InfoCons Consumer Protection informs you – Enjaymo – Package Leaflet

Before anything else

Read all of 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.
• If you have any further questions, a sk your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Enjaymo is and what it is used for

Enjaymo contains the active substance sutimlimab and belongs to a class of medicines called monoclonal antibodies.

In the rare blood disorder cold agglutinin disease (CAD) , certain antibodies of the immune defence system bind to red blood cells . This causes breakdown of the red blood cells (haemolytic anaemia) through activation of classical complement pathway (part of the immune defense system ). Enjaymo blocks the activation of this part of the immune defence system .

Enjaymo is used to treat ha emolytic an aemia in adults who have CAD. This reduces anaemia and lessen fatigue.

⚠️ 2. What you need to know before you are given Enjaymo

You must not receive Enjaymo

• if you are allergic to sutimlimab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you are given Enjaymo .

Infection s Inform your doctor if you have any infection including an ongoing infection such as HIV, hepatitis, B or hepatitis C or if you have a decreased ability to fight infections .

Vaccinations Check with your doctor that you are appropriately vaccinated, and also have received meningococcal and streptococcal vaccines.

It is recommended that y ou are vaccinated at least 2 weeks before beginning Enjaymo . You need to be aware that vaccination may not always prevent these types of infection . Immediately contact your doctor if any signs of infection appear , see section 4 “Possible side effects”.

Allergic reactions Seek medical help immediately if you notice any signs of an allergic reaction while or after you are given this medicine. For symptoms , see section 4 “Possible side effects”.

Infusion-related reactions You may experience infusion-related reactions during the infusion or immediately after the infusion. Inform your healthcare professional immediately if you experience symptoms associated with Enjaymo infusion. For symptoms, see section 4 “Possible side effects”.

Systemic lupus erythematosus (SLE) Inform your doctor if you have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus. Seek medical attention if you develop any symptoms of SLE such as joint pain or swelling, rash on the cheeks and nose or unexplained fever. Children and adolescents Enjaymo should not be used in children and adolescents under 18 years of age as CAD generally does not occur in this age group.

Other medicines and Enjaymo

Tell your doctor if you are taking, have recently taken or might take any other medicines .

P regnancy and breast ­ feeding P regnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. It is not known if Enjaymo will affect your unborn baby.

If you are pregnant, y ou should only be given Enjaymo if your doctor has clearly recommended it.

Breast -feeding It is not known whether Enjaymo passes into breast milk. If you are breastfeeding or plan ning to breastfeed, talk to your doctor before using this medicine , so you and your doctor must decide if you should breast feed or if you will be given Enjaymo.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines .

Enjaymo contains sodium

This medicine contains 3.5 mg per mL or 77 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.85% of the recommended maximum daily dietary intake of sodium for an adult.

💊 3. How Enjaymo will be givenEnjaymo will be given to you by a healthcare professional . It is given as an infusion (drip) into a vein

(intravenously). The dose you will be given will depend on your body weight.

The infusion takes usually 1 to 2 hours. After each infusion you will be monitored for allergic reactions: after the first infusion you will be monitored for at least 2 hours. After the subsequent infusions you will be monitored for at least 1 hour.

You will usually receive:

• a n initial dose of Enjaymo
• a dose of E njaymo one week later
• thereafter you will start to receive Enjaymo every 2 weeks Home infusion
• You will receive Enjaymo for at least three months at a health care facility.
• After this, y our doctor may consider that you can have home infusion of Enjaymo.
• Home infusion will be performed by a health care professional.

If you are given more Enjaymo than you should

This medicine will be given by a healthcare professional . If you think that you have been accidentally given too much Enjaymo, please contact your doctor for advice.

If you forget to use Enjaymo If you miss an appointment to receive Enjaymo, contact your doctor right away to reschedule your infusion. If you stop using Enjaymo The effects of Enjaymo will be reduced after end of the treatment. If you stop receiving Enjaymo, your doctor should check for return of signs and symptoms of CAD. The symptoms are caused by breakdown of your red blood cells and may include tiredness, shortness of breath, rapid heart ra te or dark urine.

If you have any further questions on the use of this medicine, ask your doctor .

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately tell your health care professional giving you Enjaymo if you notice any signs of an allergic reaction while or shortly after you are given this medicine. The signs may include :

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps
• feeling faint.

If any of these symptoms occur during infusion, the infusion should be stopped immediately.

Immediately tell your health care professional giving you Enjaymo if you notice any signs of a reaction related to the infusion while you are given this medicine. Common (may affect up to 1 in 10 people). The signs may include:

• nausea
• feeling flushed
• headache
• shortness of breath
• rapid heart rate.

Tell your doctor as soon as possible if you experience symptoms or signs of an infection such as:

• fever with or without rash, chills, flu -like symptoms, cough/difficulty breathing, headache with nausea, vomiting, stiff neck, stiff back, confusion, eye sensitivity to light, p ain during urination or urinating more often.
• Infections: urinary tract, upper respiratory tract, stomach and intestine, common cold, runny nose are very common (may affect more than 1 in 10 people).
• Infections: lo wer respiratory tract, urinary tract, herpes infection are common (may affect up to 1 in 10 people) .

Tell your doctor or nurse if you get any of the following other side effects:

Very common (may affect more than 1 in 10 people)

• headache
• high blood pressure
• poor circulation with skin discoloration in hands and feet in response to cold and stress (Raynaud’s phenomenon, acrocyanosis )
• belly pain
• nausea

Common (may affect up to 1 in 10 people )

• Infusion related reactions
• Fever
• Feeling cold
• Dizziness
• Aura
• Low blood pressure
• Diarrhoea
• Stomach discomfort
• Mouth ulcer (aphthous ulcer)
• Chest discomfort
• Itching

Reporting of side effects

If you ge t 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 national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Enjaymo

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 label and the carton after EXP .

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C-8°C). Do not freeze.

Store in the original carton in order to protect from light.

Enjaymo should not be throw n away via wastewater or household waste. Your healthcare professional is responsible for disposing of any unused product correctly. This measure will help protect the environment.

📦 6. Contents of the pack and other information

What Enjaymo contains

• The active substance is sutimlimab. Each vial of 22 mL solution contains 1100 mg of sutimlimab
• The other ingredients are polysorbate 80 (E 433) , sodium chloride, sodium phosphate dibasic (E 339), sodium phosphate monobasic (E 339), and water for i njection s.

This medicine contains sodium (see section 2 “Enjaymo co ntains sodium”) .

What Enjaymo looks like and contents of the pack

Enjaymo is an opalescent, colourless to slightly yellow solution for infusion , essentially free from particles.

Each pack contains 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Recordati Rare Diseases Tour Hekla 52 avenue du Général de Gaulle 92800 Puteaux France

Manufacturer

Sanofi -Aventis Deutschland GmbH Brüningstr. 50 Frankfurt am Main, 65926 Germany R ecordati Rare Diseases Eco River Parc 30 rue des Peupliers 92000 Nanterre France

This leaflet was last revised i n

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments. ————————————————————————————————————————–

🩺 Information intended for healthcare professionals only

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Preparation Enjaymo is provided as a solution in a single -dose vial and should be prepared by a healthcare professional using aseptic technique.

1. Remove Enjaymo from the refrigerator. To minimize foaming, do not shake.

2. Inspect vials visually for particulate matter and discoloration prior to administration. The solution is a n opalescent and colo urless to slightly yellow liquid. Do not administer if discolo ured or if other foreign particulate matter is present.

3. Withdraw the calculated volume from the appropriate number of vials based on the recommended dose (see Table 1 for the infusion reference) and add to an empty infusion bag.

Discard any unused portion remaining in the vial.

4. The prepared solution should be administered immediately.

Administration 1. Prior to administration, allow the infusion solution to adjust to room temperature (18°C -25°C).

Refer to Table 1 for infusion rate. The infusion should be administered over 1-2 hours depending on the patient’s body weight. Administer the infusion only through a 0.22-micron filter with a polyethersulfone (PES) membrane . Infusion warmers may be used, do not exceed a temperature of 40 °C.

2. The infusion catheter and tubing should be primed with the dosing solution immediately before infusion and flushed immediately following completion of the infusion with enough quantity (approximately 20 mL) of sodium c hloride 9 mg/mL (0.9%) solution for i njection.

3. No incompatibilities have been observed between E njaymo infusion solution and infusion bags made of Di -(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), Ethyl Vinyl Acetate (EVA) and polyolefin (PO); administration sets made of DEHP -plasticized PVC, DEHP -free polypropylene (PP) and polyethyl ene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile -butadiene -styrene (ABS).

Table 1 ­ Infusion reference table Body weight range Dose (mg) Number of vials needed Volume (mL) Maximum infusion rate Greater than or equal to 39 kg to less than 75 kg 6500 6 130 130 mL/hour 75 kg or greater 7500 7 150 150 mL/hour Storage conditions Unopened vial

• Store in a refrigerator (2 °C-8° C). Do not freeze.
• Store in the original carton in order to protect from light.

After opening

• Chemical and physical in -use stability has been demonstrated for 16 hours at 18° C to 25° C or for 72 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately.
• If not used immediately, in -use storage times and conditions prior to use are the responsibility of the user and would not normally be for longer than 24 hours at 2°C to 8° C or 8 hours at room temperature, unless vial opening and pooling into the infusion bag has taken place in controlled and validated aseptic conditions.

Home infusion Home infusions should be performed by a healthcare professional.

The decision to consider home infusion should be based on individual clinical characteristics of the patient and individual needs of the patient . Transitioning the infusion from a clinical facility to home administration includes ensuring that adequate infrastructure and resourcing is in place and consistent with treating physician orders. Infusion of E njaymo at home may be considered for patients who have tolerated their infusion well in a clinical facility and have not had infusion related reactions. A patient’s underlying co-morbidities and ability to adhere to the home infusion requirements need to be considered when evaluating the patient for eligibility to receive home infusion. In addition, the following criteria should be considered:

• The patient must have no ongoing concurrent condition that, in the opinion of the physician, may place the patient at greater risk when receiving an infusion in the home setting rather than in the clinic setting. A comprehensive evaluation should be completed before the initiation of home infusion to ensure that the patient is medically stable.
• The patient must have successfully received Enjaymo infusion in a clinical setting (hospital or outpatient) for at least three months under the supervision of a physician or care provider experienced in the management of patients with CAD.
• The patient must be willing and able to comply with home infusion procedures and recommendations of the treating physician or care provider.
• The healthcare professional administering the infusion at home should be available at all times during the home infusion and for at least 1 hour after infusion.

If the patient experiences adverse reactions during the home infusion, the infusion process should be stopped immediately, appropriate medical treatment should be initiated and the treating physician should be notified. In such cases, the treating physician should decide if subsequent infusions should occur and if so, whether the infusions should be administered in a hospital or supervised outpatient care setting.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Enjaymo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1687).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.