Herzuma

Trastuzumab

Metastatic breast cancer (MBC) who have tumors that overexpress HER2: Monotherapy for patients who have received ≥1 chemotherapy regimens for MBC. In combination w/ paclitaxel or docetaxel for patients who have not received chemotherapy for metastatic disease. In combination w/ aromatase inhibitor for patients w/ hormone-receptor-+ve MBC. HER2-+ve early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) & 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 Herzuma, for locally advanced (including inflammatory) breast cancer or tumors >2 cm in diameter. HER2-+ve advanced adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for metastatic disease in combination w/ capecitabine or IV 5-fluorouracil & platinum agent.

IV infusion HER2 testing is mandatory prior to initiation of therapy. Wkly schedule: Initial loading dose 4 mg/kg over 90 min. Recommended wkly dose: 2 mg/kg. Administer over 30 min if the prior dose is well tolerated. Alternative 3-wkly schedule: Initial loading dose 8 mg/kg, followed by 6 mg/kg 3 wk later & then 6 mg/kg repeated at 3-wkly intervals over approx 90 min. Administer over 30 min if the prior dose is well tolerated.

Hypersensitivity.

Do not administer as IV push or bolus. Hypersensitivity to benzyl alcohol. Risk of infusion/administration-related reactions. Extreme caution for patients who are experiencing dyspnea at rest due to complications of advanced malignancy or co-morbidities. Severe pulmonary events; risk factors associated w/ ILD include prior or concomitant therapy w/ other anti-neoplastic therapies known to be associated w/ it eg, taxanes, gemcitabine, vinorelbine & radiation therapy. Risk of CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction in patients receiving trastuzumab alone or in combination w/ taxane following anthracycline (doxorubicin or epirubicin)-containing chemotherapy; increased cardiac risk eg, HTN, documented CAD, CHF, diastolic dysfunction, older age; avoid anthracycline-based therapy for up to 7 mth after discontinuation of therapy. Perform cardiac assessments & should be repeated every 3 mth during treatment & every 6 mth following discontinuation until 24 mth from the last dose. Not to be given concurrently w/ anthracyclines in the metastatic breast cancer (MBC) & early breast cancer (EBC) adjuvant & neoadjuvant-adjuvant treatment setting. Further monitoring is recommended in patients who received anthracycline-containing chemotherapy in EBC, & should occur yearly up to 5 yr from the last dose, or longer if continuous decrease of LVEF is observed. Should advise patients experiencing infusion-related symptoms not to drive or use machines. Pregnancy & lactation. Elderly.

Nasopharyngitis, infection; anaemia, thrombocytopenia, febrile neutropenia, decreased WBC/leukopenia; decreased/increased wt, decreased appetite; insomnia; dizziness, headache, paraesthesia, hypoesthesia, dyspepsia; increased lacrimation, conjunctivitis; decreased ejection fraction; lymphoedema; dyspnoea, epistaxis, oropharyngeal pain, cough, rhinorrhoea; diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, constipation, stomatitis, pancreatitis; 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, pharyngitis, sinusitis, rhinitis, URTI, UTI; neutropenia; hypersensitivity; depression, anxiety; hypertonia, peripheral neuropathy, somnolence; cardiac failure (congestive), cardiomyopathy, supraventricular tachyarrhythmia, palpitation; hot flush, hypotension, HTN, vasodilation, asthma, Lune: disorder, pleural effusion, pneumonia, pneumonitis, wheezing; acne, dermatitis, dry skin, hyperhydrosis, maculopapular rash, pruritus, onychoclasis; arthritis, back pain, bone pain, muscle spasms, neck pain, pain in extremity; oedema, malaise; hepatocellular injury.

May elevate the overall exposure of 1 doxorubicin metabolite. May cause 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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