*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%.
†Irinotecan and folinic acid IV simultaneously; followed by 5-fluorouracil 400 mg/m2 IV bolus; followed by 5-fluorouracil 2400 mg/m2 IV by continuous infusion over 46 to 48 hours.
- 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 IRR, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion1
- Administer CYRAMZA prior to administration of FOLFIRI1
- See Prescribing Information for irinotecan, folinic acid, and 5-fluorouracil for toxicities and dosage recommendations
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.