Composition
Inf 440 mg: per 20 ml: Trastuzumab 440mg. Inf 160 mg: Trastuzumab 160 mg. Inf 100 mg: Trastuzumab 100 mg.
Indications & Dosage
Monotherapy for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer where trastuzumab is given separately or in combination, or recurrence of diesease during or within 6 months of completing adjuvant therapy: BY IV INF: Adults: 4mg/kg IV over 90 mins. Maintenance: 2mg/kg IV over 30 min every week.
Administration
Do not administer as an IV push or bolus only IV infusion loading doses or infused over 90 min. Reconstitute each 440 mg vial with 20 ml of bacteriostatic water for injection, containing benzyl alcohol 1.1% as a preservative, to yield a multi-dose solution containing trastuzumab 21 mg/ml. In patientswith hyper-sensitivity to benzyl alcohol, reconstitute with 20 ml of SWFI without preservative to yield a single-use solution. Using a sterile syringe, slowly inject 20 ml of the diluents into the vial containing the lyophilizied cake of trastuzumab. The streamof diluent should be directed into the lyophilized cake. Swirlthe vial gently to aid reconstitution. Do not shake. Slight foaming may be present upon reconstitution. Allow the vialto stand undisturbed for approximately 5min.
Stability
Vials are stable at 2o C-8o C (36o F-46o F) prior to reconstitution a vial of trastuzumab reconstituted with bacteriostatic water for injection, as supplied, is stable for 28 days after reconstitution when refrigerated between 2o C-8o C (36o F-46o F). Discard any remaining multi-dose reconstituted Solution after 28 days. A vial of trastuzumab reconstituted with unpreserved SWFI should be used within 24 hours. Discard any unused portion. The solution of trastuzumab for infusion diluted in polyvinyl chloride or polyethylene bags containing 0.9% NaCl should be stored between 2o C-8o C (36o F-46o F) for no more than 24 hours prior to use. Do not Freeze reconstituted or diluted solutions.
Contraindications
Hypersensitivity to murine proteins, severe dyspnoea.
Precautions
Cardiavascular disease, congestive heart failure, left ventricular dysfunction, hypertension, coronary artery disease, uncontrolled arrhythmias, dyspnoea at rest; increased risk of pulmonary events, patients over 75 years, peripheral neuropathy (temporarily discontinue), recent history of myocardial infarction, recent history of unstable angina
Interactions
Anthracyclines, cyclophosphamide.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Arthralgia,blurred vision, chills, conjunctivitis, dysgeusia, GI upset, dyspepsia, dyspnea, epistaxis, gingival bleeding, haemorrhage, hand-foot syndrome,hypertension, hypokalaemia, increased lacrimation, left ventricular dysfunction, malaise, memory impairment, myalgia, nail disorder, peripheral neuropathy, peripheral oedema, pruritus, pyrexia, rash, thrombocytopenia, urinary tract infection, urticaria, hepatic failure, hepatic toxicity, interstitial lung disease, nodular regenerative hyperplasia, pneumonitis,alopecia, bone-marrow suppression, extravasation, hyperuricaemia, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting