Trumab 440 IV Injection

Warnings & Precautions

Cardiomyopathy: Trazuma can damage the left ventricle of the heart, causing left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy and even cardiac death. It can also lower the left ventricular ejection fraction (LVEF) without causing any symptoms. Patients who receive Trazuma, either alone or combined with other treatment, have a 4 to 6 fold higher chance of symptomatic myocardial dysfunction compared with those who don't receive it. The highest absolute incidence is seen when Trazuma is given together with an anthracycline. Withhold Trazuma if the LVEF falls by 16% or more from the pre-treatment value, or if it drops below the institutional limits of normal and falls by 10% or more from the pre-treatment value. It is not known whether it is safe to continue or restart Trazuma in patients who have developed Trazuma-induced left ventricular cardiac dysfunction, as this has not been studied. Cardiac Monitoring: Your doctor should carry out a thorough cardiac assessment, including the patient's history, a physical examination, and a measurement of LVEF by echocardiogram or MUGA scan. The following schedule is recommended. Measure the baseline LVEF immediately before starting Trazuma. Measure LVEF every 3 months during treatment and when treatment is completed. If Trazuma is withheld because of significant left ventricular cardiac dysfunction, repeat the LVEF measurement at 4 week intervals. After completing Trazuma as part of adjuvant therapy, measure LVEF every 6 months for at least 2 years. Infusion Reactions: Infusion reactions form a group of symptoms, mainly fever and chills, and sometimes nausea, vomiting, pain (in some cases at the tumor site), headache, dizziness, breathlessness, low blood pressure, rash and weakness. Serious and fatal infusion reactions have been reported. Severe reactions, including bronchospasm, anaphylaxis, angioedema, hypoxia and severe hypotension, usually happen during or just after the first infusion. The onset and course vary, though. The reaction may get steadily worse, improve at first and then deteriorate, or appear later after the infusion and worsen quickly. In fatal cases, death came within hours to days after a serious infusion reaction. Stop the Trazuma infusion in any patient who develops breathlessness or clinically significant low blood pressure, and give medical treatment as needed (this may include epinephrine, corticosteroids, diphenhydramine, bronchodilators and oxygen). Keep patients under evaluation and careful monitoring until all signs and symptoms have fully settled. Permanent discontinuation should be strongly considered for all patients who have a severe infusion reaction. There is no data on the best way to identify which patients can safely be given Trazuma again after a severe infusion reaction. Before restarting the infusion, most patients who had a severe reaction were given antihistamines and/or corticosteroids beforehand. Some patients tolerated the infusions well, but others had repeated severe infusion reactions despite these pre-medications. Embryo-Fetal Toxicity: Trazuma can cause harm to the fetus when given to a pregnant woman. Use during pregnancy has led to cases of oligohydramnios and oligohydramnios sequence, which showed up as pulmonary hypoplasia, skeletal abnormalities and neonatal death. Women who could become pregnant should use effective contraception during treatment and for 7 months after the last dose of Trazuma. Pulmonary Toxicity: Trazuma can cause serious and fatal lung toxicity. This includes breathlessness, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome and pulmonary fibrosis. These events can follow infusion reactions. Patients with existing symptomatic lung disease, or with extensive tumor involvement of the lungs causing breathlessness at rest, seem to have more severe toxicity. Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient rates of NCI-CTC Grade 3-4 neutropenia and febrile neutropenia were higher in patients given Trazuma together with myelosuppressive chemotherapy than in those given chemotherapy alone. The rate of septic death was similar between patients who received Trazuma and those who did not.