Darzalex Faspro (daratumumab and hyaluronidase-fihj) is used for treating a blood cancer called multiple myeloma and a condition called light chain amyloidosis. This article will focus on Darzalex Faspro for multiple myeloma. Darzalex Faspro may be used to treat multiple myeloma that has never been treated; that has relapsed, meaning the cancer came back after treatment; or that is refractory, meaning it never went away with treatment. Darzalex Faspro is usually used in combination with other medicines but may be used by itself for certain multiple myelomas.
How Does Darzalex Faspro Work for Multiple Myeloma?
Darzalex Faspro 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 the ones that cause multiple myeloma. CD38 is expressed much more on the cells that cause multiple myeloma than healthy cells. Darzalex Faspro attaches itself to the CD38 protein and prevents the cell from growing which makes it eventually die.
How Do I Use Darzalex Faspro?
Doses of Darzalex Faspro are given by a subcutaneous (just under the skin) injection into your abdomen. Your dose will be given by a health care provider. Your dosing schedule, or how often you will use Darzalex Faspro, will depend on your specific multiple myeloma details and if you are using Darzalex Faspro alone or in combination with other medicines. Each injection is usually given over 3 to 5 minutes. You will receive these doses in a hospital, clinic, or infusion center. Your health care provider will use one dose, which is 1,800 milligrams of daratumumab and 30,000 units of hyaluronidase in 15 milliliters of liquid.
Depending on the specifics of your multiple myeloma, you may continue using Darzalex Faspro 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 Darzalex Faspro for a certain time. If you have certain side effects, your health care provider may pause your doses of Darzalex Faspro. In some cases, they may need to have you stop using Darzalex Faspro completely.
Talk with your health care provider about how long you can expect to use Darzalex Faspro and how often you will receive your doses. If you miss an appointment for a Darzalex Faspro injection, contact your health care provider right away and reschedule your appointment to make sure your treatment is effective.
How Well Does It Work for Treating Multiple Myeloma?
Darzalex Faspro was studied across multiple clinical trials to make sure it was effective for treating multiple myeloma in all of the indications listed above.
Two of the studies were later summarized in an article. These studies were PLEIADES and EQUULEUS, which looked at using Darzalex Faspro with the medicines carfilzomib and dexamethasone in people who had relapsed (cancer came back) or refractory (cancer never went away). A total of 151 people were a part of the studies, and they had up to four prior lines of treatment for multiple myeloma.
The PLEIADES trial looked at how many people had a response to the medicine. This measurement is called the overall response rate. The overall response rate for the people who used Darzalex Faspro with carfilzomib and dexamethasone in the study was 84.8%. The EQUULEUS trial had an overall response rate of 81.2%, and the mediation duration of response (how long the response lasted) was 27.5 months. This means that at least half of the people treated in EQUULEUS had their response last for at least 27.5 months. The median duration of response was not reached in PLEIADES, meaning more than half of the people were still having a response when the data was evaluated. EQUULEUS also looked at how long it took for the peoples' multiple myeloma to progress, meaning that the cancer got worse. This measurement is called progression-free survival. The median progression-free survival was 25.7 months, meaning that at least half of the people had not had their multiple myeloma progress for at least 25.7 months.
Talk with your health care provider about your specific multiple myeloma and get information about the study that tested Darzalex Faspro in multiple myeloma like yours. They will be able to talk you through the study specifics and how people who were included in the study had their cancer respond to Darzalex Faspro.
How Will My Progress Be Monitored?
Darzalex Faspro will start working as soon as you receive your first injection. Your health care provider will order regular blood tests to monitor how Darzalex Faspro 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 that you can continue to use Darzalex Faspro safely. If you have certain side effects such as frequent infections, your health care provider may do additional tests to make sure it is safe for you to continue to use Darzalex Faspro.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that treat cancer, including Darzalex Faspro. It is important to tell your health care provider about any side effects you have during or after using Darzalex Faspro. They can help to determine if your side effects are serious or provide more information to help you manage the side effects.
Your health care provider will usually instruct you to take certain medicines before and after your injection to help prevent common side effects such as itching, rash, and nausea. It is important to follow their instructions. In addition to taking any medicines before and after your injection, 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. They may also recommend 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 such as shortness of breath and heart problems and what to do if you have these side effects.
It is important to attend all of your appointments for blood tests so that your health care provider can make sure Darzalex Faspro is safe for you. This is because Darzalex Faspro 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 hurt your body’s ability to clot blood. This can be dangerous and even life-threatening.
If you have certain side effects while you use Darzalex Faspro, your health care provider may need to pause your doses or stop your medicine. This will depend on the side effect you experience and how severe it is and what treatment it needs. If your Darzalex Faspro needs to be paused, it is possible that your health care provider will restart the medication once your side effect is treated and gets better.
What Are Some Unique Considerations to Be Aware Of?
Darzalex Faspro can cause injection-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 injection-related reactions while you receive your injections. Most of the reactions happened within 3 hours of receiving the Darzalex Faspro injection but were delayed up to 3.5 days after the injection in people in the clinical trial. It is important to tell your health care provider right away if you experience any of the following symptoms of an injection-related reaction:
- Shortness of breath or trouble breathing
- Dizziness, lightheadedness, or a feeling like you are going to pass out
- Cough
- Wheezing
- A feeling that your throat is tight or irritated
- Runny or stuffy nose
- Headache
- Itching
- Eye pain
- Nausea or vomiting
- Chills or a fever
- Chest pain or discomfort
- Blurred vision
- Heart beating faster than usual
Injection site reactions are also possible with Darzalex Faspro. These are usually mild compared to injection-related reactions and are limited to your stomach area where you receive the injection. They can include redness or discoloration of the skin, itching, swelling, bruising, pain, rash, and bleeding. These may happen 24 hours or more after you use Darzalex Faspro.
Darzalex Faspro can cause harm to an unborn baby. For women and people assigned female at birth, it is important to make sure you are not pregnant before starting Darzalex Faspro. Your health care provider will talk with you about using effective birth control while you use Darzalex Faspro and for at least 3 months after your last dose. If you are a man or were assigned male at birth and have a partner who can become pregnant, it is important to use effective birth control to prevent pregnancy. You will also not be able to donate sperm while using Darzalex Faspro. Talk with your health care provider if this is a concern.
Darzalex Faspro can affect the way blood tests work for your blood type. These changes can last for up to 6 months after your last dose of Darzalex Faspro. Make sure to tell any healthcare provider that is treating you that you are using Darzalex Faspro. This is important for them to know in case you need a blood transfusion.
Is There Any Cost Assistance Available?
The manufacturer of Darzalex Faspro has a program to provide financial assistance for certain people and may be able to offer coupons or savings for Darzalex Faspro.
