Mogamulizumab is used to treat mycosis fungoides or Sézary syndrome in adults.

Mogamulizumab is given after at least one other medication did not work or has stopped working.

Mogamulizumab may also be used for purposes not listed in this medication guide.

mogamulizumab can cause serious or life-threatening side effects.

Call your doctor at once if you have a skin rash, itching, blistering or peeling, painful mouth sores, fever, chills, flu-like symptoms, trouble breathing, diarrhea, or stomach pain.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, tired, itchy, hot or cold, or short of breath.

Mogamulizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

mogamulizumab must be given slowly, and the infusion can take at least 60 minutes to complete.

Mogamulizumab is given in a 28-day treatment cycle. You may need to use the medicine only during the first 1 to 3 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.

You will need frequent medical tests to be sure this medicine is not causing harmful effects.

Usual Adult Dose for Mycosis Fungoides:

1 mg/kg IV over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity

Comments:
-Administer premedication with diphenhydramine and acetaminophen for the first infusion.

Uses: For relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy

Tell your doctor if you have ever had:

• a severe reaction after using mogamulizumab;

• liver disease, including hepatitis B;

• lung problems;

• an autoimmune disorder; or

• a stem-cell transplant from a donor.

You may need to have a negative pregnancy test before starting this treatment.

Do not use mogamulizumab if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your mogamulizumab injection.

Since mogamulizumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, tired, itchy, hot or cold, or short of breath during the infusion.

Mogamulizumab may cause serious side effects. Call your doctor at once if you have:

• a skin rash, itching, blistering or peeling;

• painful mouth sores;

• fever, chills, sore throat, cough;

• nausea, diarrhea, stomach pain; or

• shortness of breath.

Common side effects of mogamulizumab may include:

• diarrhea;

• rash;

• feeling tired;

• bone pain, muscle pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect mogamulizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.