leucovorin calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Folate Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Leucovorin is used to prevent harmful effects of methotrexate (a cancer chemotherapy medication) or to treat an overdose of methotrexate or similar medications. It is also used to treat people who have an inherited condition that prevents folate from reaching the brain. Leucovorin is in a class of medications called folic acid analogs. It works by protecting healthy cells from the effects of methotrexate or similar medications while allowing methotrexate to enter and kill cancer cells.
Read the full MedlinePlus article ↗- It depends on which chemo drug you're getting. If you're on methotrexate, leucovorin acts as a 'rescue' — it replenishes the folate that methotrexate blocks, protecting your health...
- Why am I taking leucovorin alongside my chemotherapy?
- You can take the leucovorin calcium tablet with or without food — whichever is easier on your stomach. If swallowing a whole tablet is difficult, you can crush it and mix it with f...
- Can I take the tablet with food, or does it have to be on an empty stomach?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Leucovorin Calcium — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $5.51 | $55.09 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0640 | $2.932 / J0640 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leucovorin Calcium 100 mg/10mL 00143-9554-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Leucovorin Calcium 100 mg/10mL 25021-0814-30 | Sagent | 1 vial | — | AP | FDA listed | — |
| Leucovorin Calcium 100 mg/10mL 67457-0528-10 | Mylan | 1 vial | — | AP | FDA listed | — |
| Leucovorin Calcium 100 mg/10mL 68001-0416-36 | BluePoint | 1 vial | — | AP | FDA listed | — |
| leucovorin calcium 100 mg/10mLthis 68001-0648-36 | BluePoint | 1 vial | — | AP | FDA listed | — |
| Leucovorin Calcium 100 mg 70436-0117-80 | Slate | 1 injection | — | AP | FDA listed | — |
| leucovorin calcium 100 mg/10mL 71288-0161-20 | Meitheal | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68001-0648-36 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-08-14 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Leucovorin Calcium for Injection rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin Calcium for Injection should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Advanced Colorectal Cancer Either of the following two regimens is recommended: Leucovorin calcium for injection is administered at 200 mg/m 2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-fluorouracil at 370 mg/m 2 by intravenous injection. Leucovorin calcium for injection is administered at 20 mg/m 2 by intravenous injection followed by 5-fluorouracil at 425 mg/m 2 by intravenous injection. 5-Fluorouracil and leucovorin calcium for injection should be administered separately to avoid the formation of a precipitate.
Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4 week (28-day) intervals, for 2 courses and then repeated at 4-5 week (28-35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course. In subsequent treatment courses, the dosage of 5-fluorouracil should be adjusted based on patient tolerance of the prior treatment course.
The daily dosage of 5-fluorouracil should be reduced by 20% for patients who experienced moderate hematologic or gastrointestinal toxicity in the prior treatment course, and by 30% for patients who experienced severe toxicity (see PRECAUTIONS: Laboratory Tests ). For patients who experienced no toxicity in the prior treatment course, 5-fluorouracil dosages may be increased by 10%. Leucovorin calcium for injection dosages are not adjusted for toxicity.
Leucovorin Rescue After High-Dose Methotrexate Therapy The recommendations for leucovorin rescue are based on a methotrexate dose of 12-15 grams/m 2 administered by intravenous infusion over 4 hours (see methotrexate package insert for full prescribing information). Leucovorin rescue at a dose of 15 mg (approximately 10 mg/m 2 ) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion. In the presence of gastrointestinal toxicity, nausea or vomiting, leucovorin calcium for injection should be administered parenterally.
Do not administer leucovorin calcium for injection intrathecally. Serum creatinine and methotrexate levels should be determined at least once daily. Leucovorin calcium for injection administration, hydration, and urinary alkalization (pH of 7.0 or greater) should be continued until the methotrexate level is below 5x10 -8 M (0.05 micromolar).
The leucovorin calcium for injection dose should be adjusted or leucovorin rescue extended based on the following guidelines: GUIDELINES FOR LEUCOVORIN CALCIUM FOR INJECTION DOSAGE AND ADMINISTRATION DO NOT ADMINISTER LEUCOVORIN CALCIUM FOR INJECTION INTRATHECALLY Clinical Situation Laboratory Findings Leucovorin Calcium for Injection Dosage and Duration Normal Methotrexate Elimination Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours.
15 mg PO, IM, or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). Delayed Late Methotrexate Elimination Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration. Continue 15 mg PO, IM, or IV q 6 hours, until methotrexate level is less than 0.05 micromolar.
Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration (eg, an increase from 0.5 mg/dL to a level of 1 mg/dL or more) 150 mg IV q 3 hours, until methotrexate level is less than 1 micromolar; then 15 mg IV q 3 hours until methotrexate level is less than 0.05 micromolar. Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure.
In addition to appropriate leucovorin calcium for injection therapy, these patients…
⛔ Contraindications ▾
CONTRAINDICATIONS Leucovorin calcium is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B 12 . A hematologic remission may occur while neurologic manifestations continue to progress.
⚠️ Warnings ▾
WARNINGS In the treatment of accidental overdosages of folic acid antagonists, intravenous leucovorin calcium should be administered as promptly as possible. As the time interval between antifolate administration (e.g., methotrexate) and leucovorin rescue increases, leucovorin calcium's effectiveness in counteracting toxicity decreases. In the treatment of accidental overdosages of intrathecally administered folic acid antagonists, do not administer leucovorin calcium intrathecally.
LEUCOVORIN CALCIUM MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin calcium. Delayed methotrexate excretion may be caused by a third space fluid accumulation (ie, ascites, pleural effusion), renal insufficiency, or inadequate hydration.
Under such circumstances, higher doses of leucovorin calcium or prolonged administration may be indicated. Doses higher than those recommended for oral use must be given intravenously. Because of the benzyl alcohol contained in certain diluents used for reconstituting Leucovorin Calcium for Injection, when doses greater than 10 mg/m 2 are administered, leucovorin calcium for injection should be reconstituted with Sterile Water for Injection, USP, and used immediately.
(See DOSAGE AND ADMINISTRATION ) Because of the calcium content of the leucovorin calcium solution, no more than 160 mg of leucovorin should be injected intravenously per minute (16 mL of a 10 mg per mL, or 8 mL of a 20 mg per mL solution per minute). Leucovorin calcium enhances the toxicity of 5-fluorouracil. When these drugs are administered concurrently in the palliative therapy of advanced colorectal cancer, the dosage of 5-fluorouracil must be lower than usually administered.
Although the toxicities observed in patients treated with the combination of leucovorin calcium plus 5-fluorouracil are qualitatively similar to those observed in patients treated with 5-fluorouracil alone, gastrointestinal toxicities (particularly stomatitis and diarrhea) are observed more commonly and may be more severe and of prolonged duration in patients treated with the combination. In the first Mayo/NCCTG controlled trial, toxicity, primarily gastrointestinal, resulted in 7% of patients requiring hospitalization when treated with 5-fluorouracil alone or 5-fluorouracil in combination with 200 mg/m 2 of leucovorin calcium and 20% when treated with 5-fluorouracil in combination with 20 mg/m 2 of leucovorin calcium.
In the second Mayo/NCCTG trial, hospitalizations related to treatment toxicity also appeared to occur more often in patients treated with the low dose leucovorin calcium/5-fluorouracil combination than in patients treated with the high dose combination — 11% versus 3%. Therapy with leucovorin calcium and 5-fluorouracil must not be initiated or continued in patients who have symptoms of gastrointestinal toxicity of any severity, until those symptoms have completely resolved. Patients with diarrhea must be monitored with particular care until the diarrhea has resolved, as rapid clinical deterioration leading to death can occur.
In an additional study utilizing higher weekly doses of 5-fluorouracil and leucovorin calcium, elderly and/or debilitated patients were found to be at greater risk for severe gastrointestinal toxicity. Seizures and/or syncope have been reported rarely in cancer patients receiving leucovorin calcium, usually in association with fluoropyrimidine administration, and most commonly in those with CNS metastases or other predisposing factors, however, a causal relationship has not been established. The concomitant use of leucovorin calcium with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and morbidity in a placebo-controlled study.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following administration of both oral and parenteral leucovorin calcium. No other adverse reactions have been attributed to the use of leucovorin calcium per se . The following table summarizes significant adverse events occurring in 316 patients treated with the leucovorin calcium/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. High LV= Leucovorin calcium 200 mg/m 2 Low LV=Leucovorin calcium 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 PERCENTAGE OF PATIENTS TREATED WITH LEUCOVORIN CALCIUM/FLUOROURACIL FOR ADVANCED COLORECTAL CARCINOMA REPORTING ADVERSE EXPERIENCES OR HOSPITALIZED FOR TOXICITY (High LV)/5-FU (N=155) (Low LV)/5-FU (N=161) 5-FU Alone (N=70) Any Grade3+ 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% To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
Drug Interactions Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients. Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin calcium enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1-3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin calcium may reduce the efficacy of intrathecally administered methotrexate.
Leucovorin calcium may enhance the toxicity of 5-fluorouracil. (See WARNINGS )
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Adequate animal reproduction studies have not been conducted with leucovorin calcium. It is also not known whether leucovorin calcium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Leucovorin calcium should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use See PRECAUTIONS , Drug Interactions .
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of leucovorin calcium did not show differences in safety or effectiveness between subjects over 65 and younger subjects. Other clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out. This drug is known to be excreted by the kidney and the risk of toxic reactions to the drug may be greater in patients with impaired renal function.
Because elder patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE Excessive amounts of leucovorin calcium may nullify the chemotherapeutic effect of folic acid antagonists.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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.
Administration of leucovorin calcium can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase. In contrast, leucovorin calcium can enhance the therapeutic and toxic effects of fluoropyrimidines used in cancer therapy, such as 5-fluorouracil. Concurrent administration of leucovorin calcium does not appear to alter the plasma pharmacokinetics of 5-fluorouracil.
5-Fluorouracil is metabolized to fluorodeoxyuridylic acid, which binds to and inhibits the enzyme thymidylate synthase (an enzyme important in DNA repair and replication). Leucovorin is readily converted to another reduced folate, 5,10-methylenetetrahydrofolate, which acts to stabilize the binding of fluorodeoxyuridylic acid to thymidylate synthase and thereby enhances the inhibition of this enzyme. The pharmacokinetics after intravenous, intramuscular, and oral administration of a 25 mg dose of leucovorin calcium were studied in male volunteers.
After intravenous administration, serum total reduced folates (as measured by Lactobacillus casei assay) reached a mean peak of 1259 ng/mL (range 897 – 1625). The mean time to peak was 10 minutes. This initial rise in total reduced folates was primarily due to the parent compound 5-formyl-THF (measured by Streptococcus faecalis assay) which rose to 1206 ng/mL at 10 minutes.
A sharp drop in parent compound followed and coincided with the appearance of the active metabolite 5-methyl-THF which became the predominant circulating form of the drug. The mean peak of 5-methyl-THF was 258 ng/mL and occurred at 1.3 hours. The terminal half-life for total reduced folates was 6.2 hours.
The area under the concentration versus time curves (AUCs) for l -leucovorin, d -leucovorin and 5-methyltetrahydrofolate were 28.4 ± 3.5, 956 ± 97 and 129 ± 12 (mg/min/L ± S.E.). When a higher dose of d,l -leucovorin (200 mg/m 2 ) was used, similar results were obtained. The d -isomer persisted in plasma at concentrations greatly exceeding those of the l -isomer.
After intramuscular injection, the mean peak of serum total reduced folates was 436 ng/mL (range 240-725) and occurred at 52 minutes. Similar to IV administration, the initial sharp rise was due to the parent compound. The mean peak of 5-formyl-THF was 360 ng/mL and occurred at 28 minutes.
The level of the metabolite 5-methyl-THF increased subsequently over time until at 1.5 hours it represented 50% of the circulating total folates. The mean peak of 5-methyl-THF was 226 ng/mL at 2.8 hours. The terminal half-life of total reduced folates was 6.2 hours.
There was no difference of statistical significance between IM and IV administration in the AUC for total reduced folates, 5-formyl-THF, or 5-methyl-THF. After oral administration of leucovorin calcium reconstituted with aromatic elixir, the mean peak concentration of serum total reduced folates was 393 ng/mL (range 160-550). The mean time to peak was 2.3 hours and the terminal half-life was 5.7 hours.
The major component was the metabolite 5-methyltetrahydrofolate to which leucovorin is primarily converted in the intestinal mucosa. The mean peak o…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Leucovorin Calcium for Injection, USP is supplied as a sterile lyophilized powder as follows: NDC Leucovorin Calcium for Injection, USP Package Factor 68001-648-36 100 mg Single-Dose Vial 1 vial per carton 68001-649-37 200 mg Single-Dose Vial 1 vial per carton 68001-650-38 350 mg Single-Dose Vial 1 vial per carton Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° F to 86°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use.
Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° F to 86°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📋 Description ▾
DESCRIPTION Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-calcium salt (1:1).
The formula weight is 511.51 and the structural formula of leucovorin calcium is: Leucovorin Calcium for Injection is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 100 mg, 200 mg and 350 mg vials. Each 100 mg vial of Leucovorin Calcium for Injection, when reconstituted with 10 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL. Each 200 mg vial of Leucovorin Calcium for Injection, when reconstituted with 20 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL.
Each 350 mg vial of Leucovorin Calcium for Injection, when reconstituted with 17.5 mL of sterile diluent, contains leucovorin (as the calcium salt) 20 mg/mL. In each dosage form, one milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. These lyophilized products contain no preservative.
The inactive ingredient is Sodium Chloride, USP, added to adjust tonicity and sodium hydroxide and/or hydrochloric acid for pH adjustment. pH adjusted to 7.0 to 8.5. Reconstitute with Bacteriostatic Water for Injection, USP, which contains benzyl alcohol (see WARNINGS section), or with Sterile Water for Injection, USP. Structural Formula