Leucovorin Calcium Injection Fresenius Kabi

Leucovorin Calcium Injection Fresenius Kabi

calcium folinate

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Leucovorin Ca
Indications/Uses
Leucovorin rescue after high-dose MTX therapy. Diminish toxicity & counteract effects of impaired MTX elimination & of inadvertent overdosage of folic acid antagonists. Megaloblastic anemia due to folic acid deficiency when oral therapy is not feasible. In combination w/ 5-fluorouracil to prolong survival in palliative treatment of patients w/ advanced CRC.
Dosage/Direction for Use
Leucovorin rescue after high-dose MTX therapy 15 mg every 6 hr for 10 doses 24 hr after start of MTX infusion. Normal MTX elimination 15 mg orally, IM, or IV every 6 hr for 60 hr (10 doses starting at 24 hr after start of MTX infusion). Delayed MTX elimination Continue 15 mg orally, IM, or IV every 6 hr, until MTX level is <0.05 micromolar. Delayed early MTX elimination &/or evidence of acute renal injury 150 mg IV every 3 hr, until MTX level is <1 micromolar, then 15 mg IV every 3 hr until MTX level is <0.05 micromolar. Impaired MTX elimination or inadvertent overdosage 10 mg/m2 IM, IV, or orally every 6 hr, may be increased to 100 mg/m2 IV every 3 hr until serum MTX level is <10-8 M. Megaloblastic anemia due to folic acid deficiency Up to 1 mg daily. Advanced CRC 200 mg/m2 by slow IV inj over a minimum of 3 min, followed by 5-fluorouracil at 370 mg/m2 IV inj or 20 mg/m2 IV inj followed by 5-fluorouracil at 425 mg/m2 IV inj. Repeat daily for 5 days. May be repeated at 4-wk intervals, for 2 courses & then at 4-5 wk intervals if patient has completely recovered from the toxic effects of prior treatment course.
Contraindications
Pernicious anemia & other megaloblastic anemias secondary to vit B12 deficiency.
Special Precautions
Not to be administered intrathecally. Not to be inj >160 mg. Seizures &/or syncope. GI toxicities eg, stomatitis, diarrhea. Fluid accumulation eg, ascites, pleural effusion. Monitor serum MTX conc. Not to be initiated w/ 5-fluorouracil. Combination therapy of folinic & fluorouracil. Renal insufficiency, inadequate hydration. Childn. Increased risk of severe toxicity in elderly or debilitated CRC patient.
Adverse Reactions
Allergic sensitization, including anaphylactoid reactions & urticaria. Leukopenia, thrombocytopenia, infection, nausea, vomiting, diarrhea, stomatitis, constipation, lethargy/malaise/fatigue, alopecia, dermatitis, anorexia, hospitalization for toxicity.
Drug Interactions
Counteracted antiepileptic effect of phenobarb, phenytoin & primidone w/ large amount of folic acid. Reduced efficacy of intrathecal MTX w/ high doses. Enhanced 5-fluorouracil toxicity.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AF03 - calcium folinate ; Belongs to the class of detoxifying agents used in antineoplastic treatment.
Presentation/Packing
Form
Leucovorin Calcium Injection Fresenius Kabi inj 350 mg/35 mL
Packing/Price
1's
Form
Leucovorin Calcium Injection Fresenius Kabi inj 50 mg/5 mL
Packing/Price
1's
Form
Leucovorin Calcium Injection Fresenius Kabi inj 500 mg/50 mL
Packing/Price
1's
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