Darzalex (daratumumab) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat certain types of multiple myeloma in adults. Multiple myeloma is a cancer that affects plasma cells. These are a type of white blood cell found in bone marrow.

Here are the basics about Darzalex:

  • Active ingredient: daratumumab, which is a biologic
  • Drug class: monoclonal antibody
  • Drug form: liquid solution that’s given by IV infusion
  • Available as biosimilar: no

Read on for more information about Darzalex and its use in treating multiple myeloma. You can also refer to this article for a comprehensive look at Darzalex and details about its uses.

Darzalex vs. Darzalex Faspro

Darzalex and Darzalex Faspro both contain daratumumab. But Darzalex Faspro also contains hyaluronidase-fihj. And while both are used to treat certain types of multiple myeloma, Darzalex Faspro is also used to treat light chain amyloidosis. This article focuses on Darzalex.

Read on for answers to some frequently asked questions about Darzalex and multiple myeloma.

Is Darzalex considered a first-line treatment for multiple myeloma?

It depends. For some people, Darzalex may be a first-line treatment for multiple myeloma.

National Comprehensive Cancer Network guidelines recommend Darzalex as a first-line treatment for multiple myeloma that:

  • comes back or keeps growing even after several treatments, or
  • is active (causing symptoms)

If you have questions about first-line treatments for multiple myeloma, talk with your doctor.

Why isn’t Darzalex approved to treat smoldering multiple myeloma?

The reason has to do with clinical trials of Darzalex. The trials didn’t look at whether the drug was safe or effective in treating smoldering multiple myeloma. This type of multiple myeloma doesn’t actively cause symptoms or organ damage.

Studies are currently underway to see if Darzalex is safe and effective for treating smoldering multiple myeloma.

If you have questions about treatments for this type of multiple myeloma, talk with your doctor.

Is Darzalex a cure for multiple myeloma?

No, Darzalex isn’t a cure for multiple myeloma. Currently, there isn’t a cure for this condition. But Darzalex has been shown to help people with multiple myeloma live longer and improve their quality of life.

For more information about the potential benefits of Darzalex treatment, talk with your doctor.

Below is information about using Darzalex to treat multiple myeloma, including common dosages and how the drug is given.

Dosage

For treating multiple myeloma, Darzalex dosing is calculated using body weight. For most of its uses, the recommended dose is 16 milligrams (mg) per kilogram (kg) of body weight. (One kilogram is about 2.2 pounds [lb].)

For example, the dose for someone weighing 68 kg (about 150 lb) would be 1,088 mg (16 multiplied by 68).

How to use

Darzalex comes as a liquid solution you receive by IV infusion. An infusion is an injection into your vein given over a period of time.

A healthcare professional will give you the infusion at a clinic, infusion center, or doctor’s office. They’ll monitor you for side effects throughout your infusion.

How often to use

How often you receive a Darzalex dose depends on the type of multiple myeloma you have. But Darzalex’s dosing schedule typically starts with more frequent infusions. And Darzalex may be given with other drugs, again depending on the type of multiple myeloma.

Below is an example of the Darzalex dosing schedule. This is for someone who has had one or more multiple myeloma treatments, and either the treatments didn’t work well or their multiple myeloma returned later. For this purpose, Darzalex is used with the drugs dexamethasone and Revlimid (lenalidomide).

  • Weeks 1 to 8: One dose every week (eight total doses)
  • Weeks 9 to 24: One dose every 2 weeks (eight total doses)
  • Weeks 25 and onward: One dose every 4 weeks

For details about dosing schedules for the other types of multiple myeloma that Darzalex treats, see this article.

Multiple myeloma is a cancer that affects plasma cells. These are a type of white blood cell found in the bone marrow. Plasma cells, which are part of your immune system, produce antibodies to help fight infections. Antibodies are proteins that recognize and kill bacteria, viruses, and other foreign bodies that cause infection.

In people with multiple myeloma, plasma cells grow uncontrollably, forming tumors in their bones. This causes the bones to be brittle and weak, and prevents bone marrow from making enough healthy plasma cells. Instead, the bone marrow produces multiple myeloma cells (abnormal plasma cells), which the immune system can’t use well. This weakens the immune system.

Symptoms of multiple myeloma

Some people with multiple myeloma don’t have any symptoms, especially early on. But others can develop symptoms, such as:

  • abnormal or unusual bleeding
  • bone pain
  • fatigue (lack of energy)
  • frequent infections
  • anemia (low level of red blood cells)
  • numbness or weakness in the arms or legs
  • shortness of breath
  • bones that are weak or break easily

Who Darzalex is prescribed for

Darzalex is prescribed to adults who have multiple myeloma. Specifically, it’s used in adults who:

  • Are newly diagnosed with multiple myeloma and can have an autologous stem cell transplant. “Autologous” means cells from a person’s own body. For this purpose, you’ll use Darzalex with the drugs bortezomib, dexamethasone, and thalidomide. This is followed by high-dose chemotherapy, and then a stem cell transplant. After the transplant, you’ll resume Darzalex treatment with bortezomib, dexamethasone, and thalidomide for a period of time.
  • Are newly diagnosed with multiple myeloma but can’t have an autologous stem cell transplant. For this purpose, you may take Darzalex with dexamethasone and Revlimid (lenalidomide). Another option is to take Darzalex with melphalan, prednisone, and Velcade (bortezomib).
  • Have had one or more treatments, and either they didn’t work well or the multiple myeloma came back. For this purpose, you’ll take Darzalex with dexamethasone and lenalidomide.
  • Have had one to three treatments, and either they didn’t work well or the multiple myeloma came back. In this case, you’ll take Darzalex with the Kyprolis (carfilzomib) and dexamethasone.
  • Have had two or more treatments, including lenalidomide and a type of drug called a proteasome inhibitor. In this case, you’ll take Darzalex with dexamethasone and Pomalyst (pomalidomide).
  • Have had three or more treatments, including a proteasome inhibitor and an immunomodulatory drug. For this purpose, you’ll take Darzalex by itself.
  • Have multiple myeloma that didn’t respond to treatment from a proteasome inhibitor and an immunomodulatory drug. In this case, you’ll take Darzalex by itself.

Darzalex is approved to treat multiple myeloma, which is a cancer that affects plasma cells. These are a type of white blood cell found in the bone marrow.

The way Darzalex works

Darzalex treats multiple myeloma by finding and binding (attaching) to multiple myeloma cells (abnormal plasma cells). When Darzalex binds to these cancerous cells, it sends a signal that causes those cells to die. Killing multiple myeloma cells helps to slow the cancer from spreading to other parts of the body.

Clinical studies have found Darzalex to be effective for treating adults with certain types of multiple myeloma. (For more information, see “Who Darzalex is prescribed for” in the “Multiple myeloma explained” section above.)

To read more about how the medication performed in these studies, see the full prescribing information for Darzalex.

National Comprehensive Cancer Network guidelines recommend Darzalex as a first-line treatment for multiple myeloma that:

  • comes back or keeps growing even after several treatments, or
  • is active (causing symptoms)

If you have additional questions about treatments for multiple myeloma, including how well Darzalex works, talk with your doctor.

The use of Darzalex for certain types of multiple myeloma (its only approved use) may cause side effects that are mild or serious. The lists below include some of the main side effects that have been reported with Darzalex when the drug is used alone. Other side effects are possible when Darzalex is used with other drugs.

For information about other potential side effects of this drug, talk with your doctor or pharmacist. You can also see our full article on Darzalex or refer to Darzalex’s medication guide.

Note: After the Food and Drug Administration (FDA) approves a medication, it tracks side effects of the drug. If you develop a side effect while taking Darzalex and would like to inform the FDA, visit MedWatch.

Mild side effects

Mild side effects reported by people taking Darzalex in clinical trials include:

These side effects of Darzalex may be temporary, lasting a few days or weeks. But if they last longer, or if they bother you or become severe, it’s important to talk with your doctor or pharmacist.

Serious side effects

Although not common, Darzalex may cause serious side effects. These include:

Call your doctor right away if you develop serious side effects while using Darzalex. If the side effects seem life threatening or you think you’re having a medical emergency, call 911 or your local emergency number immediately.

Before you use Darzalex, there’s some important information to keep in mind. The drug may not be a safe option for you if you have certain medical conditions or other factors that affect your health. Some of these are mentioned below.

If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before using Darzalex:

How much Darzalex costs is based on several factors. These can include your prescribed treatment regimen, the insurance plan you have, the pharmacy you use, and your location. The price is also based on the cost of the appointment to receive doses of Darzalex from a healthcare professional. For estimates of how much Darzalex costs, see WellRx.com.

Darzalex is a brand-name biologic medication. It’s not available as a biosimilar.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. Instead, biologics have biosimilars. Biosimilars are considered to be just as safe and effective as their parent drug.

Generics, on the other hand, are drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication. Like generics, biosimilars tend to cost less than brand-name medications.

Now that you’ve learned about Darzalex for multiple myeloma, you may still have some questions. Talk with your doctor or pharmacist about whether Darzalex might be right for you.

Here are some other helpful references:

  • More details. For details about other aspects of Darzalex, refer to this article.
  • Drug comparison. To find out how Darzalex compares with Empliciti, read this article.
  • Information about cancer. For more information about cancer, visit our cancer hub or see our list of cancer articles.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.