Cejemly

Package leaflet: Information for the user

Cejemly 600 mg concentrate for solution for infusion

sugemalimab

Medicine under additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• It is important to keep the patient card with you during treatment.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What Cejemly is and what it is used for
2. What you need to know before receiving Cejemly
3. How Cejemly is administered
4. Possible side effects
5. How to store Cejemly
6. Contents of the pack and other information

1. What Cejemly is and what it is used for

What Cejemly is
Cejemly contains the active substance sugemalimab, which is a monoclonal antibody (a type of protein) that binds to a specific target in the body called PDL1.

What Cejemly is used for
Cejemly is used to treat adults with a type of lung cancer called "non-small cell lung cancer". It is used alone if the lung tumour:

• has spread within the lung and cannot be removed by surgery, and has responded to or has stabilised after initial treatment with chemotherapy and radiotherapy.

It is used in combination with platinum-based chemotherapy if the lung tumour:

• has spread and can no longer be surgically removed.

It is important that you read the package leaflets of any other anticancer medicines that may be given to you.

How Cejemly works
PDL1 is found on the surface of some tumour cells and suppresses the body's immune (defence) system, thereby protecting tumour cells from being attacked by immune cells. Cejemly binds to PDL1 and helps the immune system to fight cancer.

If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before you are given Cejemly

Do not use Cejemly
You must not be given Cejemly if you are allergic to sugemalimab or to any of the other
components 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 in which the body attacks its own cells)
• you have been vaccinated with a vaccine containing a live virus within the previous 28 days before starting treatment
• you have a history of a lung disease called radiation pneumonitis, interstitial lung disease, or idiopathic pulmonary fibrosis
• you have or have had chronic viral liver infection, including hepatitis B (HBV) or hepatitis C (HCV)
• you have human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• you have liver damage
• you have kidney damage

When you are given Cejemly, you may develop some serious side effects. These side
effects can sometimes be life-threatening and may lead to death. They may
occur at any time during treatment or even weeks or months after treatment has ended:

• Cejemly may cause infusion-related reactions (such as severe sudden swelling of face/throat/limbs or anaphylaxis).
• Cejemly acts on the immune system and may cause inflammation in different parts of the body. Inflammation may cause serious damage to the body, and some inflammatory conditions may be fatal and may require treatment or discontinuation of Cejemly. These reactions may involve one or more organs, leading to inflammation and loss of function of the lungs, stomach or intestines, skin, liver, kidneys, heart muscle, other muscles, or endocrine glands.

For more details, see section 4 “Possible side effects”. If you experience related symptoms,
contact your doctor immediately.
Children and adolescents
This medicine must not be given to patients under 18 years of age, as Cejemly
has not been studied in children and adolescents.
Other medicines and Cejemly
Tell your doctor or nurse if you are taking, have recently taken, or might take
immunosuppressive treatments or any other medicines, including herbal medicines and
over-the-counter medicines.
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
you must not use this medicine. If you become pregnant during treatment with Cejemly,
contact your doctor immediately.
Contraception
If you are a woman of childbearing age, you must use an effective method of contraception during
treatment with Cejemly and for at least 4 months after the last dose.
Talk to your doctor about the reliable contraceptive methods you should use during this period.
Breastfeeding
If you are breastfeeding or plan to breastfeed, you and your doctor will decide whether you should use the
medicine or breastfeed; you cannot do both.
Driving and using machines
Cejemly may affect your ability to drive vehicles and use machinery. If you feel tired, do not
drive or operate machinery.
Cejemly contains sodium
This medicine contains 51.6 mg of sodium per 1,200 mg dose and 64.5 mg of sodium per 1,500 mg dose. This corresponds to 2.58% and 3.23% of the recommended maximum daily dietary intake of sodium for an adult, respectively. However, before you are given Cejemly, it is mixed with a solution containing 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 per 1,200 mg dose and 5.10 mg of
polysorbate 80 per 1,500 mg dose. Polysorbates may cause allergic reactions.
Inform your doctor if you have known allergies.

3. How Cejemly is administered to you

Dosage
The recommended dose of Cejemly is 1,200 mg for patients weighing less than or equal to 115 kg and
1,500 mg for patients weighing more than 115 kg.
How the medicine is administered
Cejemly will be administered to you in a hospital or clinic under the supervision of an experienced doctor.
Cejemly will be given as an intravenous infusion (drip) lasting 60 minutes, every 3 weeks.
When Cejemly is administered in combination with chemotherapy for your lung cancer,
Cejemly will be given first, followed by chemotherapy.
If you miss an appointment
It is very important to attend all your scheduled appointments. If you miss an appointment for receiving the
medicine, schedule another appointment as soon as possible.

4. Possible side effects

Like all medicines, Cejemly can cause side effects, although not everybody gets them.
Serious side effects may occur when you are given Cejemly (see section 2). Your doctor will discuss these with you and explain the risks and benefits of treatment.

Seek immediate medical advice if you develop inflammation in any part of your body or if you experience any of the following side effects or if they worsen:

• Infusion-related reactions such as chills, shaking or fever, skin problems such as itching or rash, flushing or swelling of the face, difficulty breathing or wheezing, nausea, vomiting or abdominal pain (infusion reactions may be serious or potentially life-threatening and are referred to as “anaphylactic”).
• Problems with hormone-producing glands such as mood swings, fatigue, weakness, weight fluctuations, changes in blood glucose and cholesterol levels, vision loss, unusual or persistent headache, rapid heartbeat, increased sweating, feeling colder or hotter than usual, extreme tiredness, dizziness or fainting, increased hunger or thirst, hair loss, constipation, deeper voice, very low blood pressure, more frequent urination, nausea or vomiting, stomach (abdominal) pain, changes in mood or behaviour (such as decreased sexual desire, irritability or forgetfulness), inflammation of the adrenal glands, pituitary gland or thyroid gland.
• Signs of diabetes such as feeling hungrier or thirstier than usual, needing to urinate more often, weight loss, feeling tired or unwell (nausea), stomach ache, rapid and deep breathing, confusion, unusual drowsiness, sweet-smelling breath, sweet or metallic taste in the mouth, or a different smell to urine or sweat.
• Intestinal problems such as frequent diarrhoea often accompanied by blood or mucus, more bowel movements than usual, black or tarry stools, and severe pain or tenderness in the abdomen (inflammation of the colon).
• Kidney problems: blood in the urine, swollen ankles.
• Lung problems such as new or worsening cough, shortness of breath or chest pain, inflammation of the lungs (pneumonitis).
• Liver problems such as yellowing of the skin and whites of the eyes, severe nausea or vomiting, pain on the right side of the abdomen, drowsiness, dark-coloured urine (tea-coloured), bleeding or bruising more easily than normal, and reduced appetite (inflammation of the liver).
• Pancreatic problems such as abdominal pain, nausea and vomiting (pancreatitis).
• Skin problems such as rash or itching, blisters or ulcers in the mouth, nose, eyes and genitals, or unexplained widespread skin pain, red or purple rash that spreads, skin peeling within a few days after blistering – a serious skin disease called “Stevens-Johnson syndrome”, or skin peeling and blistering over most of the body – a potentially life-threatening condition called “toxic epidermal necrolysis”.
• Heart problems such as changes in heart rhythm, rapid heartbeat, sensation of skipped beats or pounding, 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 disorders, neck stiffness.
• Inflammation of the nerves, which may include pain, weakness and paralysis of limbs (Guillain-Barré syndrome).
• Eye inflammation, which may include changes in vision.

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

• decrease in red blood cells that carry oxygen around the body
• increased levels of liver enzymes and bilirubin in the blood
• increased levels of sugar, triglycerides and cholesterol in the blood
• decreased levels of calcium, potassium and sodium in the blood
• increased level of protein in the urine
• numbness, tingling or reduced sense of touch in part of the body
• fever

Common (may affect up to 1 in 10 people):

• increased level of uric acid in the blood
• decreased levels of magnesium and/or chloride in the blood
• abnormal liver function
• increased levels of pancreatic enzymes (amylase, lipase)
• nerve inflammation causing tingling, numbness, weakness or burning pain in arms or legs (neuropathy)
• mouth inflammation, dry mouth
• dry eye, red eye (conjunctivitis)
• high blood pressure
• increased level of creatinine in the blood
• abnormal skin pigmentation

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

• abnormal blood lipids
• reduced adrenal gland function
• decreased level of the hormone cortisol in the blood
• inflammation of blood vessels
• abnormally low number of red blood cells and/or white blood cells

The following side effects have been reported with similar medicines:

• lack or reduction of digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency)
• coeliac disease (characterised by symptoms such as stomach pain, diarrhoea and bloating after consuming foods containing gluten)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cejemly

Cejemly is stored by healthcare professionals in hospital or clinic settings.
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 that month.
Unopened vials: Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton to protect the medicine from light.
After dilution, immediate use is recommended. From the time of preparation by dilution into an intravenous infusion bag, Cejemly may be stored before use for no more than 4 hours at temperatures below 25°C and for no more than 24 hours in a refrigerator (2°C - 8°C).
Any unused portions of the infusion solution must be disposed of in accordance with local regulations.

6. Package contents and other information

What Cejemly contains
The active substance is sugemalimab. 1 mL of concentrate for infusion solution contains 30 mg of
sugemalimab. Each 20 mL vial of concentrate for infusion solution contains 600 mg of
sugemalimab.
The other components are histidine, monohydrochloride histidine, mannitol (E421), sodium chloride (see
section 2 “Cejemly contains sodium”), polysorbate 80 (E433) (see section 2 “Cejemly contains
polysorbate 80”), and water for injections.
Description of the appearance of Cejemly and contents of the pack
Cejemly concentrate for infusion solution is supplied as a solution ranging from transparent to opalescent,
colourless to pale yellow, 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, D01 YC43
Ireland
Manufacturer
Manufacturing Packaging Farmaca (MPF) B.V.
Neptunus 12, 8448CN Heerenveen, The Netherlands
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:
AT / BE / CY / DE / DK / EL / ES / FI / FR / IE / IS / IT / LU / MT / NL / NO / PT / SE
CStone Pharmaceuticals Ireland Limited
Ireland
Tel: +353 1 437 0580
Lietuva България
Ewopharma UAB Евофарма ЕООД
Tel.: +370 5248 7350 Teл.: + 359 2 962 12 00
Česká republika Magyarország
Ewopharma, spol. s r. o. Ewopharma Hungary Ltd.
Tel: + 420 2 673 11 613 Tel.: + 36 1 200 46 50
Eesti Polska
Ewopharma OÜ Ewopharma AG Sp. z o.o.
Tel: + 372 600 4440 Tel.: + 48 22 620 11 71
Hrvatska România
Ewopharma d.o.o. Ewopharma România SRL
Tel: + 385 1 6646 563 Tel: + 40 21 260 13 44
Slovenija Slovenská republika
Ewopharma d.o.o. Ewopharma spol. s r.o.
Tel: + 386 590 848 40 Tel: + 421 2 54 79 35 08
Latvija
Ewopharma SIA
Tel: + 371 6770 4000
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

The following information is intended for healthcare professionals only:

Instructions for use

Preparation and administration of Cejemly concentrate for infusion solution
a. Do not shake the vial.
b. 1 200 mg dose
Withdraw 20 mL from each of the 2 vials (40 mL in total) of Cejemly using a sterile syringe and transfer to a 250 mL intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) injectable solution, to obtain a total dose of 1 200 mg. Mix the diluted solution by gently inverting it. Do not freeze or shake the solution.
1 500 mg dose
Withdraw 20 mL from each of the 2 vials and 10 mL from 1 vial (50 mL in total) of Cejemly using a sterile syringe and transfer to a 250 mL intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) injectable solution. Mix the diluted solution by gently inverting it. Do not freeze or shake the solution.
c. Do not administer other medicinal products simultaneously through the same infusion line.
The infusion solution must be administered through an intravenous line containing a sterile, low-protein-binding polyethersulfone (PES) in-line or add-on filter with a pore size of 0.22 micron.
d. Allow the diluted solution to reach room temperature before administration.
e. Discard any unused portion remaining in the vial.
Storage of the diluted solution
Cejemly does not contain preservatives.
Once prepared, administer the diluted solution immediately. If the diluted solution is not administered immediately, it may be stored temporarily:

• at room temperature up to 25°C for no more than 4 hours from the time of preparation to the end of infusion, or
• in a refrigerator at 2°C – 8°C for no more than 24 hours from the time of preparation to the end of infusion. Allow the diluted solution to reach room temperature before administration.

Do not freeze.
Disposal
Do not store any unused portions of the infusion solution for later use. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.