Kanjinti

Trastuzumab

Treatment of adult patients w/ HER2 +ve metastatic breast cancer (MBC) as monotherapy in 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 +ve patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments); in combination w/ paclitaxel for patients who have not received chemotherapy for their metastatic disease & for whom an anthracycline is not suitable; in combination w/ docetaxel for patients who have not received chemotherapy for their metastatic disease; in combination w/ an aromatase inhibitor for postmenopausal patients w/ hormone-receptor +ve MBC not previously treated w/ trastuzumab. Treatment of adult patients w/ HER2 +ve early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) & 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 trastuzumab therapy for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Treatment of adult patients w/ HER2 +ve metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease in combination w/ capecitabine or 5-fluorouracil & cisplatin.

IV infusion Administer loading dose as 90-min IV infusion. Subsequent doses may be administered as 30-min infusion if initial loading dose was well tolerated. MBC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals, 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. Treatment duration: Until disease progression. EBC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Wkly schedule: Initially 4 mg/kg followed by 2 mg/kg every wk, concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide. Treatment duration: For 1 yr or until disease recurrence, whichever occurs first. Metastatic gastric cancer (MGC) 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals beginning 3 wk after the loading dose. Treatment duration: Until disease progression.

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

Infusion-related reactions & hypersensitivity. Increased risk for developing CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy. Patients w/ increased cardiac risk (eg, HTN, documented CAD, CHF, LVEF of <55%, older age). All candidates for treatment especially whose w/ prior anthracycline & cyclophosphamide exposure should undergo baseline cardiac assessment including history & physical exam, ECG, echocardiogram, &/or multigated acquisition (MUGA) scan or magnetic resonance imaging; repeat every 3 mth during treatment & every 6 mth following discontinuation of treatment until 24 mth from the last administration. Avoid anthracycline- based therapy for up to 7 mth after stopping treatment; carefully monitor cardiac function if anthracyclines are used. Monitor cardiac function during treatment (eg, every 12 wk). Consider discontinuing therapy if patients have a continued decrease in left ventricular function, but remain asymptomatic; if LVEF has not improved or further declined, or symptomatic CHF has developed. Do not give concurrently w/ anthracyclines in the MBC settings & EBC adjuvant treatment settings. Extending treatment in EBC beyond 1 yr is not recommended. Repeat cardiac assessments, as performed at baseline every 3 mth during treatment & every 6 mth following discontinuation of treatment until 24 mth from the last administration for patients w/ EBC. Further monitoring is recommended in patients who receive anthracycline-containing chemotherapy, should occur yrly up to 5 yr from the last administration, or longer if a continuous decrease of LVEF is observed. Not 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 (HTN controlled by standard medical treatment eligible), & haemodynamic effective pericardial effusion. Concurrently use w/ anthracyclines only in chemotherapy-naïve patients & only w/ low-dose anthracycline regimens (ie, max cumulative doses of doxorubicin 180 mg/m² or epirubicin 360 mg/m²) in patients w/ EBC eligible for neoadjuvant-adjuvant treatment. Risk factors associated w/ ILD including prior or concomitant therapy w/ other antineoplastic therapies known to be associated w/ it eg, taxanes, gemcitabine, vinorelbine & RT. Do not use in patients experiencing dyspnoea at rest due to complications of advanced malignancy & comorbidities; may be at increased risk of fatal infusion reaction or pulmonary events. Pneumonitis, especially in patients being treated w/ taxanes. May have a minor influence on the ability to drive or use machines. Women of childbearing potential should use effective contraception during treatment & for 7 mth after treatment. Pregnancy. Should not be used during lactation (& for 7 mth after the last dose).

Infection, nasopharyngitis; febrile neutropenia, anaemia, neutropenia, decreased WBC/leukopenia, thrombocytopenia; decreased wt/wt loss, anorexia; insomnia; tremor, dizziness, headache, paraesthesia, dysgeusia; conjunctivitis, increased lacrimation; decreased/increased BP, irregular heartbeat, palpitation, cardiac flutter, decreased ejection fraction; 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. Neutropenic sepsis, cystitis, herpes zoster, flu, sinusitis, skin infection, rhinitis, upper resp tract infection, UTI, erysipelas, cellulitis, pharyngitis; hypersensitivity; anxiety, depression, abnormal thinking; peripheral neuropathy, hypertonia, somnolence, ataxia; dry eye; cardiac failure (congestive), supraventricular tachyarrhythmia, cardiomyopathy; hypotension, vasodilatation; pneumonia, asthma, lung disorder, pleural effusion; haemorrhoids, dry mouth; hepatocellular injury, hepatitis, liver tenderness; acne, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, pruritus, onychoclasis, dermatitis; arthritis, back/bone pain, muscle spasms, neck pain, pain in extremity; renal disorder; breast inflammation/mastitis; malaise, oedema; contusion.

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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