Kanjinti

Metastatic breast cancer (MBC) who have tumors that overexpress HER2 as monotherapy for patients who have received ≥1 chemotherapy regimens for their metastatic disease; in combination w/ paclitaxel in patients who have not received chemotherapy for their metastatic disease; w/ aromatase inhibitor for postmenopausal patients w/ hormone-receptor +ve MBC. HER2 +ve early breast cancer (EBC) chemotherapy (neoadjuvant or adjuvant) & RT (if applicable) following surgery; in combination w/ paclitaxel or docetaxel following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant Kanjinti therapy for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. HER2 +ve metastatic gastric cancer (MGC) in combination w/ capecitabine or 5-fluorouracil & cisplatin.

IV MBC Treatment duration: Until disease progression or unmanageable toxicity. Wkly schedule: Loading dose: 4 mg/kg as a 90-min infusion. Subsequent doses: 2 mg/kg wkly. Can be administered as a 30-min infusion if prior dose was well-tolerated. 3-wkly schedule: Loading dose: 8 mg/kg followed by 6 mg/kg 3 wk later & then 6 mg/kg repeated at 3-wkly interval over approx 90 min infusion. Subsequent doses: Can be administered as 30-min infusion if the initial loading dose was well tolerated. EBC Treatment duration: 1 yr or until disease recurrence or unmanageable toxicity, whichever occurs 1st. 3-wkly schedule: Loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly interval, beginning 3 wk after the loading dose. Alternative wkly schedule (wkly regimen concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide): Loading dose: 4 mg/kg followed by 2 mg/kg every wk. MGC Treatment duration: Until disease progression or unmanageable toxicity. 3-wkly schedule: Loading dose: 8 mg/kg followed by 6 mg/kg 3 wk later & then 6 mg/kg repeated at 3-wkly interval over approx 90 min infusion. Subsequent doses: Can be administered as 30-min infusion if the initial loading dose was well tolerated.

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

Hypersensitivity to benzyl alcohol. Infusion/administration-related reactions; discontinue or slow the infusion rate if infusion reaction occurs & monitor patient until resolution of all observed symptoms. Not to be used for SC & IV push or bolus administration. Extending treatment in EBC >1 yr is not recommended. Potential severe pulmonary events; prior or concomitant therapy w/ other anti-neoplastic therapies known to be associated w/ ILD (eg, taxanes, gemcitabine, vinorelbine & RT). Increased risk of developing CHF or asymptomatic cardiac dysfunction. Patients w/ increased cardiac risk (eg, HTN, documented CAD, CHF, diastolic dysfunction, older age). Avoid anthracycline-based therapy for up to 7 mth after stopping trastuzumab; carefully monitor patients cardiac function if anthracyclines are used. Monitor cardiac function during treatment (eg, every 12 wk). Repeat cardiac assessments as performed at baseline every 3 mth during treatment & every 6 mth following discontinuation until 24 mth from the last trastuzumab administration. W/hold treatment if left ventricular ejection fraction (LVEF) percentage drops 10 points from baseline & to below 50%; repeat LVEF assessment w/in approx 3 wk. Consider discontinuation if LVEF has not improved or has declined further or if clinically significant CHF has developed; if patients have continued decrease in left ventricular function but remain asymptomatic. Dizziness & somnolence may occur during treatment; patients experiencing administration-related symptoms should be advised not to drive or use machines until symptoms resolve completely. Women of childbearing potential should use effective contraception during treatment & for at least 7 mth after treatment. Pregnancy. Avoid breast-feeding during therapy. Childn <18 yr. MBC: Not for concurrent use w/ anthracyclines. EBC: Not recommended in patients w/ history of documented CHF, high-risk uncontrolled arrhythmias, angina pectoris requiring medicinal product, clinically significant valvular disease, evidence of transmural infarction on ECG, poorly controlled HTN. Patients w/ history of MI, history of or present CHF (NYHA class II-IV), other cardiomyopathy, cardiac arrhythmia requiring medication & hemodynamic effective pericardial effusion. Increased incidence of symptomatic & asymptomatic cardiac events upon administration after anthracycline-containing chemotherapy. Concurrent use w/ anthracyclines for neoadjuvant-adjuvant treatment; use only in chemotherapy-naive patients; patients >65 yr.

Nasopharyngitis, infection; anaemia, thrombocytopenia, febrile neutropenia, decreased WBC count/leukopenia, neutropenia; increased/decreased wt, decreased appetite; insomnia; tremor, dizziness, headache, paraesthesia, hypoaesthesia, hypertonia; conjunctivitis, increased lacrimation; increased/decreased BP, irregular heartbeat, cardiac flutter, decreased ejection fraction; lymphoedema, hot flush; wheezing, dyspnoea, cough, epistaxis, oropharyngeal pain, rhinorrhoea; diarrhoea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis; erythema, rash, facial swelling, nail disorder, alopecia, palmar-plantar erythrodysaesthesia syndrome; arthralgia, muscle tightness, myalgia; asthenia, chest pain, chills, fatigue, flu-like illness, infusion/administration-related reaction, pain, pyrexia, peripheral oedema, mucosal inflammation; nail toxicity. Flu, neutropenic sepsis, pharyngitis, sinusitis, rhinitis, URTI, UTI, pneumonia, cystitis, herpes zoster, skin infection, erysipelas, cellulitis; hypersensitivity; anorexia; anxiety, depression, abnormal thinking; peripheral neuropathy, somnolence, dysgeusia, ataxia; dry eye; palpitation, supraventricular tachyarrhythmia, cardiomyopathy, CHF; hypotension, HTN, vasodilation; asthma, lung disorder, pneumonia, pleural effusion; haemorrhoids, dry mouth; hepatocellular injury, hepatitis, liver tenderness; acne, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, pruritus, onychoclasis, dermatitis; arthritis, back/bone/extremity/neck pain, muscle spasms; renal disorder; breast inflammation/mastitis; malaise, oedema, inj site pain; 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.

POM