Poteligeo Approval History
Reviewed by J.Stewart B.Pharm. Last updated on Aug 8, 2018.
FDA Approved: Yes (First approved August 8, 2018)
Brand name: Poteligeo
Generic name: mogamulizumab-kpkc
Dosage form: Injection
Company: Kyowa Kirin, Inc.
Treatment for: Mycosis Fungoides; Sézary Syndrome
Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).
Dosage Forms and Strengths
- Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial.
Dosage and Administration
Poteligeo is administered as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, and on days 1 and 15 of each subsequent cycle.
Warnings and Precautions
Poteligeo may cause serious side effects that can be severe or life-threatening. The following adverse reactions may require additional treatment and/or withholding or discontinuation of Poteligeo:
- Dermatological Toxicity: Patients need to contact their healthcare provider immediately if they experience new or worsening skin rash. Treatment should be temporarily interrupted for moderate or severe skin rashes and permanently discontinued for a life-threatening rash.
- Infusion Reactions: Patients need to contact their healthcare provider immediately for signs or symptoms of infusion reactions. Treatment should be temporarily interrupted for any infusion reaction and permanently discontinued for any life-threatening infusion reaction.
- Infections: Patients need to contact their healthcare provider if they experience fever or other signs of infection. Infections should be monitored and treated promptly.
- Autoimmune Complications: Patients need to notify their healthcare provider of any history of autoimmune disease. Treatment should be interrupted or permanently discontinued as appropriate.
- Complications of Allogeneic Hematopoietic Stem Cell Transplantation after Poteligeo: Patients need to be aware of the potential risk of post-transplant complications. Patients should be monitored for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD.
- Females of Reproductive Potential: Females who are able to become pregnant should use an effective method of birth control during treatment with Poteligeo and for at least three months after the last dose.
The most common adverse reactions (reported in ≥20% of patients) were rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.
Development History and FDA Approval Process for Poteligeo
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