What is the most important information I should know about mogamulizumab?
This medicine 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.
What is mogamulizumab?
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.
What should I discuss with my healthcare provider before receiving mogamulizumab?
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.
How is mogamulizumab given?
Mogamulizumab is given as an infusion into a vein. A healthcare provider will give you this injection.
This medicine 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your mogamulizumab injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving mogamulizumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of mogamulizumab?
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.
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 may include:
- 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.
What other drugs will affect mogamulizumab?
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.
Where can I get more information?
Your pharmacist can provide more information about mogamulizumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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