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DOSAGE AND ADMINISTRATION
Do not administer CYRAMZA as an intravenous push or bolus.
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.
- 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 reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion [see 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 Premedication and WARNINGS AND PRECAUTIONS].
- 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].
- Interrupt CYRAMZA for urine protein levels ≥ 2 g/24 hours. Reinitiate treatment at a reduced dose of 6 mg/kg every 2 weeks 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 to 5 mg/kg every 2 weeks 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 ADVERSE REACTIONS].
Wound Healing Complications
- Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed [see WARNINGS AND PRECAUTIONS].
Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding
- Permanently discontinue CYRAMZA [see WARNINGS AND PRECAUTIONS].
For toxicities related to paclitaxel, refer to the current prescribing information.
Preparation For Administration
Inspect vial contents for particulate matter and discoloration prior to dilution [see DESCRIPTION]. 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 volume of CYRAMZA and further dilute with only 0.9% Sodium Chloride Injection in an intravenous infusion container to a final volume of 250 mL. Do not use dextrose containing solutions.
- Gently invert the container to ensure adequate mixing.
- DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medications.
- Store diluted infusion for no more than 24 hours at 2°C to 8°C (36°F to 46°F) or 4 hours at room temperature (below 25°C [77°F]).
- Discard vial with any unused portion of CYRAMZA.
- Visually inspect the diluted solution for particulate matter and discoloration prior to administration. If particulate matter or discolorations are identified, discard the solution.
- Administer diluted CYRAMZA infusion via infusion pump over 60 minutes through a separate infusion line. Use of a protein sparing 0.22 micron filter is recommended. Flush the line with sterile sodium chloride (0.9%) solution for injection at the end of the infusion.
Dosage Forms And Strengths
- 100 mg/10 mL (10 mg per mL) solution, single-dose vial
- 500 mg/50 mL (10 mg per mL) solution, single-dose vial
CYRAMZA is supplied in single-dose vials as a sterile, preservative-free solution.
NDC 0002-7669-01 100 mg/10
mL (10 mg/mL), individually packaged in a carton
NDC 0002-7678-01 500 mg/50 mL (10 mg/mL), individually packaged in a carton
Storage And Handling
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. DO NOT FREEZE OR SHAKE the vial.
For product diluted in 0.9% sodium chloride, the chemical and physical stability have been demonstrated for up to 24 hours at 2°C to 8°C (36°F to 46°F) or for 4 hours at room temperature (below 25°C [77°F]). DO NOT FREEZE OR SHAKE the diluted product.
Eli Lilly and Company, Indianapolis, IN 46285, USA. Revised: November 2014
Last reviewed on RxList: 11/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Cyramza Information
Report Problems to the Food and Drug Administration
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