LEVOLEUCOVORIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOLEUCOVORIN CALCIUM (UNII: 778XL6VBS8) (LEVOLEUCOVORIN - UNII:990S25980Y)

Available from:

Gland Pharma Limited

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,

Product summary:

Levoleucovorin injection is a sterile clear pale yellow color solution in a single-dose vial available as:                                        175 mg/17.5 mL solution – NDC 68083-278-01                                        250 mg/25 mL solution – NDC 68083-279-01 Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used. Manufactured by: Gland Pharma Limited Pashamylaram, Hyderabad-502 307, INDIA. Revised: 12/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOLEUCOVORIN - LEVOLEUCOVORIN INJECTION
GLAND PHARMA LIMITED
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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)
RECENT MAJOR CHANGES
Indication and Usage (1) 01/2020
Dosage and Administration (2) 11/2020
Contraindications (4) 01/2020
Warning and Precautions (5) 01/2020
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 levoleucovori