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Adverse reactions requiring dose adjustments

Adverse reactions that may require dose adjustments1

Tabulation of patients with infusion reactions and rash (drug eruption), all grades and grade ≥3

aPatients initially randomized to vorinostat could cross over to POTELIGEO upon disease progression or unacceptable toxicity.

Autoimmune complications1

  • In MAVORIC, 2% (6/319) of patients required systemic immunosuppressants for immune-mediated reactions. Grade 1 or 2 new onset hyperthyroidism occurred in 1% of patients. Grade 3 or higher immune-mediated or possibly immune-mediated reactions reported with POTELIGEO include myositis, myocarditis, polymyositis, hepatitis, pneumonitis, and a variant of Guillain-Barré syndrome
  • Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions

Drug eruption and disease progression can look very similar1

Skin biopsy is recommended for differential diagnosis1

Peripheral blood flow cytometry and skin biopsy with T-cell receptor sequencing should also be considered.2

Drug eruptiona

Drug eruptiona

MF patchb

MF patchb

  • aPhoto used with permission from JAMA Dermatol. 2019;155(8):968-971. doi:10.1001/jamadermatol.2019.0369
  • bImage courtesy of Dr Oleg Akilov.
Dermatopathology consult can provide definitive diagnosis and help determine treatment path2,3

Pictures are intended to be an example. Actual presentation can vary depending on individual patient factors.

Discontinuation rate due to rash or drug eruption1

Once drug eruption was resolved, some patients in MAVORIC chose to continue POTELIGEO treatment for as long as they derived clinical benefit.1,4

Drug eruption may look like disease progression, so distinguishing between the two may help prevent premature discontinuation of therapy5

Infusion reaction and rash (drug eruption) may require dosing adjustments1

Watch a CTCL expert discuss additional considerations for patient monitoring and management

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References:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Princeton, NJ USA.
  2. Chen L, Carson KR, Staser KW, et al. Mogamulizumab-associated cutaneous granulomatous drug eruption mimicking mycosis fungoides but possibly indicating durable clinical response. JAMA Dermatol. 2019;155(8):968-971.
  3. Poligone B, Querfeld C. Management of advanced cutaneous T-cell lymphoma: role of the dermatologist in the multidisciplinary team. Br J Dermatol. 2015;173(4):1081-1083.
  4. 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.
  5. Musiek ACM, Whittaker S, Horwitz SM, et al. Characterization and outcomes in patients with mogamulizumab-associated skin reactions in the MAVORIC trial. Abstract 1169. Presented at the American Society of Hematology (ASH) 62nd Annual Meeting (virtual); December 5-8, 2020.

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.