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Cyramza ® (ramucirumab)
What are the Recommended Dose and Dose Modifications of Cyramza® (ramucirumab) in NSCLC?
The recommended dose of Cyramza for NSCLC after platinum-based chemotherapy is 10 mg/kg on day 1 of a 21-day cycle, prior to docetaxel infusion, or 10 mg/kg every two weeks in combination with erlotinib for NSCLC with activating EGFR mutations.
Approved Dosing Regimens in NSCLC
Cyramza in combination with erlotinib for the treatment of NSCLC with activating EGFR mutations
The recommended dose of ramucirumab in combination with erlotinib is 10 mg/kg every two weeks.1
Before treatment initiation, epidermal growth factor receptor (EGFR) mutation status should be determined using a validated test method.1See erlotinib prescribing information for the posology and method of administration of erlotinib.
Cyramza in combination with docetaxel for the treatment of NSCLC after platinum-based chemotherapy
The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion.
The recommended dose of docetaxel is 75 mg/m2 administered by intravenous (IV) infusion over approximately 60 minutes on day 1 of a 21 day cycle.
For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered. See docetaxel prescribing information for specific dosing advice.1
Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.1
If a patient experiences a Grade 1 or 2 infusion-related reaction (IRR), premedication must be given for all subsequent infusions. If a patient experiences a second Grade 1 or 2 IRR, administer dexamethasone or equivalent. For subsequent infusions, premedicate with an intravenous histamine H1 antagonist (for example diphenhydramine hydrochloride), paracetamol and dexamethasone, or equivalent medicinal products.1
The infusion rate of ramucirumab should be reduced by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a grade 1 or 2 IRR. Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR.1
The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated. Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension until controlled with medical management.
If the hypertension is medically significant and cannot be controlled safely with antihypertensive therapy, discontinue ramucirumab permanently.1
Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy. If the urine protein is ≥2+ on a dipstick, a 24-hour urine collection should be performed.
Patients should temporarily discontinue ramucirumab therapy if the urine protein level is ≥2 g/24 hours. Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level, outlined in . A second dose reduction, see , is recommended if a urine protein level ≥2 g/24 hours reoccurs.1
Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.1
Initial ramucirumab dose:
First dose reduction to:
Second dose reduction to:
Elective surgery or impaired wound healing
Discontinue ramucirumab therapy temporarily for at least 4 weeks prior to elective surgery. If wound healing complications occur, discontinue therapy temporarily until the wound is fully healed.1
Severe arterial thromboembolic events, gastrointestinal perforations, severe bleeding, spontaneous development of fistula, hepatic encephalopathy or hepatorenal syndrome
Ramucirumab therapy should be permanently discontinued in the event of:
- Severe arterial thromboembolic events
- Gastrointestinal perforations
- Severe bleeding: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events CTCAE Grade 3 or 4 bleeding
- Spontaneous development of fistula
- Hepatic encephalopathy or hepatorenal syndrome1
1Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
Date of Last Review: March 25, 2020