What is daratumumab (Darzalex), and how is it used?
Darzalex is a prescription medicine used to treat multiple myeloma:
- In combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed with multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
- In combination with the medicines lenalidomide and dexamethasone, or bortezomib and dexamethasone, in people who have received at least one prior medicine to treat multiple myeloma.
- In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor.
- Alone in people who have received at least three prior medicines to treat multiple myeloma, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.
What are the side effects of daratumumab (Darzalex)?
It is not known if Darzalex is safe and effective in children.
Before you receive Darzalex, tell your healthcare provider about all of your medical conditions, including if you:
Darzalex may cause serious reactions, including:
- Infusion reactions. Infusion reactions are common with Darzalex and can be severe. Your healthcare provider may temporarily stop your infusion or completely stop treatment with Darzalex if you have infusion reactions. Get medical help right away if you get any of the following symptoms:
- Changes in blood tests. Darzalex can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of Darzalex. Your healthcare provider will do blood tests to match your blood type before you start treatment with Darzalex. Tell all of your healthcare providers that you are being treated with Darzalex before receiving blood transfusions.
- Decreases in blood cell counts. Darzalex can decrease white blood cell counts which help fight infections and blood cells called platelets which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with Darzalex. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
- shortness of breath
- muscle spasms
- back pain
- cold-like symptoms (upper respiratory infection)
- nerve damage causing tingling, numbness or pain
- swollen hands ankles or feet
- trouble sleeping
- joint pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Darzalex. Call your doctor for medical advice about side effects.
What is the dosage for daratumumab (Darzalex)?
- Darzalex may be given alone or together with other medicines used to treat multiple myeloma.
- Darzalex will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
- Your healthcare provider will decide the time between doses as well as how many treatments you will receive.
- Your healthcare provider will give you medicines before each dose of Darzalex and after each dose of Darzalex to help reduce the risk of infusion reactions.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
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What drugs interact with daratumumab (Darzalex)?
Interference with Indirect Antiglobulin Tests (Indirect Coombs Test)
Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or genotyping. Since the Kell blood group system is also sensitive to DTT treatment, K-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs.
If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given per local blood bank practices.
Interference with Serum Protein Electrophoresis and Immunofixation Tests
Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response.
Is daratumumab (Darzalex) safe to use while pregnant or breastfeeding?
- Darzalex may harm your unborn baby.
- It is not known if Darzalex passes into your breast milk.
Daratumumab (Darzalex) is a chemotherapy drug used to treat multiple myeloma given by IV infusion alone or in combination with other medicines. Side effects include tiredness, nausea, diarrhea, shortness of breath, and others.
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Cancer is a disease caused by an abnormal growth of cells, also called malignancy. It is a group of 100 different diseases, and is not contagious. Cancer can be treated through chemotherapy, a treatment of drugs that destroy cancer cells.
Multiple myeloma is a form of cancer that develops in plasma cells, the white blood cells that make antibodies. Symptoms include bone pain, weakness, extreme thirst, nausea, frequent urination, and broken bones. Treatment of multiple myeloma depends upon the staging and symptoms of the disease.
Bone cancer is a rare type of cancer that occurs in cells that make up the bones. Primary bone cancer that arises in bone cells is different than metastatic bone cancer, which is cancer that arises in another part of the body and then spreads to the bones. Hereditary and environmental factors likely contribute to the risk of bone cancer. Signs and symptoms of bone cancer may include pain, the presence of a mass or lump, and bone fractures. There are different types of bone cancer (osteosarcoma, chondrosarcoma, Ewing's sarcoma, pleomorphic sarcoma, fibrosarcoma). Treatment for bone cancer may include surgical removal of the tumor, chemotherapy, radiation, and/or a stem cell transplant. The prognosis for bone cancer depends on the type of cancer and the extent of spread.
Cancer pain results from the tumor pressing on nerves or invading bones or organs. Cancer treatments like chemotherapy, radiation, or surgery can also cause pain. Over-the-counter pain relievers, prescription medications, radiation, biofeedback, and relaxation techniques are just some treatments for cancer pain.
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All content is from U.S. Food and Drug Administration (FDA) prescribing information.