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Drug rash and disease progression in MF and SS can look very similar1,a

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 rash

Drug rash on neck

Neck

Drug rash on back

Back

Skin lesions in MF and SS

Skin lesions in MF and SS on torso

Torso

Skin lesions in MF and SS on torso

Torso

Which image shows a case of drug rash vs skin lesions in MF and SS?

Click the images below to reveal the answer

Skin lesions in MF and SS on back
Back
Back Image
SKIN LESIONS
Back
Drug rash on neck
Neck
Back Image
DRUG RASH
Neck
Drug rash on arm
Arm
Back Image
DRUG RASH
Arm
Skin lesions on back
Back
Back Image
SKIN LESIONS
Back

Photographs are intended as examples. Actual presentation can vary depending on individual patient factors.

Photos courtesy of Oleg Akilov, MD, PhD, Joan Guitart, MD, and Lauren Hughey, MD.

Steps to differentiate skin lesions

Monitor patients for rash throughout the treatment course1

Onset of drug rash is variable. In the MAVORIC trial, median time to onset was 15 weeks; 25% of cases occurred after 31 weeks.

Perform a physical exam and review of symptoms

Check for noncutaneous signs/symptoms of disease progression such as enlarged lymph nodes, fever, chills, weight loss, or fatigue.3

Note the appearance of new lesions

Most common presentation of drug rash in MAVORIC1,a:

  • Papular or maculopapular rash
  • Lichenoid rash
  • Morbilliform rash
  • Spongiotic or granulomatous dermatitis

Consider a skin biopsy1

Histology, IHC, and clonality studies have been shown to be helpful in distinguishing drug rash from disease progression. Specifically, biopsy results showing exocytosis of CD8-positive T cells, a normal or inverted CD4:CD8 positive ratio, retention of CD7 expression, and polyclonality of TCR-β and TCR-γ are generally consistent with drug rash.4-6

Dermatopathology consult may provide definitive diagnosis and help determine treatment path2,7

Download this tool to help differentiate skin lesions from cases of drug rash

Download drug rash checklist

Real-world evidence indicates that SS patients are more likely to develop drug rash than MF patients8

Incidence of rash, including drug rash1,a

Incidence of rash, including drug rash when using POTELIGEO
  • “Rash, including drug rash” was the most common adverse reaction in MAVORIC (35%)1,9
  • The incidence of drug rash alone was 24%1,9
  • Once drug rash was resolved, a majority of patients appeared to have resumed treatment10,b

POTELIGEO is administered in 28-day cycles1

Review dosing frequency
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. Ludmann P. Cutaneous T-cell lymphoma: symptoms. American Academy of Dermatology Association. Updated August 3, 2023. Accessed January 24, 2025. https://www.aad.org/public/diseases/a-z/ctcl-symptoms
  4. Hirotsu KE, Neal TM, Khodadoust MS, et al. Clinical characterization of mogamulizumab-associated rash during treatment of mycosis fungoides or Sézary syndrome. JAMA Dermatol. 2021;157(6):700-707.
  5. Trum NA, Zain J, Martinez XU, et al. Mogamulizumab efficacy is underscored by its associated rash that mimics cutaneous T-cell lymphoma: a retrospective single-centre case series. Br J Dermatol. 2022;186(1):153-166.
  6. Wang JY, Hirotsu KE, Neal TM, et al. Histopathologic characterization of mogamulizumab-associated rash. Am J Surg Pathol. 2020;44(12):1666-1676.
  7. 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.
  8. Assaf C, Booken N, Dippel E, et al. Practical recommendations for therapy and monitoring of mogamulizumab patients in Germany. J Dtsch Dermatol Ges. 2025;23(3):341-354.
  9. 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.
  10. Musiek ACM, Whittaker S, Horowitz SM, et al. Characterization and outcomes in patients with mogamulizumab-associated skin reactions in the MAVORIC trial. Eur J Cancer. 2021;156 Suppl 1:S46.

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.

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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.