phatemia, and acute renal failure which may representpossible TLS. Providers should consider additional monitoring and/or treatment as clinically indicated.
7 DRUG INTERACTIONS
Anthracyclines
Patients who receive anthracycline after stopping HERCEPTIN HYLECTA may be at increased risk of cardiacdysfunction because of HERCEPTIN HYLECTA’s estimated long washout period [see Clinical Pharmacology(12.3)]. If possible, avoid anthracycline-based therapy for up to 7 months after stopping HERCEPTIN HYLECTA.
If anthracyclines are used, carefully monitor the patient’s cardiac function.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Pharmacovigilance Program
There is a pregnancy pharmacovigilance program for HERCEPTIN HYLECTA. If HERCEPTIN HYLECTA is
administered during pregnancy, or if a patient becomes pregnant while receiving HERCEPTIN HYLECTA or
within 7 months following the last dose of HERCEPTIN HYLECTA, health care providers and patients should
immediately report HERCEPTIN HYLECTA exposure to Genentech at 1-888-835-2555.
Risk Summary
HERCEPTIN HYLECTA can cause fetal harm when administered to a pregnant woman. In post-marketingreports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramniossequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see Data). Apprisethe patient of the potential risks to a fetus. There are clinical considerations if HERCEPTIN HYLECTA is usedin a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of HERCEPTINHYLECTA (see Clinical 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 HERCEPTIN HYLECTA during pregnancy or within 7 months prior to conceptionfor oligohydramnios. 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, and neonatal 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 after use oftrastuzumab was stopped. In one case, therapy with trastuzumab resumed after amniotic index improved andoligohydramnios recurred.
Animal Data
HERCEPTIN HYLECTA for subcutaneous injection contains trastuzumab and hyaluronidase [see Description(11)].
Trastuzumab:
In studies where intravenous trastuzumab was administered to pregnant cynomolgus monkeys during the periodof organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly humandose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (Gestation Days 20 to 50) and late
(Gestation Days 120 to 150) phases of gestation. The resulting concentrations of trastuzumab in fetal serum andamni |
