LEVOLEUCOVORIN- levoleucovorin calcium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

levoleucovorin calcium (UNII: 778XL6VBS8) (levoleucovorin - UNII:990S25980Y)

Available from:

Meitheal Pharmaceuticals Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin Injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see Adverse Reactions (6.2)] . Risk Summary There are limited data with levoleucovorin use in pregnant women. Animal reproduction studies have not been conducted with levoleucovorin. Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data on the presence of levoleucovorin in human milk or its effects on the breastfed infant or on milk production. Levoleucovorin is administered in combination with methotrexate or fluorouracil. Refer to methotrexate and fluorouracil prescribing information for additional information. The safety and effectiveness of levoleucovorin have been established in pediatric patients for rescue after high-dose methotrexate therapy in osteosarcoma and diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. Use of levoleucovorin in pediatric patients is supported by open-label clinical trial data in 16 pediatric patients 6 years of age and older, with additional supporting evidence from literature [see Clinical Studies (14.1)]. The safety and effectiveness of levoleucovorin have not been established for the treatment of pediatric patients with advanced metastatic colorectal cancer. Clinical studies of levoleucovorin in the treatment of osteosarcoma did not include patients aged 65 and over to determine whether they respond differently from younger patients. In the NCCTG clinical trial of levoleucovorin in combination with fluorouracil for the treatment of metastatic colorectal cancer, no overall differences in safety or effectiveness were observed between patients age 65 years and older and younger patients.

Product summary:

Levoleucovorin Injection is a sterile colorless to yellow, clear solution in a single-dose vial, and is supplied as follows: Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light. Store in carton until contents are used. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. meitheal® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2023 Meitheal Pharmaceuticals Inc. Mfd. by Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 Revised: August 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOLEUCOVORIN- LEVOLEUCOVORIN CALCIUM INJECTION, SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOLEUCOVORIN
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOLEUCOVORIN
INJECTION.
LEVOLEUCOVORIN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1952 (_D,L_-LEUCOVORIN)
INDICATIONS AND USAGE
Levoleucovorin Injection is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in adult and pediatric
patients with osteosarcoma. (1)
Diminishing the toxicity associated with overdosage of folic acid
antagonists or impaired methotrexate
elimination in adult and pediatric patients. (1)
Treatment of adults with metastatic colorectal cancer in combination
with fluorouracil. (1)
Limitations of Use
Levoleucovorin Injection is not indicated for the treatment of
pernicious anemia and megaloblastic anemia
secondary to lack of vitamin B
, because of the risk of progression of neurologic manifestations
despite
hematologic remission. (1)
DOSAGE AND ADMINISTRATION
For intravenous administration only. Do not administer intrathecally.
(2.1)
Rescue After High-Dose Methotrexate Therapy
Rescue recommendations are based on methotrexate dose of 12 grams/m
administered by
intravenous infusion over 4 hours. Initiate rescue at a dose of 7.5 mg
(approximately 5 mg/m ) every 6
hours, 24 hours after the beginning of methotrexate infusion. (2.3)
Continue until the methotrexate level is below 5 x 10 M (0.05
micromolar). Adjust dose if necessary
based on methotrexate elimination; refer to Full Prescribing
Information. (2.3)
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. (2.4)
Administer levoleucovorin injection 7.5 mg (approximately 5 mg/m )
intravenously every 6 hours until
methotrexate level is less than 5 x 10 M (0.05 micromolar). (2.4)
Metastatic Colorec