ticosteroids. While some patients tolerated trastuzumab infusions, others hadrecurrent severe infusion reactions despite pre-medications.
5.3 Embryo-Fetal Toxicity
Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post-marketing reports,use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequencemanifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify the pregnancy status of females of reproductive potential prior to the initiation of TRAZIMERA.
Advise pregnant women and females of reproductive potential that exposure to TRAZIMERA duringpregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductivepotential to use effective contraception during treatment and for 7 months following the last dose ofTRAZIMERA [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.3)].
5.4 Pulmonary Toxicity
Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includesdyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema,pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events
can occur as sequelae of infusion reactions [see Warnings and Precautions (5.2)]. Patients with symptomaticintrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear tohave more severe toxicity.
5.5 Exacerbation of Chemotherapy-Induced Neutropenia
In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and offebrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressivechemotherapy as compared to those who received chemotherapy alone. The incidence of septic death wassimilar among patients who received trastuzumab and those who did not [see Adverse Reactions (6.1)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
• Cardiomyopathy [see Warnings and Precautions (5.1)]
• Infusion Reactions [see Warnings and Precautions (5.2)]
• Embryo-Fetal Toxicity [see Warnings and Precautions (5.3)]
• Pulmonary Toxicity [see Warnings and Precautions (5.4)]
• Exacerbation of Chemotherapy-Induced Neutropenia [see Warnings and Precautions (5.5)]
The most common adverse reactions in patients receiving trastuzumab products in the adjuvant and metastaticbreast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough,headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of trastuzumab product treatment include CHF, significant decline in left ventricular cardiac
function, severe infusion reactions, and pulmonary toxicity [see Dosage and Administration (2.3)].
In the metastatic gastric cancer setting, the most common adverse reactions (≥ 10%) that were increased(≥ 5% difference) in patients receiving trastuzumab as compared to patients receiving chemotherapy alone wereneutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever,
thrombocytopenia, mucosal inflammati |
