vykoura
Vykoura (Leucovorin Calcium) is a folate analog used to treat Megaloblastic Anemia, Folic Acid Deficiency, Drug-Related Side Effects and Adverse Reactions.
Leucovorin Calcium · by Avyxa Holdings
Available as a generic: Leucovorin Calcium
Key facts
- Active ingredient
- Leucovorin Calcium
- Drug class
- Folate Analog
- Form
- Injectable
- Strength
- Leucovorin Calcium EQ 350MG BASE/35ML (EQ 10MG BASE/ML) · Leucovorin Calcium EQ 500MG BASE/50ML (EQ 10MG BASE/ML) · Leucovorin Calcium EQ 50MG BASE/5ML (EQ 10MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- megaloblastic anemia, folic acid deficiency, drug-related side effects and adverse reactions
- Manufacturer
- Avyxa Holdings
- What the pharmacy pays
- ~$59.34 for 30 — not your price
- FDA application
- NDA220406
What is Vykoura?
From the FDA label:Leucovorin is a folate analog, also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid calcium salt. This compound has the chemical designation of Calcium N-(p-((((6RS)-2-amino-5-formyl 5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl)methyl)amino)benzoyl)-L-glutamate (1:1). The structural formula of leucovorin calcium is: Leucovorin calcium is a white to light yellow crystalline powder with the molecular formula C 20 H 21 N 7 O 7 Ca and a molecular weight of 511.50 (calculated on the anhydrous basis). VYKOURA (leucovorin calcium), for intravenous and intramuscular use, is supplied as a sterile, preservative-free, clear, colorless to yellow solution available in 50 mg/5 mL, 350 mg/35 mL and 500 mg/50 mL single-dose vials containing 10 mg/mL of leucovorin. Each mL contains 10.803 mg leucovorin calcium (equivalent to 10 mg leucovorin), 50 mg betadex sulfobutyl ether sodium, 4 mg sodium chloride, 7 mg tromethamine, and sodium hydroxide and/or hydrochloric acid for pH adjustment (pH 6.5 to 8.5). There is 0.004 mEq of calcium per mg of leucovorin. Image
How to use
VYKOURA is indicated for intravenous or intramuscular administration. Do not administer intrathecally. ( 2.1 ) 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. ( 2.2 ) Continue until the methotrexate level is below 0.05 micromolar (5 x 10 -8 M). Adjust dose, if necessary, based on methotrexate elimination. ( 2.2 ) 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. ( 2.3 ) Administer VYKOURA 10 mg/m 2 intravenously or intramuscularly every 6 hours until methotrexate level is less than 0.01 micromolar (1 x 10 -8 M). ( 2.3 ) Metastatic Colorectal Cancer in Combination with Fluorouracil : 20 mg/m 2 to 500 mg/m 2 based on specific combination regimen. Administer VYKOURA before fluorouracil. ( 2.4 ) Do not mix VYKOURA with other drugs or administer other drugs through the same intravenous line. ( 2.4 ). Megaloblastic Anemia Due to Folic Acid Deficiency: Up to 1 mg/day administered intravenously until…
Side effects
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…
Warnings
Important safety information
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.
Who should not take Vykoura
VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid [see Warnings and Precautions (5.1) ]. Reactions have included anaphylactic reactions. VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid. ( 4 )
Interactions
7.1 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. 7.2 Effects of VYKOURA on Other Drugs Certain Antiepileptic Drugs Increase monitoring for seizure activity in patients taking certain concomitant antiepileptic drugs. Folic acid in high doses may reduce the effectiveness of certain antiepileptic drugs (e.g., phenobarbital, phenytoin, and primidone) and thereby increase the frequency of seizures. It is not known whether folinic acid, including VYKOURA, has the same effects; however, both folic and folinic acids, including VYKOURA share some common metabolic pathways. Trimethoprim-Sulfamethoxazole Avoid concomitant use of VYKOURA with trimethoprim-sulfamethoxazole . The effectiveness of trimethoprim-sulfamethoxazole can be decreased if used concomitantly with VYKOURA which was associated with increased rates of treatment failure and mortality in patients with HIV infection who receive trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jirovecii pneumonia.
Drug class
May treat (source: NIH RxClass)
See how Vykoura ranks — best-rated folate analog for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Vykoura treat?
- Vykoura (Leucovorin Calcium) may be used to treat megaloblastic anemia, folic acid deficiency, drug-related side effects and adverse reactions, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Vykoura cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $59.34 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Vykoura?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vykoura. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vykoura?
- Vykoura is marketed by Avyxa Holdings. You can see Avyxa Holdings's full profile, rating, and other products on pharmaranks.
- Is Vykoura a brand-name or generic drug?
- Vykoura is a brand-name product with the active ingredient Leucovorin Calcium. Lower-cost generic equivalents containing Leucovorin Calcium are available — ask your pharmacist.
- Is Vykoura available over the counter?
- No. Vykoura is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vykoura come in?
- Vykoura is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Vykoura?
- Vykoura is classified as folate analog, per the FDA's Established Pharmacologic Class.
- Is Vykoura FDA-registered?
- Vykoura is on record with the U.S. FDA under application number NDA220406. You can verify this on its official FDA label.
- Is Vykoura safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Vykoura. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Vykoura?
- Vykoura's side effects are taken directly from its FDA label. From the label: 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 wit… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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