Mogamulizumab-kpkc (moe-gam-ue-LIZ-oo-mab - kpkc)

Treats relapsed or refractory mycosis fungoides or Sézary syndrome.

Brand Name(s):

Poteligeo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will need to stay in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor may give you other medicines (including allergy medicine, fever medicine) before your first infusion of this medicine to prevent unwanted effects.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for at least 3 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have a history of autoimmune problems or if you have had a stem cell transplant.
• This medicine may cause the following problems:
  • Serious skin reactions
  • Infusion reaction
  • Increased risk of infections
  • Autoimmune problems (including hepatitis, hypothyroidism, myocarditis, myositis, pneumonitis, polymyositis, Guillain-Barré syndrome)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest pain, trouble breathing, swelling in your hands, ankles, or feet
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches while receiving the infusion
• Muscle pain, tenderness, or weakness
• Weakness, headaches, tiredness, weight changes, or feeling unusually cold or hot

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088