This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16508/0067.
Poteligeo 4 mg/mL, Concentrate for Solution for Infusion
POTELIGEO 4 mg/mL concentrate for solution for infusion
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What POTELIGEO is and what it is used for
2. What you need to know before you use POTELIGEO
3. How POTELIGEO is given
4. Possible side effects
5. How to store POTELIGEO
6. Contents of the pack and other information
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).
This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas. The medicine is for use in patients who have received at least one medicine given by mouth or by injection.
Talk to your doctor or nurse before using POTELIGEO if you:
Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion.
Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment.
This medicine should not be used in children and adolescents below 18 years of age.
The effects of POTELIGEO in pregnancy and breast-feeding are not known. Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast-feeding.
If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment. If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO.
You must tell your doctor or nurse if you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby.
POTELIGEO is unlikely to affect your ability to drive and use machines. However, the medicine can cause tiredness in some people, so take particular care when driving and using machines until you are certain that this medicine does not affect you.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
The amount of POTELIGEO you will receive is calculated by your doctor based on your body weight. The recommended dose is 1mg POTELIGEO for each kg of body weight.
POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes. To start with, the infusions will be given once a week for the first 5 doses, then once every 2 weeks. Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse or get medical help immediately if you have any of the following symptoms after starting POTELIGEO:
Talk to your doctor if you get any other side effects. These can include:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people)
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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 the vial after “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.
Store it in the original carton in order to protect 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 discolouration.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
POTELIGEO is a clear, colourless solution. The pack contains a glass vial containing 5 mL concentrate for solution for infusion.
This leaflet was last revised in 01/2022.