CTCL is more than skin deep

There are approximately 25,000 to 50,000 people living with CTCL in the US, and 70% to 75% of them have the subtypes mycosis fungoides (MF) or Sézary syndrome (SS).3 There are more than 1,600 new cases of MF and SS diagnosed each year, and there is higher prevalence in people 70 years of age or older and in African Americans.3,4,5,6

MF may progress beyond skin lesions to the blood, lymph nodes, and/or viscera in about 1 in 3 patients, and involvement of multiple disease compartments is associated with poor prognosis.7,8

4 disease compartment icons: skin, blood, lymph nodes, and viscera

The protein CCR4 plays an important role in the underlying pathogenesis of CTCL subtypes MF and SS and is expressed at all disease stages in both.9-11 CCR4 drives the migration of malignant T-cells to the skin, which may promote tumor growth and disease progression.7,9,12

Visual of Poteligeo latching onto CCR4+ malignant T-cell
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

SEE LESS

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 www.fda.gov/medwatch.
This website uses cookies to personalize content, save your preferences, and track its performance. By continuing to use this website, you consent to the use of these cookies.
POTELIGEO is a registered trademark of
Kyowa Hakko Kirin Co., Ltd.
© 2018 Kyowa Kirin, Inc. All rights reserved.
PRC-MOG-0129 August 2018