Voraxaze™ US Supplies
Procedure to Acquire Voraxaze™ under the Intravenous (IV) Open-Label Treatment Protocol and Cost Recovery Program
The FDA has approved Protherics’ Open-Label Treatment Protocol for intravenous use of Voraxaze™ on a cost recovery basis. Voraxaze™ can now be supplied to patients who qualify under this protocol. Protherics has partnered with AAIPharma, a contract research organization, who will manage the program.
In order to continue to make Voraxaze™ available prior to FDA marketing approval and to continue development through to approval, Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™ under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations (21 CFR 312.7) to charge for Voraxaze™, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit).
Investigators interested in participating in the Open-Label Treatment Protocol and/or those investigators with eligible patients should contact AAIPharma’s 24-hour access call center at +1 866 918 1731 to obtain more information on study participation. The AAIPharma call center will answer questions about the Open-Label Treatment Protocol including verifying patient’s eligibility, discussing regulatory requirements, supplying study materials, and arranging for drug shipment/invoicing.
Prospective IRB approval is required for this study unless an exemption is granted by your institution, which usually applies only to the first patient treated with Voraxaze™ at your institution. The Open-Label Treatment Protocol and Informed Consent Form have been approved by a central IRB (Western IRB, Olympia, WA). If you are interested in participating in this study, AAIPharma can arrange for central IRB review to cover your site. If your institution requires local IRB approval, we suggest that you submit the protocol and consent form prior to having a patient eligible for the study.
Voraxaze™ Leucovorin Pharmacokinetics (LV PK) Study Information
The LV PK study is a clinical study with Voraxaze™ to investigate whether the administration of Voraxaze™ alters exposure to leucovorin (LV) and its active metabolite compared with the level of exposure in patients who have not received Voraxaze™. In this study, blood samples for LV pharmacokinetic (PK) assessment and folate analysis will be obtained in patients treated with and without Voraxaze™. If you are interested in the Voraxaze™ LV PK study or want more information, please contact the AAIPharma Call Center at +1 866 918 1731. The AAIPharma call center will answer questions about the LV PK protocol, including verifying patient’s eligibility, discussing regulatory requirements, supplying study materials, and arranging for drug shipment. Prospective IRB approval is required for the LV PK study. If you are interested in treating patients with Voraxaze™ on the LV PK study, we encourage you to work with AAIPharma to obtain IRB approval now, before you have an eligible patient. The LV PK Protocol and Informed Consent Form have been approved by a central IRB (Western IRB, Olympia, WA). If you are interested in participating in this study, AAIPharma can arrange for central IRB review to cover your site.
Procedure to Acquire Voraxaze™ under the Intrathecal (IT) Emergency Use IND
Voraxaze™ for intrathecal (IT) adminstration is available in the US free of charge for emergency use to treat IT methotrexate (MTX) overdose. Information about the Emergency Use IND procedure that needs to be used is available on the FDA website at http://www.fda.gov/cder/cancer/singleIND.htm. The treating physician is the sponsor of the IND.
Under FDA regulation 21 CFR 312.36 (emergency use of an investigational new drug), a physician may treat a patient with Voraxaze™ before he/she submits an IND, as long as the manufacturer of the product agrees to provide it and FDA authorizes treatment and provides the physician with an IND number by telephone or other rapid means of communication (please see below for instructions on how to acquire Voraxaze™ for IT use and obtain an IND number).
We will continue to update our corporate website (www.protherics.com) with information on how to request Voraxaze™.
Emergency Use Procedure to Acquire Voraxaze™ for Intrathecal Methotrexate Overdose
1. Contact Protherics at 1-888-327-1027 Monday through Friday between 08:30 and 17.30 Central Time and request Voraxaze™ for IT MTX overdose. We will send FDA and you a letter of authorization allowing FDA to cross-reference Protherics’ IND on your behalf. The letter of cross-reference shows FDA that Protherics has given consent to supply Voraxaze™ to you. You will also receive from us, by email, the Voraxaze™ Investigator’s Brochure, templates for an IT Voraxaze™ treatment plan and informed consent form, FDA Forms 1571 and 1572 and a publication on IT use of Voraxaze™. In addition you will receive a stock release form that must be completed after you receive your IND number from FDA and returned to us when you want Voraxaze™ to be shipped to you (see Step 3).
2. Contact the FDA at CDER Division of Biological Oncology Products in the Office of Oncology Drug Products at 301-796-2320 (workday telephone) or 301-796-9849 (fax) or 301-443-1240 (after-hours telephone) to obtain an IND number. Because this qualifies as an emergency situation, FDA may authorize shipment of the drug in advance of the submission of an IND. The following information must be provided when the IND is submitted:
1- Cover letter stating need for emergency use of Voraxaze™
2- Letter of authorization to cross-reference Protherics’ IND
3- Brief clinical history of patient
4- Proposed treatment plan
5- Informed consent statement
6- Curriculum vitae of investigator
7- FDA Form 1571
8- FDA Form 1572
9- Contact telephone number and facsimile number of requesting physician
3. Upon receiving approval from FDA to treat the patient, return your completed stock release form to Protherics with the FDA-issued IND number, which allows Protherics to distribute Voraxaze™ for your patient. Voraxaze™ will be shipped to the address that you provide within 24 hours. If we receive your form by 9:00 Central Time, drug will be shipped for same day delivery.
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