Leucovorin Calcium for Injection, 200 mg Single Dose Vial

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

• Critical Rescue Agent: Essential for "Leucovorin Rescue," which helps protect healthy cells from the lethal effects of high-dose methotrexate used in chemotherapy.

• Potent Antidote: Indicated to counteract the effects of impaired methotrexate elimination and inadvertent overdosages of folic acid antagonists.

• 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.

• Preservative-Free Formula: Suitable for high-dose administration without the risk of preservative-related toxicities.

• Lyophilized Stability: Supplied as a stable powder that is reconstituted with sterile water for injection or other compatible diluents immediately before administration.

Reconstitution & Administration

• Concentration: When reconstituted with 20 mL of sterile diluent, the resulting solution contains 10 mg/mL of Leucovorin.

• Compatibility: Should not be mixed in the same infusion bag as 5-fluorouracil, as a precipitate may form.

• 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.