4 mg / ml concentrate for solution for infusion
mogamulizumab
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 binds to 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’s syndrome, which are cancers called cutaneous T-cell lymphomas. This medicine is intended for patients who have previously received treatment with at least one medicine by mouth or by injection.
What you need to know before 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 cautions
Talk to your doctor or nurse before receiving POTELIGEO if you:
- have ever had a severe skin reaction from this drug
- have ever had an infusion reaction to this medicine (any symptoms of an infusion reaction are listed in section 4)
- have human immunodeficiency virus ( HIV ), herpes, cytomegalovirus ( CMV ), hepatitis B or C infection, or other ongoing infections
- have undergone or are planning to undergo a stem cell transplant, with either your own or a donor’s cells
- have had tumor lysis syndrome (a complication caused by the destruction of cancer cells) after a previous treatment
- have heart problems.
Tell the person giving you the infusion one or seek immediate medical attention if you get a reaction during or after an infusion of POTELIGEO.
Contact your doctor immediately if you experience any of the serious side effects listed in section 4 after starting treatment with POTELIGEO.
Children and young people
This medicine should not be used in children and adolescents under 18 years of age.
Pregnancy, breastfeeding, and fertility
The effects of POTELIGEO during pregnancy and lactation are not known. Due to the way this medicine works, it can harm your baby if given while you are pregnant or breastfeeding.
If you could become pregnant, use an effective contraceptive during treatment and for at least six months after stopping treatment. If you are breastfeeding, talk to your doctor about whether you can breastfeed during or after treatment.
Tell your doctor or nurse if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby.
Driving and using machines
POTELIGEO is unlikely to affect your ability to drive or use machines. However, this medicine can make some people tired, so be especially 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 sodium (23 mg) per vial, ie essentially ‘sodium-free’.
How to use POTELIGEO
The amount of POTELIGEO you receive is calculated by your doctor based on your body weight. The recommended dose is 1 mg POTELIGEO per kg body weight.
You will receive POTELIGEO in a vein ( intravenous infusion ) for at least 60 minutes. Initially, for the first five doses, the infusion is given once a week, then once every two weeks. Treatment should be continued if you do not experience serious side effects or the cutaneous T-cell lymphoma begins to worsen.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Contact a doctor or nurse or seek immediate medical attention if you experience any of the following symptoms after starting treatment with POTELIGEO :
- chills, nausea or vomiting, headache, wheezing, itching, redness, rash, dizziness or fainting, difficulty breathing, and fever, which may be signs of an infusion reaction. If this happens, the infusion may need to be stopped and you may need further treatment. When the symptoms disappear, you can usually continue the treatment, which, however, is given more slowly.
Your doctor may stop treatment if the 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, abdominal pain, nausea or vomiting, diarrhea, and severe malaise.
- skin pain, itching, blisters, rash, or sore mouth, which may be signs that you are developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
- chest pain, shortness of breath, rapid or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, fainting, and malaise. Although these are not likely to be caused by the drug, they may be a sign of a heart condition.
- fever, chills, nausea, vomiting, confusion, shortness of breath, convulsions, 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 can in some cases lead to a problem called tumor lysis syndrome.
- if you undergo a stem cell transplant, you may develop complications ( graft-versus-host disease) that are difficult to treat. Symptoms may include rash or blistering, nausea or diarrhea that does not go away, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, sores, irritation or pain in the mouth, cough that does not go away or shortness of breath, genital soreness, jaundice ( yellowish skin), dark-colored urine and swelling.
Other side effects ar
Talk to your doctor if you get any other side effects. These may include:
Very common side effects (may affect more than 1 user in 10):
- Lack of energy (fatigue)
- Constipation
- Swollen legs or ankles
- Headache
Common side effects (may affect up to 1 in 10 people):
- Reduced red blood cell count ( anemia )
- Decreased platelet count ( thrombocytopenia )
- Decreased white blood cell count ( neutropenia and leukopenia ) or decreased lymphocyte count
- Blood tests showing elevated liver enzymes
- Underactive thyroid gland
Uncommon side effects (may affect up to 1 in 100 people)
- Hepatitis _ _
How to store 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. respectively EXP. The expiration date is the last day of the specified month.
Unopened vial: Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the original box. Sensitive to light.
Prepared/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 of the solution, such as particles or discoloration.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- Each vial contains 20 mg of mogamulizumab in 5 ml of concentrate, equivalent to 4 mg/ml.
- The other ingredients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections. See section 2 “POTELIGEO contains sodium”.
What the medicine looks like and the contents of the pack
POTELIGEO is a clear, colorless solution. The pack contains a glass vial containing 5 ml of concentrate for solution for infusion.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Kyowa Kirin Holdings BV
Bloemlaan 2
2132 NP Hoofddorp
Netherlands
Manufacturer
Piramal Healthcare UK Limited
Whalton Road
Morpeth
NE61 3YA
UK
allphamed PHARBIL Arzneimittel GmbH
Hildebrand. 10-12
37081 Göttingen
Germany