Patient leaflet - Cejemly 600 mg concentrate for solution for infusion
1. What Cejemly is and what it is used for
Cejemly contains the active substance sugemalimab which is a monoclonal antibody. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body. Cejemly works by attaching to the target called programmed death-ligand 1 (PD-L 1 ). This protein suppresses the body's immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells. By attaching to the protein, Cejemly helps your immune system to fight your cancer.
Cejemly is used to treat adults with a kind of lung cancer called 'non-small cell lung cancer'. It is used alone when your lung cancer:
has spread within your lung and cannot be removed by surgery, and has responded or stabilised after initial treatment with
Material Information: 26#
Center Point: 6.875"
chemotherapy and radiotherapy.
It is used in combination with platinum-based chemotherapy when your lung cancer:
- has spread and cannot be removed by surgery.
It is important that you read the package leaflets for the other anticancer medicines you may be receiving.
If you have any questions about how this medicine works or why this medicine has been prescribed for you,askyourdoctor.
2. What you need to know before you are given Cejemly
Do not use Cejemly
You should not be given Cejemly if you are allergic to sugemalimab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before you are given Cejemly if:
- you have an autoimmune disease (a condition where the body attacks its own cells)
- you have been vaccinated with a live-virus vaccine in the 28 days before starting treatment
- you had medical history of lung disease called radiation pneumonitis, interstitial lung disease or idiopathic pulmonary fibrosis
- you have or have had chronic viral infection of the liver, including hepatitis B (HBV} or hepatitis C (HCV}
- you have human immunodeficiency virus (HIV} infection or acquired immune deficiency syndrome (AIDS)
- you have liver damage
- you have kidney damage
When you get Cejemly, you can have some serious side effects. These may happen anytime during treatment or even weeks or months after your last dose. Tell your doctor straightaway if you notice any of the following symptoms:
- Cejemly may cause infusion-related reactions (such as sudden severe swelling of face/throat/limb or anaphylaxis).
Cejemly acts on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of
Cejemly. These reactions may involve one or more organ systems. This could result in inflammation and loss of function of the lungs, the stomach or intestines, the skin, the liver, the kidneys, the heart muscle, other muscles, or hormone glands. Your risk of these side effects may be higher if you already have an autoimmune disease (a condition where the body attacks its own cells). You may also experience frequent flares of your autoimmune disease, which in the majority of cases are mild.
For details, please see section 4 - Possible side effects. If you have any related symptoms, please contact the doctor immediately.
Children and adolescents
This medicine should not be given to patients under the age of 18 years as Cejemly has not been tested in children and adolescents.
Other medicines and Cejemly
Tell your doctor or nurse if you are taking, have recently taken or might take immunosuppressive treatment (e.g., systemic corticosteroids) or any other medicines.
This includes medicines obtained without a prescription, including herbal medicines.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before having this medicine. Talk with your doctor immediately if you become pregnant while you are being treated with Cejemly.
Contraception
If you are a woman who could become pregnant, or you are a male patient with a partner who can become pregnant, you and your female partner must use effective method of birth control to avoid becoming pregnant while being treated with Cejemly and for at least 4 months after the last dose.
Talk to your doctor about the effective contraceptive methods that you must use during this time.
Breast-feeding
If you are breast-feeding or plan to breast-feed, ask your doctor for advice before having Cejemly.
. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 33"
Driving and using machines
Cejemly may have an influence on your ability to drive and use machines. If you feel tired, do not drive or use machines until you feel better.
Cejemly contains sodium
This medicine contains 51.6 mg sodium per 1200 mg dose and 64.5 mg sodium per 1500 mg dose. This is equivalent to 2.58% and 3.23% of the recommended maximum daily dietary intake of sodium for an adult. However, before Cejemly is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.
Cejemly contains polysorbate 80
This medicine contains 4.08 mg of polysorbate 80 in each 1200 mg dose and 5.10 mg polysorbate 80 in each 1500 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How you are given Cejemly
How much is given
The recommended dose of Cejemly is 1200 mg for individuals weighing less than 115 kg, and 1500 mg for individuals weighing more than 115 kg.
How the medicine is given
Cejemly will be given to you in a hospital or clinic under the supervision of an experienced doctor. Your doctor will give you Cejemly through an infusion (drip) into your vein over 60 minutes every 3 weeks.
When Cejemly is given in combination with chemotherapy for your lung cancer, it will be given first followed by chemotherapy.
If you miss an appointment
It is very important that you go to all your appointments. If you miss an appointment to receive your medication, make another one as soon as possible.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. When you are given Cejemly, you can have some serious side effects (see section 2}. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Please seek urgent medical advice if you experience inflammation in any part of your body or if you have any of the following side effects, or if they get worse:
Infusion-related reactions such as chills, shaking or fever, skin problems like itching or rash, flushing or swollen face, trouble breathing or wheezing, nausea, vomiting or abdominal pain (infusion reactions can be severe or
life-threatening - these reactions are called anaphylaxis).
- Problems with hormone-producing glands such as mood swings, fatigue, weakness, weight fluctuations, changes in blood glucose and cholesterol levels, vision loss, headache that will not go away or unusual headaches, fast heartbeat, increased sweating, feeling more cold or hot than usual, very tired, dizzy or fainting, feeling more hungry or thirsty than usual, hair loss, constipation, your voice gets deeper, very low blood pressure, passing water more often than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful), inflammation of the adrenal, pituitary or thyroid glands.
- Signs of diabetes such as feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, feeling tired or feeling sick, stomach pain, fast and deep breathing, confusion, unusual sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
- Gut problems such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness (inflammation of the colon).
- Kidney problems - passing blood, swollen ankles.
- Lung problems such as new or worsening cough, being short of breath or chest pain, inflammation of the lungs (pneumonitis)
- Liver problems such as yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on right side of your stomach (abdomen}, feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual (inflammation of the liver).
Pancreas problems such as abdominal pain, nausea and vomiting (pancreatitis).
Skin problems such as rash or itching, blisters or ulcers in mouth, nose, eyes and genitals
o unexplained wide-spread skin pain, red or purple rash that spreads, shedding of the skin within days after blisters form - a severe skin condition called 'Stevens-Johnson syndrome'.
o peeling and blistering skin over much of the body - a life-threatening skin condition called 'Toxic epidermal necrolysis'.
- Heart problems such as changes in heartbeat, heart beating fast, seeming to skip a beat or pounding sensation, chest pain, shortness of breath.
- Muscle and joint problems such as joint pain or swelling, muscle pain, weakness, or stiffness.
- Inflammation of the brain, which may include fever, headache, movement disorder, neck stiffness.
- Inflammation of the nerves, which may include pain, weakness and paralysis in the extremities (Guillain-Barre syndrome)
- Inflammation of the eyes, which may include changes in eyesight
Other side effects:
Very common (may affect more than 1 in 1 0 people):
- decreased number of red blood cells that carry oxygen around your body
- increased levels of liver enzymes, bilirubin in the blood
- increased levels of sugar, triglycerides, cholesterol in the blood
- decreased calcium, potassium, and sodium in the blood
- increased levels of protein in the urine
- numbness, tingling or decreased touch sensation in a part of the body
- fever
Common (may affect up to 1 in 10 people):
- increased levels of uric acid in the blood
- decreased magnesium and/or chloride in the blood
- abnormal liver function
- increased levels of pancreatic enzymes (amylase, lipase)
- inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs (neuropathy)
- oral mucositis, dry mouth
- increased levels of muscle enzyme (cardiac muscle or skeletal muscle) in the blood
- dry eye, pink eye (conjunctivitis)
high blood pressure
Dieline ID: AT2065-26
Flat Size: 14" X 33''
Fold Size: 2.375" X 2.375" BACKSIDE
- increased level of creatinine in the blood
- skin discoloration
Uncommon (may affect up to 1 in 100 people):
- abnormal lipids in the blood
- decreased function of the adrenal gland
- decreased levels of the hormone cortisol in the blood
- inflammation of the blood vessels
- an abnormal reduction in the number of erythrocytes and/or white blood cells
The following side effects have been reported with other similar medicines:
- lack or reduction of digestive enzymes made by the pancreas (pancreatic exocrine insufficiency)
- coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and bloating after consuming gluten-containing foods)
Reporting of side effects
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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Cejemly
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 refers to the last day of that month.
Unopened vials: Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.
Do not store any unused portion of the infusion solution for reuse. Any unused portion of the infusion solution should be disposed in accordance with local requirements.
Preferred Gutter Space: .125"
Preferred Margin: .25"
Thickness Factor: .1875"
6. Contents of the pack and other information
What Cejemly contains
The active substance is sugemalimab. One ml of concentrate for solution for infusion contains 30 mg of sugemalimab. Each 20 ml vial of concentrate for solution for infusion contains 600 mg of sugemalimab.
The other ingredients are histidine, histidine monohydrochloride, mannitol (E421 ), sodium chloride (see section 2 "Cejemly contains sodium"), polysorbate 80 (E433) (see section 2 "Cejemly contains polysorbate 80"), and water for injections.
What Cejemly looks like and contents of the pack
Cejemly concentrate for solution for infusion is supplied as a clear to opalescent, colourless to light yellow solution, essentially free from visible particles.
Each carton contains 2 glass vials.
Marketing Authorisation Holder
CStone Pharmaceuticals Ireland Limited 117 - 126 Sheriff Street Upper
Dublin 1, D0l YC43
Ireland
Manufacturer
Sciencepharma Sp. z o.o.
Ul. Chelmska 30/34
Warsaw, 00-725
Poland
The following information is intended for healthcare professionals only:
Instructions for use
Preparation and administration solution for infusion
a. Do not shake the vial.
b. 1200 mg dose
Withdraw 20 ml from each of the 2 vials (total 40 ml) of Cejemly using sterile syringe and transfer into a 250 ml intravenous bag containing sodium chloride 9 mg/ml (0.9%) solution for injection for a total 1200 mg dose. Mix diluted solution by gentle inversion. Do not freeze or shake the solution. 1500 mg dose
Withdraw 20 ml from each of 2 vials and 70 ml
from 7 vial (total 50 ml) of Cejemly using sterile syringe and transfer into a 250 ml intravenous bag containing sodium chloride 9 mg/ml (0.9%) solution for injection. Mix diluted solution by gentle inversion. Do not freeze or shake the solution c. Do not co-administer other medicinal products through the same infusion line. The infusion solution should be administered through an intravenous line containing a sterile, low-protein binding in-line or add-on polyether sulfone (PES) filter with a 0.22-micron pore size.
d. Allow the diluted solution to come to room temperature prior to administration.
e. Discard any unused portion left in the vial.
Storage of diluted solution
Cejemly does not contain a preservative.
Once prepared, administer the diluted solution immediately. If diluted solution is not administered immediately, it may be stored temporarily either:
- at room temperature up to 25°C for no more than 4 hours from the time of preparation to the end of infusion.
or
- under refrigeration at 2°c to s0 c for no more than 24 hours from the time of preparation to the end of infusion. Allow the diluted solution to come to room temperature prior to administration.
Do not freeze.
Do not store any unused portion of the infusion solution for re-use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This leaflet was last revised in September 2026.
33"
r BARCODE 1
FPO
BARCODE
FPO