Ramucirumab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Black Box Warning
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WARNING: HEMORRHAGE
See full prescribing information for complete Boxed Warning.
Condition Name: CYRAMZA increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding
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Overview
Ramucirumab is a monoclonal antibody that is FDA approved for the treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy and metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension and diarrhea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Ramucirumab FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ramucirumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ramucirumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ramucirumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ramucirumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ramucirumab in pediatric patients.
Contraindications
None.
Warnings
|
WARNING: HEMORRHAGE
See full prescribing information for complete Boxed Warning.
Condition Name: CYRAMZA increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding
|
Hemorrhage
- CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. In Study 1, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In Study 2, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel.
- Patients with gastric cancer receiving nonsteroidal anti-inflammatory drugs (NSAIDs) were excluded from enrollment in Studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. Permanently discontinue CYRAMZA in patients who experience severe bleeding.
- In Study 3, the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDS or other anti-platelet therapy other than once daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore the risk of pulmonary hemorrhage in these groups of patients is unknown.
Arterial Thromboembolic Events
- Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.
Hypertension
- An increased incidence of severe hypertension occurred in patients receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%) and in patients receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus docetaxel (2%).
- Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment.
- Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.
Infusion-Related Reactions
- Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, IRRs occurred in 6 out of 37 patients (16%), including two severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included 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.
- Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs.
Gastrointestinal Perforations
- CYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In Study 2, the incidence of gastrointestinal perforations was also increased in patients that received CYRAMZA plus paclitaxel (1.2%) as compared to patients receiving placebo plus paclitaxel (0.3%). In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel and 0.3% for placebo plus docetaxel. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.
Impaired Wound Healing
- CYRAMZA has not been studied in patients with serious or non-healing wounds. CYRAMZA is an antiangiogenic therapy with the potential to adversely affect wound healing.
- Withhold CYRAMZA prior to surgery. Resume following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.
Clinical Deterioration in Patients with Child-Pugh B or C Cirrhosis
- Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.
Reversible Posterior Leukoencephalopathy Syndrome
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported with a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death
Adverse Reactions
Clinical Trials Experience
The following adverse drug reactions are discussed in greater detail in other sections of the label:
- Hemorrhage
- Arterial Thromboembolic Events
- Hypertension
- Infusion-Related Reactions
- Gastrointestinal Perforation
- Impaired Wound Healing
- Patients with Child-Pugh B or C Cirrhosis
- Reversible Posterior Leukoencephalopathy Syndrome
Postmarketing Experience
There is limited information regarding Ramucirumab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ramucirumab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ramucirumab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ramucirumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ramucirumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ramucirumab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ramucirumab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ramucirumab in geriatric settings.
Gender
There is no FDA guidance on the use of Ramucirumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ramucirumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ramucirumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ramucirumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ramucirumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ramucirumab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ramucirumab Administration in the drug label.
Monitoring
There is limited information regarding Ramucirumab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ramucirumab and IV administrations.
Overdosage
There is limited information regarding Ramucirumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ramucirumab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ramucirumab Mechanism of Action in the drug label.
Structure
There is limited information regarding Ramucirumab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ramucirumab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ramucirumab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ramucirumab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ramucirumab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ramucirumab How Supplied in the drug label.
Storage
There is limited information regarding Ramucirumab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ramucirumab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ramucirumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ramucirumab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ramucirumab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.