Class: Biological Therapy 

Generic Name:  ramucirumab

Trade Name:  Cyramza®

For which conditions is this drug approved? Cyramza is approved for the treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma on or after flouropyrimidine- or platinum based therapy, and for metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy in combination of docetaxel. Cyramza is also used in combination with Folfiri for treatment of metastatic colorectal cancer that has progressed after first line therapy.

What is the mechanism of action? Cyramza is a targeted therapy known as a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist. By targeting VEGFR2, a protein that helps new blood vessels form, it inhibits the growth of new blood vessels in tumors and, as a result, starves tumors of nutrients needed for growth.

How is Cyramza typically given (administered)? Cyramza is administered by intravenous infusion.

How are patients typically monitored? Cyramza can place patients at an increased risk of an arterial thromboembolic event (a sudden interruption of blood flow to an organ or body part due to a clot). As a precaution, patients should undergo routine blood pressure monitoring.

What are the most common side effects of treatment with Cyramza?

• Diarrhea
• High blood pressure (hypertension)
• Fatigue
• Low white blood cells
• Nose bleeds
• Oral inflammation or ulcers
• Decreased appetite

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects? Patients should follow their prescribed infusion schedule for Cyramza. They should also discuss with their healthcare provider any health conditions or concerns and all medications they are taking, prescription and over the counter.

Are there any special precautions patients should be aware of before starting treatment?

• Cyramza can cause hypertension, infusion-related reactions, elevated protein levels, and thyroid dysfunction. Patients will be monitored during treatment.
• Patients receiving Cyramza should consult their healthcare provider before undergoing surgery because Cyramza can impair wound healing.
• Cyramza may affect ability to maintain pregnancy and may harm a baby, before and after birth (postnatal development). Women are advised to avoid becoming pregnant during and for at least three months following treatment with Cyramza.
• Mothers should not nurse during Cyramza treatment.
• Advise patients of an increased risk of an arterial thromboembolic event.

When should patients notify their physician? Cyramza can cause severe bleeding. Patients should contact their health care provider for bleeding or symptoms of bleeding including lightheadedness.

Patients should also notify their healthcare provider if they experience the following:

• Severe diarrhea
• Vomiting
• Severe abdominal pain
• Elevated blood pressure or symptoms of high blood pressure including severe headache, lightheadedness, or neurologic symptoms (such as burning, numbness, prickling sensations, muscle weakness or paralysis, and sensitivity)

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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