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POTELIGEO® Video Library

CTCL Expert Perspectives

POTELIGEO Efficacy and Safety

Hear Andrei Shustov, MD discuss the value of key endpoints used in the phase 3 MAVORIC trial, patient types appropriate for treatment with POTELIGEO, and the most common adverse reactions reported in MAVORIC.

Patient Identification

Andrei Shustov, MD discusses identifying therapy-refractive patients, how blood involvement can impact treatment selection, how clinical practice guidelines help shape decisions, and appropriate patient types for treatment with POTELIGEO based on data from the phase 3 MAVORIC trial.

Patient Communication

Lauren C. Pinter-Brown, MD, clinical professor of Hematology/Oncology at the University of California, Irvine, discusses how to communicate with patients who have mycosis fungoides (MF) or Sézary syndrome (SS) on topics including disease state, prognosis, blood involvement, staging, and prescribing.

How POTELIGEO Works

POTELIGEO Mechanism of Action

Learn about how POTELIGEO works, POTELLIGENT® technology, the role of C-C chemokine receptor type 4 (CCR4),1 and key points of the infusion process.

POTELLIGENT Technology

Explore POTELLIGENT technology, an innovative approach designed to enhance antibody-dependent cellular cytotoxicity.

The POTELIGEO Infusion Process

Find out about the POTELIGEO infusion process and how to monitor your patients with this interactive training video.

POTELIGEO and the CCR4 Target

Learn why CCR4 is a key target for mycosis fungoides and Sézary syndrome, and how POTELIGEO targets CCR4-positive T cells.1

POTELIGEO® Points Virtual Library

Take a virtual tour of all things POTELIGEO with these short, information-packed vignettes.

The MAVORIC Trial Patient Population

Explore the diverse patient population and key efficacy results of POTELIGEO vs vorinostat.1

POTELIGEO Efficacy in Skin

Learn about the response of POTELIGEO in skin, based on a post hoc analysis of data in the MAVORIC clinical trial.1

POTELIGEO Efficacy in Blood

Look at the response of POTELIGEO in the blood, based on a post hoc analysis of data in the MAVORIC clinical trial.1

How POTELIGEO Uniquely Targets CCR4

Learn about the role of C-C chemokine receptor type 4 (CCR4) in mycosis fungoides (MF) and Sézary syndrome (SS), and how POTELIGEO kills CCR4+ malignant T cells.1

Long-term Safety Follow-up

See the results of post-MAVORIC trial analysis of safety in patients with POTELIGEO treatment exposure up to 5 years.

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Reference:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, NJ USA.

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion 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 www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

Important Safety Information

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion 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.

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.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.