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Poteligeo Generic Name & Formulations
Legal Class
Rx
General Description
Mogamulizumab-kpkc 20mg/5mL; soln for IV infusion; preservative-free.
Pharmacological Class
CCR4-directed monoclonal antibody.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Poteligeo Indications
Indications
In adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
Poteligeo Dosage and Administration
Adult
Premedicate with diphenhydramine and acetaminophen for the 1st infusion. Infuse IV over ≥60mins. 1mg/kg on Days 1, 8, 15, and 22 of the first 28-day cycle, then on Days 1 and 15 of each subsequent cycle until disease progression or unacceptable toxicity. Dose modifications for toxicity: see full labeling.
Children
Not established.
Poteligeo Contraindications
Not Applicable
Poteligeo Boxed Warnings
Not Applicable
Poteligeo Warnings/Precautions
Warnings/Precautions
Monitor for skin rash; permanently discontinue if SJS/TEN or life-threatening reaction (Grade 4) occurs. Monitor for infusion reactions; interrupt for any grade reaction and treat promptly; permanently discontinue for life-threatening reaction (Grade 4). Monitor for infection; treat promptly. History of autoimmune disease. Interrupt or permanently discontinue as appropriate if immune-mediated adverse reactions suspected. Complications of allogeneic HSCT after Poteligeo (including severe acute GVHD, steroid-refractory GVHD, transplant-related death); monitor closely. Verify pregnancy status prior to initiation. Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy: not recommended. Nursing mothers.
Poteligeo Pharmacokinetics
See Literature
Poteligeo Interactions
Not Applicable
Poteligeo Adverse Reactions
Adverse Reactions
Rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, upper RTI, skin infection, pyrexia, nausea, edema, thrombocytopenia, headache, constipation, mucositis, anemia, cough, hypertension.
Poteligeo Clinical Trials
See Literature
Poteligeo Note
Not Applicable
Poteligeo Patient Counseling
See Literature
