Kanjinti

Kanjinti

trastuzumab

Manufacturer:

Amgen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Trastuzumab
Indications/Uses
Treatment of adult patients w/ HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of patients who have received at least 2 chemotherapy regimens for their metastatic disease (prior chemotherapy must have included at least an anthracycline & a taxane unless patients are unsuitable for these treatments; hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments); in combination w/ paclitaxel for the treatment of patients who have not received chemotherapy for their metastatic disease & for whom an anthracycline is not suitable; in combination w/ docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease; in combination w/ an aromatase inhibitor for the treatment of postmenopausal patients w/ hormone-receptor positive MBC, not previously treated w/ trastuzumab. Treatment of adult patients w/ HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) & radiotherapy (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/ capecitabine or 5-fluorouracil & cisplatin for the treatment of adult patients w/ HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Dosage/Direction for Use
3-wkly schedule MBC Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Wkly schedule MBC Initial loading dose: 4 mg/kg. Maintenance: 2 mg/kg at wkly intervals, beginning 1 wk after the loading dose. 3-wkly schedule EBC Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Wkly schedule EBC Initial loading dose: 4 mg/kg, followed by 2 mg/kg every wk, concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide. 3-wkly schedule metastatic gastric cancer (MGC) 3-wkly schedule Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Patients w/ MBC or MGC should be treated until disease progression. Patients w/ EBC should be treated for 1 yr or until disease recurrence, whichever occurs 1st.
Contraindications
Hypersensitivity to trastuzumab, or murine proteins. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Special Precautions
Increased risk for developing CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction, particularly following anthracycline-containing chemotherapy. Exercise caution in treating patients w/ increased cardiac risk eg, HTN, documented CAD, CHF, LVEF of <55%, older age. In the EBC setting, treatment cannot be recommended in patients w/ history of MI, angina pectoris requiring medical treatment, history of or existing CHF (NYHA class II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled HTN, & haemodynamic effective pericardial effusion. Patients who receive anthracyclines after stopping Kanjinti may possibly be at increased risk of cardiac dysfunction. Do not give concurrently w/ anthracyclines in the MBC or adjuvant treatment EBC setting. Risk of serious infusion-related reactions (ie, dyspnoea, hypotension, wheezing, HTN, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, resp distress, urticaria & angioedema); pre-medication may be used. Risk of severe pulmonary events. Exercise caution for pneumonitis, especially in patients being treated concomitantly w/ taxanes. Minor influence on the ability to drive or use machines. Women of childbearing potential should be advised to use effective contraception during treatment & for 7 mth after treatment has concluded. Pregnancy & lactation.
Adverse Reactions
Infection, nasopharyngitis; febrile neutropenia, anaemia, neutropenia, leukopenia, thrombocytopenia; wt decreased, anorexia; insomnia; tremor, dizziness, headache, paraesthesia, dysgeusia; conjunctivitis, lacrimation increased; BP decreased/increased, heartbeat irregular, palpitation, cardiac flutter, ejection fraction decreased; hot flush; wheezing, dyspnoea, cough, epistaxis, rhinorrhoea; diarrhoea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis; erythema, rash, swelling face, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome; arthralgia, muscle tightness, myalgia; asthenia, chest pain, chills, fatigue, flu-like symptoms, infusion-related reaction, pain, pyrexia, mucosal inflammation, peripheral oedema.
ATC Classification
L01XC03 - trastuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Kanjinti powd for concentrate for soln for infusion 150 mg
Packing/Price
1's
Form
Kanjinti powd for concentrate for soln for infusion 420 mg
Packing/Price
1's
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