Treatment of relapsed or refractory mycosis fungoides or Sézary syndrome in patients who have previously received ≥1 systemic therapy.
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.
Absorption: IV administration results in complete bioavailability.
Distribution: Not significantly distributed to extravascular tissues.
Metabolism and Excretion: Unknown.
Half-life: 17 days.
TIME/ACTION PROFILE (plasma concentrations)
- 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.
Adverse Reactions/Side Effects
CV: IMMUNE-MEDIATED MYOCARDITIS, edema, hypertension, arrhythmia
Derm: STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, rash, alopecia, dry skin
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
Metabolic: ↓ appetite, ↓ weight, ↑ weight
MS: IMMUNE-MEDIATED MYOSITIS, IMMUNE-MEDIATED POLYMYOSITIS, muscle spasms, pain
Neuro: GUILLAIN-BARRÉ SYNDROME, peripheral neuropathy, headache, depression, dizziness, insomnia
Resp: IMMUNE-MEDIATED PNEUMONITIS, cough, dyspnea
Misc: INFECTION, INFUSION REACTIONS, fatigue, chills, fever
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
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.
Solution for injection: 4 mg/mL
- Monitor for rash during therapy. Consider skin biopsy to help distinguish drug eruption from disease progression. If mild (Grade 1) rash occurs, topical corticosteroids may be used. If moderate or severe (Grades 2 or 3) rash occurs, hold mogamulizumab and administer at least 2 wk of topical corticosteroids. If rash improves to Grade 1 or less, may resume therapy. If life-threatening (Grade 4) rash or Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) occur, permanently discontinue therapy. If SJS or TEN is suspected, hold mogamulizumab and resume only if SJS or TEN has been excluded and cutaneous reaction resolved to Grade ≤1.
- Monitor for signs and symptoms of infusion reactions (chills, nausea, fever, tachycardia, rigors, headache, vomiting). Usually occur during or shortly after 1st infusion; may also occur after subsequent infusions. If infusion reaction occurs, administer premedication for subsequent doses. If mild to severe (Grades 1 to 3) infusion reactions occur, hold mogamulizumab and treat symptoms. Reduce infusion rate by at least 50% when restarting infusion after symptoms resolve. If reaction recurs and is unmanageable, discontinue infusion. If life-threatening (Grade 4) infusion reaction occurs, permanently discontinue therapy.
- Monitor for signs and symptoms of infection (sepsis, pneumonia, skin infection) and treat promptly. May be fatal.
- Monitor for signs and symptoms of immune-mediated complications (myositis, myocarditis, polymyositis, hepatitis, pneumonitis, Guillain-Barré syndrome, hypothyroidism) during therapy. Interrupt or permanently discontinue mogamulizumab as needed for suspected immune-mediated adverse reactions. May be fatal.
- Monitor patients receiving allogeneic stem cell transplant after receiving mogamulizumab, especially within 50 days after, for signs and symptoms of transplant complications (severe acute graft-versus-host disease [GVHD], steroid-refractory GVHD, transplant-related death).
Lab Test Considerations:
Obtain a negative pregnancy test before starting therapy.
- May cause ↓ albumin, calcium, phosphate, magnesium, glucose and ↑ uric acid and calcium. May also cause hyperglycemia and hypophosphatemia.
- May cause ↓ lymphocytes, CD4 lymphocytes and WBC. May also cause anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia.
- May cause ↑ AST, ALT, and alkaline phosphatase.
- Risk for infection (Adverse Reaction)
- Premedicate with diphenhydramine and acetaminophen before 1st dose.
- Administer medication within 2 days of scheduled dose. Administer missed doses as soon as possible and resume dosing schedule.
- Intermittent Infusion: Solution is clear to slightly opalescent and colorless; do not administer solutions that are cloudy, discolored, or contain particulate matter. Dilution: Withdraw volume required and transfer to polyvinyl chloride (PVC) or polyolefin (PO) IV bag of 0.9% NaCl. Concentration: 0.1–3.0 mg/mL. Invert gently to mix; do not shake. Infuse immediately after diluting. Solution is stable up to 4 hr if refrigerated; do not freeze.
- Rate: Infuse over at least 60 min through IV line with a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
- Y-Site Incompatibility: Do not mix or infuse with other drugs in same line.
- 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.
Improvement in progression-free survival.