Fusilev (Levoleucovorin Calcium) - Summary

FUSILEV SUMMARY

Fusilev for injection contains levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as antidote to the inhibition of dihydrofolate reductase by methotrexate.

• Fusilev™ is a folate analog.
• Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
• Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

NEWS HIGHLIGHTS

Clinical Trials Related to Fusilev (Levoleucovorin)

Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer [Recruiting]
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

A Folinic Acid Intervention for Autism Spectrum Disorders [Recruiting]
Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and blood tests. Children in the placebo group during phase 2 will be offered to receive 12 weeks of the folinic acid intervention after they have completed Phase 2.

Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients [Recruiting]
Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4: 1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) [Recruiting]
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.

Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab [Recruiting]
The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.

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Reports of Suspected Fusilev (Levoleucovorin) Side Effects

Urticaria (3),  Pruritus (2),  Vomiting (2),  Infusion Related Reaction (2),  Nausea (2),  Chills (1),  Hyperhidrosis (1),  Infusion Site Reaction (1),  Hypoglycaemic Coma (1),  White Blood Cell Count Decreased (1), more >>