ic reaction. Samples for assessment of HAHA were not collected in studies of adjuvant breast cancer.
6.3 Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of trastuzumab. Because thesereactions are reported voluntarily from a population of uncertain size, it is not always possible to reliablyestimate their frequency or establish a causal relationship to drug exposure.
•Infusion reaction [see Warnings and Precautions (5.2)]
•Oligohydramnios or oligohydramnios sequence, including pulmonary hypoplasia, skeletal abnormalities,and neonatal death [see Warnings and Precautions (5.3)]
•Glomerulopathy [see Adverse Reactions (6.1)]
•Immune thrombocytopenia
•Tumor lysis syndrome (TLS): Cases of possible TLS have been reported in patients treated withtrastuzumab products. Patients with significant tumor burden (e.g. bulky metastases) may be at a higherrisk. Patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which mayrepresent possible TLS. Providers should consider additional monitoring and/or treatment as clinicallyindicated.
7DRUG INTERACTIONS
Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiacdysfunction because of trastuzumab's long washout period based on population PK analysis [see ClinicalPharmacology (12.3)]. If possible, physicians should avoid anthracycline-based therapy for up to 7 months afterstopping trastuzumab products. If anthracyclines are used, the patient's cardiac function should be monitoredcarefully.
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
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 of oligohydramnios sequence,manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see Data). Apprise the patientof the potential risks to a fetus. There are clinical considerations if a trastuzumab product is used in a pregnantwoman or if a patient becomes pregnant within 7 months following the last dose of a trastuzumab product (seeClinical Considerations).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Monitor women who received TRAZIMERA during pregnancy or within 7 months prior to conception foroligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age andconsistent with community standards of care.
Data
Human Data
In post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and ofoligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities andneonatal death. These case reports described oligohydramnios in pregnant women who received trastuzumab
either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased aftertrastuzumab was stopped. In one case, trastuzumab therapy resumed after amniotic index improved, a |
