*For intravenous (IV) infusion only. Do not administer as IV push or bolus. Continue CYRAMZA until disease progression or unacceptable toxicity. In the event of a grade 1 or 2 infusion-related reaction (IRR), reduce infusion rate by 50%.
†See paclitaxel Prescribing Information for additional dosage and administration recommendations.
- 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
Infusion-Related Reactions (IRRs)
- Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, IRRs occurred in 6 out of 37 patients (16%), including 2 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. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for grade 3 or 4 IRRs.
References: 1. CYRAMZA (ramucirumab) [package insert]. India, Eli Lilly & Company (India) Pvt. Ltd.
2. Data on file, Eli Lilly and Company. ONC20141016a.