Approved Risk Evaluation and Mitigation Strategies (REMS)

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Iclusig (ponatinib)
NDA #203469
REMS last update: 11/28/2016



What is the purpose of the REMS?

  1. Inform prescribers of the indications for Iclusig which are limited to:
    1. Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated
    2. Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL
    3. Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
  2. Inform prescribers of the risks of arterial occlusion and venous thromboembolism associated with Iclusig treatment.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Iclusig REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS Letter to Healthcare Providers (print version) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Letter_to_Healthcare_Providers.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_REMS_Document.pdf
REMS Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Fact_Sheet.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Full.pdf
REMS Letter for Professional Societies (print version) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Letter_for_Professional_Societies.pdf
REMS website screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_REMS_Website_Screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
11/28/2016 Modified to update data regarding the incidence of arterial occlusive and venous thromboembolic events to the Letter for Healthcare Providers, Letter for Professional Societies, Factsheet, and changes to the website.
12/20/2013 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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