Leucovorin B 485 00555 0485 27 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Leucovorin calcium tablets are a folate analog indicated: To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, andFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2) Limitations of Use Leucovorin calcium tablets are not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).
What should I know before taking it?
Leucovorin calcium tablets are contraindicated in patients with a history of hypersensitivity reaction depending on indication as described below, to leucovorin (folinic acid), levoleucovorin, folic acid, or any component of leucovorin calcium tablets [see Description (11)]: Folic acid antagonist or DHFR inhibitor toxicity: history of severe hypersensitivity reaction FOLR1-CFTD: history of any hypersensitivity reaction Reactions have included anaphylactic reactions [see Warnings and Precautions (5.1)].
What important warnings are listed?
Hypersensitivity Reactions: Withhold or permanently discontinue leucovorin calcium tablets based on severity and indication. (4, 5.1)
How is this medication usually taken?
Leucovorin calcium tablets, USP: 5 mg: White, round, biconvex tablets, debossed with “stylized b” on one side and 484 on the other side25 mg: Pale green, round, biconvex tablets, debossed with “stylized b” on one side and 485 on the other side
What side effects are listed?
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)]. The following adverse reactions have been identified during postapproval use of leucovorin (d,l-leucovorin) or levoleucovorin (l-leucovorin). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: Pruritus, rash.Respiratory: Dyspnea.Other Clinical Events: Rigors, temperature change. Safety information for the treatment of FOLR1-CFTD with oral leucovorin is limited. The.
What interactions are listed?
Certain Antiepileptic Drugs: Increase monitoring for seizure activity in leucovorin-treated patients taking certain concomitant antiepileptic drugs. Certain antiepileptic drugs may reduce the effectiveness of leucovorin calcium tablets. (7.1, 7.2) Trimethoprim-Sulfamethoxazole: Avoid concomitant use of leucovorin calcium tablets with trimethoprim-sulfamethoxazole. (7.1) Fluorouracil: Leucovorin may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients. (7.1)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94669fc8-3c1c-4228-be27-09a1cd468c36
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.