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Levoleucovorin Calcium is a brand name for Levoleucovorin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION For intravenous administration only. Do not administer intrathecally. 1 ) Rescue After High-Dose Methotrexate Therapy Rescue recommendations are based on methotrexate dose of 12 grams/m 2 administered by intravenous infusion over 4 hours.
5 mg (approximately 5 mg/m 2 ) every 6 hours, 24 hours after the beginning of methotrexate infusion. 05 micromolar). Adjust dose if necessary based on methotrexate elimination; refer to Full Prescribing Information. 2 ) Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination Start as soon as possible after methotrexate overdosage or within 24 hours of delayed methotrexate elimination.
05 micromolar). 3 ) Metastatic Colorectal Cancer in Combination with Fluorouracil The following regimens have been used for the treatment of colorectal cancer: Levoleucovorin injection 100 mg/m 2 by intravenous injection over a minimum of 3 minutes, followed by fluorouracil 370 mg/m 2 once daily for 5 consecutive days.
4 ) Levoleucovorin injection 10 mg/m 2 by intravenous injection followed by fluorouracil 425 mg/m 2 once daily for 5 consecutive days. 4 ) Administer fluorouracil and levoleucovorin injection separately to avoid the formation of precipitate.
The above five-day courses may be repeated every 4 weeks for 2 courses, then every 4 to 5 weeks, if the patient has recovered from toxicity from the prior course. Do not adjust levoleucovorin injection dosage for toxicity. 1 Important Use Information Levoleucovorin injection is indicated for intravenous administration only.
Do not administer intrathecally . 2 Co-administration of Levoleucovorin Injection with other agents Due to the risk of precipitation, do not co-administer levoleucovorin injection with other agents in the same admixture. 3 Recommended Dosage for Rescue After High-Dose Methotrexate Therapy The recommended dosage for levoleucovorin injection is based on a methotrexate dose of 12 grams/m 2 administered by intravenous infusion over 4 hours.
5 mg (approximately 5 mg/m 2 ) as an intravenous infusion every 6 hours. Monitor serum creatinine and methotrexate levels at least once daily. 05 micromolar). Adjust the levoleucovorin injection dose or extend the duration as recommended in Table 1.
5 mg by intravenous infusion every 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). 05 micromolar at 96 hours after administration. 05 micromolar. 5 mg/dL to a level of 1 mg/dL or more). 05 micromolar.
2) ] The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
High-Dose Methotrexate Therapy Table 2 presents the frequency of adverse reactions which occurred during the administration of 58 courses of high-dose methotrexate 12 grams/m 2 followed by levoleucovorin rescue for osteosarcoma in 16 patients aged 6 to 21 years.
5 mg every 6 hours for 60 hours or longer, beginning 24 hours after completion of methotrexate administration.
Table 2:
Adverse Reactions with High-Dose Methotrexate Therapy Adverse Reactions Levoleucovorin n = 16 All Grades (%) Grades 3 to 4 (%) Gastrointestinal Stomatitis 38 6 Vomiting 38 0 Nausea 19 0 Diarrhea 6 0 Dyspepsia 6 0 Typhlitis 6 6 Respiratory Dyspnea 6 0 Skin and Appendages Dermatitis 6 0 Other Confusion 6 0 Neuropathy 6 0 Renal function abnormal 6 0 Taste perversion 6 0 Combination with Fluorouracil in Colorectal Cancer Table 3 presents the frequency of adverse reaction which occurred in 2 arms of a randomized controlled trial conducted by the North Central Cancer Treatment Group (NCCTG) in patients with metastatic colorectal cancer.
The trial failed to show superior overall survival with fluorouracil + levoleucovorin compared to fluorouracil + d,l -leucovorin. Patients were randomized to fluorouracil 370 mg/m 2 intravenously and levoleucovorin 100 mg/m 2 intravenously, both daily for 5 days, or to fluorouracil 370 mg/m 2 intravenously and d,l -leucovorin 200 mg/m 2 intravenously, both daily for 5 days.
5 WARNINGS AND PRECAUTIONS Hypercalcemia: Due to calcium content, inject no more than 16 mL (160 mg) of levoleucovorin solution intravenously per minute. 1 ) Increased Gastrointestinal Toxicities with Fluorouracil: Do not initiate or continue therapy with levoleucovorin and fluorouracil in patients with symptoms of gastrointestinal toxicity until symptoms have resolved.
Monitor patients with diarrhea until it has resolved as rapid deterioration leading to death can occur. 2 , 7 ) Drug Interaction with Trimethoprim-Sulfamethoxazole: Increased rates of treatment failure and morbidity with concomitant use of d,l -leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis jiroveci pneumonia in patients with HIV.
1 Hypercalcemia Because of the calcium content of the levoleucovorin solution, inject no more than 16 mL (160 mg of levoleucovorin) intravenously per minute. 2 Increased Gastrointestinal Toxicities with Fluorouracil Leucovorin products increase the toxicities of fluorouracil [see Drug Interactions (7) ] .
Gastrointestinal toxicities, including stomatitis and diarrhea, occur more commonly and may be of greater severity and of prolonged duration. Deaths from severe enterocolitis, diarrhea, and dehydration have occurred in elderly patients receiving weekly d,l- leucovorin and fluorouracil.
Monitor patients for gastrointestinal toxicities. Do not initiate or continue therapy with levoleucovorin and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until resolved, as rapid deterioration leading to death can occur.
3 Drug Interaction with Trimethoprim-Sulfamethoxazole The concomitant use of d,l- leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection was associated with increased rates of treatment failure and morbidity [see Drug Interactions (7) ] .
2 )] . Patients who have had severe hypersensitivity reactions to leucovorin products, folic acid or folinic acid. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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* These patients are likely to develop reversible renal failure. 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 levoleucovorin injection rescue for an additional 24 hours (total of 14 doses over 84 hours). , ascites, pleural effusion), renal insufficiency, or inadequate hydration can delay methotrexate elimination.
Under such circumstances, higher doses of levoleucovorin injection or prolonged administration may be indicated. 4 Recommended Dosage for Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination Start levoleucovorin injection 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 levoleucovorin injection increases, the effectiveness of levoleucovorin injection to diminish methotrexate toxicity may decrease. 05 micromolar). Monitor serum creatinine and methotrexate levels at least every 24 hours.
Increase the dosage of levoleucovorin injection to 50 mg/m 2 intravenously every 3 hours and continue levoleucovorin injection 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. 5 Dosage in Combination with Fluorouracil for Metastatic Colorectal Cancer The following regimens have been used for the treatment of colorectal cancer: Levoleucovorin injection 100 mg/m 2 by intravenous injection over a minimum of 3 minutes, followed by fluorouracil at 370 mg/m 2 by intravenous injection, once daily for 5 consecutive days.
Levoleucovorin injection 10 mg/m 2 by intravenous injection, followed by fluorouracil 425 mg/m 2 by intravenous injection, once daily for 5 consecutive days. Administer fluorouracil and levoleucovorin injection 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 levoleucovorin injection dosage for toxicity. Refer to fluorouracil prescribing information for information on fluorouracil dosage and dosage modifications for adverse reactions.
6 Preparation for Administration Levoleucovorin Injection Levoleucovorin injection contains no preservative. Observe strict aseptic technique during reconstitution of the drug product. Discard unused portion. 9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
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 levoleucovorin Injection (160 mg of levoleucovorin) intravenously per minute, because of the calcium content of the levoleucovorin solution.
Treatment was repeated week 4 and week 8, and then every 5 weeks until disease progression or unacceptable toxicity. 2 Postmarketing Experience The following adverse reaction have been identified during postapproval use of levoleucovorin products.
Because these reactions are reported 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: temperature change, rigors, allergic reactions