Ramucirumab (Cyramza)

Trade Name : CYRAMZA

Eli Lilly and Company

SOLUTION

Strength 10 mg/mL

RAMUCIRUMAB Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC],VEGFR2 Inhibitors [MoA]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ramucirumab (Cyramza) which is also known as CYRAMZA and Manufactured by Eli Lilly and Company. It is available in strength of 10 mg/mL per ml. Read more

Ramucirumab (Cyramza) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:n
  • 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. ()n
  • in combination with docetaxel, for treatment of 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. ()n
  • in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. ()n
  • as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of u2265400u00a0ng/mL and have been treated with sorafenib. ()n
  • No data
  • For intravenous infusion only.
  • Premedicate before each infusion. ()n
  • Gastric Cancer: Administer CYRAMZA 8u00a0mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel. ()n
  • Non-Small Cell Lung Cancer: Administer CYRAMZA 10u00a0mg/kg on Day 1 of a 21-day cycle prior to docetaxel. ()n
  • Colorectal Cancer: Administer CYRAMZA 8u00a0mg/kg every 2 weeks prior to FOLFIRI. ()n
  • Hepatocellular Carcinoma: Administer CYRAMZA 8u00a0mg/kg every 2 weeks. ()n
  • Injection: 100u00a0mg/10u00a0mL (10u00a0mg/mL) or 500u00a0mg/50u00a0mL (10u00a0mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vialn
  • Injection: 100u00a0mg/10u00a0mL (10u00a0mg/mL) or 500u00a0mg/50u00a0mL (10u00a0mg/mL) solution in a single-dose vial ()n
  • Nonen
  • None ()n
  • No data
  • Hemorrhage: CYRAMZA increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue CYRAMZA in patients who experience severe bleeding. ()n
  • Gastrointestinal Perforations: CYRAMZA increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. ()n
  • Impaired Wound Healing: Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established. ()n
  • Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with CYRAMZA. Permanently discontinue CYRAMZA in patients who experience an ATE. ()n
  • Hypertension: Monitor blood pressure and treat hypertension. Withhold CYRAMZA for severe hypertension. Permanently discontinue CYRAMZA for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy. ()n
  • Infusion-Related Reactions (IRR): Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR. ()n
  • Worsening of Pre-existing Hepatic Impairment: New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis. ()n
  • Posterior Reversible Encephalopathy Syndrome: Permanently discontinue CYRAMZA. ()n
  • Proteinuria Including Nephrotic Syndrome: Monitor for proteinuria. Withhold CYRAMZA for urine protein levels greater than or equal to 2u00a0g per 24 hours. Permanently discontinue CYRAMZA for urine protein levels greater than 3u00a0g per 24 hours or nephrotic syndrome. ()n
  • Thyroid Dysfunction: Monitor thyroid function during treatment. ()n
  • Embryo-Fetal Risk: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception (, , )n
  • The following serious adverse reactions are described elsewhere in the labeling:n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of u226510% and u22652% higher than placebo were hypertension and diarrhea. ()n
  • The most common adverse reactions observed in patients treated with CYRAMZA with paclitaxel at a rate of u226530% and u22652% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. ()n
  • The most common adverse reactions observed in patients treated with CYRAMZA with docetaxel at a rate of u226530% and u22652% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. ()n
  • The most common adverse reactions observed in patients treated with CYRAMZA with FOLFIRI at a rate of u226530% and u22652% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis. ()n
  • The most common adverse reactions observed in single agent CYRAMZA-treated HCC patients at a rate of u226515% and u22652% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities at a rate of u226530% and a u22652% difference in incidence between arms were thrombocytopenia, hypoalbuminemia, and hyponatremia. ()n
  • No data
  • Lactation: Advise not to breastfeed. ()n
  • Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147u00a0kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells.n
  • 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 10u00a0mg/mL in either 100u00a0mg (10u00a0mL) or 500u00a0mg (50u00a0mL) single-dose vials. CYRAMZA is formulated in glycine (9.98u00a0mg/mL), histidine (0.65u00a0mg/mL), histidine monohydrochloride (1.22u00a0mg/mL), polysorbate 80 (0.1u00a0mg/mL), sodium chloride (4.383u00a0mg/mL), and Water for Injection, USP, pH 6.0.n
  • No data
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  • CYRAMZA (ramucirumab) injection is a clear to slightly opalescent and colorless to slightly yellow, preservative-free solution supplied in single-dose vials.n
  • Store vials in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) in the original carton to protect from light until time of use. Do not freeze or shake the vial.n
  • No data
  • PACKAGE LABELING
  • This section contains a representative sample of product package labeling. Product may be manufactured at other manufacturing sites.n
  • PACKAGE CARTON u2013CYRAMZA 100 mg/10 mL single-use vial.
  • NDC 0002-7669-01n
  • Cyramzan
  • (ramucirumab)n
  • Injectionn
  • 100 mg/10 mLn
  • (10 mg/mL)n
  • For Intravenous Infusion Onlyn
  • Must Dilute Prior to Usen
  • Single-Dose Vialn
  • Discard Unused Portionn
  • Keep Refrigeratedn
  • Rx onlyn
  • www.cyramza.comn
  • Lillyn
  • CARTON FOR US ORIGINn
  • CARTON FOR IRELAND ORIGINn
  • PACKAGE CARTON u2013 CYRAMZA 500 mg/50mL single-use vial.
  • NDC 0002-7678-01n
  • Cyramzan
  • (ramucirumab)n
  • Injectionn
  • 500 mg/50 mLn
  • (10 mg/mL)n
  • For Intravenous Infusion Onlyn
  • Must Dilute Prior to Usen
  • Single-Dose Vialn
  • Discard Unused Portionn
  • Keep Refrigeratedn
  • Rx onlyn
  • www.cyramza.comn
  • Lillyn
  • CARTON FOR US ORIGINn
  • CARTON FOR IRELAND ORIGINn

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