
A single infusion of CYRAMZA, prior to docetaxel, every 3 weeks1
Recommended Dose for mNSCLC1

The recommended dose of CYRAMZA in combination with docetaxel is 10 milligrams per kilogram on day 1 of a 21-day cycle with an infusion time of 60 minutes. If the first infusion is tolerated, all subsequent CYRAMZA infusions may be administered over 30 minutes. CYRAMZA should be administered as an intravenous (IV) infusion only. Do not administer as IV push or bolus. Continue CYRAMZA until disease progression or unacceptable toxicity. The recommended dose of docetaxel is 75 milligrams per meter squared on day 1 of a 21-day cycle with an infusion time of 60 minutes. In a clinical study, due to an increased incidence of neutropenia and febrile neutropenia, 24 patients in East Asia received a starting dose of docetaxel at 60 milligrams per meter squared every 3 weeks. See docetaxel Prescribing Information for additional dosing and administration recommendations.
* For IV infusion only. Do not administer as IV push or bolus. If the first infusion is tolerated, all subsequent CYRAMZA infusions may be administered over 30 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity. In the event of a Grade 1 or 2 IRR, reduce infusion rate by 50%.1
† In a clinical study, due to an increased incidence of neutropenia and febrile neutropenia, 24 patients in East Asia received a starting dose of docetaxel at 60 mg/m2 every 3 weeks.
Refer to the Prescribing Information for docetaxel for dosage information.
- 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 docetaxel1
- Due to an increased incidence of neutropenia and febrile neutropenia, 24 patients in East Asia received a starting dose (of docetaxel) of 60 mg/m2 every 3 weeks1
- See docetaxel Prescribing Information for toxicities related to docetaxel and dosage recommendations
SELECT IMPORTANT SAFETY INFORMATION
Infusion-Related Reactions (IRR)
- IRR, including severe and life-threatening IRR, occurred in CYRAMZA clinical trials. 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. In 2137 patients with various cancers treated with CYRAMZA in which premedication was recommended or required, the incidence of all Grade IRR ranged from <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.
Dose modifications for CYRAMZA in patients with mNSCLC
For specific adverse events occurring in patients with metastatic non-small cell lung cancer (mNSCLC), the following dose modifications are recommended. For hemorrhage of grade 3 or 4, CYRAMZA should be permanently discontinued. For gastrointestinal perforations (all grades), CYRAMZA should be permanently discontinued. For wound healing complications (all grades), withhold CYRAMZA for 28 days prior to elective surgery and resume CYRAMZA no sooner than 2 weeks after surgery and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established. For arterial thromboembolic events (all grades), CYRAMZA should be permanently discontinued. For severe hypertension, withhold CYRAMZA until controlled with medical management. If severe hypertension cannot be controlled with antihypertensive therapy, permanently discontinue CYRAMZA. Reduce the infusion rate of CYRAMZA by 50 percent if Grade 1 or 2 infusion-related reactions (IRRs) occur. If Grade 3 or 4 IRRs occur, permanently discontinue CYRAMZA. For posterior reversible encephalopathy syndrome (PRES) (all grades), permanently discontinue CYRAMZA if. For the first occurrence of increase urine protein levels (proteinuria) greater than or equal to 2 grams per 24 hours, withhold CYRAMZA until urine protein level is less than 2 gram per 24 hours. Resume CYRAMZA at a reduced dose (from 8 milligrams to 6 milligrams). For reoccurrence of urine protein levels greater than 2 grams per 24 hours following initial dose reduction, withhold CYRAMZA until urine protein level is less than 2 gram per 24 hours. Resume CYRAMZA at a reduced dose (from 6 milligrams to 5 milligrams). If urine protein levels are greater than 3 grams per 24 hours or in the setting of nephrotic syndrome, permanently discontinue CYRAMZA.
IRR=infusion-related reaction; IV=intravenous; mNSCLC=metastatic non-small cell lung cancer.
References
- CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.