Molecule
Leucovorin is a folate analog indicated for rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients, among other approved uses. MedsAcross supplies Leucovorin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VYKOURA is indicated for: Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 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.
Source: US FDA prescribing information
High-Dose Methotrexate Therapy Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF). The biologically active compound of the mixture is the (-)- l isomer, known as Citrovorum factor or (-)-folinic acid. Leucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of "one-carbon" moieties. l -Leucovorin (l-5 formyltetrahydrofolate) is rapidly metabolized (via 5, 10-methenyltetrahydrofolate then 5, 10-methylenetetrahydrofolate) to l -5-methyltetrahydrofolate. L -5-methyltetrahydrofolate can in turn be metabolized via other pathways back to 5,10 methylenetetrahydrofolate, which is converted to 5-methyltetrahydrofolate by an irreversible, enzyme catalyzed reduction using the cofactors FADH 2 and NADPH.
Source: US FDA prescribing information
VYKOURA is indicated for intravenous or intramuscular administration. Do not administer intrathecally. Rescue After High-Dose Methotrexate Therapy: Rescue recommendations are based on methotrexate dose of 12 to 15 grams/m 2 administered by intravenous infusion over 4 hours. Initiate rescue at a dose of 15 mg (approximately 10 mg/m 2 ) every 6 hours beginning 24 hours after the beginning of methotrexate infusion. Continue until the methotrexate level is below 0.05 micromolar (5 x 10 -8 M). Adjust dose, if necessary, based on methotrexate elimination. Reducing the Toxicity of Methotrexate in Patients with Impaired Methotrexate Elimination or Following an Overdosage of Folic Acid Antagonists or DHFR Inhibitors: Start as soon as possible after methotrexate overdosage or within 24 hours of delayed methotrexate elimination.
Source: US FDA prescribing information
VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid. Reactions have included anaphylactic reactions.
Source: US FDA prescribing information
Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions and urticaria can occur. Withhold or permanently discontinue VYKOURA based on the severity of hypersensitivity. Hypercalcemia: Due to calcium content, inject no more than 16 mL (160 mg) of VYKOURA intravenously per minute. Risk of Administration Errors: Do not administer VYKOURA intrathecally.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Hypercalcemia The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with leucovorin rescue are stomatitis and vomiting. The most common adverse reactions (>50%) in patients receiving leucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea.
Source: US FDA prescribing information
Effects of Other Drugs on VYKOURA Glucarpidase Administer VYKOURA at least 2 hours before or 2 hours after the glucarpidase dose when administering concomitantly. Glucarpidase can decrease leucovorin concentrations, which may decrease the effect of leucovorin rescue.
Source: US FDA prescribing information
Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
18 presentations of Leucovorin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Leucovorin 200 mg/20 mL powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Leucovorin 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Leucovorin 350 mg/17.5 mL powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Leucovorin 15 mg tabletOralGeneric name | — | US FDA | Available on request |
| Leucovorin 100 mg/10 mL powder for injectable suspensionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 100 mg powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 100 mg/10 mL injectionIntramuscular, intravenous Cold chainGeneric name | — | US FDA | Available on request |
| Leucovorin 200 mg powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 350 mg powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 350 mg/17.5 mL powder for injectable suspensionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 50 mg powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 500 mg powder for injectionIntramuscular, intravenousGeneric name | — | US FDA | Available on request |
| Leucovorin 500 mg/50 mL injectionIntramuscular, intravenous Cold chainGeneric name | — | US FDA | Available on request |
| Vykoura 350 mg/35 mL injectionIntramuscular, intravenous Cold chain | Avyxa Pharma | US FDA | Available on request |
| Vykoura 50 mg/5 mL injectionIntramuscular, intravenous Cold chain | Avyxa Pharma | US FDA | Available on request |
| Vykoura 500 mg/50 mL injectionIntramuscular, intravenous Cold chain | Avyxa Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 June 1952 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 18 presentations of Leucovorin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Leucovorin, including Vykoura.
Yes. The US FDA first approved Leucovorin on 20 June 1952, according to Drugs@FDA.
At least one listed presentation of Leucovorin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.