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LABELS · c655613e-4381-461e-8e2d-4121be761c04

VYKOURA

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-03-12
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 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. 1.3 Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. 1.4 Treatment 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 )
Full extracted label fields
application numbers
  1. NDA220406
boxed warning exact
    brand names
    1. VYKOURA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d122b875-435e-4e00-b945-7a0546df95c2
    generic names
    1. LEUCOVORIN CALCIUM
    id
    c655613e-4381-461e-8e2d-4121be761c04
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 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. 1.3 Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. 1.4 Treatment 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 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Avyxa Pharma, LLC
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      1. cancer
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      1. 83831-147-05
      2. 83831-148-35
      3. 83831-149-50
      product ndcs
      1. 83831-147
      2. 83831-148
      3. 83831-149
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      1. HUMAN PRESCRIPTION DRUG
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        2. 2735355
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          all indexed label documents
          1. Appl No
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            Application Docs Date
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            Submission No
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            Submissions Public Notes
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          products
          1. Active Ingredient
            LEUCOVORIN CALCIUM
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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          2. Active Ingredient
            LEUCOVORIN CALCIUM
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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            Reference Standard
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            Strength
            EQ 350MG BASE/35ML (EQ 10MG BASE/ML)
            marketing status
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          3. Active Ingredient
            LEUCOVORIN CALCIUM
            Appl No
            220406
            Drug Name
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            Form
            SOLUTION;INTRAMUSCULAR, INTRAVENOUS
            Product No
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            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
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        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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        1 INDICATIONS AND USAGE VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate eliminatio
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              1 INDICATIONS AND USAGE VYKOURA is indicated for:
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              1 INDICATIONS AND USAGE VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 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 o
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                  1 INDICATIONS AND USAGE VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 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. 1.3 Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. 1.4 Treatment of patients with metastatic colorectal cancer in c
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                                                                Preserved source evidence · Not medical advice