Poteligeo Mogamulizumab Application Scope

Poteligeo is indicated for the treatment of adult patients with relapsed or refractory Mycosis Fungoides (MF) or Sézary Syndrome (SS)—both subtypes of cutaneous T‑cell lymphoma (CTCL)—after at least one prior systemic therapy.

Poteligeo Mogamulizumab Characteristics

Ingredients: Mogamulizumab
Properties: Sterile, preservative‑free, clear to slightly opalescent, colourless concentrate for solution for infusion
Packaging Specification: Typically supplied as a single-dose vial containing 4 mg/mL
Storage: Store at 2°C to 8°C (36°F to 46°F)
Expiry Date: Refer to the expiry date printed on the vial and outer carton
Executive Standard: Refer to local regulatory labeling
Approval Number: Varies by country/region; refer to local regulatory authority
Date of Revision: Refer to local packaging/labeling
Manufacturer: Kyowa Kirin Co., Ltd.

Guidelines for the Use of Poteligeo Mogamulizumab

Dosage and Administration:
- Recommended Dose:
  - Initial 28-day cycle: 1 mg/kg IV infusion on Days 1, 8, 15, and 22.
  - Subsequent 28-day cycles: 1 mg/kg IV infusion on Days 1 and 15 until disease progression or unacceptable toxicity.
- Administration:
  - Administer as IV infusion over at least 60 minutes using a sterile, low-protein-binding in-line filter.
  - Premedication with antihistamines and acetaminophen is recommended before the first infusion.
  - Do not administer subcutaneously or as rapid IV push.
- Missed Dose:
  - If a dose is missed, administer as soon as possible. Adjust the schedule to maintain the every-2-week interval. Consult the treating physician for specific guidance.
Adverse Reactions:
- Common Adverse Reactions: Rash, infusion-related reactions, fatigue, diarrhea, upper respiratory infection, musculoskeletal pain, edema, nausea, headache, thrombocytopenia, anemia, mucositis, cough, hypertension, lymphopenia.
- Serious Adverse Reactions:
  - Severe skin reactions, including Stevens–Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  - Infusion reactions (fever, chills, hypotension, dyspnea).
  - Serious infections due to immunosuppression.
  - Immune-mediated events and transplant-related complications.
Contraindications:
- History of severe hypersensitivity to the active substance or any excipient.
- Severe and active autoimmune disease.
Precautions:
- Monitor for skin reactions, infusion reactions, infections, and immune-mediated events.
- Do not mix with other drugs in the same IV line.
- Handle diluted solution gently; do not shake.
- Use appropriate contraception for patients of reproductive potential.

Poteligeo Interactions

Do not co-administer other medicinal products through the same IV line.
No formal drug-drug interaction studies; caution when combining with immunosuppressive therapies.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.