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
- Infusion-related reactions (IRR), including severe and life threatening IRR, occurred in CYRAMZA clinical trials. The majority of IRR across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRR 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 IRR occurred between <1-9%. Grade 3-5 IRR incidence was <1%.
- Premedicate prior to each CYRAMZA infusion. Monitor patients during the infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Reduce the infusion rate by 50% for Grade 1-2 IRR. Permanently discontinue CYRAMZA for Grade 3-4 IRR.