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Dosing

POTELIGEO Dosing frequency1

Recommended does: 1mg/kg Administer intravenous infusion over at least 1 hour through a 0.22 micron (or equivalent) in-line filter

Administer once-weekly loading dose for the first 5 infusions, then once every 2 weeks thereafter

DOSING SCHEDULE

POTELIGEO® (mogamulizumab-kpkc) dosing schedule: Administer once-weekly dose for the first 5 infusions, then once every 2 weeks

Recommended premedication for prophylaxis1:

First dose

Administer premedication with diphenhydramine and acetaminophen prior to the first POTELIGEO infusion

If infusion reaction occurs

Prior to subsequent infusions, administer diphenhydramine and acetaminophen

Infusion reaction may require dosing adjustments1:

  • 33% of patients (61/184) experienced an infusion reaction
    • 2% (4/184) were >Grade 3
    • ~90% occurred during or shortly after first infusion

Missed doses

  • If the dose is administered within 2 days of these scheduled doses, continue original schedule
  • If the scheduled dose is missed by more than 2 days, administer the missed dose as soon as possible and resume dosing schedule

No dosing changes required in special populations1

No clinically significant changes in pharmacokinetics based on:

  • Age (range 22-101 years)
  • Renal impairment (mild, moderate, or severe)
  • Disease subtype (MF or SS)
  • CCR4 expression level
  • ECOG Performance Status
  • Sex
  • Ethnicity

No differences in efficacy between older and younger patients:

  • <65 years of age
  • ≥65 years of age

Dosing modifications for dermatologic toxicity1,a

mild
Grade 1 Mild

Mild transient reaction

Treatment with POTELIGEO may continue

Consider treating drug rash with topical corticosteroids.

Moderate or severe
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.

Life-threatening
Grade 4
Life-Threatening

Life-Threatening consequences, urgent intervention indicated

Permanently discontinue for life-threatening rash or for any SJS or TENb,c

Dosing modifications for infusion reactions1,c

Common signs of infusion reactions

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

mild
Grade 1 Mild

Mild transient reaction

mild
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
Grade 4
Life-Threatening

Life-Threatening consequences, urgent intervention indicated

Permanently discontinue POTELIGEO

  • aGrades are based on CTCAE v.5.0.
  • bFor suspected SJS or TEN, stop POTELIGEO; do not resume treatment unless SJS or TEN has been excluded and the cutaneous reaction has been resolved to ≤Grade 1.1
  • cLess than 1% of all POTELIGEO-treated patients in clinical trials experienced Grade 4 skin adverse reactions; SJS occurred in <1% of patients.1
  • CCR4=C-C chemokine receptor type 4; ECOG=Eastern Cooperative Oncology Group; MF=Mycosis Fungoides; NSAID=nonsteroidal anti-inflammatory drug; SJS=Stevens-Johnson syndrome; SS=Sézary Syndrome; TEN=toxic epidermal necrolysis

See how to get started with POTELIGEO

Explore preparation and administration details
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.

Expand

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.