Sarclisa 20 mg/ml concentrate for infusion solution
Spain
Table of Contents
Package leaflet: Information for the patient
Introduction
Package leaflet: information for the patient
Sarclisa 20 mg/ml concentrate for solution for infusion
isatuximab
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Sarclisa is and what it is used for
- What you need to know before using Sarclisa
- How Sarclisa is administered
- Possible side effects
- How to store Sarclisa
- Contents of the pack and other information
1. What Sarclisa is and what it is used for
What Sarclisa is
Sarclisa is an anticancer medicine that contains the active substance isatuximab, which belongs to a group of medicines called "monoclonal antibodies".
Monoclonal antibodies, such as Sarclisa, are proteins designed to recognise and bind to a specific target substance. In the case of Sarclisa, the target is a substance called CD38 found on multiple myeloma cells, a cancer of the bone marrow. The medicine binds to multiple myeloma cells, helping your body's natural defences (immune system) to identify and destroy them.
What it is used for
Sarclisa is used to treat multiple myeloma.
It is used in combination with two other medicines in patients who have received previous treatments for multiple myeloma:
-
pomalidomide and dexamethasone or
-
carfilzomib and dexamethasone
It is used in combination with three other medicines in patients who have been newly diagnosed with multiple myeloma:
- bortezomib, lenalidomide and dexamethasone.
If you have any questions about how Sarclisa works or about your treatment with Sarclisa, please consult your doctor.
2. What you need to know before using Sarclisa
Do not use Sarclisa
- if you are allergic to isatuximab or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before starting Sarclisa and follow all instructions carefully.
Infusion reactions
Tell your doctor or nurse immediately if you experience signs of infusion reactions during or after the Sarclisa infusion – see section 4 “Possible side effects” for a list of signs of "Infusion reactions".
- Before starting the Sarclisa infusion, you may be given medications to reduce the risk of infusion reactions (see section 3 “How Sarclisa is given”).
- Infusion reactions may occur during or after the Sarclisa infusion and can be serious. These reactions are reversible. Hospital staff will closely monitor you during treatment.
If you have an infusion reaction, your doctor or nurse may give you additional medications to treat your symptoms and prevent complications. They may also temporarily interrupt treatment, slow down the infusion rate, or completely stop the Sarclisa infusion.
Fever and low white blood cell count
Tell your doctor or nurse immediately if you develop fever, as it may be a sign of infection. Sarclisa can reduce 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 medication (for example, for herpes zoster [shingles]) to help prevent infections, or a medication to help increase your white blood cell count 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 heart medication. Contact your doctor or nurse immediately if you experience difficulty breathing, cough, or swelling in your legs.
Risk of new cancers
New cancers have occurred in patients receiving Sarclisa when administered with pomalidomide and dexamethasone, with carfilzomib and dexamethasone, or with bortezomib, lenalidomida and dexamethasone. Your doctor or nurse will monitor you for the development of new cancers during treatment.
Tumour lysis syndrome
Rapid breakdown of cancer cells (tumour lysis syndrome) may occur. Symptoms may include irregular heartbeat, seizures (fits), confusion, muscle cramps, or reduced urine output. Contact your doctor immediately if you experience any of these symptoms.
Blood transfusion
If you need a blood transfusion, a blood test will first be performed to determine your blood group.
Inform the person performing the blood test that you are being treated with Sarclisa. This is because Sarclisa may affect the results of this blood test for at least 6 months after your last dose of Sarclisa.
Children and adolescents
Sarclisa is not recommended for children and adolescents under 18 years of age, as the efficacy of Sarclisa has not been established in paediatric patients.
Other medicines and Sarclisa
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines.
Tell your doctor or nurse before receiving Sarclisa if you have ever taken a medicine for the heart.
Sarclisa is used together with two or three other medicines to treat multiple myeloma:
- Pomalidomide and dexamethasone, or
- Carfilzomib and dexamethasone, or
- Bortezomib, lenalidomide and dexamethasone
For information about these other medicines used with Sarclisa, please refer to their package leaflets.
Pregnancy
Talk to your doctor, pharmacist, or nurse before using Sarclisa.
The use of Sarclisa during pregnancy is not recommended. If you are pregnant or planning to become pregnant, consult your doctor about the use of Sarclisa.
For information about pregnancy and other medicines taken together with Sarclisa, please refer to the package leaflets of these other medicines.
Breast-feeding
Talk to your doctor, pharmacist, or nurse before using this medicine.
- This is because Sarclisa may pass into breast milk. It is unknown how it might affect the baby.
- You and your doctor will decide whether the benefit of breast-feeding outweighs the risk to your baby.
Contraception
Women of childbearing potential who are receiving Sarclisa must use an effective method of contraception. Consult your doctor about which contraceptive method to 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 consult the package leaflets of the other medicines you are taking with Sarclisa.
Sarclisa contains polysorbate 80
This medicine contains 0.2 mg of polysorbate 80 per ml of isatuximab concentrate for infusion solution, equivalent to 0.1 mg/kg body weight.
Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How Sarclisa is administered
How much Sarclisa you will receive
The amount of Sarclisa you will be given is based on your body weight. The recommended dose is 10 mg of Sarclisa per kilogram of body weight.
How Sarclisa is administered
Your doctor or nurse will administer Sarclisa as an intravenous infusion (a drip into a vein).
How often Sarclisa is administered
When Sarclisa is used in combination with two other medicines, either pomalidomide and dexamethasone or carfilzomib and dexamethasone, treatment cycles last 28 days (4 weeks).
- In cycle 1: Sarclisa is administered once weekly on days 1, 8, 15, and 22
- In cycle 2 and onwards: Sarclisa is administered every 2 weeks on days 1 and 15
When Sarclisa is used in combination with three other medicines, bortezomib, lenalidomide, and dexamethasone:
- For patients not eligible for autologous stem cell transplantation (using their own stem cells):
Treatment cycles last 42 days (6 weeks) from cycle 1 to cycle 4, and 28 days (4 weeks) from cycle 5 onwards.
-
In cycle 1: Sarclisa is administered on days 1, 8, 15, 22, and 29
-
From cycle 2 to cycle 4: Sarclisa is administered every 2 weeks on days 1, 15, and 29
-
From cycle 5 to cycle 17: Sarclisa is administered every 2 weeks on days 1 and 15
-
Starting from cycle 18: Sarclisa is administered every 4 weeks on day 1
-
For patients eligible for autologous stem cell transplantation (using their own stem cells):
Treatment cycles last 42 days (6 weeks) from cycle 1 to cycle 3.
- In cycle 1: Sarclisa is administered on days 1, 8, 15, 22, and 29
- From cycle 2 to cycle 3: Sarclisa is administered every 2 weeks on days 1, 15, and 29
Your doctor will continue treating you with Sarclisa for as long as it is beneficial to you and the side effects are manageable.
Medications given before Sarclisa
You will be given the following medications before the Sarclisa infusion. These are intended to help reduce your risk of infusion reactions:
- Medications to reduce allergic reactions (antihistamines)
- Medications to reduce inflammation (corticosteroids)
- Medications to reduce pain and fever
If you miss a dose of Sarclisa
It is very important that you attend all your appointments to ensure you receive your treatment at the correct time for it to work properly. If you miss an appointment, contact your doctor or nurse as soon as possible to reschedule.
Your doctor or nurse will decide how your treatment should continue.
If you receive more Sarclisa than you should
Your doctor or nurse will administer Sarclisa to you. If you are accidentally given too much (overdose), your doctor will treat and monitor any side effects.
If you stop Sarclisa treatment
Do not stop treatment with Sarclisa unless you have discussed it with your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will discuss with you the side effects of Sarclisa and explain the risks and benefits of your treatment with Sarclisa.
Hospital staff will closely monitor your condition during treatment. Inform them immediately if you notice any of the following effects:
Infusion-related 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.
Serious signs of infusion-related reactions include:
- high blood pressure (hypertension)
- shortness of breath
- severe allergic reaction (anaphylactic reaction affecting up to 1 in 100 people) with difficulty breathing and swelling of the face, mouth, throat, lips or tongue.
More common signs of infusion-related reactions include:
- shortness of breath
- cough
- chills
- nausea
You may also experience other side effects during the infusion. Your doctor or nurse may decide to temporarily stop, slow down, or completely stop the infusion of Sarclisa. 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
Tell 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):
- low number of certain white blood cells (neutrophils), which are important for fighting infections
- low number of a type of blood cell called platelets, which help blood to clot (thrombocytopenia). Inform your doctor or nurse if you have any unusual bruising or bleeding
- lung infection (pneumonia)
- respiratory tract infection (such as nose, sinuses, or throat)
- diarrhea
- bronchitis
- shortness of breath
- nausea
- vomiting
- high blood pressure (hypertension)
- cough
- tiredness (fatigue)
- decreased appetite
- covid-19
- clouding of the eye (cataract)
Common (may affect up to 1 in 10 people):
- heart problems, which may present as difficulty breathing, cough, or swelling of the legs when Sarclisa is given with carfilzomib and dexamethasone
- fever with a severe decrease in certain white blood cells (febrile neutropenia) (see section 2 “What you need to know before you start using Sarclisa” for more information)
- low number of red blood cells (anemia)
- weight loss
- irregular heartbeat (atrial fibrillation)
- shingles (herpes zoster)
- low number of certain white blood cells (lymphocytes), which are important for fighting infections
If you experience any of the above side effects, or are unsure, speak with your doctor, pharmacist, or nurse immediately.
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Sarclisa
Sarclisa should be stored in a hospital or clinic.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and vial after “EXP”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Sarclisa
- The active substance of Sarclisa is isatuximab.
- One millilitre of concentrate contains 20 mg of isatuximab.
- Each vial of concentrate contains 100 mg of isatuximab in 5 ml of concentrate or 500 mg of isatuximab in 25 ml of concentrate.
- The other components (excipients) are sucrose, monohydrate histidine hydrochloride, histidine, polysorbate 80, and water for injections.
Nature of the product and contents of the container
Sarclisa is a concentrate for solution for infusion. It is a colourless to slightly yellow liquid, essentially free from visible particles.
Container size:
100 mg of isatuximab in 5 ml of concentrate (100 mg/5 ml): Each carton contains 1 or 3 vials.
500 mg of isatuximab in 25 ml of concentrate (500 mg/25 ml): Each carton contains 1 vial.
Not all container sizes may be marketed.
Marketing Authorization Holder
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Manufacturer responsible
Sanofi-Aventis Deutschland GmbH
Industriepark Hoechst Brueningstrasse 50
65926 Frankfurt am Main
Germany
Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00 | Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40 |
| Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium) |
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111 | Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050 |
Denmark Sanofi A/S Tlf: +45 45 16 70 00 | Malta Sanofi S.r.l. Tel: +39 02 39394275 |
Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996 Tel. from abroad: +49 69 305 70 13 | Netherlands Sanofi B.V. Tel: +31 20 245 4000 |
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30 | Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00 |
Greece Sanofi-Aventis Monoprosopi AEBE Tel: +30 210 900 16 00 | Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0 |
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00 | Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00 |
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23 | Portugal Sanofi - Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400 |
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500 | Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 |
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 | Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00 |
Iceland Vistor hf. Sími: +354 535 7000 | Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600 |
Italy Sanofi S.r.l. Tel: 800.536 389 | Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 |
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741 | Sweden Sanofi AB Tel: +46 (0)8 634 50 00 |
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50 | United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525 |
Date of the most recent review of this package leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and treatments are also available.
This package leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.
The following information is intended for healthcare professionals only:
SARCLISA vials are for single use only. The infusion solution must be prepared under aseptic conditions and administered by a healthcare professional in a setting where resuscitation facilities are available.
Preparation and administration of SARCLISA
- Calculate the required dose (mg) of SARCLISA concentrate and determine the number of vials needed for the 10 mg/kg dose based on the patient's body weight. More than one vial may be required.
- Visually inspect the SARCLISA concentrate before dilution for the presence of particles and discoloration.
- Remove the volume of diluent equivalent to the required volume of SARCLISA concentrate from a diluent bag containing 250 ml of 9 mg/ml (0.9%) sodium chloride injection solution or 5% glucose solution.
- Withdraw the appropriate volume of SARCLISA concentrate from the SARCLISA vial and dilute it into an infusion bag containing 250 ml of 9 mg/ml (0.9%) sodium chloride injection solution or 5% glucose solution.
- The infusion bag must be made of polyolefin (PO), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with di(2-ethylhexyl) phthalate (DEHP), or ethylene vinyl acetate (EVA).
- Gently invert the bag to mix the diluted solution. Do not shake.
- Administer the infusion solution by intravenous infusion using intravenous tubing sets (made of PE, PVC with or without DEHP, polybutadiene (PBD), or polyurethane (PU)) equipped with an in-line 0.22-micron filter (made of polyethersulfone (PES), polysulfone, or nylon).
- Administer the infusion solution over a time period depending on the infusion rate (see section 4.2 of the Summary of Product Characteristics, "Posology and method of administration").
- The prepared SARCLISA infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution was performed under controlled and validated aseptic conditions.
- Protection from light is not required for the prepared infusion bag under standard artificial lighting conditions.
- SARCLISA must not be administered together with other medicinal products through the same intravenous line.
Dispose of any unused solution. All materials used for dilution and administration must be discarded according to standard procedures.