Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sarclisa

Document Subject

Generated Narrative: MedicinalProductDefinition mp4fad6211e26b19476a10017c27cac221

identifier: http://ema.europa.eu/identifier/EU/1/20/1435/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: SARCLISA 20mg/mL concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4fad6211e26b19476a10017c27cac221

identifier: http://ema.europa.eu/identifier/EU/1/20/1435/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - sarclisa

Attesters

What is in this leaflet

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

What Sarclisa is Sarclisa is a cancer medicine that contains the active substance isatuximab. It belongs to a group of medicines called monoclonal antibodies .
Monoclonal antibodies, such as Sarclisa, are proteins that have been designed to recognise and attach themselves to a target substance. In the case of Sarclisa, the target is a substance called CD38 that is found on cells of multiple myeloma, a cancer of the bone marrow. By attaching to multiple myeloma cells, the medicine helps the natural defences of your body (immune system) identify and destroy them.

What is Sarclisa used for Sarclisa is used to treat multiple myeloma in patients who have received treatments for multiple myeloma before. It is used together with two other combinations of medicines:

pomalidomide and dexamethasone or

carfilzomib and dexamethasone.

If you have any questions on how Sarclisa works or about your treatment with Sarclisa, ask your doctor.

You must not be given Sarclisa if:

you are allergic to isatuximab or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor or nurse before using Sarclisa and follow all instructions carefully.

Infusion reactions Tell your doctor or nurse immediately if you have signs of infusion reactions during or after the infusion of Sarclisa - see in section 4 for the list of signs of Infusion reactions .

Before starting a Sarclisa infusion, you may be given medicines to reduce infusion reactions (see section 3).

Infusion reactions can happen during the Sarclisa infusion or after the infusion and may be serious. These reactions are reversible. The hospital staff will monitor you closely during treatment. If you get an infusion reaction, your doctor or nurse may give you additional medicines to treat your symptoms and prevent complications. They may also temporarily stop, slow down, or completely stop the Sarclisa infusion.

Fever and low number of white blood cells Tell your doctor or nurse immediately if you develop fever, as it may be a sign of infection. Sarclisa can lower the number of white blood cells - which are important for fighting infections.

Your doctor or nurse will check your blood cell counts during treatment with Sarclisa. Your doctor may prescribe an antibiotic or antiviral medicine (for example, for herpes zoster [shingles]) to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with Sarclisa.

Heart problems
Talk to your doctor or nurse before using Sarclisa in combination with carfilzomib and dexamethasone if you have heart problems, or if you have ever taken a medicine for your heart. Contact your doctor or nurse immediately if you experience any difficulty breathing, cough, or leg swelling.

Risk of new cancers
New cancers have occurred in patients during treatment with Sarclisa when given with pomalidomide and dexamethasone or with carfilzomib and dexamethasone. Your doctor or nurse will monitor you for new cancers during treatment.

Tumour lysis syndrome A fast breakdown of cancer cells (tumour lysis syndrome) may occur. Symptoms may include irregular heartbeat, seizures (fits), confusion, muscle cramps, or decrease in urine output. Contact your doctor immediately if you experience any of these symptoms.

Blood transfusion If you need a blood transfusion, you will have a blood test first to match your blood type.

Tell the person doing the blood test that you are being treated with Sarclisa. This is because it can affect the results of this blood test.

Children and adolescents Sarclisa is not recommended for use in children and adolescents aged under 18 years. This is because this medicine has not been tested in this age group.

Other medicines and Sarclisa Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines you can get without a prescription, and herbal medicines.

Tell your doctor or nurse before having Sarclisa if you have ever taken a medicine for your heart.

Sarclisa is used together with two other combinations of medicines when treating multiple myeloma:

pomalidomide and dexamethasone or

carfilzomib and dexamethasone. For information on the other medicines used with Sarclisa, see their package leaflets.

Pregnancy Ask your doctor, pharmacist or nurse for advice before using Sarclisa.
Use of Sarclisa is not recommended during pregnancy. If you are pregnant or planning to become pregnant, talk to your doctor about using Sarclisa.

For information on pregnancy and other medicines that are taken with Sarclisa, please look at the package leaflet for these other medicines.

Breast-feeding
Ask your doctor, pharmacist or nurse for advice before using Sarclisa.

This is because Sarclisa may pass into breast milk. It is not known how it could affect the baby.

You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby. Contraception Women who are using Sarclisa and are able to become pregnant must use an effective method of contraception. Talk to your doctor about the method of contraception that you must use during this time. Use contraception during treatment - and for 5 months after the last dose of Sarclisa.

Driving and using machines
Sarclisa is unlikely to affect your ability to drive or use machines. However, Sarclisa is used with other medicines that may affect your ability to drive or use machines. Please look at the package leaflet from the other medicines you take with Sarclisa.

How much Sarclisa is given The amount of Sarclisa you will be given is based on how much you weigh. The recommended dose is 10 mg of Sarclisa per kilogram of your body weight.

How Sarclisa is given
Your doctor or nurse will give you Sarclisa as a drip into a vein (intravenous infusion).

How often Sarclisa is given
Sarclisa is used in treatment cycles of 28 days (4 weeks). It is used with two other medicines, either pomalidomide and dexamethasone or carfilzomib and dexamethasone.

In cycle 1: Sarclisa is given once a week on days 1, 8, 15 and
In cycle 2 and beyond: Sarclisa is given every 2 weeks - on days 1 and Your doctor will continue to treat you with Sarclisa as long as you benefit from it and the side effects are acceptable.

Medicines given before Sarclisa You will be given the following medicines before infusion of Sarclisa. This is to help reduce your chances of getting infusion reactions:

medicines to reduce allergic reactions (antihistamine)

medicines to reduce inflammation (corticosteroids)

medicine to reduce pain and fever

If you miss a dose of Sarclisa
It is very important that you go to all your appointments to make sure you receive your treatment at the right time for it to work properly. If you miss any appointments, call your doctor or nurse as soon as possible to reschedule the appointment.

Your doctor or nurse will decide how your treatment should be continued.

If you are given more Sarclisa than you should
Sarclisa will be given to you by your doctor or nurse. If you are accidentally given too much (an overdose), your doctor will treat and monitor your side effects.

If you stop using Sarclisa
Do not stop your treatment with Sarclisa unless you have discussed that with your doctor.

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

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

Your doctor will discuss the side effects of Sarclisa with you and will explain the possible risks and benefits of your treatment with Sarclisa.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of the effects below.

Infusion reactions - Very common (may affect more than 1 in 10 people): Tell your doctor or nurse immediately if you feel unwell during or after the infusion of Sarclisa.

Severe signs of infusion reaction include:

high blood pressure (hypertension)

feeling short of breath

serious allergic reaction (anaphylactic reaction affecting up to 1 in 100 people) with breathing difficulty and swelling of the face, mouth, throat, lips or tongue. The most common signs of infusion reaction include:

feeling short of breath

cough

chills

nausea

You may also have other side effects during the infusion. Your doctor or nurse may decide to temporarily stop, slow down, or completely stop the Sarclisa infusion. They may also give you additional medicines to treat your symptoms and prevent complications.

Tell your doctor or nurse immediately if you feel unwell during or after the infusion of Sarclisa.

Other side effects Talk to your doctor, pharmacist or nurse immediately if you have any of the side effects listed below:

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

lower number of red blood cells (anaemia)

lower number of some white blood cells (neutrophils or lymphocytes) which are important in fighting infection

lower number of blood platelets (thrombocytopenia) - tell your doctor or nurse if you have any unusual bruising or bleeding.

infection of the lungs (pneumonia)

infection of the airways (such as nose, sinuses or throat)

diarrhoea

bronchitis

feeling short of breath

nausea

fever with a severe decrease in some white blood cells (febrile neutropenia) (see section 2 for further details)

vomiting

high blood pressure (hypertension)

cough

tiredness (fatigue)

Common (may affect up to1 in 10 people):

heart problems, which may present as difficulty breathing, cough, or leg swelling when Sarclisa is given with carfilzomib and dexamethasone

decreased appetite

weight loss

irregular heart beat (atrial fibrillation)

herpes zoster (shingles)

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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.

Sarclisa will be stored at the hospital or clinic.

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 the vial 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 package in order to protect from light.

Medicines should not be disposed of via wastewater. Your doctor, pharmacist or nurse will throw away any medicines that are no longer being used. These measures will help protect the environment.

What Sarclisa contains

The active substance of Sarclisa is isatuximab.

One mL of concentrate contains 20 mg of isatuximab.

Each vial of concentrate contains either 100 mg of isatuximab in 5 mL of concentrate or 500 mg of isatuximab in 25 mL of concentrate.

The other ingredients (excipients) are sucrose, histidine hydrochloride monohydrate, histidine, polysorbate 80, and water for injections.

What Sarclisa looks like and contents of the pack Sarclisa is a concentrate for solution for infusion. It is a colourless to slightly yellow liquid, essentially free of visible particles. Sarclisa is supplied as a carton pack containing 1 or 3 glass vials.

Marketing Authorisation Holder Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturer
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brueningstrasse 65926 Frankfurt am Main Germany

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 39394Sanofi-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 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 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 6616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in .

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