Ziihera Prescribing Information
Based on the mechanism of action, ZIIHERA can cause fetal harm when administered to a pregnant woman. There are no human or animal data on the use of ZIIHERA in pregnancy. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception while receiving ZIIHERA and for 4 months following the last dose of ZIIHERA.
Based on mechanism of action, ZIIHERA can cause fetal harm when administered to a pregnant woman. There are no human or animal data on the use of ZIIHERA in pregnancy. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Use of ZIIHERA is not recommended during pregnancy (see CLINICAL CONSIDERATIONS). Advise patients of potential risks to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.
Monitor women who received ZIIHERA during pregnancy or within 4 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with local standard of care.
ZIIHERA can cause fetal harm when administered to a pregnant woman
Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA
ZIIHERA can cause embryo-fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.
ZIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test
Select patients for treatment of unresectable or metastatic biliary tract cancer based on HER2-positive (IHC 3+) tumor specimens, as detected by an FDA-approved test
Information on FDA-approved tests for HER2 protein expression in biliary tract cancers is available at: http://www.fda.gov/CompanionDiagnostics.
This indication is approved under accelerated approval based on overall response rate and duration of response
ZIIHERA is supplied as a sterile, preservative free, white lyophilized powder in a single-dose vial. Each single-dose vial (NDC 68727‑950‑01) contains 300 mg zanidatamab‑hrii. Each carton of ZIIHERA (NDC 68727‑950‑02) contains 2 single-dose vials.
Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton until time of reconstitution. Do not freeze.
• Premedicate patients with acetaminophen, an antihistamine and a corticosteroid, 30‑60 minutes prior to each administration of ZIIHERA infusion to prevent potential infusion-related reactions (IRRs). ()2.2 PremedicationsPremedicate all patients 30 to 60 minutes prior to each dose of ZIIHERA to reduce the risk of infusion-related reactions
[see Warnings and Precautions ]:• Administer acetaminophen, an antihistamine (such as diphenhydramine) and a corticosteroid (such as hydrocortisone).
• The recommended dosage of ZIIHERA is 20 mg/kg given as an intravenous infusion once every 2 weeks. ()2.3 Recommended DosageRecommended Dosage and AdministrationThe recommended dosage of ZIIHERA is 20 mg/kg, administered as an intravenous infusion once every 2 weeks until disease progression or unacceptable toxicity.
Missed doseIf a planned dose of ZIIHERA is delayed or missed, administer the dose as soon as possible; do not wait until the next planned dose. Adjust the administration schedule to maintain a 2-week interval between doses.
For injection: 300 mg white lyophilized powder in a single-dose vial.
• Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of ZIIHERA. ()8.3 Females and Males of Reproductive PotentialZIIHERA can cause fetal harm when administered to a pregnant woman
[see Warnings and Precautions (5.1), Use in Specific Populations ].Pregnancy TestingVerify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA
[see Use in Specific Populations ].ContraceptionFemalesZIIHERA can cause embryo-fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.
None.