Sarclisa 20 mg/ml concentrado para solucion para perfusion

Prescribing Information for the Patient

Sarclisa 20 mg/ml Concentrate for Solution for Infusion

isatuximab

Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4 “Possible Adverse Effects”.

What is Sarclisa

Sarclisa is a cancer medication that contains the active ingredient isatuximab, which belongs to a group of medications called “monoclonal antibodies”.

Monoclonal antibodies, such as Sarclisa, are proteins designed to recognize and bind to a target substance. In the case of Sarclisa, the target is a substance called CD38 that is found in multiple myeloma cells, a bone marrow cancer. The medication binds to multiple myeloma cells, helping the body's natural defenses (immune system) to identify and destroy them.

How is it used

Sarclisa is used to treat multiple myeloma.

It is used in combination with two other medications 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 medications in patients with newly diagnosed multiple myeloma:

• bortezomib, lenalidomide, and dexamethasone.

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

No use Sarclisa

• If you are allergic to isatuximab or any of the other components of this medication (listed in section 6).

Advertencias y precauciones

Consult your doctor or nurse before starting to use Sarclisa and follow all instructions carefully.

Reacciones a la perfusión

Inform your doctor or nurse immediately if you experience signs of infusion reactions during or after the infusion of Sarclisa -see section 4 “Possible side effects” for the list of signs of"Infusion Reactions".

• Before starting the infusion of Sarclisa, you may be given medications to reduce infusion reactions (see section 3 “How Sarclisa is administered”).
• Infusion reactions can occur during the infusion of Sarclisa or after the infusion and can be severe. These reactions are reversible. Hospital staff will closely monitor you during treatment.

If you experience an infusion reaction, your doctor or nurse may give you additional medications to treat your symptoms and prevent complications. They may also temporarily suspend treatment, reduce the infusion rate, or completely stop the infusion of Sarclisa.

Fiebre y bajo número de glóbulos blancos

Inform your doctor or nurse immediately if you experience fever, as it may be a sign of infection. Sarclisa may 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 (e.g., for herpes zoster [shingles]) to help prevent infections, or a medication to help increase white blood cell counts during treatment with Sarclisa.

Problemas del corazón

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. Inform your doctor or nurse immediately if you experience any difficulty breathing, coughing, or swelling in your legs.

Riesgo de nuevos cánceres

New cancers have occurred in patients during treatment with Sarclisa when administered with pomalidomida and dexamethasone or with carfilzomib and dexamethasone, or with bortezomib, lenalidomida and dexamethasone. Your doctor or nurse will monitor you for new cancers during treatment.

Síndrome de lisis tumoral

A rapid breakdown of cancer cells (tumor lysis syndrome) may occur. Symptoms may include irregular heartbeats, seizures (convulsions), confusion, muscle cramps, or decreased urine production. Inform your doctor immediately if you experience any of these symptoms.

Transfusión de sangre

If you need a blood transfusion, a blood test will be performed first to determine your blood type.

Inform the person performing the blood test that you are being treated with Sarclisa. This is because it may affect the results of this blood test for at least 6 months after your last dose of Sarclisa.

Niños y adolescentes

Sarclisa is not recommended for children or adolescents under 18 years of age, as the efficacy of Sarclisahas not been established in pediatric patients.

Otros medicamentos y Sarclisa

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal remedies.

Inform your doctor or nurse before receiving Sarclisa if you have ever taken a heart medication.

Sarclisa is used in combination with two or three other medications to treat multiple myeloma:

• Pomalidomida and dexamethasone or
• Carfilzomib and dexamethasone or
• Bortezomib, lenalidomida and dexamethasone

For information on these other medications used with Sarclisa, see their package inserts.

Embarazo

Consult your doctor, pharmacist, or nurse before using Sarclisa.

The use of Sarclisa during pregnancy is not recommended. If you are pregnant or plan to become pregnant, consult your doctor about the use of Sarclisa.

For information on pregnancy and other medications taken with Sarclisa, see the package insert for these other medications.

Lactancia

Consult your doctor, pharmacist, or nurse before using this medication.

• This is because Sarclisa may pass into breast milk. The effect on the baby is unknown.
• You and your doctor will decide if the benefits of breastfeeding outweigh the risks for your baby.

Anticoncepción

Women receiving Sarclisa and who may become pregnant should use an effective contraceptive method. Consult your doctor about the contraceptive method you should useduring this time.Use contraception during treatment and for 5 months after thelast dose of Sarclisa.

Conducción y uso de máquinas

Sarclisa is unlikely to affect your ability to drive and use machines. However, Sarclisa is used with other medications that may affect your ability to drive or use machines. Please see the package insert for the other medications you take with Sarclisa.

Sarclisa contiene polisorbato 80

This medication contains 0.2 mg of polisorbate 80 in each ml of isatuximab concentrate for infusion, which is equivalent to 0.1 mg/kg of body weight.

Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

How Much Sarclisa You Will Receive

The amount of Sarclisa you will receive 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 through a vein (intravenous infusion).

How Often Sarclisa Is Administered

When Sarclisa is used with other medications, either pomalidomida and dexametasona or carfilzomib and dexametasona, treatment cycles last 28 days (4 weeks).

• In cycle 1: Sarclisa is administered once a week on days 1, 8, 15, and 22
• In cycle 2 and subsequent: Sarclisa is administered every 2 weeks, on days 1 and 15

When Sarclisa is used with three other medications, bortezomib, lenalidomida, and dexametasona, treatment cycles last 42 days (6 weeks) from cycle 1 to 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 4: Sarclisa is administered every 2 weeks - on days 1, 15, and 29
• From cycle 5 to 17: Sarclisa is administered every 2 weeks - on days 1 and 15
• From cycle 18 onwards: Sarclisa is administered every 4 weeks - on day 1

Your doctor will continue treating you with Sarclisa as long as it is beneficial for you and the side effects are acceptable.

Medications Used Before Sarclisa

You will be given the following medications before the infusion of Sarclisa to help reduce your chances of having infusion reactions:

• allergy-reducing medications (antihistamines)
• inflammation-reducing medications (corticosteroids)
• medications to reduce pain and fever

What to Do 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, please contact your doctor or nurse as soon as possible to reschedule.

Your doctor or nurse will decide how to continue your treatment.

What to Do If You Receive More Sarclisa Than You Should

Your doctor or nurse will administer Sarclisa. If you accidentally receive too much (overdose), your doctor will treat and manage any side effects.

What to Do If You Stop Taking Sarclisa

Do not stop taking Sarclisa unless you have discussed it with your doctor.

If you have any questions about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

The hospital staff will closely monitor your condition during treatment. Inform them immediately if you notice any of the following side effects:

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

Inform your doctor or nurse immediately if you do not feel well during or after the infusion of Sarclisa.

Severe signs of infusion 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.

Common signs of infusion reactions include:

• shortness of breath
• cough
• chills
• nausea

You may also experience other side effects during infusion. Your doctor or nurse may decide to temporarily suspend, reduce the speed, or completely stop the infusion of Sarclisa. They may also administer additional medications to treat your symptoms and prevent complications.

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

Other side effects

Inform your doctor, pharmacist, or nurse immediately if you experience any of the following side effects:

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

• low white blood cell count (neutropenia), which is important for fighting infections
• low platelet count (thrombocytopenia). Inform your doctor or nurse if you have any bruising or unusual bleeding
• lung infection (pneumonia)
• upper respiratory tract infection (such as the nose, sinuses, or throat)
• diarrhea
• bronchitis
• shortness of breath
• nausea
• vomiting
• high blood pressure (hypertension)
• cough
• fatigue (tiredness)
• loss of appetite
• covid-19
• eye opacity (cataract)

Common(may affect up to 1 in 10 people):

• cardiac problems, which may present as difficulty breathing, cough, or swelling of the legs when Sarclisa is administered with carfilzomib and dexamethasone
• fever with severe low white blood cell count (neutropenic fever) (see section 2 “What you need to know before starting to use Sarclisa” for more information)
• low red blood cell count (anemia)

• weight loss
• irregular heartbeat (atrial fibrillation)
• shingles (herpes zoster)

Unknown frequency(cannot be estimated from available data):

• low white blood cell count (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 side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.

By reportingside effects, you can contribute to providing more information on the safety of this medicine.

Sarclisa must be stored in the hospital or clinic.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and vial after “CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Sarclisa

• The active ingredient of Sarclisa is isatuximab.
• One milliliter 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, histidine hydrochloride monohydrate, histidine, polysorbate 80, and water for injection preparations.

Appearance of the product and contents of the package

Sarclisa is a concentrate for solution for infusion. It is a colorless to slightly yellow liquid, essentially free of visible particles.

Package size:

100 mg of isatuximab in 5 ml of concentrate (100 mg/5 ml): Each box contains 1 or 3 vials.

500 mg of isatuximab in 25 ml of concentrate (500 mg/25 ml): Each box contains 1 vial.

It is possible that not all package sizes will be marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

Sanofi-Aventis Deutschland GmbH

Industriepark Hoechst Brueningstrasse 50

65926 Frankfurt am Main

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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The following information is intended only for healthcare professionals:

The vials of SARCLISA are for single use. The solution for infusion must be prepared in aseptic conditions and administered by a healthcare professional in an environment where resuscitation facilities are available.

Preparation and administration of SARCLISA

• Calculate the dose (mg) of the SARCLISA concentrate required, and determine the number of vials needed for the dose of 10 mg/kg, based on the patient's weight. More than one vial may be needed.
• Visually inspect the SARCLISA concentrate before dilution to discard the presence of particles and discoloration.
• Remove the volume of diluent equivalent to the required volume of SARCLISA concentrate from a bag of diluent containing 250 ml of 9 mg/ml sodium chloride solution (0.9%) or a 5% glucose solution.
• Extract the required volume of SARCLISA concentrate from the SARCLISA vial and dilute it in the infusion bag containing 250 ml of 9 mg/ml sodium chloride solution (0.9%) or a 5% glucose solution.
• The infusion bag must be made of polyolefins (PO), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with di(2-ethylhexyl) phthalate (DEHP) or ethylene-vinyl acetate (EVA).
• Gently invert the infusion bag to homogenize the diluted solution. Do not agitate.
• Administer the infusion solution through intravenous infusion using an intravenous tubing set (of PE, PVC with or without DEHP, polybutadiene (PBD) or polyurethane (PU)) with an in-line filter of 0.22 microns (polyethersulfone (PES), polysulfone or nylon).
• Administer the infusion solution over a period of time that will depend on the infusion rate (see section 4.2 of the Technical Dossier “Posology and method of administration”).
• The prepared SARCLISA infusion solution must be used immediately. If not used immediately, the storage times in use and the conditions before use are the responsibility of the user and should not exceed, normally, 24 hours at 2-8°C, unless the dilution has been performed in controlled and validated aseptic conditions.
• No protection against light is required for the prepared infusion bag in standard artificial light.
• SARCLISA must not be administered with other medications through the same intravenous line.

Dispose of any unused solution. All materials used for dilution and administration must be disposed of in accordance with standard procedures.