Generic name: LEVOLEUCOVORIN CALCIUM 50mg in 5mL
Dosage form: injection, powder, lyophilized, for solution
Medically reviewed by Drugs.com. Last updated on Nov 24, 2020.
Important Use Information
Fusilev is indicated for intravenous administration only. Do not administer intrathecally.
Co-adminstration of Fusilev with other agents
Due to the risk of precipitation, do not co-administer Fusilev with other agents in the same admixture.
Recommended Dosage for Rescue After High-Dose Methotrexate Therapy
The recommended dosage for Fusilev is based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours. Twenty-four hours after starting the methotrexate infusion, initiate Fusilev at a dose of 7.5 mg (approximately 5 mg/m2) as an intravenous infusion every 6 hours.
Monitor serum creatinine and methotrexate levels at least once daily. Continue Fusilev administration, hydration, and urinary alkalinization (pH of 7 or greater) until the methotrexate level is below 5 x 10-8 M (0.05 micromolar). Adjust the Fusilev dose or extend the duration as recommended in Table 1.
|Normal Methotrexate Elimination
||Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours
||Administer 7.5 mg by intravenous infusion every 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion).
|Delayed Late Methotrexate Elimination
||Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration.
||Continue 7.5 mg by intravenous infusion every 6 hours, until methotrexate level is less than 0.05 micromolar.
|Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury*
||Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration,
100% or greater increase in serum creatinine level at 24 hours after methotrexate administration (e.g., an increase from 0.5 mg/dL to a level of 1 mg/dL or more).
|Administer 75 mg by intravenous infusion every 3 hours until methotrexate level is less than 1 micromolar; then 7.5 mg by intravenous infusion every 3 hours until methotrexate level is less than 0.05 micromolar.
*These patients are likely to develop reversible renal failure. In addition to appropriate Fusilev therapy, continue hydration and urinary alkalinization and monitoring fluid and electrolyte status, until the serum methotrexate level has fallen to below 0.05 micromolar and the renal failure has resolved.
Impaired Methotrexate Elimination or Renal Impairment
Decreased methotrexate elimination or renal impairment which are clinically important but less severe than the abnormalities described in Table 1 can occur following methotrexate administration. If toxicity associated with methotrexate is observed, in subsequent courses extend Fusilev rescue for an additional 24 hours (total of 14 doses over 84 hours).
Third-Space Fluid Collection and Other Causes of Delayed Methotrexate Elimination
Accumulation in a third space fluid collection (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration can delay methotrexate elimination. Under such circumstances, higher doses of Fusilev or prolonged administration may be indicated.
Recommended Dosage for Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination
Start Fusilev as soon as possible after an overdosage of methotrexate or within 24 hours of methotrexate administration when methotrexate elimination is impaired. As the time interval between methotrexate administration and Fusilev increases, the effectiveness of Fusilev to diminish methotrexate toxicity may decrease. Administer Fusilev 7.5 mg (approximately 5 mg/m2 ) by intravenous infusion every 6 hours until the serum methotrexate level is less than 5 x 10-8 M (0.05 micromolar).
Monitor serum creatinine and methotrexate levels at least every 24 hours. Increase the dosage of Fusilev to 50 mg/m2 intravenously every 3 hours and continue Fusilev at this dosage until the methotrexate level is less than 5 x 10-8 M for the following:
• if serum creatinine at 24-hours increases 50% or more compared to baseline
• if the methotrexate level at 24-hours is greater than 5 x 10-6 M
• if the methotrexate level at 48-hours is greater than 9 x 10-7 M,
Continue concomitant hydration (3 L per day) and urinary alkalinization with sodium bicarbonate. Adjust the sodium bicarbonate dose to maintain urine pH at 7 or greater.
Dosage in Combination with Fluorouracil for Metastatic Colorectal Cancer
The following regimens have been used for the treatment of colorectal cancer:
• Fusilev 100 mg/m2 by intravenous injection over a minimum of 3 minutes, followed by fluorouracil at 370 mg/m2 by intravenous injection, once daily for 5 consecutive days.
• Fusilev 10 mg/m2 by intravenous injection, followed by fluorouracil 425 mg/m2 by intravenous injection, once daily for 5 consecutive days.
Administer Fluorouracil and Fusilev separately to avoid the formation of a precipitate.
This five-day course may be repeated every 4 weeks for 2 courses, then every 4 to 5 weeks, if the patient has recovered from the toxicity from the prior course. Do not adjust Fusilev dosage for toxicity.
Refer to fluorouracil prescribing information for information on fluorouracil dosage and dosage modifications for adverse reactions.
Preparation for Administration
Fusilev for Injection
• Prior to intravenous injection, reconstitute the 50 mg vial of Fusilev for Injection with 5.3 mL of 0.9% Sodium Chloride Injection, USP to yield a levoleucovorin concentration of 10 mg per mL. Reconstitution with Sodium Chloride solutions with preservatives (e.g. benzyl alcohol) has not been studied. The use of solutions other than 0.9% Sodium Chloride Injection, USP is not recommended.
• The reconstituted 10 mg per mL levoleucovorin contains no preservative. Observe strict aseptic technique during reconstitution of the drug product. Discard unused portion.
• Saline reconstituted levoleucovorin solutions may be further diluted, immediately, to concentrations of 0.5 mg/mL to 5 mg/mL in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Do not store the reconstituted product or reconstituted product dilutedusing 0.9% Sodium Chloride Injection, USP for more than 12 hours at room temperature. Do not store reconstituted product diluted using 5% Dextrose Injection, USP for more than 4 hours at room temperature.
• Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. Do not use if cloudiness or precipitate is observed.
• Do not intravenously inject more than 16 mL of reconstituted solutions (160 mg of levoleucovorin) per minute, because of the calcium content of the levoleucovorin solution.
• Levoleucovorin contains no preservative. Observe strict aseptic technique during reconstitution of the drug product. Discard unused portion.
• Levoleucovorin solutions may be further diluted to concentrations of 0.5 mg/mL in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Do not store the product diluted using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP for more than 4 hours at room temperature.
• Visually inspect the diluted solution for particulate matter and discoloration prior to administration. Do not use if cloudiness or precipitate is observed.
• Inject no more than 16 mL of Fusilev Injection (160 mg of levoleucovorin) intravenously per minute, because of the calcium content of the levoleucovorin solution.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Fusilev (levoleucovorin)
- Side Effects
- During Pregnancy
- Drug Interactions
- Generic Availability
- Drug class: antidotes
- FDA Alerts (1)
- FDA Approval History
Other brands: Khapzory