Darzalex is available only as a brand-name medication. It's not currently available in generic form.

Darzalex contains one active drug ingredient: daratumumab.

Darzalex can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Darzalex. This list does not include all possible side effects.

For more information on the possible side effects of Darzalex, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The common side effects of Darzalex can include:

If the side effects you're feeling seem more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Darzalex aren't common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Infusion reaction, a type of allergic reaction. Symptoms can include:
  • Pneumonia, a type of lung infection. Symptoms can include:
    • coughing up phlegm (mucus)
    • fever and chills
    • shortness of breath
    • chest pain
  • Hepatitis B, if you've had it in the past. Symptoms can include:
    • worsening tiredness
    • yellowing of your skin or the white part of your eyes
  • Peripheral sensory neuropathy (nerve damage that causes tingling, numbness, or pain). Symptoms can include:
    • numbness or tingling
    • burning pain
    • sensitivity
    • weakness in your hands or feet
  • Peripheral edema (swelling of the hands and feet). Symptoms can include:
    • swelling of the arms or legs
    • stretched skin
    • skin that dents (pits) when pressed for a few seconds

Other serious side effects, explained in more detail below in "Side effect details," include:

  • allergic reactions
  • thrombocytopenia, a low level of platelets, which are a type of blood cell that helps blood clot
  • neutropenia, a low level of neutrophils, which are a type of white blood cell that helps fight infections
  • shingles (herpes zoster infection)

Side effect details

You may wonder how often certain side effects occur with this drug. Here's some detail on serious side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Darzalex. It's not known how often people using Darzalex have allergic reactions. Symptoms of a mild allergic reaction can include:

  • skin rash or hives (itchy welts on your skin)
  • itchiness
  • flushing (warmth and redness in your skin)
  • fever

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Darzalex. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Infusion reaction

Darzalex is given an intravenous (IV) infusion in your doctor's office or a clinic. This is an injection into your vein that's given over a period of time. As with most drugs that are given as an IV infusion, you may have an infusion reaction after receiving Darzalex. (An infusion reaction is a type of allergic reaction.)

During clinical studies, infusion reactions occurred in about half of all people treated with a Darzalex infusion. Typically, reactions occurred during the first infusion and were mild to moderate. Most people who received Darzalex had a reaction during or within 4 hours of the end of an infusion. Infusion reactions are less likely to occur with future treatments. In the studies, people who received medications other than Darzalex weren't given the drugs in the form of infusions.

If you do have an infusion reaction that's mild or moderate, your doctor may pause your infusion to treat the reaction. They may then restart the infusion at a lower rate (speed) so you get the medication more slowly. If your infusion reaction is severe or anaphylactic (life-threatening), your doctor may completely stop treatment with Darzalex and start emergency medical care.

To decrease the chance of an infusion reaction, your doctor will give you a combination of drugs. One to three hours before each Darzalex infusion, you'll receive:

  • a corticosteroid (to reduce swelling)
  • an antipyretic (to prevent or reduce fever)
  • an antihistamine (to prevent or reduce the symptoms of allergic reactions)

You may also receive a corticosteroid 1 day after an infusion to avoid delayed reactions. But if you're already taking a steroid such as dexamethasone or prednisone, you most likely won't need the extra steroid boost.

If you have a severe allergic reaction to Darzalex after you leave your doctor's office or the infusion center, call your doctor right away. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Blood cell disorders

Darzalex can cause thrombocytopenia, which is a decrease in the level of your platelets. (These are a type of blood cell that helps blood clot.) Symptoms can include bruising and bleeding.

In clinical studies, about 48% to 90% of people who took Darzalex or Darzalex with standard multiple myeloma treatment had thrombocytopenia. In comparison, 58% to 88% of people who had just standard treatments also had thrombocytopenia.

Darzalex can also cause neutropenia. This is a decrease in the level of neutrophils, which is a type of white blood cell that helps fight infections. Symptoms can include fever and infection.

In clinical studies, about 58% to 95% of people who took Darzalex or Darzalex along with standard multiple myeloma treatment had neutropenia. In comparison, 40% to 87% of people who had just standard treatments also had neutropenia.

During your Darzalex treatment, your doctor will regularly check your platelet and white blood cell counts. They'll also monitor you for any bruising, bleeding, or infections. If you develop any of these signs or symptoms, tell your doctor.

Shingles

While you're taking Darzalex, you could develop an infection called shingles (herpes zoster). This is because having multiple myeloma and receiving multiple myeloma treatments can increase your risk for an infection.

When you get shingles, you may have:

  • burning pain
  • tingling
  • itching
  • a rash and blisters on only one side of your body

The same virus that causes shingles can also cause chickenpox. If you've had chickenpox in the past, the virus doesn't leave your body after you recover from the infection. Instead, the virus just "goes to sleep" in your nerves.

No one knows exactly why, but the virus can reactivate or "wake up" with certain triggers such as a weak immune system. (Your immune system is your body's defense against infections.)

Cancer or cancer treatments can weaken your immune system and reactivate the herpes zoster virus. When it awakens, it expresses itself as shingles instead of chickenpox.

In clinical studies, shingles was reported in 3% of people who were treated with only Darzalex. In comparison, shingles occurred in 2% to 5% of people who took Darzalex with an additional cancer medication.

If you've had chickenpox or shingles in the past and are taking Darzalex, your doctor may prescribe an antiviral medication. This type of drug may help prevent shingles from developing in your body. You'll need to take the antiviral treatment within 1 week of first receiving Darzalex. Then you'll continue to take it for 3 months after you finish treatment with Darzalex.

Pneumonia

Taking Darzalex may lead you to develop to a lung infection called pneumonia. This is because if you have multiple myeloma, you're much more likely to get infections than healthy people.

In clinical studies, 11% to 26% of people who took Darzalex developed pneumonia. This is compared to 6% to 14% of people who took a placebo (no treatment).

Pneumonia was the most commonly reported severe infection. Up to 4% of people across all the Darzalex studies had to stop taking the drug due to pneumonia. Death from pneumonia was very rare. But if death did occur, it was because of pneumonia and sepsis (a life-threatening response to infection).

Symptoms of pneumonia can include:

  • coughing up phlegm (mucus)
  • fever and chills
  • shortness of breath
  • chest pain

If you develop any symptoms of pneumonia, tell your doctor. They may pause your Darzalex doses to treat the pneumonia. In clinical studies, about 1% to 4% of people who took Darzalex or only standard cancer treatment had to stop their medications because of severe pneumonia.

As with all medications, the cost of Darzalex can vary. To find current prices for Darzalex in your area, check out WellRx.com. The cost you find on WellRx.com is what you may pay without insurance. The actual price you'll pay will depend on your insurance coverage and the pharmacy you use.

Your insurance plan may require you to get prior authorization before they approve coverage for Darzalex. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Darzalex.

If you're not sure if you'll need to get prior authorization for Darzalex, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Darzalex, or if you need help understanding your insurance coverage, help is available.

Janssen Biotech, Inc., the manufacturer of Darzalex, offers a program called Janssen CarePath. For more information and to find out if you're eligible for support, call 844-553-2792 or visit the program website.

The Darzalex dosage your doctor prescribes will depend on several factors. These include:

  • if your condition is newly diagnosed or you've received one or more previous multiple myeloma treatment(s)
  • any other treatments you're receiving along with Darzalex to treat multiple myeloma
  • other medical conditions you may have
  • any side effects that don't go away

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs. To get the most out of this treatment, it's important to go to all of your appointments and not skip any days.

Drug forms and strengths

Darzalex comes as a solution (liquid mixture) that you'll receive in the form of an injection. The solution may be colorless to pale yellow. Darzalex is available in two sizes:

  • 100 mg/5 mL in a single-dose vial
  • 400 mg/20 mL in a single-dose vial

A healthcare provider will mix part of Darzalex with 0.9% sodium chloride (a type of saltwater solution). Then they'll give you this medication through a needle that's placed in your vein. This is called an intravenous (IV) infusion.

Typically, your doctor will start you on a recommended dosage but at a lower rate (speed) of infusion. Over time, they'll adjust the infusion to the rate that's right for you. This will depend on any infusion reactions you have.

Your first infusion of Darzalex may take about 7 hours. This is because your doctor will infuse (give you) your medication very slowly into your vein. In the future, infusions will last about 3 to 5 hours because you'll be getting the medication infused faster. A healthcare provider will always be monitoring you during your infusions.

Dosage for multiple myeloma

Darzalex is prescribed by itself or with other types of cancer therapies for adults with multiple myeloma. The treatment plan and length will depend on if you're newly diagnosed or have had previous treatments. Darzalex hasn't been studied in children.

The recommended dose of Darzalex is 16 milligrams/kilogram (mg/kg) of actual body weight as an IV infusion. For example, a 110-pound woman weighs about 50 kg. That means her recommended Darzalex dose would be 50 kg multiplied by 16 mg/kg, which is 800 mg.

Adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant

With an autologous stem cell transplant, your own stem cells are used. One treatment option is Darzalex with lenalidomide (Revlimid) and dexamethasone. The recommended dosage schedule is:

  • Weeks 1 to 8: One dose each week (for a total of eight doses)
  • Weeks 9 to 24: One dose every 2 weeks (for a total of eight doses)
  • Week 25 onward: One dose every 4 weeks

Another treatment option is Darzalex with bortezomib (Velcade), melphalan, and prednisone. The recommended dosage schedule is:

  • Weeks 1 to 6: One dose each week (for a total of six doses)
  • Weeks 7 to 54: One dose every 3 weeks (for a total of 16 doses)
  • Week 55 onward: One dose every 4 weeks

Adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back

You'll receive Darzalex with lenalidomide and dexamethasone. The recommended dosage schedule is:

  • Weeks 1 to 8: One dose each week (for a total of eight doses)
  • Weeks 9 to 24: One dose every 2 weeks (for a total of eight doses)
  • Week 25 onward: One dose every 4 weeks

Adults who have received one or more previous multiple myeloma treatment(s)

You'll receive Darzalex with bortezomib and dexamethasone. The recommended dosage schedule is:

  • Weeks 1 to 9: One dose each week (for a total of nine doses)
  • Weeks 10 to 24: One dose every 3 weeks (for a total of five doses)
  • Week 25 onward: One dose every 4 weeks

Adults who have received two or more previous multiple myeloma treatments, including lenalidomide and a proteasome inhibitor

You'll receive Darzalex with pomalidomide (Pomalyst) and dexamethasone. The recommended dosage schedule is:

  • Weeks 1 to 8: One dose each week (for a total of eight doses)
  • Weeks 9 to 24: One dose every 2 weeks (for a total of eight doses)
  • Week 25 onward: One dose every 4 weeks

Adults who have received three or more previous multiple myeloma treatments, including a proteasome inhibitor and an immunomodulatory drug, or didn't respond to a proteasome inhibitor and an immunomodulatory drug

You'll receive only Darzalex. The recommended dosage schedule is:

  • Weeks 1 to 8: One dose each week (for a total of eight doses)
  • Weeks 9 to 24: One dose every 2 weeks (for a total of eight doses)
  • Week 25 onward: One dose every 4 weeks

To decrease the chance of an infusion reaction, your doctor will give you a combination of drugs. One to three hours before each Darzalex infusion, you'll receive:

  • a corticosteroid (to reduce swelling)
  • an antipyretic (to prevent or reduce a fever)
  • an antihistamine (to prevent or reduce the symptoms of allergic reactions).

You may also receive a corticosteroid 1 day after an infusion to avoid delayed reactions. But if you're already taking a steroid such as dexamethasone or prednisone, you most likely won't need the extra steroid boost.

What if I miss a dose?

If you miss an appointment for a Darzalex infusion, call your doctor right away to reschedule. They'll adjust your dosing schedule to make sure you receive the right number of treatments in the right time frame.

Will I need to use this drug long term?

In clinical studies, the average time it took for Darzalex to start working was 1 month.

However, you may be given your doses over a longer period of time. This will depend on how your body responds to Darzalex and if your multiple myeloma starts to get worse.

The length of treatment will also depend on if your multiple myeloma is newly diagnosed or if you've had treatments in the past.

The Food and Drug Administration (FDA) has approved Darzalex for the treatment of multiple myeloma.

This is a form of a cancer that that affects certain white blood cells called plasma cells. Plasma cells make up a part of your immune system and help fight infections in your body. In multiple myeloma, plasma cells change into multiple myeloma cells. As multiple myeloma cells grow and spread, they may crowd out healthy cells and damage bone around them.

Darzalex is approved to be used:

  • In adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant. (With an autologous stem cell transplant, your own stem cells are used.) In this situation:
    • Darzalex may be used with the medications lenalidomide (Revlimid) and dexamethasone.
    • Darzalex may also be used with the medications bortezomib (Velcade), melphalan, and prednisone.
  • In adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back. In this situation, Darzalex is used with lenalidomide and dexamethasone.
  • In adults who have received one or more previous multiple myeloma treatment(s). In this situation, Darzalex is used with bortezomib and dexamethasone.
  • In adults who have received two or more previous multiple myeloma treatments that included lenalidomide and a proteasome inhibitor, which is a type of drug. In this situation, Darzalex is used with the medications pomalidomide (Pomalyst) and dexamethasone.
  • In adults who have received three or more previous multiple myeloma treatments that included a proteasome inhibitor and an immunomodulatory medication. In this situation, Darzalex is used by itself.
  • In adults who have tried a proteasome inhibitor and an immunomodulatory medication but neither drug worked for multiple myeloma. In this situation, Darzalex is used by itself.

Effectiveness

Six clinical studies looked at how effective Darzalex was at treating multiple myeloma alone and combined with other cancer-fighting drugs. These studies are called MAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, and SIRIUS. The research showed that treatment was more effective if Darzalex was added to standard cancer treatments than if these standard treatments were given alone.

The MAIA study

The MAIA study looked at people newly diagnosed with multiple myeloma who couldn't receive an autologous stem cell transplant. People received either a standard cancer treatment of lenalidomide (Revlimid) and low-dose dexamethasone or the same treatment plus Darzalex. Compared to the standard treatment group, the Darzalex group had a 44% lower risk of their multiple myeloma getting worse or death.

For the 42 months of the study, multiple myeloma didn't get worse in people who took Darzalex along with standard treatment. For people who took just the standard treatment, it took about 31.9 months before their multiple myeloma started getting worse. The complete response rate was 47.6% for people treated with Darzalex and 24.9% for those who received just standard treatment. (Complete response means all of the cancer is gone and there are no signs of disease in lab tests, X-rays, or clinical exams.)

The ALCYONE study

The ALCYONE study looked at people newly diagnosed with multiple myeloma who couldn't receive an autologous stem cell transplant. These people received either a standard cancer treatment of bortezomib (Velcade), melphalan, and prednisone or that treatment plus Darzalex. Compared to the standard treatment group, the Darzalex group had a 50% lower risk of their multiple myeloma getting worse or death.

Of the people who received the Darzalex treatment, 42.6% had a complete response. This was compared to 24.4% of people who received only the standard treatment.

The POLLUX study

The POLLUX study looked at people with multiple myeloma who had at least one previous treatment. The people took either a standard treatment of lenalidomide and dexamethasone or the same treatment plus Darzalex. Results showed that about 91.3% of people responded to treatment with Darzalex versus about 74.6% of people who received only standard treatment.

Compared to the standard treatment group, the group treated with Darzalex had a 63% lower risk of their multiple myeloma getting worse. After 13.5 months, 19% of the Darzalex group saw their multiple myeloma get worse or they passed away. This was compared to 41% of the standard treatment group.

The CASTOR study

The CASTOR study also looked at people with multiple myeloma who had at least one previous treatment. The people took either a standard treatment of bortezomib and dexamethasone or the same treatment plus Darzalex. The results were similar to those of the POLLUX study. About 73.9% of people had a response to treatment with Darzalex compared to about 59.9% of people who received only standard treatment.

Compared to the standard treatment, the Darzalex treatment was linked to a 61% lower risk of multiple myeloma getting worse or death. The people who took Darzalex were also able to stay in remission for a longer time. (Remission means that the rate of the cancer spreading slowed down.)

The EQUULEUS study

The EQUULEUS study looked at 103 people with multiple myeloma who had previously been treated about four times for their multiple myeloma. These people had already received two types of treatment: a proteasome inhibitor and an immunomodulatory drug. Everyone in the study took a standard treatment of pomalidomide (Pomalyst) and dexamethasone plus Darzalex. The main goal of the study was to see how many people responded to treatment.

Overall, the treatment started working in about 1 month in most people. The treatment worked for an average of about 13.6 months. Multiple myeloma symptoms eased by 90% or more in 42% of the people. Some people even had no cancer left at the end of the study.

The SIRIUS study

The SIRIUS study looked at 106 people with multiple myeloma who were very sick and had received an average of five previous treatments. All the people in the study were given just Darzalex. The main goal of the study was to see how many people responded to treatment.

Overall, 31 people who received Darzalex had their multiple myeloma symptoms decrease. About 64.8% of people who took Darzalex in this study survived for at least 12 months.

To decrease the chance of having an infusion reaction, people in all these studies were given a combination of drugs. One to three hours before every Darzalex infusion, they received:

  • a corticosteroid (to reduce swelling)
  • an antipyretic (to prevent or reduce a fever)
  • an antihistamine (to prevent or reduce the symptoms of allergic reactions)

They may have also received a corticosteroid 1 day after an infusion to avoid delayed reactions. But if the people were already taking a steroid such as dexamethasone or prednisone, they most likely didn't need the extra steroid boost.

Darzalex for other conditions

In addition multiple myeloma, Darzalex is being studied as a treatment for immunoglobulin light chain amyloidosis.

Darzalex for immunoglobulin light chain amyloidosis (under study)

Immunoglobulin light chain amyloidosis (AL) is a condition in which certain proteins called light chains build up in your organs throughout your body. Typically, your heart, kidney, spleen, and liver are affected. The protein buildup can damage and cause these organs to fail.

Darzalex isn't FDA-approved to treat AL. However, there is some limited research using Darzalex off-label to treat this condition. (Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.)

In one study, Darzalex was given to people with AL who had, on average, received three different treatments that didn't work. Darzalex produced an almost complete or complete response in 76% of people who took the drug. (Complete response means that all the disease is gone and there are no signs of disease in lab tests, X-rays, clinical exams.) These people had side effects similar to those expected in people who took Darzalex to treat multiple myeloma. In other reported cases, Darzalex was effective in treating AL and improving the quality of life of the people who took the drug.

More studies are needed to prove that Darzalex works well and is safe when used in people with AL. Until then, researchers may use Darzalex for people with AL who have no more first-choice, FDA-approved treatment options left.

Darzalex is prescribed by itself or with other types of cancer treatments for adults with multiple myeloma. The treatment plan and length will depend on if you're newly diagnosed or have had previous treatments.

Darzalex is approved to be used along with:

  • lenalidomide (Revlimid) and dexamethasone in adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant. (With an autologous stem cell transplant, your own stem cells are used.)
  • lenalidomide and dexamethasone in adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back.
  • bortezomib (Velcade), melphalan, and prednisone in adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant.
  • bortezomib and dexamethasone in adults who have received one or more previous multiple myeloma treatment(s).
  • pomalidomide (Pomalyst) and dexamethasone in adults who have received two or more previous multiple myeloma treatments. These treatments must have included lenalidomide and a proteasome inhibitor.

Six clinical studies looked at how effective Darzalex was at treating multiple myeloma, alone and combined with other cancer-fighting drugs. These studies are called MAIA, ALCYONE, POLLUX, CASTOR, EQUULEUS, and SIRIUS. The research showed that treatment of multiple myeloma was more effective if Darzalex was added to standard cancer treatments than if these standard treatments were given alone. For details about these studies, please see the "Darzalex for multiple myeloma" section above.

Other drugs are available that can treat multiple myeloma. Some may be better suited for you than others. If you're interested in finding an alternative to Darzalex, talk with your doctor to learn more about other medications that may work well for you.

Below is a list of drugs recommended by the National Comprehensive Cancer Network guidelines for treating multiple myeloma:

  • Chemotherapy drugs, such as:
    • bendamustine (Bendeka or Treanda)
    • cisplatin
    • cyclophosphamide (Cytoxan)
    • doxorubicin (Doxil)
    • etoposide (Etopophos)
    • melphalan (Alkeran)
  • Proteasome inhibitors, such as:
    • bortezomib (Velcade)
    • carfilzomib (Kyprolis)
    • ixazomib (Ninlaro)
  • Monoclonal antibodies, such as:
    • elotuzumab (Empliciti)
  • Histone deacetylase inhibitors, such as:
    • panobinostat (Farydak)
  • Immunomodulators, such as:
    • lenalidomide (Revlimid)
    • pomalidomide (Pomalyst)
    • thalidomide (Thalomid)
  • Corticosteroids, such as:
    • dexamethasone (Decadron)

Note: Some of the drugs listed here may be used off-label to treat multiple myeloma.

You may wonder how Darzalex compares to other medications that are prescribed for similar uses. Here we look at how Darzalex and Empliciti are alike and different.

About

Darzalex contains daratumumab, while Empliciti contains elotuzumab. Both Darzalex and Empliciti belong to a class of drugs called monoclonal antibodies. (A class of drugs is a group of medications that work in a similar way.) Both Darzalex and Empliciti are considered targeted therapies for multiple myeloma.

Uses

The Food and Drug Administration (FDA) has approved both Darzalex and Empliciti to treat multiple myeloma.

Darzalex is approved to be used:

  • In adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant. (With an autologous stem cell transplant, your own stem cells are used.) In this situation:
    • Darzalex may be used with the medications lenalidomide (Revlimid) and dexamethasone.
    • Darzalex may also be used with the medications bortezomib (Velcade), melphalan, and prednisone.
  • In adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back. In this situation, Darzalex is used with lenalidomide and dexamethasone.
  • In adults who have received one or more previous multiple myeloma treatment(s). In this situation, Darzalex is used with bortezomib and dexamethasone.
  • In adults who have received two or more previous multiple myeloma treatments that included lenalidomide and a proteasome inhibitor, which is a type of drug. In this situation, Darzalex is used with the medications pomalidomide (Pomalyst) and dexamethasone.
  • In adults who have received three or more previous multiple myeloma treatments that included a proteasome inhibitor and an immunomodulatory medication. In this situation, Darzalex is used by itself.
  • In adults who have tried a proteasome inhibitor and an immunomodulatory medication but neither drug worked for multiple myeloma. In this situation, Darzalex is used by itself.

Empliciti is approved to be used:

  • In adults who have received one to three previous treatments for their multiple myeloma. Empliciti is used with lenalidomide (Revlimid) and dexamethasone.
  • In adults who have received at least two previous treatments that included lenalidomide and a proteasome inhibitor. Empliciti is used with pomalidomide (Pomalyst) and dexamethasone.

Typically, Empliciti is given if your multiple myeloma has come back after other treatments.

Drug forms and administration

Both Darzalex and Empliciti are given as an intravenous (IV) infusion. This is an injection that is infused slowly over time through a needle that is placed in your vein.

For Darzalex

Darzalex comes as a solution (liquid mixture) that you'll receive in the form of an injection. The solution can be colorless to pale yellow. The medication is available in two sizes:

  • 100 mg/5 mL in a single-dose vial
  • 400 mg/20 mL in a single-dose vial

To decrease the chance of an infusion reaction, your doctor will give you a combination of drugs. One to three hours before each Darzalex infusion, you'll receive:

  • a corticosteroid to reduce swelling
  • an antipyretic to prevent or reduce fever
  • an antihistamine to prevent or reduce the symptoms of allergic reactions

You may also receive a corticosteroid 1 day after an infusion to avoid delayed reactions. But if you're already taking a steroid such as dexamethasone or prednisone, you most likely won't need the extra steroid boost.

For Empliciti

Empliciti comes as a white to off-white powder. A healthcare provider will mix this with a solution to give you as an injection. Empliciti is available in two strengths:

  • 300 mg in a single-dose vial
  • 400 mg in a single-dose vial

To decrease the chance of an infusion reaction, your doctor will give you a combination of drugs. About 45 to 90 minutes before an Empliciti infusion, you'll receive:

  • acetaminophen to prevent or reduce fever
  • diphenhydramine (Benadryl) to prevent or reduce the symptoms of allergic reactions
  • ranitidine to prevent or reduce the symptoms of allergic reactions
  • dexamethasone to reduce swelling

Side effects and risks

Darzalex and Empliciti both contain drugs that work the same. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Darzalex, with Empliciti, or with both drugs (when taken individually).

  • Can occur with Darzalex:
    • weakness
    • body aches or joint pain
    • nausea
    • trouble sleeping
    • bronchitis, a type of lung infection
    • dizziness
  • Can occur with Empliciti:
  • Can occur with both Darzalex and Empliciti:
    • feeling tired or lack of energy
    • upset stomach including diarrhea or constipation
    • decreased appetite
    • fever
    • chills
    • shortness of breath or cough
    • upper respiratory infection such as a cold
    • muscle spasms (twitches)
    • vomiting
    • peripheral edema, which is swelling of the hands and feet

* When Empliciti is used with pomalidomide plus dexamethasone

** When Empliciti is used with lenalidomide plus dexamethasone

Serious side effects

These lists contain examples of serious side effects that can occur with Darzalex, with Empliciti, or with both drugs (when taken individually).

Effectiveness

Darzalex and Empliciti have different FDA-approved uses, but they're both used to treat multiple myeloma in adults.

These drugs haven't been directly compared in clinical studies (called head-to-head studies). However, a review of 13 clinical studies of Darzalex and Empliciti found that both drugs were effective in delaying the progression (worsening) of multiple myeloma.

For people whose multiple myeloma has come back or keeps growing even after many treatments, the National Comprehensive Cancer Network guidelines recommend Darzalex first. If Darzalex doesn't work, treatment with Empliciti is another option.

Costs

Darzalex and Empliciti are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Darzalex generally costs less than Empliciti. The actual price you'll pay for either drug depends on your insurance plan and your location.

Like Empliciti (above), the drug Kyprolis has uses similar to those of Darzalex. Let's now look at how Darzalex and Kyprolis are alike and different.

About

Darzalex contains daratumumab, while Kyprolis contains carfilzomib. Both drugs are considered targeted therapy for multiple myeloma. However, the drugs are in different drug classes. (A class of drugs is a group of medications that work in a similar way.) Darzalex is a type of drug called a monoclonal antibody. Kyprolis is a type of drug called a proteasome inhibitor.

Uses

The Food and Drug Administration (FDA) has approved Darzalex to be used:

  • In adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant. (With an autologous stem cell transplant, your own stem cells are used.) In this situation:
    • Darzalex may be used with the medications lenalidomide (Revlimid) and dexamethasone.
    • Darzalex may also be used with the medications bortezomib (Velcade), melphalan, and prednisone.
  • In adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back. In this situation, Darzalex is used with lenalidomide and dexamethasone.
  • In adults who have received one or more previous multiple myeloma treatment(s). In this situation, Darzalex is used with bortezomib and dexamethasone.
  • In adults who have received two or more previous multiple myeloma treatments that included lenalidomide and a proteasome inhibitor, which is a type of drug. In this situation, Darzalex is used with the medications pomalidomide (Pomalyst) and dexamethasone.
  • In adults who have received three or more previous multiple myeloma treatments that included a proteasome inhibitor and an immunomodulatory medication. In this situation, Darzalex is used by itself.
  • In adults who have tried a proteasome inhibitor and an immunomodulatory medication but neither drug worked for multiple myeloma. In this situation, Darzalex is used by itself.

Kyprolis is FDA-approved to be used:

  • In adults who have received one to three previous treatments for their multiple myeloma. Kyprolis is used with dexamethasone or with lenalidomide and dexamethasone.
  • In adults who have received one or more previous treatments for their multiple myeloma. Kyprolis is used by itself.

Drug forms and administration

Both Darzalex and Kyprolis are given as an intravenous (IV) infusion. This is an injection that is infused slowly over time through a needle that is placed in your vein.

For Darzalex

Darzalex comes as a solution (liquid mixture) that you'll receive in the form of an injection. The solution can be colorless to pale yellow. The medication is available in two sizes:

  • 100 mg/5 mL in a single-dose vial
  • 400 mg/20 mL in a single-dose vial

To decrease the chance of an infusion reaction, your doctor will give you a combination of. drugs. One to three hours before each Darzalex infusion, you'll receive:

  • a corticosteroid to reduce swelling
  • an antipyretic to prevent or reduce fever
  • an antihistamine to prevent or reduce the symptoms of allergic reactions

You may also receive a corticosteroid 1 day after an infusion to avoid delayed reactions. But if you're already taking a steroid such as dexamethasone or prednisone, you most likely won't need the extra steroid boost.

For Kyprolis

Kyprolis comes in a cake or powder form in a single-dose vial. It comes in three strengths: 10 mg, 30 mg, and 60 mg.

To decrease the chance of having an infusion reaction, your doctor will give you a steroid. You'll receive the steroid 30 minutes to 4 hours before your Kyprolis infusion. But if you're already taking a steroid such as dexamethasone, your doctor won't need to give you the extra dose.

Side effects and risks

Darzalex and Kyprolis can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Darzalex, with Kyprolis, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Darzalex, with Kyprolis, or with both drugs (when taken individually).

Effectiveness

Darzalex and Kyprolis have different FDA-approved uses, but they're both used to treat multiple myeloma.

The use of Darzalex and Kyprolis for multiple myeloma hasn't been directly compared in clinical studies. However, studies have found both Darzalex and Kyprolis to be effective for treating multiple myeloma.

Researchers are now studying the use of the two drugs together with dexamethasone to treat this type of cancer. The results have showed that people who had already been treated for multiple myeloma responded well to the combination treatment. But more tests are needed before the FDA can approve a combination treatment of Darzalex and Kyprolis for multiple myeloma.

Costs

Darzalex and Kyprolis are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Darzalex generally costs less than Kyprolis. The actual price you'll pay for either drug will depend on your insurance plan and your location.

Multiple myeloma is a cancer that starts in a type of white blood cell called a plasma cell. Plasma cells make up a part of your immune system and help fight infections in your body.

Sometimes sudden changes in your genes, called mutations, can turn healthy cells into cancerous ones. (Genes are a set of instructions that help control the way your cells grow and behave). When plasma cells change into multiple myeloma cells, they start to build up in bone marrow (the insides of your bones). As multiple myeloma cells grow and spread, they can crowd out healthy cells and damage bone around them.

Darzalex is a man-made drug called a monoclonal antibody. (Monoclonal antibodies are proteins in your immune system. They're designed to target and attack a specific part of a cancer cell.)

When plasma cells turn into multiple myeloma cells, they develop a large amount of a protein called CD38 on their surface. The monoclonal antibody Darzalex works by attaching to the CD38 protein on the multiple myeloma cell. By doing this, Darzalex directly kills or helps your immune system destroy the multiple myeloma cell.

How long does it take to work?

In clinical studies, the average time it took Darzalex to start working was 1 month. However, you may be given your doses over a longer period of time. This depends on how your body responds to Darzalex and if your multiple myeloma starts to get worse. The length of treatment also depends on if your multiple myeloma is newly diagnosed or if you've already had treatments in the past.

There aren't any known interactions between Darzalex and alcohol. But it's recommended that you avoid consuming alcohol while taking Darzalex. This has to do with how long it takes to receive the medication.

Darzalex is given as intravenous (IV) infusion. This is an injection into your vein that's given over a period of time. Infusions of Darzalex can last from 3 to 7 hours. So it's important to stay hydrated before and during your infusions. Alcoholic drinks can make you dehydrated, so avoid alcohol while taking Darzalex.

If you have questions about alcohol and Darzalex, ask your doctor.

Before taking Darzalex, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Darzalex and laboratory tests

Taking Darzalex can alter the results of certain lab tests.

Blood type lab errors

If you're taking Darzalex and have a blood test to match your blood type, the results may not be correct. Errors on these tests can last up to 6 months after your last dose of Darzalex.

Darzalex works by attaching to the CD38 protein on the surface of a multiple myeloma cell and damaging the protein. Sometimes red blood cells can also have CD38 proteins on them. Darzalex can accidently attach itself to a CD38 protein on a red blood cell instead of a multiple myeloma cell. When this happens, it changes the way a red blood cell "looks" on blood tests. However, Darzalex won't affect your blood type.

To avoid blood typing errors, your doctor will test your blood type before your first dose of Darzalex. They'll do this in case you need a blood transfusion in the future.

To receive your doses of Darzalex, you'll go to your doctor's office or an infusion center. The medication comes as a solution (liquid mixture). A healthcare provider will mix Darzalex with 0.9% sodium chloride (a type of saltwater solution). Then they'll give you this medication over time through a needle that's placed in your vein. This is called an intravenous (IV) infusion. You may receive Darzalex by itself or with other treatments.

Your doctor will decide how much Darzalex to give you based on your weight and your specific treatment plan. A healthcare provider will always be monitoring you during the infusion time.

When to take

Your doctor will decide on the time between doses and how many treatments you'll need. This will be based on whether you're taking Darzalex alone or with other treatments. Ask your doctor to recommend the best day and time to get your infusions based on your daily routine.

How often you get Darzalex and the length of time of the infusion will decrease over time. Your first infusion of Darzalex may take about 7 hours. This is because your doctor will infuse the medication very slowly into your vein. Infusions in the future will take less time and last about 3 to 5 hours because you'll be getting the medication infused faster.

Taking Darzalex with food

Darzalex infusion times can range from 3 to 7 hours, depending on your treatment plan. That's why it's a good idea to come prepared with healthy snacks and drinks if it's OK with your doctor.

Darzalex hasn't been studied in pregnant women or animals. But Darzalex is a monoclonal antibody, which is a type of drug that targets cancer cells. And monoclonal antibodies are known to cross the placenta. (The placenta is an organ inside your womb that passes nutrients from your body to your baby.)

Based on the way Darzalex works, the medication may cause decreased bone density in an unborn baby. It may also decrease the amount of blood and immune cells that the growing baby makes.

Before you start to take Darzalex, be sure to tell your doctor if you're pregnant, may be pregnant, or plan to become pregnant.

Darzalex with lenalidomide or pomalidomide

Darzalex is sometimes taken with a drug called lenalidomide (Revlimid) or pomalidomide (Pomalyst) for multiple myeloma. Lenalidomide and pomalidomide both have a boxed warning* for severe and life-threatening birth defects. If you're a woman and your doctor prescribes Darzalex with lenalidomide or pomalidomide, you must not get pregnant:

  • for at least 4 weeks before starting treatment
  • while taking the treatment
  • during any pauses in treatment
  • for at least 4 weeks after stopping lenalidomide or pomalidomide

If you have questions about taking Darzalex, lenalidomide, or pomalidomide while pregnant, talk with your doctor.

* This is the most serious warning from the Food and Drug Administration (FDA).

If there's a chance that you could get pregnant, it's recommended that you use birth control while taking Darzalex. You should keep using birth control for 3 months after your Darzalex treatment is complete. This is because the drug can stay in your system for a short time after you stop taking it.

If you're a man and are sexually active with a woman, there's a chance for pregnancy to occur. Consider using a barrier method of birth control, such as a condom, even if your sexual partner is also using birth control.

Darzalex with lenalidomide or pomalidomide

In some cases, you may take Darzalex with medications called lenalidomide (Revlimid) or pomalidomide (Pomalyst). If you're a woman and are taking Darzalex with lenalidomide or pomalidomide, you must agree to use two forms of birth control. You'll need to start using birth control at least 4 weeks before you start treatment with the drugs. Keep using birth control while taking Darzalex and lenalidomide or pomalidomide, and during any pauses in treatment. You'll also need to keep using birth control for at least 4 weeks after you stop taking lenalidomide or pomalidomide.

Lenalidomide and pomalidomide can pass into human semen. So all men should use a latex or synthetic condom when sexually active with a woman who can become pregnant. Men should use this method of birth control for the same period of time that their sexual partner is taking birth control.

If you're sexually active and you or your sexual partner can become pregnant, talk with your doctor. They can help you decide on your birth control needs while you're using Darzalex.

It's not known if Darzalex can pass into breast milk or how the drug can affect breast milk. It's also not known if Darzalex can affect a breastfed child.

Darzalex with lenalidomide or pomalidomide

In some cases, you may take Darzalex with medications called lenalidomide (Revlimid) or pomalidomide (Pomalyst). If you're a woman who's breastfeeding, you shouldn't use lenalidomide or pomalidomide. It's not known if this medication could pass into your breast milk and harm your baby.

If you want to breastfeed your child and are thinking about taking Darzalex, talk with your doctor. They can tell you about the pros and cons of using this medication while breastfeeding.

Here are answers to some frequently asked questions about Darzalex.

Why do I need to take steroids and other medications at my appointments for Darzalex infusions?

When you receive Darzalex, you may have an allergic reaction. To help prevent this, your doctor may give you medications called corticosteroids and other drugs.

A healthcare provider will give you Darzalex as an intravenous (IV) infusion in your doctor's office or a clinic. This is an injection into your vein that's given over a period of time. One to three hours before each Darzalex infusion, you'll usually receive the following drugs:

  • a corticosteroid (to reduce swelling)
  • an antipyretic (to prevent or reduce fever)
  • an antihistamine (to prevent or reduce the symptoms of allergic reactions)

You may also receive a corticosteroid 1 day after an infusion to avoid delayed reactions. But if you're already taking a steroid such as dexamethasone or prednisone, you most likely won't need the extra steroid boost.

If you have questions about any of the medications given with Darzalex infusions, ask your doctor.

Will I be able to drive myself home after my Darzalex infusion?

It's not recommended. This is because it's common to feel tired after an infusion or even have an infusion reaction. (See "Infusion reactions" in the "Side effect details" section above to learn more.) So to be safe, have a family member, friend, or caregiver drive you to and from your infusion appointments.

Pay attention to how you feel after your infusions and keep a diary of your symptoms. This can help you decide if you can drive yourself, if you ever need to.

In case you can't find a driver, Janssen Biotech, Inc., the manufacturer of Darzalex, may be able to help. You can talk with a Janssen CarePath coordinator about getting to and from your appointments and receiving help with the cost of travel. To learn more, call 844-553-2792 or visit the Darzalex website.

Can I use Darzalex if I've had shingles?

Yes, you can use Darzalex if you have had an infection called shingles. But before you take Darzalex, it's important to tell your doctor if you've ever had shingles or chickenpox. (The same virus that causes shingles can also cause chickenpox.)

If you've had chickenpox in the past, the virus doesn't leave your body after you recover from the infection. Instead, the virus just "goes to sleep" in your nerves.

No one knows exactly why, but the virus can reactivate or "wake up" with certain triggers such as a weak immune system. (Your immune system is your body's defense against infections.)

Cancer treatments such as Darzalex can weaken your immune system and reactivate the virus. When it awakens, it expresses itself as shingles instead of chickenpox.

So if you've had shingles or chickenpox, your doctor will prescribe an antiviral medication to prevent shingles from developing again in your body. You'll need to take the antiviral treatment within 1 week of starting to take Darzalex. Then you'll keep taking the antiviral for 3 months after you finish treatment with Darzalex.

If you're not sure whether you've had shingles or chickenpox, talk with your doctor.

Does Darzalex cure multiple myeloma?

Right now, there is no cure for multiple myeloma. But what Darzalex can do is improve your quality and length of life, depending on your diagnosis. Your doctor can tell you more.

Before taking Darzalex, talk with your doctor about your health history. Darzalex may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Hepatitis B. If you may have hepatitis B or have had it in the past, taking Darzalex may cause it to be active again. Before you start taking Darzalex, your doctor will check you for hepatitis B. They'll also check you after you've ended your treatment. Symptoms of hepatitis B include tiredness that gets worse, and a yellowish color of your skin and the white of your eyes. If you notice these symptoms, tell your doctor.
  • Shingles. While you're taking Darzalex, you could develop an infection called shingles. The same virus that causes shingles can also cause chickenpox. So if you've had chickenpox or shingles in the past and are taking Darzalex, your doctor may prescribe an antiviral medication. This type of drug may help prevent shingles from developing in your body.
  • Chronic obstructive pulmonary disease (COPD). If you have a history of a breathing disorder called chronic obstructive pulmonary disease (COPD), tell your doctor before you start taking Darzalex. They may give you an inhaler to help you breathe easier and corticosteroids to help reduce swelling in your lungs.
  • Pregnancy. Darzalex hasn't been studied in pregnant women. But it's a type of drug that may cross the placenta. (The placenta is an organ inside your womb that passes nutrients from your body to your baby.) For more information, please see the "Darzalex and pregnancy" section above.
  • Breastfeeding. It's not known if it's safe to breastfeed while taking Darzalex. For more information, please see the "Darzalex and breastfeeding" section above.

Tell your healthcare provider if you develop any of these conditions during or after treatment with Darzalex.

Note: For more information about the potential negative effects of Darzalex, see the "Darzalex Side Effects" section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

The Food and Drug Administration (FDA) has approved and indicated Darzalex for use:

  • In adults with newly diagnosed multiple myeloma who can't receive an autologous stem cell transplant. (With an autologous stem cell transplant, your own stem cells are used.) In this situation:
    • Darzalex may be used with the medications lenalidomide (Revlimid) and dexamethasone.
    • Darzalex may also be used with the medications bortezomib (Velcade), melphalan, and prednisone.
  • In adults who have received one or more previous treatments that didn't work well or whose multiple myeloma came back. In this situation, Darzalex is used with lenalidomide and dexamethasone.
  • In adults who have received one or more previous multiple myeloma treatment(s). In this situation, Darzalex is used with bortezomib and dexamethasone.
  • In adults who have received two or more previous multiple myeloma treatments that included lenalidomide and a proteasome inhibitor, which is a type of drug. In this situation, Darzalex is used with the medications pomalidomide (Pomalyst) and dexamethasone.
  • In adults who have received three or more previous multiple myeloma treatments that included a proteasome inhibitor and an immunomodulatory medication. In this situation, Darzalex is used by itself.
  • In adults who have tried a proteasome inhibitor and an immunomodulatory medication but neither drug worked for multiple myeloma. In this situation, Darzalex is used by itself.

Mechanism of action

Darzalex is a monoclonal antibody and inhibits or destroys tumor cell growth of multiple myeloma cells. When plasma cells turn into multiple myeloma cells, they develop large numbers of surface proteins called CD38. Darzalex targets and attaches itself to these CD38 proteins. Through immune-mediated and direct on-tumor actions, Darzalex inhibits the growth of the multiple myeloma cell and starts the process of apoptosis (cell death).

Pharmacokinetics and metabolism

No clinically significant differences in the pharmacokinetics of Darzalex as monotherapy or as combination therapy were observed based on specific populations.

Following infusion of the recommended dosage of Darzalex alone or as combination therapy, blood concentrations of Darzalex were almost three times higher at the end of the weekly dosing in comparison to the first dose.

Splitting the first dose of Darzalex resulted in different blood concentrations than if a person received a first full dose. However, similar peaks and troughs of blood concentrations were seen and predicted after receiving a second split dose on week 1, day 2 of treatment.

When Darzalex was given alone, a steady blood concentration level (steady state) was reached about 5 months into the every 4-week dosing period (by the 21st infusion). At steady state, Darzalex mean accumulation ratio for the maximum blood concentration was 1.6.

Distribution:

  • monotherapy: 4.7 ± 1.3 L
  • combination therapy: 4.4 ± 1.5 L

Half-life elimination for monotherapy and combination therapy was 18 ± 9 days. Darzalex clearance decreased with increasing dose and with multiple dosing. Clearance was estimated to be 171.4 ± 95.3 mL/day. As body weight increased, the volume of distribution and the rate at which Darzalex was removed from the body increased.

Contraindications

Darzalex is contraindicated in patients with a history of severe anaphylactic reactions to daratumumab or any of the excipients of the drug formula. Severe cases of neutropenia, thrombocytopenia, or infusion reactions due to treatment may require Darzalex to be halted or permanently stopped.

Storage

Darzalex should be kept in a refrigerator at 36°F to 46°F (2°C to 8°C).

Do not shake or freeze Darzalex. The drug should be protected from light. Darzalex doesn't contain any preservatives.

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 other 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.