Zydus Cadila




Mega Lifesciences
Concise Prescribing Info
HER2 overexpressing metastatic breast cancer (MBC). Combination therapy w/ aromatase inhibitor in HER2 overexpressing & hormone receptor-positive MBC. HER2 overexpressing early breast cancer following surgery, neo-adjuvant or adjuvant chemotherapy &, if applicable, radiotherapy. Adjuvant treatment in HER2 overexpressing node positive or negative breast cancer in combination w/ doxorubicin, cyclophosphamide, & either paclitaxel or docetaxel; docetaxel & carboplatin. Combination therapy w/ capecitabine or 5-fluorouracil & cisplatin in patients w/ HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-cancer treatment.
Dosage/Direction for Use
IV infusion Wkly schedule: Loading dose: Initially 4 mg/kg as 90-min IV infusion. Subsequent dose: 2 mg/kg as 30-min infusion wkly. Alternative 3-wkly schedule: 1st loading dose of 8 mg/kg over approx 90 min followed by 6 mg/kg repeated at 3 wkly intervals, subsequent doses may be administered as 30-min infusion, if previous dose was well tolerated.
Special Precautions
Not to be administered as IV push or bolus. Evaluate cardiac function prior & during treatment, especially w/ prior anthracycline & cyclophosphamide exposure. Cardiac assessment should be repeated 3 mthly during treatment & 6 mthly after discontinuation until 24 mth from last administration. Discontinue treatment for cardiomyopathy, anaphylaxis, angioedema, interstitial pneumonitis or acute resp distress syndrome, severe or life-threatening infusion-related reactions & in patients w/ continued decrease in LVEF but remain asymptomatic. Perform HER2 testing prior to initiation of therapy. To reduce risk of infusion-related reactions, premedication may be used. Discontinue infusion or slow the rate of infusion if infusion reaction occurs. Increased risk of interstitial lung disease w/ prior or concomitant anticancer eg, gemcitabine, taxanes, vinorelbine & radiation therapy. Patients experiencing dyspnoea at rest due to complications of advanced malignancy/comorbidities are at risk of fatal infusion reactions & should not be treated w/ trastuzumab. Use w/ caution in pneumonitis especially w/ concomitant therapy w/ taxanes. Patients experiencing infusion-related symptoms should not drive & use machines. Avoid pregnancy & lactation. Associated toxicity w/ benzyl alcohol in neonates & childn up to 3 yr.
Adverse Reactions
Anaemia, neutropenia; stomatitis, vomiting; chills; arthralgia; peripheral neuropathy; alopecia.
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.
Vivitra lyo powd for infusion soln
(multi-dose + 20 mL bacteriostatic water for injection (diluent)) 1's
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