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Dosing modifications

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
mild-icon
Grade 1
Mild

Mild transient reaction

Treatment with POTELIGEO may continue

Consider treating rash, including drug eruption, with topical corticosteroids.

mild-icon
Grade 2 or 3
Moderate or severe

Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids): prophylactic medications indicated for ≤24 hours

Grade 3: Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae

Interrupt POTELIGEO

Administer at least 2 weeks of topical corticosteroids.

If rash improves to ≤Grade 1, POTELIGEO may be resumed.

mild-icon
Grade 4
Life-threatening

Life-threatening consequences, urgent intervention indicated

Permanently discontinue for life-threatening rash or for any SJS or TEN

For suspected SJS or TEN, stop POTELIGEO; do not resume treatment unless SJS or TEN have been excluded and the cutaneous reaction has been resolved to ≤Grade 1.a

  • *Grades are based on CTCAE v.50.
  • aLess than 1% of all POTELIGEO-treated patients in clinical trials experienced grade 4 skin adverse reactions; SJS occurred in <1% of patients.1
  • SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis

Infusion reactions

Common signs of infusion reactions

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

mild-icon
Grade 1
Mild

Mild transient reaction

mild-icon
Grade 2 or 3
Moderate or severe

Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids): prophylactic medications indicated for ≤24 hours

Grade 3: Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae

Temporarily interrupt the infusion of POTELIGEO and treat symptoms

  • Slow infusion rate by at least 50% when restarting the infusion after symptoms resolve
  • If reaction recurs and is not manageable, discontinue infusion
  • Prior to subsequent infusions, administer diphenhydramine and acetaminophen
mild-icon
Grade 4
Life-threatening

Life-threatening consequences, urgent intervention indicated

Permanently discontinue POTELIGEO

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
  • 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

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Reference:
  1. POTELIGEO [package insert]. Kyowa Kirin Inc., Princeton, 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.

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.