Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Dermatologic Toxicity [ see Warnings and Precautions (5.1) ].
Infusion Reactions [ see Warnings and Precautions (5.2) ].
Infections [ see Warnings and Precautions (5.3) ].
Autoimmune Complications [ see Warnings and Precautions (5.4) ].
Complications of Allogeneic HSCT after POTELIGEO [ see Warnings and Precautions (5.5) ].
The most common adverse reactions (reported in ≥20% of patients) are rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc.
at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to POTELIGEO in Study 0761-010, a randomized, open-label, actively controlled clinical trial for adult patients with MF or SS who received at least one prior systemic therapy [ see Clinical Studies (14) ].
5 WARNINGS AND PRECAUTIONS Dermatologic Toxicity : Temporarily interrupt POTELIGEO for moderate or severe skin rashes.
Permanently discontinue POTELIGEO for life-threatening rash ( 5.1 ).
Infusion Reactions : Temporarily interrupt POTELIGEO for any infusion reaction.
Permanently discontinue POTELIGEO for any life-threatening infusion reaction ( 5.2 ).
Infections : Monitor and treat promptly ( 5.3 ).
Like all medications, Poteligeo can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: