SARCLISA 20 mg/mL concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• It is important that you keep the Patient Card with you during treatment and for at least 6 months after the treatment has ended.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4 "Possible side effects").

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

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.

Sarclisa is used to treat multiple myeloma.

It is used together with two other medicines in patients who have received treatments for multiple myeloma before:

• pomalidomide and dexamethasone or
• carfilzomib and dexamethasone.

It is used together with three other medicines in patients with a newly diagnosed multiple myeloma:

• bortezomib, lenalidomide and dexamethasone.

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

Talk to your doctor or nurse before using Sarclisa and follow all instructions carefully.

Tell your doctor or nurse immediately if you have signs of infusion reactions during or after the infusion of Sarclisa – see in section 4 "Possible side effects" 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 "How Sarclisa is given").
• Infusion reactions can happen during the Sarclisa infusion or after the infusion and may be serious. These reactions are reversible. Some serious allergic reactions and infusion reactions have resulted in death. 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.

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.

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.

New cancers have occurred in patients during combination treatment with Sarclisa. Your doctor or nurse will monitor you for new cancers during treatment.

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.

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

Tell the healthcare professional doing 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. This is also explained in the Patient Card that you have been given by your doctor. Keep this Patient Card during treatment and for at least 6 months after the treatment has ended and share it with your healthcare team.

Sarclisa is not recommended for use in children and adolescents aged under 18 years. This is because the effectiveness of Sarclisa has not been established in paediatric patients.

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.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before being given Sarclisa.

Pregnancy

Use of Sarclisa is not recommended during pregnancy. If you are pregnant or planning to become pregnant, talk to your doctor about using Sarclisa.

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 should use an effective method of contraception. Talk to your doctor about the method of contraception that you should use during this time. Use contraception during treatment – and for 7 months after the last dose of Sarclisa.

Sarclisa has mild to moderate influence on your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or use machines until you feel better.

This medicine contains 0.2 mg of polysorbate 80 in each mL of isatuximab concentrate for solution for infusion, which is equivalent to 0.1 mg/kg of body weight. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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.

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

When Sarclisa is used with two other medicines, either pomalidomide and dexamethasone or carfilzomib and dexamethasone, the treatment cycles last 28 days (4 weeks).

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

When Sarclisa is used with three other medicines, bortezomib, lenalidomide and dexamethasone:

• For patients unsuitable for autologous bone marrow (their own stem cells) transplant:

The treatment cycles last 42 days (6 weeks) from cycle 1 to 4 and lasts 28 days (4 weeks) from cycle 5 and onwards.

• In cycle 1: Sarclisa is given on days 1, 8, 15, 22 and 29
• From cycle 2 to 4: Sarclisa is given every 2 weeks – on days 1, 15 and 29
• From cycle 5 to 17: Sarclisa is given every 2 weeks – on days 1 and 15
• From cycle 18 and onwards: Sarclisa is given every 4 weeks – on day 1

• For patients suitable for autologous bone marrow (their own stem cells) transplant:

The treatment cycles last 42 days (6 weeks) from cycle 1 to 3.

• In cycle 1: Sarclisa is given on days 1, 8, 15, 22 and 29
• From cycle 2 to 3: Sarclisa is given every 2 weeks - on days 1, 15 and 29

Your doctor will continue to treat you with Sarclisa as long as you benefit from it and the side effects are acceptable. Your doctor may increase the time between administrations based on how you tolerate your treatment. You may start your treatment with Sarclisa given as an intravenous infusion (Sarclisa 20 mg/mL concentrate for solution for infusion) or as a subcutaneous injection (Sarclisa 1400 mg solution for injection). The doctor may decide to switch your treatment from intravenous infusions to subcutaneous injections, any time after the first cycle is completed.

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 and/or montelukast)
• medicines to reduce inflammation (corticosteroids)
• medicine to reduce pain and fever

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.

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.

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

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 some white blood cells (neutrophils) which are important in fighting infection. This may lead to infections and fever.
• 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 upper airways (such as nose, sinuses or throat)
• diarrhoea
• bronchitis
• feeling short of breath
• nausea
• vomiting
• high blood pressure (hypertension)
• cough
• tiredness (fatigue)
• decreased appetite
• Covid-19
• clouding of your eye (cataract)

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

• heart problems, which may present as difficulty breathing, cough, or leg swelling when Sarclisa is given with carfilzomib and dexamethasone
• fever with a severe decrease in some white blood cells (febrile neutropenia) (see section 2 "What you need to know before you use Sarclisa" for further details)
• lower number of red blood cells (anaemia)
• new cancers, such as skin cancer
• weight loss
• irregular heartbeat (atrial fibrillation)
• herpes zoster (shingles)
• lower number of some white blood cells (lymphocytes) which are important in fighting infection

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

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• 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 (see section 2 “What you need to know before you use Sarclisa”).

Sarclisa is a concentrate for solution for infusion.

It is a colourless to slightly yellow liquid, essentially free of visible particles.

Pack 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 pack sizes may be marketed.