FDA

Vykoura

Approved 3 Feb 2026Intramuscular, IntravenousSolution

The FDA lists this product in 3 strengths and forms.

Official labelAsk Osler about it

Indications

VYKOURA is indicated for:

1.1Rescue

after high-dose methotrexate (MTX) therapy in adult and pediatric patients.

1.2Reducing

the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate elimination or Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients.

1.3Treatment

of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible.

1.4Treatment

of patients with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use VYKOURA is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. VYKOURA is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adult and pediatric patients.

( 1.1 ) Reducing the toxicity of methotrexate in adult and pediatric patients with impaired methotrexate elimination or folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients. ( 1.2 ) Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. ( 1.3 ) Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil.

( 1.4 ) Limitations of Use : VYKOURA is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. ( 1.3 )

Contraindications

Indications

VYKOURA is indicated for:

1.1Rescue

after high-dose methotrexate (MTX) therapy in adult and pediatric patients.

1.2Reducing

1.3Treatment

of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible.

1.4Treatment

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.

6.1Clinical 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%

Vykoura

Indications

1.1Rescue

1.2Reducing

1.3Treatment

1.4Treatment

Contraindications

Two medicines in one question?

Vykoura

Indications

1.1Rescue

1.2Reducing

1.3Treatment

1.4Treatment

Contraindications

Two medicines in one question?

Warnings and precautions

5.1Hypersensitivity

Interactions

7.1Effects of Other Drugs on

7.2Effects of

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information

At a glance