Poteligeo

Patient Information Leaflet

POTELIGEO 4 mg/mL concentrate for solution for infusion

mogamulizumab
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What POTELIGEO is and what it is used for
2. What you need to know before using POTELIGEO
3. How POTELIGEO is administered
4. Possible side effects
5. How to store POTELIGEO
6. Contents of the pack and other information

1. What POTELIGEO is and what it is used for

POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies. Mogamulizumab targets cancer cells, which are then destroyed by the immune system (the body's defence mechanism).
This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas. This medicine is intended for use in patients who have received at least one prior medicine taken by mouth or by injection.

2. What you need to know before using POTELIGEO

Do not use POTELIGEO

• if you are allergic to mogamulizumab or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before using POTELIGEO if:

• You have previously had a severe skin reaction to this medicine.
• You have previously had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4).
• You have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), hepatitis B or C, or other ongoing infections.
• You have undergone or are planning to undergo a stem cell transplant, using either your own cells or those from a donor.
• You have previously experienced tumor lysis syndrome (a complication arising from the destruction of cancer cells) after prior treatment.
• You have heart problems.

If you experience a reaction during or after any infusion of POTELIGEO,
inform the healthcare professional administering the infusion or seek immediate medical help.
Inform your doctor immediately if you experience any of the side effects
listed in section 4 after starting treatment with POTELIGEO.
Other medicines and POTELIGEO
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Pregnancy and breastfeeding
The effects of POTELIGEO during pregnancy and breastfeeding are unknown. Due to its
mechanism of action, this medicine could harm your baby if administered during
pregnancy or breastfeeding.
If you are able to have children, you must use an effective method of contraception during treatment and
for at least six months after receiving treatment.
If you are breastfeeding, ask your doctor whether you may continue during or after treatment with
POTELIGEO.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, consult your doctor or nurse.
Driving and using machines
It is unlikely that POTELIGEO will affect your ability to drive or operate machinery. However, this
medicine may cause fatigue in some people, so you should exercise particular caution when driving or
using machines until you are certain that this medicine does not cause any adverse effects.
POTELIGEO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial and is therefore essentially
"sodium-free".

3. How POTELIGEO is administered

The amount of POTELIGEO you will receive will be calculated by your doctor based on your body weight.
The recommended dose is 1 mg of POTELIGEO per kilogram of body weight.
POTELIGEO will be administered to you through a vein (intravenous infusion) over a period of at least
60 minutes. Initially, infusions will be given once a week for the first 5 doses, then once every 2 weeks.
Treatment should be continued unless you develop serious adverse reactions or your cutaneous T-cell lymphoma begins to worsen.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following signs or symptoms after starting treatment with POTELIGEO, inform your doctor or nurse immediately or seek medical help:
Very common side effects: may affect more than 1 in 10 people

• Chills, nausea or vomiting, headache, wheezing, itching, flushing, rash, dizziness or feeling faint, difficulty breathing and fever, which could be signs of an infusion reaction. If this occurs, it may be necessary to stop the infusion and give you additional treatment. Once symptoms have resolved, resuming treatment with POTELIGEO is generally possible, but at a slower rate of administration. Your doctor may permanently discontinue treatment with POTELIGEO if your reaction is severe.
• Signs of infection, which may include fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling unwell.
• Skin rash (which may become severe) or sore throat. In some people treated with POTELIGEO for other types of tumour, skin pain, burning sensation, itching, blistering/skin peeling, mouth, lip or genital ulcers have occurred, which are possible signs of a serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrolysis (which has affected up to 1 in 100 people).
  Uncommon side effects: may affect up to 1 in 100 people
• Fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness and/or muscle or joint pain. The destruction of cancer cells and the body's response to this destruction may, in very rare cases, lead to a condition called tumour lysis syndrome.
• Chest pain, shortness of breath, rapid or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and malaise. Although it is unlikely that these are caused by the medicine, they could be signs of a heart problem.
  Not known: frequency cannot be estimated from the available data
• If you undergo a stem cell transplant, you may develop complications (graft-versus-host disease) that are difficult to manage. Symptoms may include skin rashes or blistering, nausea or diarrhoea that do not go away, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, mouth sores, irritation or pain in the mouth, persistent cough or difficulty breathing, genital sensitivity, jaundice (yellowing of the skin or eyes), dark urine and swelling of any kind.

Other side effects
If you experience any other side effect, inform your doctor. These may include:
Very common side effects: may affect more than 1 in 10 people

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

Common side effects: may affect up to 1 in 10 people

• Anaemia (reduced number of red blood cells)
• Decreased platelet count (thrombocytopenia)
• Decreased white blood cell count (neutropenia and leucopenia) or decreased lymphocyte count
• Blood tests showing increased levels of liver enzymes
• Underactive thyroid gland

Uncommon side effects: may affect up to 1 in 100 people

• Inflammation of the liver (hepatitis)

Not known: frequency cannot be estimated from the available data

• Small nodules on the skin, bones or other tissues caused by accumulation of immune cells in response to inflammation (granuloma)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POTELIGEO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial, after "EXP/EXP". The expiry date refers to the last day of that month.
Unopened vial: store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Reconstituted/diluted solution: use immediately or store in a refrigerator (2 °C – 8 °C) and use within 24 hours.
Do not use this medicine if you notice signs of deterioration, such as particulate matter or discoloration.
Do not dispose of any medicine via wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What POTELIGEO contains

• Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL.
• The other excipients are monohydrate citric acid, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections. See section 2 “POTELIGEO contains sodium”.

Description of the appearance of POTELIGEO and contents of the pack
POTELIGEO is a clear, colourless solution. The pack contains one glass vial containing 5 mL of concentrate for solution for infusion.
Marketing Authorisation Holder
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands
[email protected]
Manufacturer
allphamed PHARBIL Arzneimittel GmbH
Hildebrandstr. 10-12
37081 Göttingen
Germany
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.