How it is administered

Daratumumab is available in two main forms:

• Intravenous (IV) infusion: Daratumumab is given as an infusion into a vein. The dose is based on your body weight (16 mg/kg) and is diluted in a saline solution. Infusions are given in cycles, starting weekly, then every two weeks, and then every four weeks, depending on your treatment plan and how you respond.

• Subcutaneous injection: A combination of daratumumab and hyaluronidase is injected under the skin (usually in the abdomen). This form is given over about 3–5 minutes and follows a similar schedule to the IV form.

Both forms are administered by healthcare professionals in a clinic or hospital setting. Pre-medications (such as corticosteroids, antihistamines, and acetaminophen) are given before each dose to help prevent reactions.

How it works

Daratumumab is a type of targeted therapy called a monoclonal antibody. It works by attaching to a protein called CD38, which is found on the surface of many blood cancer cells, especially in multiple myeloma and some other blood disorders.

When daratumumab binds to CD38, it helps your immune system recognize and attack the cancer cells. It does this by several mechanisms:

• Directly causing cancer cell death (apoptosis)
• Recruiting other immune cells to destroy the cancer cells through processes called antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP)
• Reducing the number of certain immune-suppressing cells, which can help your body fight the cancer more effectively

This targeted approach helps to slow or stop the growth of cancer cells and can lead to remission or better disease control.

Who Should take it

Daratumumab is indicated for adult patients with multiple myeloma, a type of blood cancer. It can be used:

• In combination with other medicines (such as lenalidomide, dexamethasone, bortezomib, melphalan, prednisone, thalidomide, carfilzomib, pomalidomide, and cyclophosphamide) for newly diagnosed or relapsed/refractory multiple myeloma.
• As a single agent for patients who have received several prior treatments and whose disease is resistant to both a proteasome inhibitor and an immunomodulatory agent.
• In combination with other drugs for newly diagnosed light chain (AL) amyloidosis (subcutaneous form only).

Your doctor will determine if daratumumab is appropriate based on your diagnosis, previous treatments, and overall health.

Who should not take it

You should not take daratumumab if you have had a severe allergic reaction (such as anaphylaxis) to daratumumab, hyaluronidase (for the subcutaneous form), or any of the ingredients in the formulation.

Daratumumab is not recommended for patients with certain severe heart problems (NYHA Class IIIB or IV cardiac disease) or advanced Mayo Stage IIIB light chain amyloidosis, unless in a clinical trial.

It should not be used during pregnancy, as it may cause harm to the unborn baby. Women of childbearing potential should use effective contraception during treatment and for 3 months after the last dose. The combination of daratumumab with lenalidomide, thalidomide, or pomalidomide is also contraindicated in pregnancy due to the risk of birth defects from these drugs.

Commonly used with

Daratumumab is commonly used in combination with other medications for blood cancers, especially multiple myeloma. These include:

• Lenalidomide and dexamethasone
• Bortezomib (with or without melphalan, prednisone, or thalidomide)
• Carfilzomib and dexamethasone
• Pomalidomide and dexamethasone
• Cyclophosphamide and dexamethasone (for light chain amyloidosis)

The choice of combination depends on your specific diagnosis, prior treatments, and eligibility for stem cell transplant.

Commonly tested with

Daratumumab has been tested in clinical trials with a variety of other medications used in blood cancers, including:

• Lenalidomide, bortezomib, melphalan, prednisone, thalidomide, carfilzomib, pomalidomide, cyclophosphamide, and dexamethasone.

It has also been studied in different settings, such as newly diagnosed and relapsed/refractory multiple myeloma, and in patients eligible or ineligible for stem cell transplant. Your doctor will select the most appropriate regimen based on the latest evidence and your individual needs.