Poteligeo 4 mg/ml concentrate for infusion solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
POTELIGEO 4 mg/ml concentrate for solution for infusion.
mogamulizumab
Read all of this leaflet carefully before you start using this medicine because 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 experience any side effects, talk to your doctor or nurse, even if it is not one of the side effects listed in this leaflet. See section 4.
Contents of the leaflet
- What POTELIGEO is and what it is used for
- What you need to know before receiving POTELIGEO
- How POTELIGEO is administered
- Possible side effects
- How to store POTELIGEO
- 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 defenses).
This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancer known as cutaneous T-cell lymphomas. This medicine is used in patients who have received at least one prior systemic therapy (oral or injectable).
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
Consult your doctor or nurse before starting to use POTELIGEO if:
- you have ever had a severe skin reaction to this medicine.
- you have ever had an infusion reaction to 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, whether using your own cells or a donor's.
- you have had tumor lysis syndrome (a complication involving the destruction of cancer cells) following previous treatment.
- you have heart problems.
Inform the person administering the infusion or seek immediate medical attention 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 medicines and POTELIGEO
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Children and adolescents
This medicine must not be used in children or adolescents under 18 years of age.
Pregnancy and breastfeeding
The effects of POTELIGEO during pregnancy and breastfeeding are unknown. Due to the mechanism of action of this medicine, it could affect your child if administered while you are pregnant or breastfeeding.
If you could become pregnant, you must use an effective method of contraception during treatment and for at least six months after treatment ends.
If you are breastfeeding, you should discuss with your doctor whether you may breastfeed during or after treatment with POTELIGEO.
If you are pregnant or breastfeeding, think you might 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 or operate machinery. However, this medicine may cause tiredness in some people, so you should exercise particular caution when driving or operating machinery until you are certain 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, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Inform 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 administered 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 adverse effects or your cutaneous T-cell lymphoma begins to worsen.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Tell your doctor or nurse or seek immediate medical attention if you experience any of the following signs and symptoms after starting POTELIGEO administration:
Very common adverse effects: may affect more than 1 in 10 people
- Chills, nausea or vomiting, headache, wheezing, itching, flushing (reddening), rash, dizziness or feeling faint, difficulty breathing and fever, which may be signs of an infusion reaction. If this occurs, the infusion may need to be interrupted and you may require additional treatment. Once symptoms have resolved, POTELIGEO administration can usually continue, but at a slower rate. Your doctor may discontinue 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, diarrhoea or severe discomfort.
- Skin rash (which may worsen) or mouth pain. In some people who received POTELIGEO for other types of cancer, skin pain/burning sensation, itching, blistering/skin peeling, or ulcers in the mouth, lips or genitals occurred, which may be possible signs of a serious skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (which affected up to 1 in 100 people).
Common adverse effects: may affect up to 1 in 10 people
- Watery diarrhoea, more bowel movements than usual, severe abdominal pain or tenderness to touch, which may be possible signs of inflammation of the large intestine (colitis).
Uncommon adverse 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 may very occasionally lead to a condition called tumour lysis syndrome.
- Chest pain, shortness of breath, fast or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and discomfort. Although it is unlikely these are caused by this medicine, these may be signs of a heart disorder.
Frequency not known: cannot be estimated from available data
- If you are going 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 persistent diarrhoea, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, mouth ulcers, irritation or pain in the mouth, persistent cough or difficulty breathing, genital sensitivity, jaundice (yellowing), dark urine and any kind of swelling.
Other adverse effects
Consult your doctor if you experience any other adverse effects. These may include the following:
Very common adverse effects: may affect more than 1 in 10 people
- Lack of energy (fatigue)
- Constipation
- Swelling of legs or ankles
- Headache
Common adverse effects: may affect up to 1 in 10 people
- Anaemia (reduction in red blood cells)
- Reduction in platelets (thrombocytopenia)
- Reduction in white blood cells (neutropenia and leucopenia) or reduction in lymphocytes
- Blood tests indicating increased liver enzyme levels
- Underactive thyroid (hypothyroidism)
Uncommon adverse effects: may affect up to 1 in 100 people
- Inflammation of the liver (hepatitis)
Frequency not known: cannot be estimated from available data
- Small lumps in the skin, bones or other tissues caused by accumulation of immune cells in response to inflammation (granuloma)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.
Unopened vial: Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep in the original packaging 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. Doing so helps protect the environment.
6. Contents of the container and other 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 monohydrate citric acid, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections. See section 2, "POTELIGEO contains sodium".
Appearance of the product and contents of the pack
POTELIGEO is a clear, colourless solution. The pack contains one glass vial with 5 ml concentrate for solution for infusion.
Marketing Authorisation Holder
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands
Manufacturer
allphamed PHARBIL Arzneimittel GmbH
Hildebrandstr. 10-12
37081 Göttingen
Germany
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands
Kyowa Kirin Services Ltd. Dutch Branch
Bloemlaan 2
Hoofddorp 2132 NP
The Netherlands
Date of the most recent review of this package leaflet: <{MM/YYYY }> <{month YYYY }>.
Other sources of information
Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicinal products.