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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity : Hypersensitivity reactions, including anaphylactic reactions and urticaria can occur. Withhold or permanently discontinue VYKOURA based on the severity of hypersensitivity. ( 5.1 ) Hypercalcemia : Due to calcium content, inject no more than 16 mL (160 mg) of VYKOURA intravenously per minute. ( 5.2 ) Risk of Administration Errors : Do not administer VYKOURA intrathecally. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylactic reactions and urticaria, have been reported following the administration of leucovorin. VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin, levoleucovorin, or folic acid [see Contraindications (4) ]. Withhold or permanently discontinue VYKOURA based on the severity of hypersensitivity. 5.2 Hypercalcemia Because of the calcium content of the VYKOURA, do not administer more than 160 mg of VYKOURA intravenously per minute [see Dosing and Administration (2.6) ] . 5.3 Risk of Administration Errors In the treatment of accidental overdosages of intrathecally administered folic acid antagonists, do not administer VYKOURA intrathecally. VYKOURA MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hypercalcemia [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with leucovorin rescue are stomatitis and vomiting. ( 6.1 ) The most common adverse reactions (>50%) in patients receiving leucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 clinical practice. Table 2 summarizes significant adverse events occurring in 316 patients treated with the leucovorin/5-fluorouracil combinations compared against 70 patients treated with 5-fluorouracil alone for advanced colorectal carcinoma. These data are taken from the Mayo/NCCTG large multicenter prospective trial evaluating the efficacy and safety of the combination regimen. Table 2: Percentage of Patients Treated with Leucovorin and Fluorouracil for Advanced Colorectal Carcinoma Reporting Adverse Experiences or Hospitalized for Toxicity High LV = Leucovorin 200 mg/m 2 , Low LV = Leucovorin 20 mg/m 2 Any = percentage of patients reporting toxicity of any severity Grade 3+ = percentage of patients reporting toxicity of Grade 3 or higher (High LV)/5-FU (N = 155) (Low LV)/5-FU (N = 161) 5-FU Alone (N = 70) Any (%) Grade 3+ (%) Any (%) Grade 3+ (%) Any (%) Grade 3+ (%) Leukopenia 69 14 83 23 93 48 Thrombocytopenia 8 2 8 1 18 3 Infection 8 1 3 1 7 2 Nausea 74 10 80 9 60 6 Vomiting 46 8 44 9 40 7 Diarrhea 66 18 67 14 43 11 Stomatitis 75 27 84 29 59 16 Constipation 3 0 4 0 1 - Lethargy/Malaise/Fatigue 13 3 12 2 6 3 Alopecia 42 5 43 6 37 7 Dermatitis 21 2 25 1 13 - Anorexia 14 1 22 4 14 - Hospitalization for Toxicity 5% 15% 7%