Product Specifications
| Specification | Details |
| Manufacturer / Brand | Fresenius Kabi USA, LLC. |
| Manufacturer # / SKU | 63323071050 |
| NDC # | 63323-0710-50 |
| Active Ingredient | Leucovorin Calcium |
| Product Type | Rx Only / Antidote & Rescue Agent |
| Dosage Form | Injection, Powder, Lyophilized (For Solution) |
| Strength | 200 mg per Vial |
| Route of Admin | Intramuscular (IM) or Intravenous (IV) |
| Preservative | Preservative-Free |
| Packaging / Sold As | Individual 50 mL Single Dose Vial |
| UNSPSC Code | 51110000 |
Key Features
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Critical Rescue Agent: Essential for “Leucovorin Rescue,” which helps protect healthy cells from the lethal effects of high-dose methotrexate used in chemotherapy.
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Potent Antidote: Indicated to counteract the effects of impaired methotrexate elimination and inadvertent overdosages of folic acid antagonists.
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Combination Therapy: Frequently used in “5-FU/Leucovorin” regimens to increase the binding of fluorouracil to its target enzyme, thereby prolonging survival in colorectal cancer patients.
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Preservative-Free Formula: Suitable for high-dose administration without the risk of preservative-related toxicities.
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Lyophilized Stability: Supplied as a stable powder that is reconstituted with sterile water for injection or other compatible diluents immediately before administration.
Reconstitution & Administration
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Concentration: When reconstituted with 20 mL of sterile diluent, the resulting solution contains 10 mg/mL of Leucovorin.
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Compatibility: Should not be mixed in the same infusion bag as 5-fluorouracil, as a precipitate may form.
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Parenteral Preference: Parenteral administration is preferred over oral dosing if the patient is experiencing vomiting or malabsorption.
⚠️ Contraindication: Leucovorin is improper therapy for pernicious anemia or other megaloblastic anemias caused by Vitamin B12 deficiency; while it may improve blood counts, neurological damage can continue to progress.
⚠️ Toxicity Warning: Leucovorin can significantly enhance the toxicity of 5-fluorouracil. Therapy must be strictly monitored by a physician experienced in antimetabolite cancer chemotherapy, particularly in elderly or debilitated patients.
