Sarclisa 1400 mg solution for injection

• 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 1400 mg solution for injection is and what it is used for
2. What you need to know before you are given Sarclisa 1400 mg solution for injection
3. How Sarclisa 1400 mg solution for injection is given
4. Possible side effects
5. How to store Sarclisa 1400 mg solution for injection
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 plasma cells in patients with multiple myeloma, a cancer of the bone marrow. By attaching to plasma cells, the medicine helps the natural defences of your body (immune system) to identify and destroy them.

Sarclisa is used to treat multiple myeloma, a cancer of the bone marrow.

Sarclisa is used with other medicines in adult patients.

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.

• you are allergic to isatuximab or any of the other ingredients of this medicine (listed in section 6).

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

Systemic administration reactions (reactions to the active substance, isatuximab, that affects the whole body)

The most common signs of systemic administration reactions to the injection include:

• fever, chills
• feeling short of breath (dyspnoea)
• faster heart rate (sinus tachycardia)
• cough
• nausea

Severe symptoms of systemic administration reactions include:

• high blood pressure (hypertension)
• feeling extremely short of breath (dyspnoea)
• serious allergic reaction with breathing difficulty and swelling of the face, mouth, throat, lips or tongue.

Tell your doctor or nurse immediately if you have signs of systemic administration reactions during or after the injection of Sarclisa 1400 mg solution for injection.

• Before your first injection of Sarclisa 1400 mg solution for injection, you will receive other medicines to reduce the symptoms of the systemic administration reactions, at least for the first injections. It makes them less frequent and severe (see section 3 “How Sarclisa 1400 mg solution for injection is given”).
• Systemic administration reactions can happen during or after the injection of Sarclisa 1400 mg solution for injection, up to three days after administration. If you get a systemic administration reaction, your doctor or nurse may give you additional medicines to treat your symptoms and prevent complications. They may also adjust your treatment, as needed.

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 (called tumour lysis syndrome) was reported with Sarclisa intravenous formulation. In case it occurs, 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 this medicine.

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 should not be used in children and adolescents under the age of 18. 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 the 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 during treatment and for 7 months after the last dose of Sarclisa. Talk to your doctor about the method of contraception that you should use during this time.

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.

The recommended dose of Sarclisa 1400 mg solution for injection is 1400 mg.

Your doctor or nurse will prepare and inject your dose of Sarclisa 1400 mg solution for injection under your skin (subcutaneous injection). If you tolerate the treatment, your doctor may propose that you receive Sarclisa 1400 mg solution for injection at home.

• Injections will be given only into the stomach area (abdomen) where the skin is not tender, red, bruised, with scars or excessively hairy.
• Your doctor or nurse will either use a special injector (the CirCLIQ on-body injector) or a syringe to inject Sarclisa 1400 mg solution for injection. The injection will usually last less than 20 minutes with CirCLIQ on-body injector and 6 minutes with the syringe.
• Your doctor or nurse will make sure to rotate the injection site for each injection of Sarclisa 1400 mg solution for injection.
• Your doctor or nurse will use different places for injection for the other medicines that need to be injected.
• If you experience signs of systemic administration reactions, (see section 2 “What you need to know before you use Sarclisa 1400 mg solution for injection”) tell your doctor or nurse immediately.
• If you experience pain during the injection, the doctor or nurse may pause the injection and, if using a syringe, may give you the remaining injection in another area of your abdomen.

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 who cannot receive their own stem cells (autologous bone marrow 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 who can receive their own stem cells (autologous bone marrow 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 administration of Sarclisa 1400 mg solution for injection. This is to help reduce the symptoms of the allergic reactions to Sarclisa injection:

• medicines to reduce allergic reactions (antihistamines and/or montelukast)
• medicines to reduce inflammation (corticosteroids)
• medicines to reduce pain and fever (such as paracetamol)

It is very important that you meet 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.

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 1400 mg solution for injection is isatuximab.
• One mL of solution contains 140 mg of isatuximab.
• Each vial of Sarclisa 1400 mg solution for injection contains 1400 mg of isatuximab in 10 mL of solution.
• The other ingredients (excipients) are arginine hydrochloride, sucrose, poloxamer 188, histidine, histidine hydrochloride monohydrate, and water for injections.

Sarclisa 1400 mg solution for injection is a solution for injection. It is a colourless to slightly yellow liquid. The solution may contain a few translucent to white particles.

Pack size of one vial.

CirCLIQ on-body injector is packaged separately from Sarclisa 1400 mg solution for injection.