Poteligeo 4 mg/ml concentrado para solucion para perfusion

Prospect: Patient Information

POTELIGEO 4 mg/ml concentrate for solution for infusion.

Mogamulizumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

POTELIGEO contains the active ingredient mogamulizumab, which belongs to a group of medicines called monoclonal antibodies. Mogamulizumab attacks cancer cells, which are then destroyed by the immune system (the body's defenses).

This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of skin cancers called cutaneous T-cell lymphomas. This medicine is used in patients who have received at least one oral or injectable medication.

No use POTELIGEO:

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

Warnings and precautions

Consult your doctor or nurse before starting to use POTELIGEO if:

• you have ever had a severe skin reaction with this medication.
• you have ever had a reaction to infusion with this medication (the 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, whether using your own cells or a donor's cells.
• you have had tumor lysis syndrome (a complication involving the destruction of cancer cells) after previous treatment.
• you have heart problems.

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

Inform your doctor immediately if you experience any of the adverse effects listed in section 4 after starting treatment with POTELIGEO.

Other medications and POTELIGEO

Inform your doctor if you are taking, have recently taken, or may need to take any other medication.

Children and adolescents

This medication should not be used in children or adolescents under 18 years old.

Pregnancy and breastfeeding

The effects of POTELIGEO during pregnancy and breastfeeding are unknown. Due to the mechanism of action of this medication, it may affect your child if you are administered it while pregnant or breastfeeding.

If you can become pregnant, you should use an effective contraceptive method during treatment and for at least six 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, breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or nurse.

Driving and operating machinery

It is unlikely that POTELIGEO will affect your ability to drive and operate machinery. However, the medication may cause fatigue in some people, so you should exercise special care when driving and operating machinery until you are certain that this medication does not affect you.

POTELIGEO contains sodium

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

Side effectsvery common (may affect more than 1 in 10 people):

• chills, nausea or vomiting, headache, wheezing, itching, redness, rash, dizziness or feeling of fainting, difficulty breathing, and fever, which may be signs of a reaction to infusion. If this occurs, the infusion may need to be interrupted and additional treatment may be required. When symptoms subside, POTELIGEO administration can be continued normally, but at a slower rate. Your doctor may suspend POTELIGEO treatment 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 intense discomfort.

• skin rash (which may worsen) or mouth pain. In some people who received POTELIGEO for other types of cancer, skin pain/tingling, itching, blisters/skin peeling, or mouth ulcers, 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).

Side effects uncommon (may affect up to 1 in 100 people):

fever, chills, nausea, vomiting, confusion, shortness of breath, convulsions, irregular heartbeat, dark or cloudy urine, unusual fatigue and/or muscle or joint pain. The destruction of cancer cells and the body's reaction to it may, on rare occasions, lead to a condition called tumor lysis syndrome.

• chest pain, shortness of breath, rapid or slow heart rate, sweating, dizziness, nausea or vomiting, weakness, feeling of fainting, and discomfort. Although it is unlikely to be caused by this medication, these may be signs of a heart condition.

Unknown frequency (cannot be estimated from available data):

• If you are to undergo a stem cell transplant, you may develop complications (graft-versus-host disease) that are difficult to manage. Symptoms may include skin rashes or blisters, nausea or diarrhea that does not subside, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, ulcers, mouth irritation or pain, persistent cough or difficulty breathing, genital sensitivity, jaundice (turning yellow), dark urine, and any type of swelling.

Other side effects

Consult your doctor if you experience any other side effects. These may include the following:

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

• fatigue (lack of energy)
• 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)
• reduction in platelets (thrombocytopenia)
• reduction in white blood cells (neutropenia and leucopenia) or reduction in lymphocytes
• blood tests indicating elevated liver enzyme levels
• hypothyroidism

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

• inflammation of the liver (hepatitis)

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

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

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

Medications should not be disposed of through drains or in the trash. This will help protect the environment.

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, polisorbate 80, sodium hydroxide, hydrochloric acid, and water for injection preparations. See section 2, "POTELIGEO contains sodium."

Appearance of the product and contents of the packaging

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

Marketing Authorization Holder

Kyowa Kirin Holdings B.V.

Bloemlaan 2

2132 NP Hoofddorp

Netherlands

[email protected]

Responsible for Manufacturing

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 10-12

37081 Göttingen

Germany

Kyowa Kirin Holdings B.V.

Bloemlaan 2

2132 NP Hoofddorp

Netherlands

Last review date of this leaflet:<{MM/YYYY}> <{month YYYY}.>

Other sources of information

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