INDICATIONS AND USAGE
ZELVARA (celdatuzumab-mkrz) is indicated, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative, claudin 18.2 (CLDN18.2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. CLDN18.2 positivity should be determined by an FDA-approved test.
Warnings and Precautions
Nausea and Vomiting: ZELVARA can cause severe nausea and vomiting. In the BEACON-1 trial, nausea occurred in 70.2% of patients treated with ZELVARA plus chemotherapy, including Grade 3 events in 14.8%. Vomiting occurred in 64.8%, including Grade 3 events in 12.1%. Administer antiemetic prophylaxis prior to and during treatment. Withhold, dose reduce, or permanently discontinue based on severity.
Infusion-Related Reactions: Infusion-related reactions have been reported. Monitor patients during and after infusion. Interrupt or slow the rate of infusion for mild to moderate reactions. Permanently discontinue for severe or life-threatening reactions.
Embryofetal Toxicity: Based on its mechanism of action and findings from animal studies, ZELVARA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
Adverse Reactions
The most common adverse reactions (≥20%) in patients receiving ZELVARA plus chemotherapy were nausea (70.2%), vomiting (64.8%), decreased appetite (42.1%), fatigue (38.4%), diarrhea (28.7%), and peripheral neuropathy (22.5%).
Serious adverse reactions occurred in 42% of patients treated with ZELVARA plus chemotherapy, including vomiting (8.2%), nausea (4.1%), dehydration (3.8%), and decreased appetite (2.4%). Fatal adverse reactions occurred in 2.1% of patients.
Drug Interactions
No formal drug interaction studies have been conducted with ZELVARA. No clinically significant pharmacokinetic interactions are expected based on the known elimination pathways of celdatuzumab.
Use in Specific Populations
Pregnancy: ZELVARA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Lactation: Advise women not to breastfeed during treatment and for 3 months after the last dose.
Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation. Advise females to use effective contraception during treatment and for 3 months after the last dose.
Pediatric Use: The safety and efficacy of ZELVARA have not been established in pediatric patients.
Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. ZELVARA has not been studied in patients with moderate or severe hepatic impairment.
