Herceptin

Trastuzumab

Human epidermal growth factor receptor 2 (HER2) +ve metastatic breast cancer (MBC): Monotherapy for patients who have received ≥1 chemotherapy regimens for their metastatic disease; in combination w/ paclitaxel or docetaxel for patients who have not received chemotherapy for their metastatic disease; in combination w/ aromatase inhibitor for patients w/ hormone-receptor +ve MBC. HER2 +ve early breast cancer (EBC): Following surgery, neoadjuvant or adjuvant chemotherapy & RT (if applicable); following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide, in combination w/ paclitaxel or docetaxel; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant Herceptin, for locally advanced (including inflammatory) breast cancer or tumours >2 cm in diameter. IV: HER2 +ve metastatic gastric cancer (MGC): In combination w/ capecitabine or 5-fluorouracil & cisplatin for HER2 +ve metastatic stomach or gastroesophageal junction adenocarcinoma for patients who have not received prior anti-cancer for their metastatic disease.

IV MBC & EBC Wkly schedule: Loading dose: 4 mg/kg as 90-min infusion. Subsequent dose: 2 mg/kg wkly. MBC, EBC & MGC 3-wkly dose: Loading dose: 8 mg/kg, followed by 6 mg/kg 3 wk later, then 6 mg/kg repeated at 3-wkly interval. SC MBC & EBC 600 mg fixed dose every 3 wk.

Hypersensitivity.

Infusion/administration-related reactions; increased risk of pulmonary events & fatal infusion reaction in patients experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities. Increased risk of developing CHF NYHA class II-IV or asymptomatic cardiac dysfunction. Pulmonary reactions. Perform baseline cardiac assessment & repeat every 3 mth during treatment & every 6 mth following discontinuation until 24 mth after last dose. Not to be concurrently used w/ anthracycline. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & for 7 mth after treatment. Avoid use during pregnancy & lactation. Associated toxicity w/ benzyl alcohol in neonates & childn up to 3 yr. Paed patients <18 yr. IV: Discontinue use if clinically significant decreased left ventricular function occurs. Not to be administered as IV push or bolus. SC: Not to be inj IV.

Nasopharyngitis, infection; anaemia, thrombocytopenia, febrile neutropenia, leukopenia, neutropenia; increased/decreased wt, decreased appetite; insomnia; dizziness, headache, paraesthesia, hypoaesthesia, dysgeusia; increased lacrimation, conjunctivitis; decreased ejection fraction; lymphoedema, hot flush; dyspnoea, epistaxis, oropharyngeal pain, cough, rhinorrhoea; diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, constipation, stomatitis; erythema, rash, alopecia, palmar-plantar erythrodysaesthesia syndrome, nail disorder; arthralgia, myalgia; asthenia, chest pain, chills, fatigue, flu-like symptoms, infusion/administration-related reaction, pain, pyrexia, peripheral oedema, mucosal inflammation; nail toxicity. Flu, neutropenic sepsis, pharyngitis, sinusitis, rhinitis, URTI, UTI; hypersensitivity; depression, anxiety; hypertonia, peripheral neuropathy, somnolence; supraventricular tachyarrhythmia, congestive cardiac failure, cardiomyopathy, palpitation; hypotension, HTN, vasodilation; asthma, lung disorder, pleural effusion, pneumonia; hepatocellular injury; acne, dermatitis, dry skin, hyperhydrosis, maculopapular rash, pruritus, onychoclasis; arthritis, back, bone & neck pain, muscle spasms, pain in extremity; oedema, inj site pain, malaise.

Elevated overall exposure of doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone). Higher conc & longer t_½ of capecitabine.

Targeted Cancer Therapy

L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.

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