Treatment Plan for Voraxaze in Patients with High Methotrexate Levels
Sponsor: BTG International Inc.
ClinicalTrials ID:NCT00481559
This treatment plan is for patients with high levels of methotrexate in their blood due to slow clearance caused by kidney problems. Voraxaze is used to help reduce these levels safely.
Patient Parameters
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Program Overview
This plan is designed to help patients who have high levels of methotrexate in their blood because their kidneys are not clearing it properly. Voraxaze is a medication that can help lower these levels. It is available to patients in the U.S. through a special program where doctors can request it for their patients. There is a cost for Voraxaze, which covers the expenses of making and handling the drug, but it is not for profit. Patients will continue to receive their usual care, including treatments like leucovorin and supportive measures such as staying hydrated and possibly dialysis if needed.
Description
Doctors can request Voraxaze for their patients who have high methotrexate levels due to kidney issues. To get the medication, doctors need to contact a central call center. Patients will receive a single dose of Voraxaze through an injection that takes about 5 minutes. Along with Voraxaze, patients will continue their regular treatments, which include leucovorin therapy and supportive care like drinking plenty of fluids and possibly dialysis if necessary. The program is set up to ensure that patients can access Voraxaze while it is still being made available before it becomes widely available in pharmacies.
Eligibility Criteria
Inclusion Criteria
- Patients of any age, male or female, who have high methotrexate levels in their blood due to slow clearance from kidney problems.
Exclusion Criteria
- Patients who are clearing methotrexate as expected or have normal or only slightly impaired kidney function should not use Voraxaze, as it may not be necessary and could affect methotrexate levels.
- Patients who are allergic to Voraxaze or its components should not use it.
- Patients who cannot tolerate lactose in food can still use Voraxaze.
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