Safety profile for POTELIGEO1

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

  • POTELIGEO patients were treated twice as long with nearly half of patients staying on therapy for at least 6 months
poteligeo range of treatment exposure

Serious adverse reactions reported in >2% of patients randomized to POTELIGEO were1:

  • Pneumonia (5%), sepsis (4%), pyrexia (4%), skin infection (3%)

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

adverse reactions chart of poteligeo iv vs. vorinostat po

Of the 136 patients who crossed over to POTELIGEO, 20% were due to adverse reactions.3

No specific laboratory test is required to prescribe POTELIGEO.

  • aAdverse reactions include groupings of individual preferred terms.
  • bIncludes adverse reactions reported up to 90 days after randomized treatment.
  • cPer study protocol, no prophylactic premedication with corticosteroids was permitted; however, patients taking low-/intermediate-potency topical steroids or low-dose (≤20 mg) systemic steroids for at least 4 weeks could continue.

No new safety issues with exposure up to 5 years1,4

adverse reactions long-term follow-up chart of poteligeo iv vs. vorinostat po after 5 years

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

laboratory tests chart of poteligeo iv vs. vorinostat po
  • dIncludes lab abnormalities reported up to 90 days after treatment that were new or worsening in grade or with worsening from baseline unknown.
  • eOut of 99 evaluated recipients of POTELIGEO and 36 evaluable recipients of vorinostat.
  • No specific laboratory test is required to prescribe POTELIGEO

Discontinuation1,3

  • 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 patients3
    - 20% of patients crossed over to POTELIGEO due to adverse reactions

Being able to distinguish between treatment-related rash and disease progression is an important step in managing patients

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References:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Princeton, NJ USA.
  2. Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. Supplementary appendix published online August 9, 2018. doi.org/10.1016/S1470-2045(18)30379-6
  3. Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.
  4. Bagot M, Dalle S, Sokol L, et al. Long-term disease control and safety with the anti-CCR4 antibody mogamulizumab: post-hoc analyses from the MAVORIC trial of patients with previously treated cutaneous T-cell lymphoma. Dermatol Ther. 2022;35(8):e15634.

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.

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.