Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - enjaymo

Document Subject

Generated Narrative: MedicinalProductDefinition mpc419fe066011304c4fef1d514818ee22

identifier: http://ema.europa.eu/identifier/EU/1/22/1687/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Enjaymo 50 mg/mL solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c419fe066011304c4fef1d514818ee22

identifier: http://ema.europa.eu/identifier/EU/1/22/1687/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - enjaymo

Attesters

What is in this leaflet

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

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 haemolytic anaemia in adults who have CAD. This reduces anaemia and lessen fatigue.

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

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 you 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.

Pregnancy and breast-feeding

Pregnancy

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, you 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 planning 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.

Enjaymo 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:

• an initial dose of Enjaymo
• a dose of Enjaymo 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, your 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 rate or dark urine.

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

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, pain 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: lower 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 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 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.

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 thrown 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.

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 injections.

This medicine contains sodium (see section 2 Enjaymo contains 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
Sanofi B.V. Paasheuvelweg 1105 BP Amsterdam The Netherlands

Manufacturer Sanofi-Aventis Deutschland GmbH
Br ningstr. Frankfurt am Main, 65Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A.
Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda Tel: +351 21 35 89 Hrvatska
Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800 536 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: