Leucovorin Calcium
Injection, Powder, Lyophilized, For Solution · Intramuscular, Intravenous, Oral
Uses
Leucovorin 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
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 to 5 week (28 to 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 to 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 alkalinization (pH of 7.0 or greater) should be continued until the methotrexate level is below 5 x 10 -8 M (0.05 micromolar). The leucovorin calcium for injection dose should be adjusted or leucovorin rescue extended based on the guidelines provided in Table 2 . 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 require continuing hydration and urinary alkalinization, and close monitoring of fluid and electrolyte status, until the serum methotrexate level has fallen to below 0.05 micromolar and the renal failure has resolved. Some patients will have abnormalities in methotrexate elimination or renal function following methotrexate administration, which are significant but less severe than the abnormalities described in Table 2 . These abnormalities may or may not be associated with significant clinical toxicity. If significant clinical toxicity is observed, leucovorin rescue should be extended for an additional 24 hours (total of 14 doses over 84 hours) in subsequent courses of therapy. The possibility that the patient is taking other medications which interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be reconsidered when laboratory abnormalities or clinical toxicities are observed. Impaired Methotrexate Elimination or Inadvertent Overdosage Leucovorin rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see WARNINGS ). Leucovorin calcium for injection 10 mg/m 2 should be administered IV, IM, or PO every 6 hours until the serum methotrexate level is less than 10 -8 M. 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 24 hour intervals. If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10 -6 M or the 48 hour level is greater than 9 x 10 -7 M, the dose of leucovorin calcium for injection should be increased to 100 mg/m 2 IV every 3 hours until the methotrexate level is less than 10 -8 M. Hydration (3 L/d) and urinary alkalinization with sodium bicarbonate solution should be employed concomitantly. The bicarbonate dose should be adjusted to maintain the urine pH at 7.0 or greater. Megaloblastic Anemia Due to Folic Acid Deficiency Up to 1 mg daily. There is no evidence that doses greater than 1 mg/day have greater efficacy than those of 1 mg; additionally, loss of folate in urine becomes roughly logarithmic as the amount administered exceeds 1 mg. Each 500 mg vial of leucovorin calcium for injection when reconstituted with 50 mL of sterile diluent yields a leucovorin concentration of 10 mg per mL. Leucovorin calcium for injection contains no preservative. Reconstitute with Bacteriostatic Water for Injection, USP, which contains benzyl alcohol, or with Sterile Water for Injection, USP. When reconstituted with Bacteriostatic Water for Injection, USP, the resulting solution must be used within 7 days. If the product is reconstituted with Sterile Water for Injection, USP, it must be used immediately. Because of the benzyl alcohol contained in Bacteriostatic Water for Injection, USP, 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 WARNINGS ).
Contraindications
Leucovorin 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
In the treatment of accidental overdosages of folic acid antagonists, intravenous leucovorin should be administered as promptly as possible. As the time interval between antifolate administration [e.g., methotrexate (MTX)] and leucovorin rescue increases, leucovorin's effectiveness in counteracting toxicity decreases. In the treatment of accidental overdosages of intrathecally administered folic acid antagonists, do not administer leucovorin intrathecally. LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY. Monitoring of the serum MTX concentration is essential in determining the optimal dose and duration of treatment with leucovorin. Delayed MTX excretion may be caused by a third space fluid accumulation (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of leucovorin 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 leucovorin, when doses greater than 10 mg/m 2 are administered, leucovorin should be reconstituted with Sterile Water for Injection, USP, and used immediately (see DOSAGE AND ADMINISTRATION ). Because of the calcium content of the leucovorin 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 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 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 and 20% when treated with 5-fluorouracil in combination with 20 mg/m 2 of leucovorin. 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/5-fluorouracil combination than in patients treated with the high dose combination — 11% versus 3%. Therapy with leucovorin/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-FU and leucovorin, 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, 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 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.
Precautions
General Parenteral administration is preferable to oral dosing if there is a possibility that the patient may vomit or not absorb the leucovorin. Leucovorin has no effect on non-hematologic toxicities of MTX, such as the nephrotoxicity resulting from drug and/or metabolite precipitation in the kidney. Since leucovorin enhances the toxicity of fluorouracil, leucovorin/5-fluorouracil combination therapy for advanced colorectal cancer should be administered under the supervision of a physician experienced in the use of antimetabolite cancer chemotherapy. Particular care should be taken in the treatment of elderly or debilitated colorectal cancer patients, as these patients may be at increased risk of severe toxicity. Laboratory Tests Patients being treated with the leucovorin/5-fluorouracil combination should have a CBC with differential and platelets prior to each treatment. During the first two courses a CBC with differential and platelets has to be repeated weekly and thereafter once each cycle at the time of anticipated WBC nadir. Electrolytes and liver function tests should be performed prior to each treatment for the first three cycles then prior to every other cycle. Dosage modifications of fluorouracil should be instituted as follows, based on the most severe toxicities: Diarrhea and/or Stomatitis WBC/mm 3 Nadir Platelets/mm 3 Nadir 5-FU Dose Moderate Severe 1,000 to 1,900 < 1,000 25 to 75,000 < 25,000 decrease 20% decrease 30% If no toxicity occurs, the 5-fluorouracil dose may increase 10%. Treatment should be deferred until WBC's are 4,000/mm 3 and platelets 130,000/mm 3 . If blood counts do not reach these levels within two weeks, treatment should be discontinued. Patients should be followed up with physical examination prior to each treatment course and appropriate radiological examination as needed. Treatment should be discontinued when there is clear evidence of tumor progression. 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 enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate. Leucovorin may enhance the toxicity of 5-fluorouracil (see WARNINGS ).
Side effects
Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following administration of both oral and parenteral leucovorin. No other adverse reactions have been attributed to the use of leucovorin per se . Table 1 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 1 PERCENTAGE OF PATIENTS TREATED WITH LEUCOVORIN/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% TABLE 2 GUIDELINES FOR LEUCOVORIN CALCIUM DOSAGE AND ADMINISTRATION DO NOT ADMINISTER LEUCOVORIN CALCIUM INTRATHECALLY Clinical Situation Laboratory Findings Leucovorin Calcium 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 (e.g., 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. To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 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 enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate. Leucovorin may enhance the toxicity of 5-fluorouracil (see WARNINGS ).
Pregnancy
Pregnancy Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with leucovorin. It is also not known whether leucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Leucovorin should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when leucovorin is administered to a nursing mother. Pediatric Use See Drug Interactions . Geriatric Use Clinical studies of leucovorin 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.
Pediatric use
Pediatric Use See Drug Interactions .
Geriatric use
Geriatric Use Clinical studies of leucovorin 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
Excessive amounts of leucovorin may nullify the chemotherapeutic effect of folic acid antagonists. Impaired Methotrexate Elimination or Inadvertent Overdosage Leucovorin rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see WARNINGS ). Leucovorin calcium for injection 10 mg/m 2 should be administered IV, IM, or PO every 6 hours until the serum methotrexate level is less than 10 -8 M. 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 24 hour intervals. If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10 -6 M or the 48 hour level is greater than 9 x 10 -7 M, the dose of leucovorin calcium for injection should be increased to 100 mg/m 2 IV every 3 hours until the methotrexate level is less than 10 -8 M. Hydration (3 L/d) and urinary alkalinization with sodium bicarbonate solution should be employed concomitantly. The bicarbonate dose should be adjusted to maintain the urine pH at 7.0 or greater.
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 Calcium N -[ p -[[[(6 RS )-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: C 20 H 21 CaN 7 O 7 M.W. 511.51 Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 500 mg vials. Each 500 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 50 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg per mL. In this dosage form, one milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. This lyophilized product contains no preservative. The inactive ingredient is sodium chloride added to adjust tonicity. Reconstitute with Bacteriostatic Water for Injection, USP, which contains benzyl alcohol (see WARNINGS ), or with Sterile Water for Injection, USP. The inactive ingredient is sodium chloride 450 mg per vial for the 500 mg. Sodium hydroxide and/or hydrochloric acid may be added for pH adjustment. pH adjusted to approximately 7.8. There is 0.004 mEq of calcium per mg of leucovorin. Solution contains no bacteriostat or antimicrobial agents. Structural Formula
How supplied
Leucovorin Calcium for Injection, USP is supplied as follows: NDC Leucovorin Calcium for Injection, USP Package Factor 25021-828-50 500 mg Single-Dose Vial 1 vial per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Discard unused portion. Lyophilized Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals Revised: September 2025
Storage
Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Discard unused portion. Lyophilized Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals Revised: September 2025
Label text from the FDA structured product label by Sagent Pharmaceuticals (revised Jun 16, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Leucovorin Calcium in 56 products
Leucovorin Calcium NDC products (56)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 60687-227 | Leucovorin Calcium 25 mg/1 Tablet | American Health Packaging | ANDA |
| 68001-650 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-649 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-648 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-418 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-417 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-416 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 42806-133 | Leucovorin Calcium 10 mg/1 Tablet | Epic Pharma LLC | ANDA |
| 42806-134 | Leucovorin Calcium 15 mg/1 Tablet | Epic Pharma LLC | ANDA |
| 42806-358 | Leucovorin Calcium 5 mg/1 Tablet | Epic Pharma LLC | ANDA |
| 42806-359 | Leucovorin Calcium 25 mg/1 Tablet | Epic Pharma LLC | ANDA |
| 63323-631 | Leucovorin Calcium 10 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 63323-710 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-711 | Leucovorin Calcium 500 mg/50mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 68083-587 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68462-767 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 0054-4497 | Leucovorin Calcium 10 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0054-4498 | Leucovorin Calcium 15 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0054-4499 | Leucovorin Calcium 25 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0054-8496 | Leucovorin Calcium 5 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9368 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9552 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9553 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9554 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9555 | Leucovorin Calcium 50 mg/5mL Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0054-4496 | Leucovorin Calcium 5 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | ANDA |
| 50742-181 | Leucovorin Calcium 5 mg/1 Tablet | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-182 | Leucovorin Calcium 10 mg/1 Tablet | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-183 | Leucovorin Calcium 15 mg/1 Tablet | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-184 | Leucovorin Calcium 25 mg/1 Tablet | Ingenus Pharmaceuticals, LLC | ANDA |
| 69315-186 | Leucovorin Calcium 15 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 69315-184 | Leucovorin Calcium 5 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 69315-185 | Leucovorin Calcium 10 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 69315-187 | Leucovorin Calcium 25 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 0904-7584 | Leucovorin Calcium 25 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 71288-164 | Leucovorin Calcium 500 mg/50mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-160 | Leucovorin Calcium 50 mg/5mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-161 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-162 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-163 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 67457-530 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Suspension | Mylan Institutional LLC | ANDA |
| 67457-529 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Suspension | Mylan Institutional LLC | ANDA |
| 67457-528 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Suspension | Mylan Institutional LLC | ANDA |
| 71205-908 | Leucovorin Calcium 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 25021-813 | Leucovorin Calcium 50 mg/5mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-814 | Leucovorin Calcium 100 mg/10mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-815 | Leucovorin Calcium 200 mg/20mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-816 | Leucovorin Calcium 350 mg/17.5mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-828 | Leucovorin Calcium 500 mg/50mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 70436-116 | Leucovorin Calcium 50 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-117 | Leucovorin Calcium 100 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-118 | Leucovorin Calcium 200 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-119 | Leucovorin Calcium 350 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-120 | Leucovorin Calcium 500 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 0555-0484 | Leucovorin Calcium 5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0555-0485 | Leucovorin Calcium 25 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
Leucovorin Calcium recalls
- D-1490-2020 Aug 19, 2020 · Class III · Terminated
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Frequently asked questions
What is Leucovorin Calcium used for?
Leucovorin 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…
What are the side effects of Leucovorin Calcium?
Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following administration of both oral and parenteral leucovorin. No other adverse reactions have been attributed to the use of leucovorin per se . Table 1 summarizes significant adverse events occurring in 316 patients treated with the leucovorin-5-fluorouracil combinations compared against 70 patients… See the full label for the complete list.
Who makes Leucovorin Calcium?
Leucovorin Calcium is listed by 16 labelers in the FDA NDC directory, including American Health Packaging, BluePoint Laboratories, Epic Pharma LLC, Fresenius Kabi USA, LLC.
Has Leucovorin Calcium been recalled?
The FDA enforcement database lists 1 recall for Leucovorin Calcium, most recently D-1490-2020 (class iii): Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.