Poteligeo 4 mg/ml concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Poteligeo is and what it

Poteligeo contains the active substan a group of medicines called monoclo cancer cells which are then destroyed defence).

This medicine is used to treat adults w syndrome, which are types of cancers The medicine is for use in patients wh given by mouth or by injection.

2. What you need to know befor

Do not use Poteligeo

• if you are allergic to mogamulizuma

  medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before

• ever had a severe skin reaction with

• ever had an infusion reaction with t

  infusion reaction are listed in sectio

• have human immunodeficiency vir

  or hepatitis B or C infection, or othe

• have had or plan to have a stem cell

  a donor’s.

• have had tumour lysis syndrome (a

  cancer cells) after a previous treatm

• have heart problems.

Tell the person giving you the infus you experience a reaction during or Tell your doctor immediately if you effects listed in Section 4 after start

Other medicines and Poteligeo

Tell your doctor if you are taking, have medicines.

Children and adolescents

This medicine should not be used in c of age.

Pregnancy and breast-feeding

The effects of Poteligeo in pregnancy Due to the mechanism of action of th administered when you are pregnant If you can get pregnant, you will need during and for at least six months afte are breast-feeding, you should discuss breast-feed during or after treatment You must tell your doctor or nurse if y think you may be pregnant, or are pla Driving and using machines

Poteligeo is unlikely to affect your abil the medicine can cause tiredness in s driving and using machines until you affect you.

Poteligeo contains sodium

This medicine contains less than 1 mm essentially ‘sodium-free’.

Poteligeo contains polysorbate

This medicine contains 1 mg of polyso to 0.2 mg/mL. Polysorbates may cause have any known allergies.

EN

HEAD

Poteligeo/

mogamulizumab

Package leaflet: Information for the patient

LF-041-020-001-GB-06

Poteligeo/ mogamulizumab Package leaflet: Information for the patient

FPO

LF-041-020-001-GB-06 23006247/06

ormation for the patient

o 4 mg/mL olution for infusion mulizumab re you start using this medicine mation for you.

ead it again.

sk your doctor or nurse.

ur doctor or nurse. This includes any is leaflet. See section 4.

d for

use Poteligeo rmation

is used for ce mogamulizumab, which belongs to nal antibodies. Mogamulizumab targets by the immune system (the body’s ith mycosis fungoides and Sézary called cutaneous T-cell lymphomas.

o have received at least one medicine e you use Poteligeo b or any of the other ingredients of this using Poteligeo if you:

this medicine.

his medicine (possible symptoms of an n 4).

us (HIV), herpes, cytomegalovirus (CMV), r on-going infections.

transplant, either using your own cells or complication involving the destruction of ent.

ion or get medical help straight away if after any Poteligeo infusion.

experience any of the serious side ing Poteligeo treatment.

recently taken,or might take any other hildren and adolescents below 18 years and breast-feeding are not known. e medicine, it may harm your baby if it is or breast-feeding.

to use effective contraception r receiving this treatment. If you with your doctor whether you can with Poteligeo.

ou are pregnant, breast-feeding, nning to have a baby.

ity to drive and use machines. However, ome people, so take particular care when are certain that this medicine does not ol sodium (23 mg) per vial, that is to say rbate 80 in each vial which is equivalent allergic reactions. Tell your doctor if you

3. How Poteligeo is given

The amount of Poteligeo you will receiv on your body weight. The recommende body weight.

Poteligeo will be given to you through a least 60 minutes. To start with, the infusi first 5 doses, then once every 2 weeks. T you get serious side effects or the cutan worse.

4. Possible side effects

Like all medicines, this medicine can cau gets them.

Serious side effects

Tell your doctor or nurse or get medic of the following signs and symptoms Very common side effects: may affect

• chills, nausea or vomiting, headache, dizziness or feeling faint, difficulty br signs of an infusion reaction. If this h stopped and you may require additi go away, Poteligeo can normally con Your doctor may stop Poteligeo treat
• signs of infection, which may include symptoms, sore throat or difficulty sw stomach pain, nausea or vomiting, di

• skin rash (which may become severe)

  receiving Poteligeo for other types of itching, skin blisters//peeling, ulcers i occurred, which are possible signs of Stevens-Johnson syndrome or toxic e to 1 in 100 people).

Common side effects: may affect up t

• Watery diarrhoea, more bowel movem tenderness which are possible signs of Uncommon side effects: may affect u
• fever, chills, nausea, vomiting, confusi irregular heartbeat, dark or cloudy uri or joint pain. The destruction of cance very occasionally lead to a problem c
• chest pain, shortness of breath, fast o nausea or vomiting, weakness, feelin unlikely to be caused by this medicin disorder.

Not known: frequency cannot be esti

• if you go on to have a stem cell transp then develop complications (graft ver to manage. Symptoms may include s diarrhoea that doesn’t go away, stom stiffness, dry or irritated eyes or blurre a cough that does not go away or diff jaundice (turning yellow), dark urine,

Other side effects

Talk to your doctor if you get any other

Very common side effects: may affect

• Lack of energy (fatigue)
• Constipation
• Swollen legs or ankles
• Headache

Common side effects: may affect up t

• Anaemia (reduced red blood cells)
• Reduced blood platelets (thrombocyt
• Reduced white blood cells (neutrope lymphocytes
• Blood tests showing raised liver enzy
• Underactive thyroid

Uncommon side effects: may affect u

• Inflammation of the liver (hepatitis) Not Known: frequency cannot be esti
• Small lumps of the skin, bone or othe immune cells as a response to inflam Reporting of side effects

If you get any side effects, talk to your d possible side effects not listed in this lea directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Google Play or Apple App Store. By repo more information on the safety of this m

e is calculated by your doctor based d dose is 1mg Poteligeo for each kg of vein (intravenous infusion) over at ons will be given once a week for the reatment should be continued unless eous T-cell lymphoma starts to get se side effects, although not everybody al help immediately if you have any after starting Poteligeo:

more than 1 in 10 people wheezing, itching, flushing, rash, eathing and fever, which may be appens, the infusion may need to be onal treatment. When the symptoms tinue to be given, but more slowly. ment if your reaction is severe. a fever, sweats or chills, flu-like allowing, cough, shortness of breath, arrhoea and feeling very unwell. , or sore mouth. In some people cancers, skin pain/burning sensation, n the mouth or on the lips or genitals a severe skin reaction, such as pidermal necrolysis (which affected up

o 1 in 10 people ents than usual, severe abdominal pain or inflammation of the large bowel (colitis). p to 1 in 100 people on, shortness of breath, seizures, ne, unusual tiredness and/or muscle r cells and the body’s reaction to it can alled tumour lysis syndrome.

r slow heartbeat, sweating, dizziness, g faint and feeling unwell. Although e, these may be signs of a heart mated from the available data lant, it is possible that you could sus host disease) that are difficult kin rashes or blistering, nausea or ach pain or vomiting, joint pain or d vision, mouth sores, irritation or pain, iculty breathing, sensitive genitals, and any swelling.

side effects. These can include:

more than 1 in 10 people

o 1 in 10 people openia)

nia and leucopenia) or reduced me levels p to 1 in 100 people mated from the available data r tissues caused by accumulation of mation (granuloma)

octor or nurse. This includes any flet. You can also report side effects or search for MHRA Yellow Card in the rting side effects, you can help provide edicine.

5. How to store Poteligeo

Keep this medicine out of the sight and re Do not use this medicine after the expiry the vial after “EXP”. The expiry date refers t Unopened vial: Store in a refrigerator (2°C Store in the original carton in order to pro Reconstituted/diluted solution: Use imme (2°C - 8°C) and use within 24 hours. Do not use this medicine if you notice sig matter or discolouration.

Do not throw away any medicines via was measures will help protect the environme

ach of children.

date which is stated on the carton and

o the last day of that month.

• 8°C). Do not freeze.

tect from light diately or store in a refrigerator ns of deterioration, such as particulate tewater or household waste. These nt.

formation umab in 5 mL of concentrate, ohydrate, glycine, polysorbate 80, nd water for injections. See section 2 of the pack e pack contains a glass vial containing

LF-041-020-001-GB-06

6. Contents of the pack and other in

What Poteligeo contains

• Each vial contains 20 mg of mogamuliz corresponding to 4 mg/mL.
• The other excipients are citric acid mon sodium hydroxide, hydrochloric acid, a “Poteligeo contains sodium”.

What Poteligeo looks like and contents

Poteligeo is a clear, colourless solution. Th 5 mL concentrate for solution for infusion.

Marketing Authorisation Holder

Kyowa Kirin Limited

Galabank Business Park

Galashiels

TD1 1QH

United Kingdom medinfo@kyowakirin.com

Manufacturer

Kyowa Kirin Services Ltd. Dutch Branch Bloemlaan 2

Hoofddorp 2132 NP

Netherlands

This leaflet was last revised in 08/2026.