Generic Name: ramucirumab
Date of Approval: April 21, 2014
Company: Eli Lilly and Company

Treatment for: Advanced Gastric Cancer; Non-Small Cell Lung Cancer

FDA Approves Cyramza

The U.S. Food and Drug Administration (FDA) has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced gastric cancer, after prior fluoropyrimidine- or platinum-containing chemotherapy.

Cyramza (ramucirumab injection 10 mg/mL solution) was approved based on results of REGARD, a multicenter, randomized, placebo-controlled, double-blind trial of patients with locally advanced or metastatic gastric cancer including gastroesophageal junction adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy.

On December 12, 2014, the U.S. Food and Drug Administration expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

What is Cyramza?

Cyramza (ramucirumab) is a cancer medication called a vascular endothelial growth factor (VEGF) Receptor 2 antagonist. It works by blocking the blood supply to tumors.

Slideshow: Flashback: FDA Drug Approvals 2013

It is used to treat advanced gastric cancer and non-small cell lung cancer.

What is the most important information I should know about Cyramza?

The labeling for Cyramza contains a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal events. Cyramza treatment should be discontinued immediately in patients who experience severe bleeding.

Do not use Cyramza if you are pregnant. It could harm the unborn baby.

Cyramza may cause serious side effects. Contact your healthcare provider immediately if you experience:

  • Severe Bleeding which may be fatal. Symptoms of hemorrhage (severe bleeding) can include lightheadedness. Treatment should be stopped immediately and permanently in patients who experience severe bleeding.
  • Arterial Thromboembolic Events including myocardial infarction, cardiac arrest, cerebrovascular accident,and cerebral ischemia. Treatment should be stopped immediately and permanently in patients who experience arterial thromboembolic events.
  • Hypertension. Your health care provider should routinely monitor your blood pressure while you are receiving treatment, and should be contacted immediately if you experience symptoms from high blood pressure including severe headache, lightheadedness, or neurologic symptoms.
  • Gastrointestinal Perforations. Symptoms include severe abdominal pain, chills, fever, nausea and vomiting. Treatment should be stopped immediately and permanently in patients who experience gastrointestinal perforations.
  • Clinical Deterioration in Child-Pugh B or C Cirrhosis. Tell your doctor if you have Child-Pugh B or C cirrhosis. Potential benefits will need to be weighed up against the risks of clinical deterioration of your condition.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Symptoms include headache, nausea, vomiting, altered mental status, seizures, stupor, and visual disturbances

Cyramza may also cause infusion-related reactions including rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension.

Advise your health care provider if you experience severe diarrhea, vomiting, or severe abdominal pain.

Before using Cyramza

Before starting treatment, tell your doctor if you are allergic to any drugs.

Pregnancy Category C: Based on its mechanism of action, Cyramza may cause fetal harm. Females of child bearing potential should avoid getting pregnant, and should use adequate birth control, while receiving Cyramza and for at least 3 months after the last dose.

Do not breast feed an infant while you are being treated with Cyramza. It may harm your baby.

Let your health care provider know if you are to undergo surgery. Cyramza has the potential to impair wound healing.

How is Cyramza given?

Cyramza is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting, usually every two weeks. It will be given slowly over a period of 60 minutes.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your injection.

What other drugs will affect Cyramza?

There may be other drugs that can interact with . Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Cyramza side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

The most common side effects of Cyramza include:

  • hypertension
  • diarrhea
  • headache
  • hyponatremia

The most common serious side effects include:

  • anemia
  • intestinal obstruction

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.