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MINT-LEUCOVORIN is a brand name for Leucovorin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MINT-LEUCOVORIN (leucovorin calcium) is indicated for: • diminishing the toxicity and counteracting the effect of impaired methotrexate elimination. • treatment of megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of pregnancy and infancy. 1.1 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Impaired methotrexate Elimination or Accidental Overdosage: MINT-LEUCOVORIN rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see 7 WARNINGS AND PRECAUTIONS).
As the time interval between the administration of antifolate and MINT-LEUCOVORIN rescue increases, the effectiveness of MINT-LEUCOVORIN in counteracting toxicity decreases. There are no fixed guidelines regarding the dose of methotrexate that triggers an automatic subsequent leucovorin calcium administration, since tolerance to this folate antagonist depends on various factors.
The dose of methotrexate varies, nevertheless folinate rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2 and has to be considered with doses of 100 mg - 500 mg/m2. Leucovorin calcium rescue treatment should commence approximately 24 hours after the beginning of methotrexate infusion.
Dosage regimens vary depending upon the dose of methotrexate administered. In general, leucovorin calcium should be administered at a dose of 15 mg (approximately 10 mg/m2) every 6 hours for 10 doses, either parenterally by intramuscular injection, bolus intravenous injection, intravenous infusion, or orally using leucovorin calcium tablets.
Monitoring of the serum methotrexate (MTX) concentration is essential in determining the optimal dose and duration of therapy. If serum creatinine increases after methotrexate therapy or if methotrexate plasma concentrations are above certain threshold (see Table 1), the dose of leucovorin calcium should be increased according to the plasma methotrexate concentrations, as soon as the risk is recognized.
In the presence of gastrointestinal toxicity, nausea, or vomiting, leucovorin calcium should be administered parenterally. In the case of intravenous administration, no more than 160 mg of leucovorin calcium should be injected per minute due to the calcium content of the solution.
Further, oral administration of doses greater than 25 mg is not recommended since the digestive absorption of leucovorin calcium is saturable; these doses should be administered parenterally. In addition to leucovorin calcium administration, measures to ensure the prompt excretion of methotrexate are an integral part of the leucovorin calcium rescue treatment.
1 Adverse Reaction Overview Allergic sensitization, including anaphylactoid/anaphylactic reactions (including shock) and urticaria, has been reported following administration of leucovorin. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and MINT-LEUCOVORIN (leucovorin calcium) Page 11 of 25 should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Leucovorin in Combination with 5-fluorouracil (5-FU) In combination regimens, the toxicity profile of 5FU is enhanced by leucovorin calcium.
The most common manifestations are mucositis, stomatitis, leukopenia and/or diarrhea, which may be dose-limiting. In clinical trials with this drug combination, these toxicities were found to be reversible with appropriate modification of 5-FU administration.
Generally, the safety profile depends on the applied regimen of 5-fluorouracil due to enhancement of the 5-fluorouracil induced toxicities. 5 Post-Market Adverse Reactions Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some fatal, have been reported in patients receiving leucovorin calcium in combination with other agents known to be associated with these disorders.
A contributory role of leucovorin in these occurrences of SJS/TEN cannot be excluded. Fatalities have occurred as a result of gastrointestinal toxicity (predominantly mucositis and diarrhea) and myelosuppression. In patients with diarrhea, rapid clinical deterioration leading to death can occur.
MINT-LEUCOVORIN (leucovorin calcium) Page 12 of 25
3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS MINT-LEUCOVORIN therapy is contraindicated in patients with: • Known hypersensitivity to the active substance or to any of the excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient. A hematologic remission may occur while neurologic manifestations continue to progress. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • MINT-LEUCOVORIN should only be used with 5-fluorouracil or methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
• Cases of Stevens - Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some fatal, have been reported in patients receiving leucovorin calcium in combination with other agents known to be associated with these disorders.
• Fatalities have occurred as a result of gastrointestinal toxicity (particularly mucusitis and diarrhea) associated with leucovorin calcium use. 2 Recommended Dose and Dosage Adjustment Impaired methotrexate Elimination or Accidental Overdosage: MINT-LEUCOVORIN rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see 7 WARNINGS AND PRECAUTIONS).
As the time interval between the administration of antifolate and MINT-LEUCOVORIN rescue increases, the effectiveness of MINT-LEUCOVORIN in counteracting toxicity decreases. There are no fixed guidelines regarding the dose of methotrexate that triggers an automatic subsequent leucovorin calcium administration, since tolerance to this folate antagonist depends on various factors.
The dose of methotrexate varies, nevertheless folinate rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2 and has to be considered with doses of 100 mg - 500 mg/m2. Leucovorin calcium rescue treatment should commence approximately 24 hours after the beginning of methotrexate infusion.
MINT-LEUCOVORIN therapy is contraindicated in patients with: • Known hypersensitivity to the active substance or to any of the excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient.
A hematologic remission may occur while neurologic manifestations continue to progress.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These measures include: a) Maintenance of urine output above 2,500 mL/24hr in adults by increased oral or intravenous fluids 12 hours before and for 36 hours after the end of methotrexate infusion. 0 before methotrexate MINT-LEUCOVORIN (leucovorin calcium) Page 6 of 25 infusion.
Foods, drinks and drugs that may increase urinary acidity should be avoided during the therapy. c) Plasma methotrexate concentration and serum creatinine should be measured at least 24, 48, and 72 hours after the initiation of the methotrexate infusion.
These measurements must be continued until the plasma methotrexate level is less than 5 x 10-8 molar. 05μm). Delayed methotrexate excretion may be seen in some patients. This may be caused by a third space accumulation (as seen in ascites or pleural effusion for example), renal insufficiency or inadequate hydration (see 7 WARNINGS AND PRECAUTIONS).
Under such circumstances, higher doses of leucovorin calcium and/or prolonged administration may be indicated. Some dosage and administration guidelines are given in Table 1. 1 μM at 72 hours. 15 mg PO, IM, or IV every 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion).
1 μM at 96 hours after administration. 1 μM. Delayed early methotrexate elimination and/or evidence of acute renal failure Serum methotrexate level of > 10 μM at 24 hours, or > 1 μM at 48 hours after administration OR a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration.
1 μM. Hydration (3 L/d) and urinary alkalinization with NaHC03 should be employed concomitantly. 0 or greater.
Megaloblastic Anemia Due to Folic Acid Deficiency:
Doses up to 15 mg daily have been suggested. MINT-LEUCOVORIN (leucovorin calcium) Page 7 of 25 Health Canada has not authorized an indication for pediatric use. 4 Administration Tablets are administered orally.
Dosage regimens vary depending upon the dose of methotrexate administered. In general, leucovorin calcium should be administered at a dose of 15 mg (approximately 10 mg/m2) every 6 hours for 10 doses, either parenterally by intramuscular injection, bolus intravenous injection, intravenous infusion, or orally using leucovorin calcium tablets.
Monitoring of the serum methotrexate (MTX) concentration is essential in determining the optimal dose and duration of therapy. If serum creatinine increases after methotrexate therapy or if methotrexate plasma concentrations are above certain threshold (see Table 1), the dose of leucovorin calcium should be increased according to the plasma methotrexate concentrations, as soon as the risk is recognized.
In the presence of gastrointestinal toxicity, nausea, or vomiting, leucovorin calcium should be administered parenterally. In the case of intravenous administration, no more than 160 mg of leucovorin calcium should be injected per minute due to the calcium content of the solution.
Further, oral administration of doses greater than 25 mg is not recommended since the digestive absorption of leucovorin calcium is saturable; these doses should be administered parenterally. In addition to leucovorin calcium administration, measures to ensure the prompt excretion of methotrexate are an integral part of the leucovorin calcium rescue treatment.
These measures include: a) Maintenance of urine output above 2,500 mL/24hr in adults by increased oral or intravenous fluids 12 hours before and for 36 hours after the end of methotrexate infusion. 0 before methotrexate MINT-LEUCOVORIN (leucovorin calcium) Page 6 of 25 infusion.
Foods, drinks and drugs that may increase urinary acidity should be avoided during the therapy. c) Plasma methotrexate concentration and serum creatinine should be measured at least 24, 48, and 72 hours after the initiation of the methotrexate infusion.
These measurements must be continued until the plasma methotrexate level is less than 5 x 10-8 molar. 05μm). Delayed methotrexate excretion may be seen in some patients. This may be caused by a third space accumulation (as seen in ascites or pleural effusion for example), renal insufficiency or inadequate hydration (see 7 WARNINGS AND PRECAUTIONS).
Under such circumstances, higher doses of leucovorin calcium and/or prolonged administration may be indicated. Some dosage and administration guidelines are given in Table 1. 1 μM at 72 hours. 15 mg PO, IM, or IV every 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion).
1 μM at 96 hours after administration. 1 μM. Delayed early methotrexate elimination and/or evidence of acute renal failure Serum methotrexate level of > 10 μM at 24 hours, or > 1 μM at 48 hours after administration OR a 100% or greater increase in serum creatinine level at 24 […]