20 mg / ml concentrate for solution for infusion
isatuximab
What Sarclisa is and what it is used for
What Sarclisa is
Sarclisa is a cancer medicine that contains the active substance isatuximab. It belongs to a group of drugs called monoclonal antibodies.
Monoclonal antibodies, such as Sarclisa, are proteins that have been developed to recognize and bind specific target substances in the body. Sarclisa has been designed to bind a surface molecule called CD38 that is found on the plasma cells (myeloma cells), a type of bone marrow cancer. By binding to CD38 on myeloma cells, the drug helps the body’s natural defense system (immune system) to identify and destroy them.
What Sarclisa is used for
Sarclisa is used for the treatment of multiple myeloma in patients who have undergone previous multiple myeloma treatments.
It is used in combination with two other drug combinations
- pomalidomide and dexamethasone or
- carfilzomib and dexamethasone.
Contact your doctor if you have any questions about how Sarclisa works or your treatment with Sarclisa.
What you need to know before using Sarclisa
You should 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 cautions
Talk to your doctor or nurse before using Sarclisa and follow all instructions carefully.
Infusion-related reactions
Tell your doctor or nurse immediately if you get infusion-related reactions during or after treatment with Sarclisa – see section 4 for signs of infusion-related reactions.
- Before treatment with Sarclisa, you may be given medicines that reduce the risk of infusion-related reactions (see section 3).
- Infusion-related reactions may occur during or after treatment with Sarclisa and may be serious. The reactions go back. The medical staff will monitor you closely during the treatment.
If you get infusion-related reactions, your doctor or nurse may give you other medicines to relieve the symptoms and prevent complications. They may also need to temporarily discontinue, slow down or discontinue Sarclisa infusion completely.
Fever and decreased white blood cell count
Tell your doctor or nurse immediately if you get a fever, as it may be a sign of infection. Sarclisa can reduce the number of white blood cells – which are important in fighting infections.
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 are taking or have been taking medicines for the heart. Contact a doctor or nurse immediately if you have difficulty breathing, coughing, or swollen legs.
Risk of new cancer
New cancers have occurred in patients treated with Sarclisa when co-administered with pomalidomide and dexamethasone or with carfilzomib and dexamethasone. Your doctor or nurse will follow you up due to the onset of new cancer during treatment.
Blood transfusion
If you need a blood transfusion, you will first have to submit a blood sample to determine your blood type.
Tell the person taking the test that you are being treated with Sarclisa. This is because it can affect the results of the blood test.
Children and young people
Sarclisa is not recommended for children and adolescents under 18 years of age. The reason for this is that the drug has not been tested in that 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 also applies to over-the-counter medicines and (traditional) herbal and herbal medicines.
Talk to your doctor or nurse before using Sarclisa if you are taking or have been taking heart medicine.
Sarclisa is given together with two other drug combinations in the treatment of multiple myeloma:
- pomalidomide and dexamethasone or
- carfilzomib and dexamethasone.
For information on the other medicines used with Sarclisa, read their package leaflets.
Pregnancy, breastfeeding, and contraception
Pregnancy
Consult your doctor, pharmacist, or nurse before using Sarclisa.
The use of Sarclisa during pregnancy is not recommended. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Sarclisa.
For information on pregnancy for the other medicines given with Sarclisa, see the package leaflets for each medicine.
Breast-feeding
Consult your doctor, pharmacist, or nurse before using Sarclisa.
- The reason for this is that the drug can pass into breast milk and it is not known how the drug can affect the baby.
- You and your doctor will decide if the benefits of breastfeeding outweigh the risks to your baby.
Contraceptive
Women treated with Sarclisa and of childbearing potential must use effective contraception. Talk to your doctor about which contraceptive to use during treatment. Use contraception during treatment and for 5 months after the last Sarclisa treatment.
Driving and using machines
Sarclisa is unlikely to affect your ability to drive or use machines. However, Sarclisa is given with other medicines that may affect your ability to drive or use machines. Read the package leaflet for the other medicines you are taking with Sarclisa.
How Sarclisa is given
How much Sarclisa should you be given?
The amount of Sarclisa that you will receive is based on your body weight. The recommended dose is 10 mg Sarclisa per kg body weight.
How Sarclisa is given
Your doctor or nurse will give you Sarclisa as a drip via a vein ( intravenous infusion ).
How often is Sarclisa given?
Sarclisa is given in treatment cycles lasting 28 days (4 weeks). It is given 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 22
- In cycle 2 and subsequent cycles: Sarclisa is given every two weeks on days 1 and 15
Your doctor will treat you with Sarclisa as long as the disease improves and the side effects are acceptable.
Medicines are given before Sarclisa infusion
You will receive the following medicines before infusion one with Sarclisa. These medicines help reduce the risk of infusion-related reactions:
- medicines to reduce allergic reactions ( antihistamines )
- drugs to reduce inflammation ( cortisone )
- medicines to reduce pain and fever
If you miss a dose of Sarclisa
You must arrive at all booked treatment sessions at the right time for your treatment to work. If you forget a treatment opportunity, book a new one as soon as possible.
The doctor or nurse will decide how to continue the treatment.
If you take more Sarclisa than you should
Sarclisa will be given by a doctor or nurse. If you are unlikely to get too much (an overdose), your doctor will check and treat the side effects.
If you stop using Sarclisa
Do not stop treatment with Sarclisa unless you have discussed it with your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss the side effects with you and will explain the risks and benefits of Sarclis treatment.
The medical staff will monitor you closely during the treatment. Tell them right away if you get any of the side effects below.
Infusion-related reactions – Very common (may affect more than 1 user in 10)
Tell your doctor or nurse immediately if you feel unwell during or after an infusion of Sarclisa.
Serious infusion-related reactions are:
- high blood pressure ( hypertension )
- breathing problems
- severe allergic reaction ( anaphylactic reaction occurring in up to 1 in 100 users) with difficulty breathing and swelling of the face, mouth, throat, lips, or tongue.
The most common infusion-related reactions are:
- breathing problems
- cough
- overindulge
- nausea
Other symptoms may also occur during infusion one. Your doctor or nurse may consider stopping, reducing the infusion rate, or stopping Sarclisa infusion. They may also give you other medicines to treat the symptoms and prevent complications.
Tell your doctor or nurse immediately if you feel unwell during or after an infusion of Sarclisa.
Other side effects are
Tell your doctor, pharmacist, or nurse immediately if you get any of the side effects listed below:
Very common (may affect more than 1 user in 10):
- low red blood cell count ( anemia )
- a low number of white blood cells ( neutrophils or lymphocytes ) that are important in fighting infection.
- low platelet count ( thrombocytopenia ) – tell your doctor or nurse if you have any abnormal bruising or bleeding.
- lung infection ( pneumonia )
- respiratory tract infection – (eg in the nose, sinuses, or throat)
- diarrhea
- bronchitis ( bronchitis )
- breathing problems
- nausea
- fever with a sharp decrease in certain white blood cells (febrile neutropenia ) (see section 2 for more information)
- vomiting
- high blood pressure ( hypertension )
- cough
- fatigue
Common (may affect up to 1 in 10 people):
- heart problems, which may manifest as difficulty breathing, coughing, or swollen legs when Sarclisa is given with carfilzomib and dexamethasone
- decreased appetite
- weight loss
- irregular heartbeat ( atrial fibrillation )
Tell your doctor, pharmacist, or nurse immediately if you get any of the side effects listed above.
How to store Sarclisa
Sarclisa is stored in 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 vial after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze.
Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater. Doctors, pharmacists, or nurses will discard medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is isatuximab.
- 1 ml of concentrate contains 20 mg of isatuximab.
- Each 5 ml concentrate vial contains 100 mg of isatuximab and every 25 ml concentrate vial contains 500 mg of isatuximab.
- The other ingredients (excipients) are sucrose, histidine hydrochloride monohydrate, histidine, polysorbate 80, and water for injections.
What the medicine looks like and the contents of the pack
Sarclisa is a concentrated solution for infusion. It is a colorless to yellowish liquid mainly free of visible particles. Sarclisa is supplied in packs of 1 or 3 glass vials.
Holder of approval
sanofi-aventis groupe
54 rue La Boétie
75008 Paris
France
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industrial park Hoechst Brueningstrasse 50
65926 Frankfurt am Main
Germany
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00