Class: Biological Therapy
Generic Name: ramucirumab
Trade Name: Cyramza®
For which conditions is Cyramza approved for? Cyramza is approved for the following:
- CYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
- CYRAMZA, in combination with erlotinib, is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- 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 epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (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 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.
- CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
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?
- High blood pressure (hypertension)
- 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
- 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.
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