Trade Name(s): Sarclisa®
Isatuximab is the generic name for the trade name drug Sarclisa®. In some cases, health care professionals may use the trade name Sarclisa® when referring to the generic drug name isatuximab.
Drug Type: Isatuximab is an anti-cancer (“antineoplastic” or “cytotoxic”) drug. This medication is a monoclonal antibody directed against CD38, a molecule present on myeloma cells (for more detail, see “How Isatuximab Works” below).
What Isatuximab Is Used For
- Treatment of Multiple Myeloma
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Isatuximab Is Given
- As an infusion into a vein (intravenous, IV). The first infusion may take up to 4 hours. The time of infusion may be shortened or extended, depending on how well you tolerate this drug during the first infusion.
- Medications will be given before the infusion to reduce the occurrence of infusion-related symptoms
- You may receive some medications after the infusion to prevent delayed infusion-related symptoms
- There is no pill form of isatuximab
- The usual schedule for isatuximab is a treatment once a week for the first four weeks, then treatments every other week thereafter.
The amount of isatuximab that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of isatuximab:
- Most people will not experience all the isatuximab side effects listed.
- Isatuximab side effects are often predictable in terms of their onset, duration, and severity.
- Isatuximab side effects will improve after therapy is complete.
- Isatuximab side effects may be quite manageable.
- There are many options to minimize or prevent the side effects of isatuximab.
The follow side effects are common (occurring in greater than 30%) for patients taking isatuximab:
These are less common side effects (occurring in 10-29%) for patients receiving isatuximab:
Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
The following symptoms require medical attention but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting isatuximab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over the counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Do not receive any kind of immunization or vaccination without your doctor’s approval while taking isatuximab.
- Inform your health care provider if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Isatuximab may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.) This drug should not be given to pregnant women or a woman who intends to become pregnant. If a woman becomes pregnant while taking isatuximab, the drug should be stopped and the woman given appropriate counseling.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking isatuximab. Barrier methods of contraception, such as condoms, are recommended for at least 5 months after last dose of isatuximab.
- Do not breast feed while taking isatuximab.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Isatuximab
You will be checked regularly by your doctor while you are taking isatuximab, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
A type and screen blood test should be done before you start isatuximab. If you require a blood transfusion after starting isatuximab, the blood bank should be informed that you are receiving this medication as it masks antibody detection to minor antigens in your blood. Your ABO and Rh blood type are not affected.
This treatment may affect some of the blood work your provider used previously to monitor your multiple myeloma. Your provider may monitor your myeloma in a different way after starting this therapy.
How Isatuximab Works
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently, but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Isatuximab is a targeted therapy (IgG1-monoclonal antibody) that targets CD38. CD38 is a cell surface glycoprotein which is highly expressed on myeloma cells. It is expressed at lower levels on normal myeloid and lymphoid types of white blood cells. When isatuximab binds to CD38, it induces apoptosis (death) of tumor cells and activation of immune system mechanisms including antibody-dependent cell-mediated cytotoxicity, antibody-dependent cellular phagocytosis, and complement dependent cytotoxicity. Isatuximab inhibits the enzymatic activity of CD36. Isatuximab can also activate the body’s natural killer cells in the absence of CD38 positive target tumor cells and suppresses CD38 positive T-regulatory cells.
Notes: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational but is not a substitute for medical advice.