Poteligeo: Uses, Side Effects and Dosage

What POTELIGEO is used for:

• POTELIGEO is a prescription medicine used to treat mycosis fungoides (MF) or Sézary syndrome (SS) in adults when you have tried at least one prior medicine (taken by mouth or injection) and it did not work or the disease has come back.

How POTELIGEO works:

POTELIGEO is a monoclonal antibody that binds to certain cancerous T-cells, triggering your body’s immune cells to specifically target them.

The ingredients in POTELIGEO are:

Medicinal ingredients: mogamulizumab

Non-medicinal ingredients: citric acid monohydrate, glycine, polysorbate 80, and Water for Injection, USP

POTELIGEO comes in the following dosage form(s):

20 mg / 5 mL (4 mg / mL) solution in a single-use vial

Do not use POTELIGEO if:

• You are allergic to POTELIGEO or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take POTELIGEO. Talk about any health conditions or problems you may have, including if you:

• have had a severe skin reaction after receiving POTELIGEO.
• have had an infusion-related reaction during or after receiving POTELIGEO.
• have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or C infection, or other on-going infections.
• have a history of autoimmune problems.
• have undergone or plan to have a stem cell transplant, using stem cells from a donor.

• are pregnant or plan to become pregnant. It is not known if POTELIGEO will harm your unborn baby.

  • If you are able to become pregnant, your healthcare professional will do a pregnancy test before you start treatment with POTELIGEO.
  • Females who are able to become pregnant should use an effective method of birth control during treatment with POTELIGEO and for at least 6 months after the last dose of POTELIGEO. Talk to your healthcare professional about birth control methods that you can use during this time. Tell your healthcare professional right away if you become pregnant during treatment with POTELIGEO.
• are breastfeeding or plan to breastfeed. It is not known if POTELIGEO passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby during treatment with POTELIGEO.

Other warnings you should know about:

Give yourself time after taking POTELIGEO to see how you feel before driving a vehicle or using machinery.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Studies to test how POTELIGEO interacts with other medicines have not been done.

How to take POTELIGEO:

• Your healthcare professional will give you POTELIGEO into your vein through an intravenous (IV) line over at least 60 minutes.
• POTELIGEO is usually given on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each 28-day cycle thereafter.
• Your healthcare professional will decide how many treatments you need based on how well you respond and tolerate the treatment.
• If you miss any appointments call your healthcare professional as soon as possible.

Usual dose:

The dose is based on your body weight. Your healthcare professional will work out the right dose for you.

Overdose:

POTELIGEO is administered under the supervision of a healthcare professional, who will check that the correct dose has been given and treat any overdose.

If you think you, or a person you are caring for, have taken too much POTELIGEO, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

POTELIGEO should be administered within 2 days of the scheduled dose. If a dose is missed, your healthcare professional should administer the next dose as soon as possible and resume the dosing schedule.

Possible side effects from using POTELIGEO:

POTELIGEO may cause serious side effects that can be severe, life-threatening or lead to death.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These are not all the possible side effects you may have when taking POTELIGEO. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of POTELIGEO include:

• Rash
• Tiredness
• Diarrhea
• Constipation
• Nausea
• Stomatitis (mouth ulcer)
• Fever
• Swollen legs or ankles
• Headache
• Infusion reaction

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

POTELIGEO vials must be stored under refrigeration at 2°C to 8°C in original package to protect from light until time of use.

Do NOT freeze. Do NOT shake.

Keep out of reach and sight of children.

If you want more information about POTELIGEO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database); the manufacturer’s website https://kkna.kyowakirin.com/canada-en; or by calling 1-866-590-9508.

Date of Authorization: January 08, 2026