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Zaltrap (Aflibercept) - Summary

 
 



WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, COMPROMISED WOUND HEALING

Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage [ see Dosage and Administration, Warnings and Precautions ].

Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation [ see Dosage and Administration, Warnings and Precautions ].

Compromised Wound Healing: Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed [ see Dosage and Administration, Warnings and Precautions ].

 

ZALTRAP SUMMARY

Ziv-aflibercept is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa.

ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen [see Clinical Studies].


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NEWS HIGHLIGHTS

Media Articles Related to Zaltrap (Aflibercept)

NICE publishes final guidance for EYLEA for visual impairment due to diabetic macular oedema
Source: Eye Health / Blindness News From Medical News Today [2015.07.23]
Bayer HealthCare is pleased to announce that NICE has made the final recommendation for EYLEA® (aflibercept solution for injection) for the treatment of visual impairment due to diabetic...

more news >>

Published Studies Related to Zaltrap (Aflibercept)

Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. [2012]
Bayer HealthCare, Berlin, Germany) with monthly ranibizumab... CONCLUSIONS: Intravitreal aflibercept dosed monthly or every 2 months after 3

Safety and Efficacy of Combined Yttrium 90 Resin Radioembolization with Aflibercept and FOLFIRI in a Patient with Metastatic Colorectal Cancer. [2015]
Background. When associated with isolated four or fewer liver foci, metastatic colorectal cancer is amenable to surgical resection... An ongoing randomized clinical trial aims to define the role of combined targeted therapy and chemotherapy with radioembolization with Y90.

Systemic levels of vascular endothelial growth factor before and after intravitreal injection of aflibercept or ranibizumab in patients with age-related macular degeneration: a randomised, prospective trial. [2015]
patients with exudative age-related macular degeneration (AMD)... CONCLUSION: After intravitreal aflibercept injection, the systemic VEGF levels

Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial). [2014]
patients with recalcitrant exudative age-related macular degeneration (AMD)... CONCLUSIONS: Aflibercept 2.0 mg treatment maintained mean visual acuity

Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer. [2014]
clinical setting... CONCLUSION: Ziv-aflibercept improved the 3-month PFS in patients who had

more studies >>

Clinical Trials Related to Zaltrap (Aflibercept)

REGN910 (SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies [Recruiting]
This is an open-label, multicenter, ascending, multiple dose study of REGN910 (SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U. S.)

Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery [Recruiting]
This randomized phase II clinical trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.

The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy [Recruiting]
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Aflibercept in Treating Patients With Myelodysplastic Syndromes [Recruiting]
This phase II trial is studying how well aflibercept works in treating patients with myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by blocking blood flow to the cancer

Aflibercept in Treating Patients With Stage II or Stage III Multiple Myeloma That Has Relapsed or Not Responded to Previous Treatment [Recruiting]
This phase II trial is studying the side effects and how well aflibercept works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment. Aflibercept may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer

more trials >>


Page last updated: 2015-08-10

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