Brand Name
Cyramza
Generic Name
Ramucirumab
View Brand Information FDA approval date: April 21, 2014
Classification: Vascular Endothelial Growth Factor Receptor 2 Antagonist
Form: Solution
What is Cyramza (Ramucirumab)?
CYRAMZA ® is a human vascular endothelial growth factor receptor 2 antagonist indicated: as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
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Brand Information
CYRAMZA (ramucirumab)
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/10 mL (10 mg/mL) or 500 mg/50 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial
2CONTRAINDICATIONS
None
3ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Hemorrhage
- Gastrointestinal Perforations
- Impaired Wound Healing
- Arterial Thromboembolic Events
- Hypertension
- Infusion-Related Reactions
- Worsening of Pre-existing Hepatic Impairment
- Posterior Reversible Encephalopathy Syndrome
- Proteinuria Including Nephrotic Syndrome
- Thyroid Dysfunction
3.1Clinical 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.
The data described in the Warnings and Precautions section reflect exposure to CYRAMZA in 2137 patients from six studies: REGARD, RAINBOW, RAISE, REVEL, REACH-2, and RELAY.
3.2Immunogenicity
As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may be misleading.
In clinical trials, 86/2890 (3%) of CYRAMZA-treated patients tested positive for treatment-emergent anti-ramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in 14 of the 86 patients who tested positive for treatment-emergent anti-ramucirumab antibodies.
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of CYRAMZA. Because such reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic system: Thrombotic microangiopathy
- Neoplasms benign, malignant and unspecified: Hemangioma
- Respiratory, thoracic, and mediastinal: Dysphonia
- Vascular: Arterial (including aortic) aneurysms, dissections, and rupture
- Cardiac: Heart failure
4DESCRIPTION
Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells.
CYRAMZA (ramucirumab) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution. CYRAMZA is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-dose vials. CYRAMZA is formulated in glycine (9.98 mg/mL), histidine (0.65 mg/mL), histidine monohydrochloride (1.22 mg/mL), polysorbate 80 (0.1 mg/mL), sodium chloride (4.383 mg/mL), and Water for Injection, USP, pH 6.0.
5HOW SUPPLIED/STORAGE AND HANDLING
CYRAMZA (ramucirumab) injection is a clear to slightly opalescent and colorless to slightly yellow, preservative-free solution supplied in single-dose vials.
- NDC 0002-7669-01
- NDC 0002-7678-01
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake the vial.
6PATIENT COUNSELING INFORMATION
Hemorrhage
Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness
Gastrointestinal Perforations
Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain
Impaired Wound Healing
Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider
Arterial Thromboembolic Events
Advise patients of an increased risk of an arterial thromboembolic event
Hypertension
Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms
Posterior Reversible Encephalopathy Syndrome
Advise patients to inform their health care provider if they develop neurological symptoms consistent with PRES (seizure, headache, nausea/vomiting, blindness, or altered consciousness)
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their health care provider of a known or suspected pregnancy and to use effective contraception during CYRAMZA treatment and for 3 months after the last dose
Lactation
Advise women not to breastfeed during CYRAMZA treatment and for 2 months after the last dose
Infertility
Advise females of reproductive potential that CYRAMZA may impair fertility
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License No. 1891
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