"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
CYRAMZA®as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy.
Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
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.
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.
- 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.
- 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].
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 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 (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 and ADVERSE REACTIONS].
Table 1: CYRAMZA Dose Reductions for Proteinuria
|Initial CYRAMZA Dose||First Dose Reduction to:||Second Dose Reduction to:|
|8 mg/kg||6 mg/kg||5 mg/kg|
|10 mg/kg||8 mg/kg||6 mg/kg|
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, docetaxel, or the components of FOLFIRI, 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.
Revised: April 2015 Eli Lilly and Company, Indianapolis, IN 46285, USA. Revised: April 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/14/2015
Additional Cyramza Information
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