• Treatment of relapsed or refractory mycosis fungoides or Sézary syndrome in patients who have previously received 1 systemic therapy.

Contraindicated in:

• OB: Pregnancy (may cause fetal harm).

Use Cautiously in:

• Autoimmune disease
• Recipient of allogeneic hematopoietic stem cell transplantation after therapy (↑ risk of transplant complications)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: IMMUNE-MEDIATED MYOCARDITIS, edema, hypertension, arrhythmia.

Derm: STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, rash, alopecia, dry skin.

EENT: conjunctivitis.

Endo: hypoglycemia, hyperglycemia, hyperuricemia, immune-mediated hypothyroidism.

F and E: hypercalcemia, hypocalcemia, hypomagnesemia, hypophosphatemia.

GI: IMMUNE-MEDIATED HEPATITIS, constipation, diarrhea, hypoalbuminemia, ↑liver enzymes, mucositis, nausea, abdominal pain, vomiting.

GU: renal impairment.

Hemat: neutropenia, thrombocytopenia, anemia, lymphocytopenia.

Metab: ↓appetite, ↓ weight, ↑ weight.

MS: IMMUNE-MEDIATED MYOSITIS, IMMUNE-MEDIATED POLYMYOSITIS, muscle spasms, pain.

Neuro: GUILLAIN-BARR SYNDROME, peripheral neuropathy , headache, depression, dizziness, insomnia.

Resp: IMMUNE-MEDIATED PNEUMONITIS, cough, dyspnea.

Misc: infection, infusion reactions, fatigue, chills, fever.

Drug-Drug:

• None reported.

• Solution for injection: 4 mg/mL;

• IV (Adults): 1 mg/kg on Days 1, 8, 15, and 22 of the first 28–day cycle, then on Days 1 and 15 of each subsequent 28–day cycle. Continue until disease progression or unacceptable toxicity.

Poteligeo

• Selectively binds to C-C chemokine receptor 4 (CCR4) which is expressed on surface of T-cell malignancies (including mycosis fungoides and Sézary syndrome) and results in cytotoxicity and depletion of these target cells.

• Improvement in progression-free survival.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Not significantly distributed to extravascular tissues.

Metabolism/Excretion: Unknown.

Half-life: 17 days.

(plasma concentrations)

• Explain purpose of mogamulizumab to patient. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
• Advise patient to notify health care professional promptly if signs and symptoms of skin problems (skin pain, itching, skin blistering or peeling, rash, painful sores or ulcers in mouth, nose, throat, or genital area), infusion reactions (chills or shaking, flushing, itching or rash, shortness of breath, coughing, wheezing, dizziness, feeling like passing out, tiredness, fever), or infections (fever, sweats, chills, nausea, flu-like symptoms, sore throat, difficulty swallowing, shortness of breath, diarrhea, stomach pain, cough) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
• Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception during and at least 3 mo after last dose. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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