Zuhera

Human epidermal growth factor receptor 2 (HER2) +ve metastatic breast cancer (MBC): Monotherapy for patients who have received ≥1 chemotherapy regimens; in combination w/ paclitaxel or docetaxel for patients who have not received chemotherapy; in combination w/ aromatase inhibitor for 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 Zuhera for locally advanced (including inflammatory) breast cancer or tumours >2 cm in diameter. Metastatic gastric cancer (MGC): In combination w/ capecitabine or 5-FU & cisplatin for patients w/ HER2 +ve metastatic stomach or gastroesophageal junction adenocarcinoma who have not received prior anti-cancer treatment.

MBC & EBC Wkly dose: Loading dose: 4 mg/kg IV infusion over 90 min. Maintenance dose: 2 mg/kg IV infusion over 30 min. MBC, EBC & MGC 3-wkly dose: Loading dose: 8 mg/kg IV infusion over 90 min. Maintenance dose: 6 mg/kg IV infusion over 30 min.

Hypersensitivity to trastuzumab or murine proteins. Severe dyspnoea at rest due to complications of advanced malignancy; requiring supplementary O₂ therapy.

Discontinue use if left ventricular ejection fraction does not improve, declines further or clinically significant CHF develops. Not to be administered as IV push or bolus. Not to be used in patients at increased risk of pulmonary events & w/ dyspnoea at rest due to complications of advanced malignancy or co-morbidities. Infusion-/administration-related reactions (IRRs/ARRs). Increased risk of developing CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction; increased cardiac risk eg, HTN, documented CAD, CHF, diastolic dysfunction. Perform baseline cardiac assessment, repeat every 3 mth during & every 6 mth following discontinuation until 24 mth after last dose. Not to be mixed w/ other drugs. Not to be given concurrently w/ anthracycline in MBC & adjuvant treatment settings. Avoid anthracycline-based therapy for up to 7 mth after last dose. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & at least 7 mth thereafter. Avoid use during pregnancy, lactation & for 7 mth after last dose. Not to be used in paed <18 yr. Associated toxicity w/ benzyl alcohol in neonates & childn up to 3 yr. Elderly.

Nasopharyngitis, infection; anaemia, thrombocytopenia, febrile neutropenia, decreased WBC/leukopenia; increased/decreased wt, decreased appetite; insomnia; dizziness, headache, para- & hypoaesthesia, dysgeusia; increased lacrimation, conjunctivitis; decreased ejection fraction; lymphoedema; 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, IRRs/ARRs, pain, pyrexia, peripheral oedema, mucosal inflammation; nail toxicity. Flu, pharyngitis, sinusitis, rhinitis, URTI, UTI; neutropenia; hypersensitivity; depression, anxiety; hypertonia, peripheral neuropathy, somnolence; congestive cardiac failure, cardiomyopathy, supraventricular tachyarrhythmia, palpitation; hot flush, hypotension, HTN, vasodilation; asthma, lung disorder, pleural effusion, pneumonia; acne, dermatitis, dry skin, hyperhidrosis, maculopapular rash, pruritus, onychoclasis; arthritis, back, bone & neck pain, muscle spasms, pain in extremity; oedema, inj site pain, malaise; hepatocellular injury.

Elevated overall exposure of doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone). Higher conc & longer t_½ of capecitabine. Not to be diluted w/ glucose soln due to protein aggregation.

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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