Hertraz

Hertraz

trastuzumab

Manufacturer:

Biocon

Distributor:

Biocon
Concise Prescribing Info
Contents
Trastuzumab
Indications/Uses
HER2 +ve metastatic breast cancer (MBC); as monotherapy treatment for patients who have received at least 2 chemotherapy regimens; in combination w/ paclitaxel & docetaxel for patients who have not received chemotherapy for their metastatic disease; in combination w/ aromatase inhibitor for postmenopausal patients w/ hormone-receptor +ve MBC not previously treated w/ trastuzumab. HER2 +ve early breast cancer (EBC); in combination w/ paclitaxel or docetaxel following adjuvant chemotherapy; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant trastuzumab for locally advanced disease or tumours >2 cm. In combination w/ capecitabine or 5-fluorouracil & cisplatin for patients w/ HER2 +ve metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment. 
Dosage/Direction for Use
IV infusion Metastatic breast cancer 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose at 3-wkly interval: 6 mg/kg beginning 3 wk after the loading dose. Wkly schedule: Initial loading dose: 4 mg/kg. Maintenance dose: 2 mg/kg beginning 1 wk after the loading dose. Early breast cancer 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose at 3-wkly interval: 6 mg/kg beginning 3 wk after the loading dose. Wkly schedule: Initial loading dose: 4 mg/kg followed by 2 mg/kg every wk concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide. Metastatic gastric cancer 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose at 3-wkly: 6 mg/kg beginning 3 wk after the loading dose.
Contraindications
Hypersensitivity to trastuzumab, murine proteins. Severe dyspnoea.
Special Precautions
Hypersensitivity. Cardiac dysfunction. History of MI, angina pectoris, history or existing CHF (NYHA II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, cardiac valvular disease, poorly controlled HTN, severe pulmonary events; pneumonitis. May impair ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infection, nasopharyngitis; febrile neutropenia, anaemia, neutropenia, decreased WBC/leukopenia; wt loss, anorexia; insomnia; tremor, dizziness, headache, paraesthesia, dysgeusia; conjunctivitis, increased lacrimation; decreased/increased BP, irregular heart beat, palpitation, cardiac flutter, decreased ejection fraction; hot flush; wheezing, dyspnoea, cough, epistaxis, rhinorrhea; diarrhoea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis; erythema, rash, face swelling, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome; arthralgia, muscle tightness, myalgia; asthenia, chest pain, chills, fatigue, flu-like symptoms, infusion-related reactions, pain, pyrexia, mucosal inflammation, peripheral oedema.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Hertraz powd for infusion 440 mg
Packing/Price
(+ 1.1% bacteriostatic water for inj as diluent) 50 mL x 1's
Form
Hertraz powd for soln for infusion 150 mg
Packing/Price
(+ 10-mL diluent) 15 mL x 1's
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