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Safety profile for POTELIGEO1

POTELIGEO patients were treated twice as long…

  • Median treatment exposure was 5.6 months for patients treated with POTELIGEO and 2.8 months for patients treated with vorinostat

…with nearly half of patients staying on therapy for at least 6 months

Graphic showing Poteligeo range of exposure

Adverse reactions in ≥10% of patients with a ≥2% higher incidence within the POTELIGEO treatment arm1,a,b

Table of adverse reactions: Poteligeo versus vorinostat

Laboratory abnormalities in ≥10% of patients with a ≥2% higher incidence within the POTELIGEO treatment arm1

Table of laboratory abnormalities: Poteligeo versus vorinostat
  • No specific laboratory test is required to prescribe POTELIGEO


  • POTELIGEO was discontinued due to adverse reactions in 18% of patients1
  • Most frequent was rash (drug eruption) (7%)
  • Vorinostat was discontinued due to adverse reactions in 23% of patients2
  • 20% of patients crossed over to POTELIGEO due to adverse reactions
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information


Warnings and Precautions

  • Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
  • Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.
  • Infections: Monitor patients for signs and symptoms of infection and treat promptly.
  • Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
  • Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

  • The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
  • You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or
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POTELIGEO is a registered trademark of
Kyowa Kirin Co., Ltd.
© 2020 Kyowa Kirin, Inc. All rights reserved.
PM-US-POT-0042 November 2020