Zuellig Pharma
Concise Prescribing Info
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/ an aromatase inhibitor for post-menopausal patients w/ hormone-receptor positive MBC. 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 docetaxel & carboplatin, & w/ neoadjuvant chemotherapy followed by adjuvant Kanjinti therapy, for locally advanced (including inflammatory) disease or tumors >2 cm in diameter. HER2-positive metastatic gastric cancer (MGC) in combination w/ capecitabine or 5-fluorouracil & cisplatin.
Dosage/Direction for Use
IV MBC Treatment duration: Until progression of disease or unmanageable toxicity. Wkly schedule: Loading dose: 4 mg/kg as a 90-min IV 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 year 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 used w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide): Loading dose: 4 mg/kg. Followed by 2 mg/kg every wk. MGC Treatment duration: Until progression of disease 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.
Special Precautions
Hypersensitivity to benzyl alcohol. Infusion/administration-related reactions. Not 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/ interstitial lung disease eg, taxanes, gemcitabine, vinorelbine & radiation therapy. 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 patient's cardiac function if anthracyclines are used. Monitor cardiac function during treatment (eg, every 12 wk). Repeat cardiac assessments 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) drops 10% from baseline; & repeat LVEF assessment w/in approx 3 wk. Consider treatment discontinuation if LVEF has not improved, or has declined further or if clinically significant CHF has developed; if patients have a continued decrease in left ventricular function, but remain asymptomatic. Contains benzyl alcohol. 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 lactation 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 a medicinal product, clinically significant valvular disease, evidence of transmural infarction on ECG, poorly controlled HTN. Patients w/ history of MI, angina pectoris requiring medication, history of or present CHF, other cardiomyopathy, cardiac arrhythmia requiring medication, clinically significant cardiac valvular disease, poorly controlled HTN, & 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.
Adverse Reactions
Nasopharyngitis, infection; anaemia, thrombocytopenia, febrile neutropenia, leukopenia, neutropenia; increased wt, wt loss, 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, rhinorrhea; 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 reactions, pain, pyrexia, peripheral oedema, mucosal inflammation; nail toxicity. Flu, neutropenic sepsis, pharyngitis, sinusitis, rhinitis, upper resp tract infection, 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; hemorrhoids, 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.
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.
Kanjinti powd for inj 150 mg
Kanjinti powd for inj 440 mg
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