Calcium Folinate Injection

Applies to leucovorin: injectable, powder for solution, solution, tablet

Along with its needed effects, leucovorin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking leucovorin:

• Skin rash, hives, or itching
• wheezing

Check with your doctor as soon as possible if any of the following side effects occur while taking leucovorin:

• Convulsions (seizures)

Applies to leucovorin: compounding powder, injectable powder for injection, injectable solution, oral tablet

General

Adverse events attributed to use of leucovorin/folinic acid by itself include allergic sensitization, including anaphylactoid reactions and urticaria; gastrointestinal and hematologic adverse events were common when used with fluorouracil.[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis (75%, when used with fluorouracil), nausea (74%, when used with fluorouracil), diarrhea (66%, when used with fluorouracil), vomiting (46%, when used with fluorouracil), dehydration (when used with fluorouracil)
Common (1% to 10%): Constipation (when used with fluorouracil)
Rare (less than 0.1%): Gastrointestinal disorders (after high doses)
Frequency not reported: Mucositis (when used with fluorouracil), cheilitis (when used with fluorouracil)[Ref]

When used with fluorouracil, diarrhea and dehydration have resulted in hospital admission and death.[Ref]

Hematologic

Very common (10% or more): Leucopenia (69%, when used with fluorouracil)
Common (1% to 10%): Thrombocytopenia (when used with fluorouracil)[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic reactions (sensitization, including anaphylactoid reactions, shock, and urticaria)
Frequency not reported: Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (in combination with other agents)[Ref]

Dermatologic

Very common (10% or more): Alopecia (42%, when used with fluorouracil), dermatitis (21%, when used with fluorouracil)
Frequency not reported: Palmar-plantar erythrodysesthesia (when used with fluorouracil)[Ref]

Other

Very common (10% or more): Lethargy/malaise/fatigue (13%, when used with fluorouracil)
Uncommon (0.1% to 1%): Pyrexial reactions (following parenteral administration)[Ref]

Metabolic

Very common (10% or more): Anorexia (14%, when used with fluorouracil)
Frequency not reported: Hyperammonemia (when used with fluorouracil)

Immunologic

Common (1% to 10%): Infection (when used with fluorouracil)[Ref]

Nervous system

Rare (less than 0.1%): Increase in the frequency of attacks in epileptics, seizures, syncope[Ref]

Psychiatric

Rare (less than 0.1%): Insomnia, agitation, depression[Ref]

Some side effects of leucovorin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Leucovorin Rescue:
15 mg (approximately 10 mg/m2), orally, IV, or IM, every 6 hours for 10 doses; start 24 hours after beginning of methotrexate infusion (based on a methotrexate dose of 12 to 15 g/m2 IV over 4 hours)

Impaired Methotrexate Elimination or Inadvertent Overdosage:
10 mg/m2 orally, IV, or IM, every 6 hours until methotrexate level is less than 10(-8) mol

Comments:
-Determine serum creatinine and methotrexate levels at least once a day.
-Continue leucovorin, hydration, and urinary alkalization until methotrexate levels are below 5 x 10(-8) mol.
-Give parenterally if gastrointestinal toxicity, nausea, or vomiting are present.

Uses: Leucovorin rescue after high dose methotrexate therapy; diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages.

200 mg/m2, by slow IV injection (minimum 3 minutes), followed by 5-fluorouracil (the manufacturer product information should be consulted), once a day for 5 days
OR
20 mg/m2, IV, followed by 5-fluorouracil (the manufacturer product information should be consulted), once a day for 5 days

Comments:
-Do not be mix in the same infusion as 5-fluorouracil; a precipitate may form.
-May repeat 5 day treatment course at 4 week (28 day) intervals for 2 courses, then repeat at 4 to 5 week (28 to 35 day) intervals provided the patient is completely recovered from toxicities of the prior course.

Use: For use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.

5 to 15 mg orally once a day

Use: Diminish the toxicity and counteract the effects of inadvertent overdosages of folic acid antagonists.

Data not available