Prescription medicine

Mogamulizumab Brand names: Poteligeo

Mogamulizumab (Poteligeo) is a prescription medicine. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the mogamulizumab FDA label on DailyMed (effective March 2, 2026); every mogamulizumab label on DailyMed.

Highlights of the record

FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
POTELIGEO 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.

Forms and strengths

4 mg/ml

Injection.

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is mogamulizumab used for?

From the label: indications and usage
POTELIGEO 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. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy ( 1 ).

FDA pharmacologic class: Chemokine Receptor Type 4 Interaction and Monoclonal Antibody.

Source: FDA drug label (POTELIGEO), Kyowa Kirin, Inc., effective March 2, 2026 (SPL set e53960ab-42a1-40d1-9c7d-eb013fe7f18f), via openFDA; the full label on DailyMed

What does the patient leaflet for mogamulizumab say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about POTELIGEO?
POTELIGEO may cause serious side effects that can be severe, life-threatening or lead to death. Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse: Skin problems. Signs and symptoms of skin reactions may include: skin pain itching skin blistering or peeling rash painful sores or ulcers in your mouth, nose, throat, or genital area Infusion reactions. Signs and symptoms of infusion reactions may include: chills or shaking redness on your face (flushing) itching or rash shortness of breath, coughing, or wheezing dizziness feeling like passing out tiredness fever Infections. Signs and symptoms of infection may include: fever, sweats, or chills nausea flu-like symptoms sore throat or difficulty swallowing shortness of breath diarrhea or stomach pain cough Autoimmune problems. Some people receiving POTELIGEO develop autoimmune problems (a condition where the immune cells in your body attack other cells or organs in the body). Some people who already have an autoimmune disease may get worse during treatment with POTELIGEO. Complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with POTELIGEO. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with POTELIGEO. Your healthcare provider may need to delay or completely stop treatment with POTELIGEO if you have severe side effects.

Source: FDA drug label (POTELIGEO), Kyowa Kirin, Inc., effective March 2, 2026 (SPL set e53960ab-42a1-40d1-9c7d-eb013fe7f18f), via openFDA; the full label on DailyMed

Is there a generic for mogamulizumab (Poteligeo)?

No generic mogamulizumab is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the mogamulizumab label say about other medicines?

The mogamulizumab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Acetaminophen	warnings and precautions	Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of POTELIGEO in all patients.
Diphenhydramine	warnings and precautions	Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of POTELIGEO in all patients.
Levothyroxine	warnings and precautions	New-onset hypothyroidism (Grade 1 or 2) was reported in 1.3% of patients and managed with observation or levothyroxine.

Check mogamulizumab against other medicines

Source: FDA drug label (POTELIGEO), Kyowa Kirin, Inc., effective March 2, 2026 (SPL set e53960ab-42a1-40d1-9c7d-eb013fe7f18f), via openFDA; the full label on DailyMed

What next?

Check an interaction: what two or more labels say about each other