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See related Herceptin powd for inj information |
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Manufacturer |
Roche |
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Distributor |
Hong Kong: DKSH |
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Contents |
Trastuzumab |
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Indications |
Treatment of metastatic breast cancer (MBC) w/ overexpress HER2 as monotherapy for patients who have received at least 2 chemotherapy regimens, or in combination w/ paclitaxel for chemotherapy-naive patients whom an anthracycline is not suitable, or in combination w/ docetaxel for chemotherapy-naive patients, or in combination w/ aromatase inhibitor for treatment of postmenopausal patients w/ hormone-receptor positive metastatic breast cancer not previously treated w/ trastuzumab. HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) & radiotherapy (if applicable). In combination w/ capecitabine or 5-fluorouracil & cisplatin as treatment of HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction for patients who have not received prior anti-cancer treatment (MGC). |
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Dosage |
IV infusion only. MBC (wkly schedule) Loading dose: 4 mg/kg body wt as a 90-min IV infusion. Subsequent dose: 2 mg/kg body wt, beginning 1 wk after the loading dose. Administer as a 30-min infusion if prior dose was well-tolerated. EBC (wkly schedule) Loading dose: 4 mg/kg body wt, followed by 2 mg/kg every wk for 1 yr, concomitantly administer paclitaxel following 4 cycles of anthracycline. 3-wkly schedule (MBC, EBC & MGC): Loading dose: 8 mg/kg body wt, followed by 6 mg/kg body wt 3 wk later & then 6 mg/kg body wt repeated at 3-wk intervals administered as infusion over approximately 90 min. If the prior dose was well tolerated, administer as 30-min infusion. |
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Contraindications |
Hypersensitivity to trastuzumab. |
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Special Precautions |
HER2 testing is mandatory prior to initiation of therapy. Monitor cardiac function esp when used w/ anthracycline. Symptomatic intrinsic lung disease or w/ extensive tumour involvement of the lungs. Symptomatic heart failure, history of HTN, CAD, EBC, LVEF ≤55%. Childn <18 yr. Pregnancy & lactation. |
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Adverse Drug Reactions |
Abdominal pain, asthenia, chest pain, chills, fever, headache, pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, rash. Peripheral oedema, fatigue, mucosal inflammation, pyrexia, lethargy, flu-like illness, rigors, alopecia, nail disorder, erythema, constipation, stomatitis, dyspepsia, paraesthesia, dysgeusia, hypoaesthesia, pain in extremity, cough, dyspnoea, nasopharyngitis, increased lacrimation, conjunctivitis, epistaxis, rhinorrhea, lymphoedema, anorexia, increased wt, insomnia, nail toxicity; back, bone & pharyngolaryngeal pain.
View ADR Monitoring Form |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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ATC Classification |
L01XC03 - trastuzumab ; Belongs to the class of monoclonal antibodies antineoplastic agents. Used in the treatment of cancer. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Herceptin powder for injection |
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Herceptin 150 mg x 1's |
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Herceptin 440 mg x 1's |
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Manufacturer: |
Roche |
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Distributor: |
Hong Kong: DKSH |
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