Ramucirumab: Difference between revisions

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*[[Patients with Child-Pugh B or C Cirrhosis]]
*[[Patients with Child-Pugh B or C Cirrhosis]]
*[[Reversible Posterior Leukoencephalopathy Syndrome]]
*[[Reversible Posterior Leukoencephalopathy Syndrome]]
===Clinical Trials Experience===
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
=====Gastric Cancer=====
*Safety data are presented from two randomized, placebo controlled clinical trials in which patients received CYRAMZA: Study 1, a randomized (2:1), double-blind, clinical trial in which 351 patients received either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks and Study 2, a double-blind, randomized (1:1) clinical trial in which 656 patients received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle plus either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks. Both trials excluded patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or greater, uncontrolled [[hypertension]], major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. Study 1 excluded patients with [[bilirubin]] ≥1.5 mg/dL and Study 2 excluded patients with [[bilirubin]] >1.5 times the upper limit of normal.
=====CYRAMZA Administered as a Single Agent
*Among 236 patients who received CYRAMZA (safety population) in Study 1, median age was 60 years, 28% were women, 76% were White, and 16% were Asian. Patients in Study 1 received a median of 4 doses of CYRAMZA; the median duration of exposure was 8 weeks, and 32 (14% of 236) patients received CYRAMZA for at least six months.
*In Study 1, the most common adverse reactions (all grades) observed in CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were [[hypertension]] and [[diarrhea]]. The most common serious adverse events with CYRAMZA were [[anemia]] (3.8%) and [[intestinal obstruction]] (2.1%). [[Red blood cell]] transfusions were given to 11% of CYRAMZA-treated patients versus 8.7% of patients who received placebo.
[[file:Ramucirumab AR1.png|none|400px]]
Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in Study 1 were: neutropenia (4.7% CYRAMZA versus 0.9% placebo), epistaxis (4.7% CYRAMZA versus 0.9% placebo), rash (4.2% CYRAMZA versus 1.7% placebo), intestinal obstruction (2.1% CYRAMZA versus 0% placebo), and arterial thromboembolic events (1.7% CYRAMZA versus 0% placebo) [see Dosage and Administration (2.3) and Warnings and Precautions (5.1, 5.2)].
Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions.
In Study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in Study 1 was 0.8% and the rate of infusion-related reactions was 0.4% [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.4, 5.5)].
|alcohol=Alcohol-Ramucirumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Ramucirumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
}}

Revision as of 15:38, 17 February 2015

Ramucirumab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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

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

Hypertension

Infusion-Related Reactions

Gastrointestinal Perforations

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:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Gastric Cancer
  • Safety data are presented from two randomized, placebo controlled clinical trials in which patients received CYRAMZA: Study 1, a randomized (2:1), double-blind, clinical trial in which 351 patients received either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks and Study 2, a double-blind, randomized (1:1) clinical trial in which 656 patients received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle plus either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks. Both trials excluded patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or greater, uncontrolled hypertension, major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. Study 1 excluded patients with bilirubin ≥1.5 mg/dL and Study 2 excluded patients with bilirubin >1.5 times the upper limit of normal.

=====CYRAMZA Administered as a Single Agent

  • Among 236 patients who received CYRAMZA (safety population) in Study 1, median age was 60 years, 28% were women, 76% were White, and 16% were Asian. Patients in Study 1 received a median of 4 doses of CYRAMZA; the median duration of exposure was 8 weeks, and 32 (14% of 236) patients received CYRAMZA for at least six months.
  • In Study 1, the most common adverse reactions (all grades) observed in CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. The most common serious adverse events with CYRAMZA were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients versus 8.7% of patients who received placebo.

Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in Study 1 were: neutropenia (4.7% CYRAMZA versus 0.9% placebo), epistaxis (4.7% CYRAMZA versus 0.9% placebo), rash (4.2% CYRAMZA versus 1.7% placebo), intestinal obstruction (2.1% CYRAMZA versus 0% placebo), and arterial thromboembolic events (1.7% CYRAMZA versus 0% placebo) [see Dosage and Administration (2.3) and Warnings and Precautions (5.1, 5.2)].

Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions.

In Study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in Study 1 was 0.8% and the rate of infusion-related reactions was 0.4% [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.4, 5.5)].

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

{{#ask: Page Name::Ramucirumab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ramucirumab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.

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