Levoleucovorin is the levo isomeric form of racemic d,l -leucovorin, present as the calcium salt. Levoleucovorin is the pharmacologically active isomer of leucovorin [(6-S)-leucovorin].
Limitations of Use
- FusilevÂ® 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.
- Fusilev is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
- Fusilev is not approved for pernicious anemia and megaloblastic anemias secondary to the lack of vitamin B12. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
Clinical Trials Related to Fusilev (Levoleucovorin)
Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn [Withdrawn]
The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent
or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® [Withdrawn]
To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related
Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.
Study of Combination Treatment With IMO-2125 and Ribavirin in Naï¿½ve Hepatitis C-infected, Genotype 1 Patients [Completed]
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).
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88L265P Mutation [Recruiting]
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in
approximately 10% of the patients with Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an
initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs),
including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400
is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9.
Recent studies indicate that in the presence of L265P mutation ligand activation of those
TLRs results in markedly increased signaling with subsequent increased cell activation, cell
survival, and cell proliferation. The scientific rationale for assessing the use of IMO-8400
to treat patients with DLBCL and the L265P mutation is based on laboratory observations that
IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the
survival and proliferation of the cell populations responsible for the propagation of the
A Folinic Acid Intervention for Autism Spectrum Disorders [Suspended]
Researchers at Arkansas Children's Hospital Research Institute, in conjunction with the
Rossignol Medical Center and Driscoll Children's Hospital, 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 a single blood test. Children that complete phase 2 will be eligible
for a 12 week open-label trial of folinic acid which is phase 3.
Reports of Suspected Fusilev (Levoleucovorin) Side Effects
Infusion Related Reaction (2),
Infusion Site Reaction (1),
Hypoglycaemic Coma (1),
White Blood Cell Count Decreased (1), more >>
Page last updated: 2011-04-30