ENJAYMO 50 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Enjaymo 50 mg/mL solution for infusion
   1. What is Enjaymo and what is it used for
   2. What you need to know before you use Enjaymo
   3. How Enjaymo is administered
   4. Possible side effects
   5. How to store Enjaymo
   6. Contents of the pack and other information

Enjaymo 50 mg/mL solution for infusion

sutimlimab
▼Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
encountered during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Enjaymo and what is it used for

Enjaymo contains the active substance sutimlimab and belongs to a class of medicines called
monoclonal antibodies.
In cold agglutinin disease (CAD), a rare blood disorder, some antibodies of the immune
system bind to red blood cells. This causes the breakdown of red blood cells (hemolytic anemia)
through the activation of the classical complement pathway (part of the immune system). Enjaymo
blocks the activation of this part of the immune system.
Enjaymo is used to treat the breakdown of red blood cells (hemolytic anemia) in adults with
cold agglutinin disease (cold agglutinin disease, CAD). This reduces anemia and
decreases fatigue.

2. What you need to know before you use 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.
Infections

Tell your doctor if you have an infection, such as an ongoing infection like HIV, hepatitis B or
hepatitis C, or if you have a reduced ability to fight infections.
Vaccinations

Check with your doctor that you are adequately vaccinated, and that you have also received meningococcal and streptococcal vaccines.
It is recommended that you are vaccinated at least 2 weeks before starting to take Enjaymo. You should
be aware that vaccination may not always be able to prevent these types of infection. Contact your
doctor immediately if any signs of infection should appear, see section 4 “Possible side effects”.
Allergic reactions
Seek immediate medical attention if you notice signs of an allergic reaction during or after the
administration of 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. Immediately inform the healthcare professional if you experience symptoms associated
with the infusion of Enjaymo. For symptoms, see section 4 “Possible side effects”.
Systemic lupus erythematosus (SLE)
Tell your doctor if you have an autoimmune disease such as systemic lupus erythematosus (SLE), also
known simply as lupus. Consult a doctor if you develop symptoms of SLE such as joint pain or
swelling, rash on the cheeks and nose or unexplained fever.

Children and adolescents
Enjaymo must not be used in children and adolescents under 18 years of age, as CAD is generally
not present in this age group.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before you are given this medicine. It is not known whether Enjaymo can affect
the unborn child. If you are pregnant, Enjaymo should only be given to you if your doctor
has clearly recommended it.
Breastfeeding
It is not known whether Enjaymo passes into breast milk. If you are breastfeeding or planning
to breastfeed, ask your doctor before using this medicine, so that you and your doctor can decide
whether to breastfeed or to give you Enjaymo.

Driving and using machines
This medicine does not or negligibly alters the ability to drive and operate
machines.

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

3. How Enjaymo is administered

Enjaymo will be administered to you by a healthcare professional. It is administered by infusion (drip)
into a vein (i.e. intravenously). The dose that is administered depends on body weight.
The infusion usually takes 1 to 2 hours. After each infusion you will be monitored for reactions
allergies: after the first infusion you will be monitored for at least 2 hours. After subsequent infusions
you will be monitored for at least 1 hour.
You will usually receive:

• an initial dose of Enjaymo
• a dose of Enjaymo one week later
• afterwards you will start receiving Enjaymo every 2 weeks

Home infusion

• You will receive Enjaymo for at least three months at a healthcare facility.
• After that, your doctor may consider that you can receive the Enjaymo infusion at your home.
• The infusion at home will be performed by a healthcare professional.

If you are given too much Enjaymo
This medicine will be administered by a healthcare professional. If you think you have accidentally received
too much Enjaymo, ask your doctor for advice.

If you forget to use Enjaymo
If you miss an appointment where you were supposed to receive Enjaymo, you should contact your doctor immediately
to reschedule the infusion.

If you stop taking Enjaymo
The effects of Enjaymo will be reduced after the end of treatment. If you stop taking Enjaymo, your doctor should check for the possible reappearance of signs and symptoms of CAD. The symptoms
are caused by the breakdown of red blood cells and may include fatigue, shortness of breath,
rapid heart rate, or dark urine.
If you have any questions about using this medicine, ask your doctor.

4. Possible side effects

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

Immediately inform the doctor who administered Enjaymo if you notice signs of an allergic reaction during or shortly after administration of 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 of fainting.

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

Immediately inform the doctor who administered Enjaymo if you notice signs of an infusion-related reaction during administration of this medicine.These are common events that can affect 1 in 10 people. The signs may include:

• nausea
• feeling of flushing
• headache
• shortness of breath
• fast heartbeat.

Inform 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, back stiffness, confusion, sensitivity of the eyes to light, pain when urinating or more frequent urination. infections: urinary tract infections, upper respiratory tract infections, stomach and intestinal infections, common cold, runny nose are very common (may affect more than 1 in 10 people).
• infections: lower respiratory tract infections, urinary tract infections and herpes infections are common (may affect up to 1 in 10 people).

Inform your doctor or nurse if you experience any of the following other side effects:

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

• headache
• high blood pressure
• poor circulation with abnormal skin colour of hands and feet in response to cold and stress (Raynaud's phenomenon, acrocyanosis)
• abdominal 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 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 through 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 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 packaging 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 packaging to protect the medicine from light.
Enjaymo must not be disposed of via wastewater or household waste. The healthcare professional is
responsible for the correct disposal of any unused product. This will help to
protect the environment.

6. Contents of the pack and other information

What Enjaymo contains

• The active substance is sutimlimab. Each 22 mL solution vial contains 1 100 mg of sutimlimab
• The other ingredients are polysorbate 80 (E 433), sodium chloride, disodium phosphate (E 339), monosodium phosphate (E 339) and water for injections.

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

Description of the appearance of Enjaymo and contents of the pack
Enjaymo is an opalescent, colourless to slightly yellow solution for infusion, essentially
particle-free.
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

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. Additionally, links to other websites on rare diseases
and related therapeutic treatments are provided.
for medicines and on the website: www.enjaymo.info.sanofi, or by scanning the QR code
below (also included on the outer packaging) with a smartphone.

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The following information is intended for healthcare professionals only:
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
medicine administered must be clearly recorded.
Preparation
Enjaymo is supplied as a solution in a single-dose vial and must be prepared by a
healthcare professional using aseptic technique.

• 1. Remove Enjaymo from the refrigerator. To minimise foam formation, do not shake.
• 2. Visually inspect the vial for particulate matter and colour change before administration. The solution is an opalescent liquid and colourless to slightly yellow. Do not administer if there is a colour change or if other foreign particles are present.
• 3. Withdraw the calculated volume from the appropriate number of vials according to the recommended dose (see Reference Table 1 for infusions) and add it to an empty infusion bag. Discard any remaining unused portion in the vial.
• 4. The prepared solution must be administered immediately.

Administration

• 1. Before administration, allow the infusion solution to reach room temperature (18°C – 25°C). Refer to Table 1 for the infusion rate. The infusion must be administered over 1–2 hours depending on the patient’s body weight. Administer the Enjaymo infusion only through a 0.22 micron membrane polyethersulfone (PES) filter. Warming devices may be used, do not exceed a temperature of 40°C.
• 2. The infusion catheter and tubing must be filled with the dosage solution immediately before the infusion and flushed immediately after completion of the infusion with a sufficient amount (approximately 20 mL) of sodium chloride 9 mg/mL (0.9%) for injection.
• 3. No incompatibilities have been observed between the Enjaymo infusion solution and polyvinyl chloride (PVC) infusion bags plasticized with di-(2-ethylhexyl)phthalate (DEHP), ethylene vinyl acetate (EVA) and polyolefin (PO); administration sets made of PVC plasticized with DEHP, polypropylene (PP) without DEHP and polyethylene (PE) and vial adapters made of polycarbonate (PC) and acrylonitrile butadiene styrene (ABS).

Table 1 - Reference table for infusions

Storage conditions

Unopened vial

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

After opening

• Chemical and physical stability during use 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 must be used immediately.
• If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours at a temperature between 2°C and 8°C or 8 hours at room temperature, unless the vial opening and pooling in the infusion bag have been performed in controlled and validated aseptic conditions.

Home infusion
Infusions at home must be performed by a healthcare professional.
The decision to consider home infusion should be based on the patient’s specific clinical characteristics and individual needs. Transitioning the infusion
from a clinical setting to administration at home requires ensuring that adequate infrastructure and resources are in place and in line with the treating physician’s instructions. Home infusion of
Enjaymo may be considered for patients who have tolerated the infusion well
in a clinical setting and who have not experienced infusion-related reactions. When assessing
patient suitability for receiving the infusion at home, their
underlying comorbidities and ability to adhere to home infusion requirements should be considered. Furthermore, the following criteria must be considered:

• The patient must not have any ongoing concomitant illness that, at the physician’s discretion, may expose the patient to a higher risk when receiving the infusion in a home setting rather than a clinical setting. A complete assessment must be completed before starting home infusion to ensure that the patient is clinically stable.
• The patient must have successfully received an Enjaymo infusion in a clinical setting (hospital or outpatient clinic) for at least three months under the supervision of a physician or healthcare professional experienced in managing patients with CAD.
• The patient must demonstrate willingness and ability to comply with home infusion procedures and recommendations given by the treating physician or healthcare professional.
• The healthcare professional administering the home infusion must be available at all times during the home infusion and for at least 1 hour after the infusion.

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