LEVOLEUCOVORIN CALCIUM 10 mg/mL
levoleucovorin injection · INJECTION, SOLUTION · Hainan Poly Pharm. Co., Ltd.
LEVOLEUCOVORIN CALCIUM is a injection, solution containing levoleucovorin injection at 10 mg/mL, taken intravenous. Manufactured by Hainan Poly Pharm. Co., Ltd..
Key Facts
- Brand Name
- LEVOLEUCOVORIN CALCIUM
- Generic Name
- levoleucovorin injection
- NDC Code (Product)
14335-340- Manufacturer
- Hainan Poly Pharm. Co., Ltd.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217314
- Marketing Start
- 05/31/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 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 B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. 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 …
Dosage & Administration
2 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 2 administered by intravenous infusion over 4 hours. Initiate rescue at a dose of 7.5 mg (approximately 5 mg/m 2 ) every 6 hours, 24 hours after the beginning of methotrexate infusion. ( 2.2 ) Continue until the methotrexate level is below 5 x 10 -8 M (0.05 micromolar). Adjust dose if necessary based on methotrexate elimination; refer to Full Prescribing Information. ( 2.2 ) 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. ( 2.3 ) Administer levoleucovorin injection 7.5 mg (approximately 5 mg/m 2 ) intravenously every 6 hours until methotrexate level is less than 5 x 10 -8 M (0.05 micromolar). ( 2.3 ) 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, follow…
Contraindications
4 CONTRAINDICATIONS Levoleucovorin injection is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see Adverse Reactions ( 6.2 )] . Patients who have had severe hypersensitivity reactions to leucovorin products, folic acid or folinic acid. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Effects of Leucovorin Products on Other Drugs Antiepileptic Drugs Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone and increase the frequency of seizures in susceptible children. It is not known whether folinic acid has the same effects; however, both folic and folinic acids share some common metabolic pathways. Monitor patients taking folinic acid in combination with antiepileptic drugs. Fluorouracil Leucovorin products increase the toxicity of fluorouracil. 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 the diarrhea has resolved, as rapid deterioration leading to death can occur [see Warnings and Precautions (5.2) ]. 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 in a placebo-controlled study [see Warnings and Precautions (5.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypercalcemia [see Warnings and Precautions (5.1) ] Increased gastrointestinal toxicities with fluorouracil [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting. ( 6.1 ) The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 o r www.fda.gov/medwatch. 6.1 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 methot…
Frequently Asked Questions
What is LEVOLEUCOVORIN CALCIUM used for?
LEVOLEUCOVORIN CALCIUM contains levoleucovorin injection. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is LEVOLEUCOVORIN CALCIUM a controlled substance?
LEVOLEUCOVORIN CALCIUM is not classified as a controlled substance by the DEA.
What is the generic name for LEVOLEUCOVORIN CALCIUM?
The generic name for LEVOLEUCOVORIN CALCIUM is levoleucovorin injection. There are no other listed brand versions of levoleucovorin injection.
What is the NDC code for LEVOLEUCOVORIN CALCIUM 10 mg/mL?
The NDC (National Drug Code) for LEVOLEUCOVORIN CALCIUM 10 mg/mL is 14335-340, listed by Hainan Poly Pharm. Co., Ltd..
Other LEVOLEUCOVORIN CALCIUM Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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