POTELIGEO 4 mg/ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you start using POTELIGEO

Do not use POTELIGEO:

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

Warnings and precautions

Consult your doctor or nurse before starting treatment with POTELIGEO if:

• you have ever had a severe skin reaction with this medicine.
• you have ever 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), or hepatitis B or C infection, or other ongoing infections.
• you have undergone or plan to undergo a stem cell transplant, either using your own cells or a donor's.
• you have had tumor lysis syndrome (a complication involving the destruction of cancer cells) after previous treatment.
• you have heart problems.

Tell the person administering the infusion or seek medical attention immediately if you experience a reaction during or after any infusion with POTELIGEO.

Tell 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 not known. Due to the mechanism of action of this medicine, it could affect your child if you are given it while pregnant or breastfeeding.

If you can become pregnant, you must use an effective contraceptive method during treatment and for at least 6 months after treatment.

If you are breastfeeding, you should discuss with your doctor whether you can breastfeed during or after treatment with POTELIGEO.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse.

Driving and using machines

It is unlikely that POTELIGEO will affect your ability to drive and use machines. However, the medicine may cause fatigue in some people, so you should be careful when driving and using machines until you are sure that this medicine does not affect you.

POTELIGEO contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which is essentially 'sodium-free'.

POTELIGEO contains polysorbate

This medicine contains 1 mg of polysorbate 80 per vial, which is equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How POTELIGEO is administered

Your doctor will calculate the amount of POTELIGEO you will receive based on your body weight. The recommended dose is 1 mg of POTELIGEO per kilogram of body weight.

POTELIGEO will be given to you through a vein (intravenous infusion) over a minimum of 60 minutes. Initially, infusions will be given once a week for the first 5 doses, and then once every 2 weeks. Treatment should continue unless you experience severe side effects or your cutaneous T-cell lymphoma starts to worsen.

4. Possible side effects

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

Serious side effects

Tell your doctor or nurse or seek medical attention immediately if you have any of the following signs and symptoms after starting POTELIGEO:

Very common side effects (may affect more than 1 in 10 people):

• chills, nausea or vomiting, headache, wheezing, itching, flushing (redness), rash, dizziness or feeling of fainting, difficulty breathing, and fever, which may be signs of an infusion reaction. If this happens, the infusion may need to be interrupted and you may need additional treatment. When the symptoms disappear, POTELIGEO administration can continue normally, but more slowly. Your doctor may stop treatment with POTELIGEO if your reaction is severe.
• signs of infection, which may include fever, sweating or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhea, or severe discomfort.
• skin rash (which may worsen) or mouth pain. In some people who received POTELIGEO for other types of cancer, there was pain/burning sensation in the skin, itching, blisters/peeling of the skin, or ulcers in the mouth, lips, or genitals, which are possible signs of a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (which affected up to 1 in 100 people).

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

• watery diarrhea, more bowel movements than usual, severe abdominal pain, or tenderness to the touch, which are possible signs of inflammation of the large intestine (colitis).

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 reaction to it can, very occasionally, lead to a problem called tumor lysis syndrome.
• chest pain, shortness of breath, rapid or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling of fainting, and discomfort. Although it is unlikely to be caused by this medicine, these may be signs of a heart disorder.

Frequency not known (cannot be estimated from the available data):

• If you are going to have a stem cell transplant, it is possible that you may develop complications (graft-versus-host disease) that are difficult to manage. The symptoms may include skin rash or blisters, nausea or diarrhea that does not go away, stomach pain or vomiting, pain or stiffness in the joints, dry or irritated eyes or blurred vision, ulcers, irritation, or pain in the mouth, persistent cough or difficulty breathing, genital sensitivity, jaundice (turning yellow), dark urine, and any type of swelling.

Other side effects

Ask your doctor if you have any other side effects. These may include:

Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (may affect up to 1 in 10 people)

• Anemia (reduction in red blood cell count)
• Low platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia and leucopenia) or low lymphocyte count
• Blood tests showing increased liver enzyme levels
• Underactive thyroid

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

• Liver inflammation (hepatitis)

Reporting of side effects

If you experience any side effects, ask your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of POTELIGEO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date is the last day of the month shown.

Unopened vial: Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original package to protect from light.

Reconstituted/diluted solution: Use immediately or store in a refrigerator (between 2°C and 8°C) and use within 24 hours.

Do not use this medicine if you notice signs of deterioration, such as particulate matter or discoloration.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and further information

Composition of POTELIGEO

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

Appearance and pack contents

POTELIGEO is a clear and colorless solution. The pack contains a glass vial with 5 ml of concentrate for solution for infusion.

Marketing authorisation holder

Kyowa Kirin Holdings B.V.

Bloemlaan 2

2132 NP Hoofddorp

Netherlands

[email protected]

Manufacturer

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 10-12

37081 Göttingen

Germany

Kyowa Kirin Holdings B.V.

Bloemlaan 2

2132 NP Hoofddorp

Netherlands

Date of last revision of this leaflet:<{MM/YYYY}> <{Month YYYY}.>

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.