Advanced or metastatic gastric or GEJ adenocarcinoma
A single infusion of CYRAMZA every 2 weeks, for monotherapy or in combination with paclitaxel1
- Prior to each CYRAMZA infusion, premedicate all patients with an IV histamine H1 antagonist (eg, diphenhydramine hydrochloride)1
- For patients who have experienced a grade 1 or 2 infusion reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion1
- When given in combination, administer CYRAMZA prior to administration of paclitaxel1
- Prior to administration of each dose of paclitaxel, patients were required to have adequate hematopoietic and hepatic function. The paclitaxel dose was permanently reduced in increments of 10 mg/m2 for a maximum of two dose reductions for grade 4 hematologic toxicity or grade 3 paclitaxel-related non-hematologic toxicity
- For toxicities related to paclitaxel, refer to the current paclitaxel Prescribing Information
SELECT IMPORTANT SAFETY INFORMATION
- Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, IRRs occurred in 6 out of 37 patients (16%), including two severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
- Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA in which premedication was recommended or required, the incidence of all Grade IRRs occurred between <1-9%. Grade 3-5 IRRs incidence was <1%.
- Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Premedicate prior to each CYRAMZA infusion. Reduce the infusion rate by 50% for Grade 1-2 IRRs. Permanently discontinue CYRAMZA for Grade 3-4 IRRs.