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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)

Visual Gains With Aflibercept Upheld at 52 Weeks in VIBRANT
Source: Medscape Ophthalmology Headlines [2014.12.08]
For macular edema secondary to branch retinal vein occlusion, visual benefit is greater with monthly intravitreal aflibercept injections than with laser therapy, the latest data confirm.
Medscape Medical News

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

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

Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer. [2013]
following, an oxaliplatin-containing regimen... CONCLUSION: Extrapolation of survival curves suggests the mean OS difference for

Aflibercept. [2013]
Aflibercept, an intravenously administered anti-VEGF and antiplacental growth factor (PlGF) agent, has recently been approved by the U.S. Food and Drug Administration in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer who have previously received an oxaliplatin-containing chemotherapy regimen...

Aflibercept for the treatment of neovascular age-related macular degeneration. [2012]
Age-related macular degeneration (AMD) can have devastating effects on vision, especially in its neovascular form. In the last decade, the use of intravitreal pharmacotherapy targeted to vascular endothelial growth factor (VEGF) has significantly improved the visual outcomes in patients with neovascular AMD...

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: 2014-12-08

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