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KANJINTI(trastuzumab-anns)for injection, for intravenous useInitial U.S.(八)
red to a pregnant woman. In post-marketingreports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramniossequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify the pregnancy status of females of reproductive potential prior to the initiation of KANJINTI.
Advise pregnant women and females of reproductive potential that exposure to KANJINTI 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 ofKANJINTI [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 pulmonaryedema, 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)]. Patientswith symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting indyspnea at rest, appear to have more severe toxicity.
5.5 Exacerbation of Chemotherapy-Induced Neutropenia
In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3–4 neutropeniaand of febrile neutropenia were higher in patients receiving trastuzumab in combination withmyelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidenceof septic death was similar among patients who received trastuzumab and those who did not [see AdverseReactions (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 andmetastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections,increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactionsrequiring interruption or discontinuation of trastuzumab product treatment include CHF, significantdecline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity [see Dosageand 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
were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections,fever, thrombocytopenia, mucosal inflammation,nasopharyngitis, and dysgeusia. The most commonadverse reactions which resulted in discontinuation of trastuzumab treatment in the absence of diseaseprogression were infection, diarrhea, and febrile neutropenia.
6.1 Clinical Trials Experience
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