LEVOLEUCOVORIN CALCIUM- levoleucovorin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOLEUCOVORIN CALCIUM PENTAHYDRATE (UNII: WA16A5Y52X) (LEVOLEUCOVORIN - UNII:990S25980Y)

Available from:

Mylan Institutional LLC

INN (International Name):

LEVOLEUCOVORIN CALCIUM

Composition:

LEVOLEUCOVORIN 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levoleucovorin injection is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Animal reproduction studies have not been conducted with levoleucovorin. It is not known whether levoleucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Levoleucovorin should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from levoleucovorin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. [See Clinical Studies (14).] Clinical studies of levoleucovorin in the treatment of osteosarcoma did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. In the NCCTG clinical trial of levoleucovo

Product summary:

Levoleucovorin Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. NDC 67457-600-20 175 mg/17.5 mL solution - carton containing one single-use vial Levoleucovorin Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. NDC 67457-601-30 250 mg/25 mL solution - carton containing one single-use vial Store in refrigerator at 2° to 8°C (36° to 46°F). Protect from light. Store in carton until contents are used. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: Alidac Pharmaceuticals Limited Ahmedabad, India Code No.: GUJ/DRUGS/G/28/1304 Revised: 4/2018 MI:LEVOLIJ:R4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOLEUCOVORIN CALCIUM- LEVOLEUCOVORIN INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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: 2008 (LEVOLEUCOVORIN)
INDICATIONS AND USAGE
Levoleucovorin injection is a folate analog indicated for:
•
•
•
LIMITATIONS OF USE
Levoleucovorin injection is not approved for pernicious anemia and
megaloblastic anemias. Improper use may cause a
hematologic remission while neurologic manifestations continue to
progress. (1.1)
DOSAGE AND ADMINISTRATION
Do not administer intrathecally. (2.1)
Levoleucovorin injection is dosed at ONE-HALF the usual dose of
racemic _d,l_-leucovorin. (2.1)
LEVOLEUCOVORIN INJECTION RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY
Levoleucovorin injection rescue recommendations are based on a
methotrexate dose of 12 grams/m administered by
intravenous infusion over 4 hours. Levoleucovorin injection rescue at
a dose of 7.5 mg (approximately 5 mg/m ) every 6
hours for 10 doses starts 24 hours after the beginning of the
methotrexate infusion. Determine serum creatinine and
methotrexate levels at least once daily. Continue levoleucovorin
injection administration, hydration, and urinary
alkalinization (pH of 7.0 or greater) until the methotrexate level is
below 5 x 10
M (0.05 micromolar). The levoleucovorin
injection dose may need to be adjusted. (2.3)
LEVOLEUCOVORIN INJECTION ADMINISTRATION IN COMBINATION WITH
5-FLUOROURACIL (5-FU)
The following regimens have been used historically for the treatment
of colorectal cancer:
1. Levoleucovorin injection is administered at 100 mg/m by slow
intravenous injection over a minimum of 3 minutes,
followed by 5-FU at 370 mg/m by intravenous injection. (2.5)
2. Levoleucovorin injection is administered at 10 mg/m by intravenous
injection followed by 5-FU at 425 mg/m by
intravenous inject