Sarclisa (isatuximab-irfc) is a prescription injection medicine for people with a type of blood cancer called multiple myeloma. Sarclisa may be used with other medicines in adults to treat multiple myeloma that has come back after treatment (relapsed), that never went away with treatment (refractory), or that has never been treated (newly diagnosed). Sarclisa is used together with the following medicines.
- Pomalidomide and dexamethasone in people with multiple myeloma who have tried at least two other therapies, including lenalidomide (an immune system modulator that helps boost the immune system to fight cancer) and a medicine called a proteasome inhibitor, OR
- Carfilzomib and dexamethasone in people with relapsed or refractory multiple myeloma who have tried one to three prior therapies, OR
- Bortezomib, lenalidomide, and dexamethasone in people with newly diagnosed multiple myeloma who are not able to have a stem cell transplant.
Sarclisa is given as an infusion into a vein (IV) by a health care provider.
How Does Sarclisa Work in Multiple Myeloma?
Sarclisa is a type of medicine called a monoclonal antibody that is also known as a targeted therapy or an immunotherapy. It works by targeting a specific protein called CD38 that can be on the surface of blood and bone marrow cells, including multiple myeloma cells. CD38 is expressed much more on multiple myeloma cells than healthy cells. Sarclisa attaches itself to the CD38 protein and helps the immune system find and attack the myeloma cells. This causes the cells to die.
How Do I Use Sarclisa?
Sarclisa is given as an IV infusion. Your dose will be given by a health care provider. Your dosing schedule, or how often you will use Sarclisa, will depend on your specific multiple myeloma details. You can expect that each IV infusion will last a couple of hours. You will receive these doses in a hospital, clinic, or infusion center. Your health care provider will use your weight to calculate the exact amount of Sarclisa that you will need.
Depending on the specifics of your multiple myeloma, you may continue using Sarclisa for as long as possible, meaning you will use it until your cancer progresses or you have side effects that make it not safe for you to use. You may also only use Sarclisa for a certain time. If you have certain side effects, your health care provider may pause your doses of Sarclisa. In some cases, they may need to have you stop using Sarclisa completely.
Talk with your health care provider about how long you can expect to use Sarclisa. They can also talk with you about how often you will use Sarclisa and how long you can expect your IV infusions to last. If you miss an appointment for a Sarclisa IV, contact your health care provider right away to reschedule your appointment, to make sure your treatment is effective.
How Was Sarclisa Studied?
Sarclisa was studied across multiple clinical trials to make sure it was effective for treating multiple myeloma for all of the uses listed above.
Relapsed and/or refractory multiple myeloma. A clinical study called ICARIA-MM was done to look at the benefits and risks of Sarclisa along with other medicines (pomalidomide and dexamethasone) in people with relapsed and/or refractory multiple myeloma. The people in the study had to have tried at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The main goal of the study was to look at progression-free survival – the amount of time people live with cancer before it progresses or gets worse after starting a certain medicine.
A total of 307 people were in the study: 154 were given Sarclisa, pomalidomide, and dexamethasone, and 153 people were given pomalidomide and dexamethasone only. The ages of people in the study ranged from 36 to 86 years. The median age (meaning half of the people were younger and half were older) was 67 years, and 20% were 75 or older. Overall, 52% of the people in the study were male. Most were White (79%), 12% were Asian, 1% were Black or African American, 1% were Native Hawaiian or other Pacific Islander, and about 7% were “unknown” or did not report their ethnicity. People continued getting the treatment until their cancer got worse, they had serious side effects, they chose to stop, they passed away, or the study ended.
The median time people in the study were given Sarclisa, pomalidomide, and dexamethasone was 41 weeks, compared to 24 weeks in those who were given pomalidomide and dexamethasone alone.
A clinical study called IKEMA was also done to look at the benefits and risks of Sarclisa along with other medicines (carfilzomib and dexamethasone) in people with relapsed and/or refractory multiple myeloma. The people in the study had to have tried one to three prior therapies.
The main goal of the study was to look at progression-free survival.
A total of 302 people were in the study: 179 were given Sarclisa, carfilzomib, and dexamethasone, and 123 people were given carfilzomib and dexamethasone only. The ages of people in the study ranged from 33 to 90 years. The median age was 64 years, and 9% were 75 or older. About 56% of the people in the study were male. Most were White (71%), 17% were Asian, 3% were Black or African American, and 9% were “other” or did not report their ethnicity. People continued getting the treatment until their cancer got worse, they had serious side effects, they chose to stop, they passed away, or the study ended.
The median time people in the study were given Sarclisa, carfilzomib, and dexamethasone was 80 weeks, compared to 61 weeks in those who were given carfilzomib and dexamethasone alone.
Newly diagnosed multiple myeloma. A clinical study called IMROZ was done to look at Sarclisa along with other medicines (bortezomib, lenalidomide, and dexamethasone) in people with newly diagnosed multiple myeloma who had not received any prior treatments and were not eligible for a stem cell transplant.
The main goal of the study was to look at progression-free survival.
A total of 446 people were in the clinical trial, with 265 using Sarclisa, bortezomib, lenalidomide, and dexamethasone and 181 people using bortezomib, lenalidomide, and dexamethasone only. People continued getting the treatment until their cancer got worse, they had serious side effects, they chose to stop, they passed away, or the study ended.
The ages of people in the study ranged from 55 to 80 years. The median age was 72 years, and 28% were 75 or older. Overall, about 53% of the people studied were male. Most were White (72%), 11% were Asian, about 1% were American Indian or Alaska Native, 0.9% were Black or African American, 0.5% Native Hawaiian or other Pacific Islander, and about 14.6% did not report their ethnicity.
The median time people in the study were given Sarclisa, bortezomib, lenalidomide, and dexamethasone was 53.2 months, compared to 31.3 months for those who were given bortezomib, lenalidomide, and dexamethasone alone.
What Benefits of Sarclisa Were Seen:
Relapsed and/or refractory multiple myeloma. In the ICARIA-MM study, the median progression-free survival (the time it took for half of the people in the study to have disease progression or die after starting the medicine) was about 11.5 months in those receiving Sarclisa, pomalidomide, and dexamethasone, compared to about 6.5 months for those getting pomalidomide and dexamethasone alone. This suggests that people taking Sarclisa added to pomalidomide and dexamethasone lived longer without progression, compared to those taking pomalidomide and dexamethasone alone.
In the IKEMA study, the median progression-free survival was not reached in those receiving Sarclisa, carfilzomib, and dexamethasone, compared to about 19.2 months for those getting carfilzomib and dexamethasone alone. The true median progression-free survival in the study was not reached for the people in the Sarclisa group because they were still being followed and their cancer did not worsen. This suggests that people taking Sarclisa added to carfilzomib and dexamethasone had a lower risk of disease progression or death, compared to those taking carfilzomib and dexamethasone alone.
Newly diagnosed multiple myeloma. After following the people in the IMROZ study for a median (midpoint) of about five years (60 months), the estimated progression-free survival for the people who were given Sarclisa along with bortezomib, lenalidomide, and dexamethasone was about 63.2%, compared to 45.2% for the people who were given bortezomib, lenalidomide, and dexamethasone alone. This suggests that adding Sarclisa to bortezomib, lenalidomide, and dexamethasone was more effective than bortezomib, lenalidomide, and dexamethasone alone for people who were not able to have a stem cell transplant.
Your results may differ from what was seen in clinical studies.
How Will My Progress Be Monitored?
Sarclisa will start working as soon as you receive your first IV. Your health care provider will do regular bloodwork to monitor how Sarclisa is working in your body and treating your cancer. These tests will monitor your blood counts, such as white blood cells, neutrophils, and platelets, so that your health care provider knows you can continue to use Sarclisa safely. If you have certain side effects, such as frequent infections, your health care provider may do more tests to make sure it is safe for you to continue to use Sarclisa.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that treat cancer, including Sarclisa. It is important to tell your health care provider about any side effects you have during your Sarclisa treatment or after it is done. It can help them know if your side effects are serious or if they can give you more information to help you manage the side effects.
Your health care provider will usually tell you to take certain medicines before your IV to help prevent common side effects, such as infusion-related reactions like itching, a rash, and nausea. It is important to follow their instructions. Besides taking medicines before your IV, you can ask your health care provider what else you can do to prevent or treat common side effects. For example, you can help prevent and treat nausea, vomiting, and diarrhea by eating bland foods and having multiple small meals throughout the day instead of three large meals. Your health care provider may also recommend that you keep certain over-the-counter medicines on hand to treat common side effects like diarrhea. They will also tell you how to watch for severe side effects, and what to do if you have these side effects.
Your health care provider will have you do bloodwork regularly while you are using Sarclisa. It is important to go to all of your appointments for bloodwork so that your health care provider can make sure Sarclisa is safe for you. These tests will look at your blood cell counts to make sure it is safe for you to continue to use the medicine. This is because Sarclisa can cause low blood cell counts, such as low platelets (thrombocytopenia) and low white blood cells (neutropenia). If not treated, low blood cell counts can cause serious infections or affect your body’s ability to clot blood. This can be dangerous and even life-threatening.
If you have certain side effects while you use Sarclisa, your health care provider may need to pause your doses or even stop your medicine altogether. This will depend on the side effect you have, how severe it is, and what treatment it needs. If your Sarclisa needs to be paused, it is possible that your health care provider will restart the medication once your side effect is treated and you get better.
These are not all the possible side effects of Sarclisa. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Are Other Unique Considerations to Be Aware Of?
Sarclisa can cause infusion-related reactions. These are considered common reactions, and for some people, they can be serious and even life-threatening. Your health care provider will monitor you closely for infusion-related reactions while you get your IV infusions. Most of the reactions happened within a few hours of starting the Sarclisa IV. It is important to tell your health care provider right away if you have any of the following symptoms of an infusion-related reaction.
- Shortness of breath or trouble breathing
- Dizziness, lightheadedness, or a feeling like you are going to pass out
- Coughing
- Wheezing
- A feeling that your throat is tight or irritated
- Runny or stuffy nose
- Headache
- Itching
- Nausea or vomiting
- Chills or a fever
- Chest pain or discomfort
- Blurred vision
- Heart beating faster than usual or a feeling of skipped heartbeats
It is possible that Sarclisa can affect the way blood tests work for your blood type. These changes can last for about six months after your last dose of Sarclisa. Make sure to tell any health care provider who is treating you that you are using Sarclisa. This is important for them to know in case you need a blood transfusion.
Sarclisa can harm a fetus. For people who were assigned female at birth, it is important to make sure you are not pregnant before starting Sarclisa. Talk with your health care provider about using effective birth control while you use Sarclisa and for five months after your last dose.
If you were assigned male at birth, have a partner who can become pregnant, and you will be taking Sarclisa with either pomalidomide or lenalidomide, it is important to use effective birth control to prevent pregnancy. You will also not be able to donate sperm while using Sarclisa with pomalidomide or lenalidomide. Talk with your health care provider about your birth control options and if this is a concern for you.
Is There Any Cost Assistance Available?
There is a patient support program offered by the drugmaker called CareASSIST that may help you afford Sarclisa. Your health care provider can help you get started. You can find out more at Sarclisa (isatuximab-irfc) | CareASSIST Patient Support or by calling 833-930-2273.
