Eylea 40mg Injection

Aflibercept, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Aflibercept, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in patients who have received Aflibercept. Do not administer Aflibercept to patients with severe hemorrhage. Gastrointestinal Perforation: Discontinue Aflibercept therapy in patients who experience GI perforation. Impaired Wound Healing: Withhold Aflibercept for at least 4 weeks prior to elective surgery. Do not administer for at least 4 weeks following major surgery and until wounds have adequately healed. Discontinue Aflibercept in patients with impaired wound healing. The safety of resumption of Aflibercept after resolution of wound healing complications has not been established. Fistula Formation: Discontinue Aflibercept if fistula occurs. Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Aflibercept if hypertension is not controlled. Discontinue Aflibercept if hypertensive crisis develops. Arterial Thromboembolic Events (ATE): Discontinue Aflibercept if ATE develops. Proteinuria: Monitor urine protein. Suspend Aflibercept for proteinuria of 2 grams per 24 hours or more. Discontinue Aflibercept if nephrotic syndrome or thrombotic microangiopathy (TMA) develops. Neutropenia and Neutropenic Complications: Delay administration of Aflibercept/FOLFIRI until neutrophil count is 1.5 × 10 9 /L or higher. Diarrhea and Dehydration: Incidence of severe diarrhea and dehydration is increased. Monitor elderly patients more closely. Reversible Posterior Leukoencephalopathy Syndrome: Discontinue Aflibercept. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception. Hemorrhage Patients treated with Aflibercept have an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. In patients with mCRC, bleeding/hemorrhage (all grades) was reported in 38% of patients treated with Aflibercept/FOLFIRI compared to 19% of patients treated with placebo/FOLFIRI. Grade 3–4 hemorrhagic events, including gastrointestinal hemorrhage, hematuria, and post-procedural hemorrhage, were reported in 3% of patients receiving Aflibercept/FOLFIRI compared with 1% of patients receiving placebo/FOLFIRI. Severe intracranial hemorrhage and pulmonary hemorrhage/hemoptysis including fatal events have also occurred in patients receiving Aflibercept. Monitor patients for signs and symptoms of bleeding. Do not initiate Aflibercept in patients with severe hemorrhage. Discontinue Aflibercept in patients who develop severe hemorrhage. Gastrointestinal Perforation Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving Aflibercept. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage Gastrointestinal Perforation Impaired Wound Healing Fistula Formation Hypertension Arterial Thromboembolic Events Proteinuria Neutropenia and Neutropenic Complications Diarrhea and Dehydration Reversible Posterior Leukoencephalopathy Syndrome Most common adverse reactions (≥20% incidence) were leukopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache. Clinical 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 safety of Aflibercept in combination with FOLFIRI was evaluated in VELOUR (EFC102621). Patients received Aflibercept 4 mg per kg (N=611) or placebo (N=605) intravenously every two weeks (one cycle) in combination with FOLFIRI. Patients received a median of 9 cycles of Aflibercept/FOLFIRI. The most common Grade 3–4 adverse reactions (≥5%) in the Aflibercept/FOLFIRI arm were neutropenia, diarrhea, hypertension, leukopenia, stomatitis, fatigue, proteinuria, and asthenia. The most frequent adverse reactions leading to permanent discontinuation in ≥1% of patients treated with Aflibercept/FOLFIRI regimen were asthenia/fatigue, infections, diarrhea, dehydration, hypertension, stomatitis, venous thromboembolic events, neutropenia, and proteinuria. The Aflibercept dose was reduced and/or omitted in 17% of patients. Cycle delays >7 days occurred in 60% of patients treated with Aflibercept/FOLFIRI. The most common adverse reactions (≥20%) in the Aflibercept/FOLFIRI arm were leukopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache. Adverse reactions and laboratory abnormalities that occurred in ≥5% (all grades) of patients receiving Aflibercept in combination with FOLFIRI and which occurred at ≥2% higher frequency in patients who received Aflibercept/FOLFIRI compared to those who received placebo/FOLFIRI in VELOUR are shown in Table 1. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.