Darzalex
Darzalex (daratumumab) is an anti-CD38 monoclonal antibody. It's used to treat multiple myeloma in adults, often in combination with other anticancer medications. Darzalex (daratumumab) is given as an intravenous infusion through your vein (IV). Typically, you receive it every week or every few weeks, depending on where you are in the treatment process. Some common side effects of Darzalex (daratumumab) include infusion-related reactions, higher risk of infection, and feeling tired.
What is Darzalex (daratumumab)?
What is Darzalex (daratumumab) used for?
Adults newly diagnosed with multiple myeloma (MM), but not able to receive stem cell transplant (in combination with other anticancer medications)
Adults newly diagnosed with MM and able to receive stem cell transplant (in combination with other anticancer medications)
Adults with advanced MM who already received but didn’t respond well to at least one prior anticancer treatment (in combination with other anticancer medications)
Adults with advanced MM who already received but didn’t respond well to at least three prior anticancer treatments (given alone)
How Darzalex (daratumumab) works
Darzalex (daratumumab) is an anti-CD38 monoclonal antibody. It treats multiple myeloma by targeting a specific protein called CD38 on the cells’ surface. Many cells, including healthy cells, have this protein. But multiple myeloma cells just have more of them. By binding to this protein, Darzalex (daratumumab) attacks and kills the cancer cells, and also signals to the immune system to do the same. As a result, multiple myeloma cells can’t grow and spread as well.
Drug Facts
More on Darzalex (daratumumab) essentials
What are the side effects of Darzalex (daratumumab)?
Common Side Effects
- Infusion-related reactions
- Decreases in blood cell counts
- Cold-like symptoms (upper respiratory infection)
- Diarrhea
- Constipation
- Nerve damage causing tingling, numbness or pain
- Tiredness
- Swollen hands, ankles, or feet
- Nausea
- Cough
- Fever
- Shortness of breath
- Feeling weak
Other Side Effects
- Changes in blood tests
Serious Side Effects
- Serious reaction during infusion: shortness of breath or trouble breathing, dizziness or lightheadedness, cough, wheezing, heart beating faster than usual, throat tightness or irritation, runny or stuffy nose, headache, itching, high blood pressure, eye pain, nausea, vomiting, chills, fever, chest discomfort, blurred vision
- Serious infections (from low white blood cell levels): fever, headache, sore throat, cough, body aches, chills, weakness, tiredness
- Serious bleeds (from low platelet count): bruising that won't go away or bleeding that's difficult to stop
Source: DailyMed
More on Darzalex (daratumumab) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Diarrhea
- Fatigue
- Nausea
- Pain, tingling, or numbness in the hands or feet
- Swelling of the ankles, hands, or feet
Pros and cons of Darzalex (daratumumab)
Pros
Recommended treatment option for people with multiple myeloma
Works in a more specific, targeted way than traditional chemotherapy
Not known to cause hair loss
Cons
Might cause serious infusion-related reactions
Each infusion lasts several hours long, so not very convenient
Infused into the veins
Pharmacist tips for Darzalex (daratumumab)
Darzalex (daratumumab) can cause lower white blood cell counts. This makes it harder for your body to fight infections if you get sick. You can help prevent infections by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
Taking Darzalex (daratumumab) can raise your risk of an infection. Check your body temperature regularly, especially when you don't feel well. Call your healthcare team immediately if you have a fever, which is a temperature of 100.4 degrees Fahrenheit or higher. Sometimes, a fever might be the only sign that you’re sick.
Darzalex (daratumumab) is typically given along with other medications to treat multiple myeloma, and it can be difficult to keep track of the treatment schedule. Talk to your oncologist about using a treatment calendar so all your doses and infusion appointments are written down, or consider using an app on your phone to help you remember.
Your oncologist might recommend you take a corticosteroid such as methylprednisolone for 1 or 2 days after your Darzalex (daratumumab) infusion. This is to help prevent a delayed infusion-related reaction. If you experience a fever, chills, trouble breathing, or blood pressure changes, seek medical attention right away.
Darzalex (daratumumab) treatment might lead to lower platelet counts in your body. Platelets are the cells in your blood that form blood clots and prevent bleeding. When platelet levels are low, your body can’t stop bleeding as well. Contact your healthcare team right away if you have bruising that won't go away, nose bleeds, or blood in the stool or urine.
If you have multiple myeloma and are taking certain medications like Darzalex (daratumumab), your immune system might not work as well. Your oncologist might recommend you take an antiviral medication such as acyclovir (Zovirax) to prevent shingles, while you’re taking Darzalex (daratumumab) and for 3 months after the last dose.
Frequently asked questions about Darzalex (daratumumab)
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What are the risks and warnings for Darzalex (daratumumab)?
Darzalex (daratumumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infusion-related reactions
People who receive Darzalex (daratumumab) have experienced infusion-related reactions. Sometimes, the reactions can be life-threatening. Infusion-related reactions are most common after the first infusion. Symptoms typically appear during or within 4 hours after an infusion, though some people have reported reactions up to 48 hours later. Your oncology team will give you medications (e.g. antihistamines, corticosteroids) before and after each Darzalex (daratumumab) infusion to prevent a reaction. If you have mild or moderate infusion-related reactions, your oncologist will pause Darzalex (daratumumab) to treat your symptoms and continue your infusion at a slower rate in the future. But if you experience serious reactions, they'll recommend that you stop Darzalex (daratumumab) permanently. Let your care team know right away if you have symptoms of an infusion-related reaction, such as cough, chills, nausea, trouble breathing, fever, and vision changes.
Changes in lab test results for blood transfusions
Risk factors: Blood transfusion
Darzalex (daratumumab) 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 (daratumumab). Your oncology team will do blood tests to match your blood type before you start treatment with Darzalex (daratumumab). Tell all healthcare professionals (HCPs) on your care team that you're being treated with Darzalex (daratumumab) before receiving blood transfusions.
Lower white blood cell counts (risk of infection)
People who take Darzalex (daratumumab) often have low blood cell counts, particularly low white blood cells (neutropenia). White blood cells are an important part of your immune system, so when their levels are low you might have a higher risk of serious infections. Your oncology team will regularly monitor your blood cell counts while you’re taking Darzalex (daratumumab). In addition, they might prescribe other medications such as antibiotics or antivirals to protect you from serious infections. You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your healthcare team right away if your temperature is 100.4 degrees Fahrenheit or higher.
Lower platelet counts (risk of bleeding)
Some people who take Darzalex (daratumumab) might have lower platelet counts in their body. Platelets are the cells in your blood that form blood clots and prevent bleeding. So, when their levels are low, your body has a hard time forming clots when you’ve an injury. Your oncology team will monitor your blood cell counts while you’re taking Darzalex (daratumumab). Get medical help right away if you notice bruising that won't go away or bleeding that's difficult to stop.
Changes in test results for treatment response
Darzalex (daratumumab) might cause abnormal results on certain lab tests that are used to monitor how well your multiple myeloma is responding to treatment. Ask your healthcare team about how they monitor your multiple myeloma and response to treatment.
Harm to unborn baby
Darzalex (daratumumab) hasn’t been studied in human pregnancy, but based on the way the medication works it can cause harm during pregnancy. Females who can get pregnant should use effective birth control while taking Darzalex (daratumumab) and for 3 months after the last dose.
In addition, many of the other medications you take along with Darzalex (daratumumab) for multiple myeloma can also harm an unborn baby. Whether you’re a male or female, if you’re taking Darzalex (daratumumab) together other anticancer medications, such as lenalidomide (Revlimid) or Pomalyst (pomalidomide), your oncology team will give you information about specific requirements for birth control and pregnancy tests (for females).
Darzalex (daratumumab) dosage forms
Typical dosing for Darzalex (daratumumab)
Darzalex (daratumumab) is given as an infusion into the veins (IV) by a trained professional on your oncology team, either in a hospital or clinic setting.
Adults: Your oncology team will determine your dose of Darzalex (daratumumab) based on your body weight. They will decide the timing between doses as well as how many treatments you will receive.
Your oncology team will give you medications before and after each dose of Darzalex (daratumumab) to lower the risk of infusion-related reactions. If you miss any appointments, call your oncology team as soon as possible to reschedule your appointment.
What are alternatives to Darzalex (daratumumab)?
Adults newly diagnosed with multiple myeloma (MM), but not able to receive stem cell transplant (in combination with other anticancer medications)
Adults newly diagnosed with MM and able to receive stem cell transplant (in combination with other anticancer medications)
Adults with advanced MM who already received but didn’t respond well to at least one prior anticancer treatment (in combination with other anticancer medications)
Adults with advanced MM who already received but didn’t respond well to at least three prior anticancer treatments (given alone)
Multiple myeloma in adults who’ve received at least two previous therapies, given together with Pomalyst (pomalidomide) and dexamethasone
Multiple myeloma in adults who’ve received one to three previous therapies, given together with Kyprolis (carfilzomib) and dexamethasone
Multiple myeloma in people who’ve already taken 1 to 3 therapies; given with lenalidomide (Revlimid) and dexamethasone
Multiple myeloma in people who’ve already taken at least 2 therapies; given with Pomalyst (pomalidomide) and dexamethasone
What is the latest news about Darzalex (daratumumab)?
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References
Best studies we foundAmerican Cancer Society. (n.d.). Stem cell or bone marrow transplant.
American Cancer Society. (n.d.). Targeted therapy.
American Cancer Society. (2018). Tests to find multiple myeloma.
American Cancer Society. (2020). What are infusion or immune reactions?
American Cancer Society. (2024). Fevers.
American Cancer Society. (2024). Neutropenia (low white blood cell counts).
Centers for Disease Control and Prevention. (n.d.). What you need to know: Neutropenia and risk for infection.
Gozzetti, A., et al. (2022). Anti CD38 monoclonal antibodies for multiple myeloma treatment. Human Vaccines & Immunotherapeutics.
InformedHealth.org. (2020). How does the immune system work? Institute for Quality and Efficiency in Health Care.
Janssen Biotech, Inc. (2024). Darzalex- daratumumab injection, solution, concentrate; Darzalex IV- daratumumab injection, solution, concentrate [package insert]. DailyMed.
National Comprehensive Cancer Network. (2023). Multiple myeloma.
Theis, S. R., et al. (2022). Coombs test. StatPearls.
van de Donk, N. W. C. J., et al. (2018). CD38 antibodies in multiple myeloma: Mechanisms of action and modes of resistance. Frontiers in Immunology.
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