CYRAMZA 10 mg/mL
ramucirumab · SOLUTION · Eli Lilly and Company
CYRAMZA is a solution containing ramucirumab at 10 mg/mL, taken intravenous. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- CYRAMZA
- Generic Name
- ramucirumab
- NDC Code (Product)
0002-7678- Manufacturer
- Eli Lilly and Company
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125477
- Drug Class
- Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]
- Marketing Start
- 04/21/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CYRAMZA ® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. ( 1.1 ) in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. ( 1.2 ) in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. ( 1.2 ) in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. ( 1.3 ) as a single agent, for the treatment of adults with hepatocellular ca…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous infusion only. Do not administer as an intravenous push or bolus. ( 2.7 ) Premedicate before each infusion. ( 2.1 ) Gastric Cancer : Administer CYRAMZA 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel. ( 2.2 ) Non-Small Cell Lung Cancer : Administer CYRAMZA 10 mg/kg every 2 weeks with daily erlotinib. ( 2.3 ) Administer CYRAMZA 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel. ( 2.3 ) Colorectal Cancer : Administer CYRAMZA 8 mg/kg every 2 weeks prior to FOLFIRI. ( 2.4 ) Hepatocellular Carcinoma : Administer CYRAMZA 8 mg/kg every 2 weeks. ( 2.5 ) 2.1 Premedication Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine-1 receptor antagonist (e.g., diphenhydramine hydrochloride) [see Warnings and Precautions ( 5.6 )] . For patients who have experienced a Grade 1 or 2 IRR, premedicate with a histamine-1 receptor antagonist, dexamethasone (or equivalent), and acetaminophen prior to each CYRAMZA infusion [see Dosage and Administration ( 2.6 )] . 2.2 Recommended Dosage for Gastric Cancer The recommended dosage of CYRAMZA, either as a single agent or in combination with weekly …
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] . Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )] . Impaired Wound Healing [see Warnings and Precautions ( 5.3 )] . Arterial Thromboembolic Events [see Warnings and Precautions ( 5.4 )] . Hypertension [see Warnings and Precautions ( 5.5 )] . Infusion-Related Reactions [see Warnings and Precautions ( 5.6 )] . Worsening of Pre-existing Hepatic Impairment [see Warnings and Precautions ( 5.7 )] . Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.8 )] . Proteinuria Including Nephrotic Syndrome [see Warnings and Precautions ( 5.9 )] . Thyroid Dysfunction [see Warnings and Precautions ( 5.10 )] . The most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. ( 6.1 ) The most common adverse reactions observed in patients treated with CYRAMZA with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. ( …
Frequently Asked Questions
What is CYRAMZA used for?
CYRAMZA contains ramucirumab. It is a solution taken intravenous. Consult your doctor for specific uses.
Is CYRAMZA a controlled substance?
CYRAMZA is not classified as a controlled substance by the DEA.
What is the generic name for CYRAMZA?
The generic name for CYRAMZA is ramucirumab. There are no other listed brand versions of ramucirumab.
What is the NDC code for CYRAMZA 10 mg/mL?
The NDC (National Drug Code) for CYRAMZA 10 mg/mL is 0002-7678, listed by Eli Lilly and Company.
Other CYRAMZA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)