Voraxaze™ US Supplies
Voraxaze Leucovorin Pharmacokinetics (LV PK) Interaction Study Information
The LV PK study is a clinical study 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 from patients treated with and without Voraxaze.
If you are interested in the Voraxaze LV PK study or want more information, please contact the AAIPharma’s 24-hour access 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 Intravenous (IV) Open-Label Treatment Protocol and Cost Recovery Program
Voraxaze is available in the US for intravenous (IV) administration to patients who qualify under Protherics’ Open-Label Treatment Protocol. Protherics has partnered with AAIPharma, a contract research organisation, who is managing the program.
In order to continue to make Voraxaze available prior to FDA marketing approval, and to fund its development through to approval, 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 the charge does not include other commercial costs (profit).
Investigators interested in participating in the Open-Label Treatment Protocol, and/or those investigators with potentially 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 the 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. If you do not obtain prospective IRB approval for treatment of a patient at your institution, and you do not have a waiver, AAIPharma will be unable to distribute Voraxaze.
Procedure to Acquire Voraxaze under the Intrathecal (IT) Emergency Use IND
Voraxaze for intrathecal (IT) administration 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).
Emergency Use Procedure to Acquire Voraxaze for IT MTX Overdose
1. Contact Protherics at 1-888-327-1027 on Monday through Friday between 08:30 and 17.30 Central Time to request Voraxaze for IT MTX overdose. We will send both you and the FDA a letter of authorisation, allowing the FDA to cross-reference Protherics’ IND on your behalf. The letter of cross-reference shows the FDA that Protherics has given consent to supply Voraxaze to you. You will also receive from us, by email:
- Voraxaze Investigator’s Brochure
- Templates for an IT Voraxaze treatment plan and informed consent form
- FDA Forms 1571 and 1572
- Publication on IT use of Voraxaze
- Stock release form that must be completed after you receive your IND number from the 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, the FDA may authorise shipment of the drug in advance of the submission of an IND. The following information must be provided when the IND is submitted:
- Cover letter stating need for emergency use of Voraxaze
- Letter of authorisation to cross-reference Protherics’ IND
- Brief clinical history of patient
- Proposed treatment plan
- Informed consent statement
- Curriculum vitae of investigator
- FDA Forms 1571 and 1572
- 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 am Central Time, drug will be shipped for same day delivery.
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