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FDA Date: 11/5/13
Iclusig (ponatinib) FDA Drug Safety Communication
FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales This information is a follow up to the FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales issued on October 31, 2013.
The U.S. Food and Drug Administration (FDA) is providing instructions to health care professionals whose patients have been taking Iclusig (ponatinib) and are benefiting from the drug, on how to continue those patients on the drug. We are working closely with Iclusig's manufacturer, ARIAD Pharmaceuticals (ARIAD), to avoid interruptions in treatment. At this time, Iclusig treatment may be continued for appropriate patients under an emergency Investigational New Drug (IND) application.
Health care professionals (HCPs) may continue to use Iclusig for patients who they determine are responding to the drug and for whom the potential benefits outweigh the risks. As stated previously, HCPs should immediately discontinue Iclusig treatment for patients who are not responding to the drug and discuss alternative treatment options with them. New patients should not be started on Iclusig unless no other treatment options are available and all other available therapies have failed.
How Health Care Professionals Can Obtain Emergency Access to Iclusig:
Step 1: You, the health care professional, should contact FDA to receive an emergency IND number:
- 301-796-7550 between 8:00 a.m. and 4:30 p.m. EST Monday through Friday
- 866-300-4374 or 301-796-8240 after 4:30 p.m. EST
Please have the following information when calling FDA:
- Patient initials and date of birth
- Your name and contact information (address, phone number, and email address)
- Indication for treatment and dosing regimen
If you have multiple patients who will need Iclusig, you may request multiple INDs during a single telephone call to FDA. We will provide the corresponding amount of IND numbers at the end of the call. You should anticipate when the drug supply would be needed and initiate the emergency IND process as early as possible. Contact FDA at least 48-72 hours in advance of the anticipated drug need.
Step 2: Contact ARIAD at 855-552-7423 and provide the IND number and address for shipping. ARIAD will send a shipment request form and informed consent document to you. After ARIAD receives the signed shipment request form back from you, ARIAD will have the drug shipped by courier to your office.
Step 3: ARIAD also will provide a packet that you will be required to submit to the FDA within 15 working days of your emergency IND request being granted.