platin, and a fluoropyrimidine.
2 DOSAGE AND ADMINISTRATION
Do not administer CYRAMZA as an intravenous push or bolus.
2.1 Recommended Dose and Schedule
The recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity.
When given in combination, administer CYRAMZA prior to administration of paclitaxel.
Non-Small Cell Lung Cancer
The recommended dose of CYRAMZA is 10 mg/kg administered by intravenous infusion over 60 minutes on day 1 of a 21-day cycle prior to docetaxel infusion. Continue CYRAMZA until disease progression or unacceptable toxicity.
Colorectal Cancer
The recommended dose of CYRAMZA is 8 mg/kg every 2 weeks administered by intravenous infusion over 60 minutes prior to FOLFIRI administration. Continue CYRAMZA until disease progression or unacceptable toxicity.
2.2 Premedication
Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride).
For patients who have experienced a Grade 1 or 2 infusion-related reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion [see Dosage and Administration (2.3)].
2.3 Dose Modifications
Infusion-Related Reactions (IRR)
Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs.
Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)].
Hypertension
Interrupt CYRAMZA for severe hypertension until controlled with medical management.
Permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with antihypertensive therapy [see Warnings and Precautions (5.3)].
Proteinuria
Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment at a reduced dose (see Table 1) once the urine protein level returns to <2 g/24 hours. If the protein level ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose (see Table 1) once the urine protein level returns to <2 g/24 hours.
Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of nephrotic syndrome [see Warnings and Precautions (5.9) and Adverse Reactions (6.1)].
Table 1: CYRAMZA Dose Reductions for Proteinuria
Wound Healing Complications
Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed [see Warnings and Precautions (5.6)].
Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding
Permanently discontinue CYRAMZA [see Warnings and Precautions (5.1, 5.2, 5.5)].
For toxicities related to paclitaxel, docetaxel, or the components of FOLFIRI, refer to the current prescribing information.
2.4 Preparation for Administration
Inspect vial contents for particulate matter and discoloration prior to dilution [see Description (11)]. Discard the vial, if particulate matter or discolorations are identified. Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light.
Calculate the dose and the required volume of CYRAMZA needed to prepare the infusion solution. Vials contain either 100 mg/10 mL or 500 mg/50 mL at a concentration of 10 mg/mL solution of CYRAMZA.
Withdraw the required v |
