solution for infusion vials | 1 vial P £366.66 (Hospital only) Trastuzumab 420 mg Trazimera 420mg powder for concentrate for solution for infusion vials | 1 vial P £1,026.65 (Hospital only)

Source page 959

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult product literature or local protocols)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 957

Adults

First line only; read the complete Indications and dose section above.

Women with oestrogen-receptor-positive breast

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 958

Adults

First line only; read the complete Indications and dose section above.

(consult product literature or local protocols)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 958

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

trastuzumab

Reference monograph

Part of registered formulation

TRASTUZUMAB

Reference record: Trastuzumab
Source: BNF 80 (2020–2021)
Printed source pages: 957, 958, 959
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Trastuzumab only.

Indications And Dose

Source pages 957, 958

Contra Indications

Severe dyspnoea at rest

Source page 958

Cautions

Coronary artery disease. history of hypertension. symptomatic heart failure. uncontrolled arrhythmias

Source page 958

Prescribing And Dispensing Information

Source page 958

National Funding Access Decisions

Source pages 958, 959

Safety

Extracted information for Trastuzumab only.

Interactions

→Appendix 1: monoclonal antibodies

Source page 958

Side Effects

Source page 958

Conception And Contraception

Manufacturer advises effective contraception in women of childbearing potential during and for 7 months after treatment. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 958

Pregnancy

Manufacturer advises avoid— oligohydramnios reported. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 958

Breast Feeding

Avoid breast-feeding during treatment and for 7 months afterwards.

Source page 958

Monitoring Requirements

▶Cardiotoxicity Monitor cardiac function before and during treatment—for details of monitoring and managing cardiotoxicity, consult product literature.

Source page 958

Dose and formulations

Extracted information for Trastuzumab only.

Directions For Administration

Resuscitation facilities should be available during administration of trastuzumab.

Source page 958

Medicinal Forms

Source page 959

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult product literature or local protocols)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 957

Adults

First line only; read the complete Indications and dose section above.

Women with oestrogen-receptor-positive breast

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 958

Adults

First line only; read the complete Indications and dose section above.

(consult product literature or local protocols)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 958

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.