Prescription medicine
Levoleucovorin Brand names: Khapzory; first approved as Fusilev
Levoleucovorin (Khapzory) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the levoleucovorin FDA label on DailyMed (effective August 29, 2023, Slate Run Pharmaceuticals); the NDA 20140 record on Drugs@FDA; every levoleucovorin label on DailyMed.
Highlights of the record
FDA label of August 29, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLevoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma.
Forms and strengths
- 10 mg
- 10 mg/ml
- 50 mg/5ml
- 175 mg/3.5ml
- 175 mg/17.5ml
- 250 mg/25ml
Injection (solution); injection (powder) (lyophilized) for solution; injection.
On the market
- Earliest approval on file
- March 7, 2008 Fusilev, Acrotech Biopharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first March 9, 2015; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 25, 2039 Khapzory injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2019 1 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 3,706 through July 30, 2026
What is levoleucovorin used for?
From the label: indications and usageLevoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use: Levoleucovorin injection 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. […]
Conditions named in the indications of levoleucovorin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Folate Analog.
Source: FDA drug label (LEVOLEUCOVORIN CALCIUM), Slate Run Pharmaceuticals, effective August 29, 2023 (SPL set 124bc214-62f8-40f9-a227-a35e2d1ff2a0), via openFDA; the full label on DailyMed
Is there a generic for levoleucovorin (Khapzory)?
The FDA approved the first generic levoleucovorin on March 9, 2015. 12 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists levoleucovorin from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Khapzory injection, the last expiring on March 25, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2015 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has levoleucovorin been recalled?
The FDA's Enforcement Report lists 1 recall naming levoleucovorin since 2019: 1 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of levoleucovorin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 1, 2019 | Class I | Mylan Institutional Inc not a listed maker | Presence of Particulate Matter: particulate matter identified as copper salts |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levoleucovorin label say about other medicines?
The levoleucovorin label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name levoleucovorin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorouracil | drug interactions | Fluorouracil Leucovorin products increase the toxicity of fluorouracil. |
| Leucovorin | contraindications | CONTRAINDICATIONS Levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see Adverse Reactions ( 6.2 )]. |
| Phenobarbital | drug interactions | DRUG INTERACTIONS 7.1 Effects of Leucovorin Products on Other Drugs Antiepileptic Drugs Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone and increase the frequency of seizures in susceptible children. |
| Phenytoin | drug interactions | DRUG INTERACTIONS 7.1 Effects of Leucovorin Products on Other Drugs Antiepileptic Drugs Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone and increase the frequency of seizures in susceptible children. |
| Primidone | drug interactions | DRUG INTERACTIONS 7.1 Effects of Leucovorin Products on Other Drugs Antiepileptic Drugs Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone and increase the frequency of seizures in susceptible children. |
Source: FDA drug label (LEVOLEUCOVORIN CALCIUM), Slate Run Pharmaceuticals, effective August 29, 2023 (SPL set 124bc214-62f8-40f9-a227-a35e2d1ff2a0), via openFDA; the full label on DailyMed
What do FAERS reports show for levoleucovorin?
The FDA Adverse Event Reporting System holds 3,706 reports that list levoleucovorin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 545 are coded as a death and 1,415 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as levoleucovorin?
8 other medicines are given the same way (intravenous) and in the same FDA class as levoleucovorin or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxaliplatin | Colorectal cancer | 17 labelers | n/a | A presentation being discontinued |
| Fluorouracil | Colorectal cancer | 12 labelers | n/a | No current entry |
| Irinotecan | Colorectal cancer | 12 labelers | n/a | A presentation being discontinued |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
| Cetuximab | Colorectal cancer | none listed | n/a | No current entry |
| Panitumumab | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as levoleucovorin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to levoleucovorin
- 8 medicines for the same use
- Other folate analogs
- the pharmacologic class, with prices and generics
- Levoleucovorin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other