Dosing modifications for adverse reactions1

Dermatologic toxicity

  • Monitor patients for rash throughout the treatment course
  • Rash (drug eruption) may be visually indistinguishable from disease progression
  • Consider skin biopsy to help make a differential diagnosis
Table of dosing modification recommendations for dermatologic toxicity (by grade)

Infusion reactions

Common signs of infusion reactions

chills | nausea | fever | tachycardia | rigors | headache | vomiting

Table of dosing modification recommendations for infusion reaction (by grade)

Use in special populations

Pharmacokinetics

No clinically significant changes in the pharmacokinetics of POTELIGEO were observed based on age, renal impairment, or mild/moderate hepatic impairment. As a result, no corresponding dose modifications are required.

Geriatric use

  • In MAVORIC, 51% of patients treated with POTELIGEO were 65 years of age or older (range: 25 to 101)
  • No overall differences in effectiveness were observed between patients 65 or older and younger patients
  • Patients 65 or older had a greater number of grade 3 or higher adverse reactions than patients under 65, but the difference was not statistically significant

For more information on dosing, see the POTELIGEO Dosing and Administration Guide

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.
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POTELIGEO is a registered trademark of
Kyowa Hakko Kirin Co., Ltd.
© 2019 Kyowa Kirin, Inc. All rights reserved.
PM-US-POT-0042 July 2019