Darzalex is a brand-name IV infusion prescribed for multiple myeloma. Darzalex contains the active ingredient daratumumab.

Specifically, the Food and Drug Administration (FDA) has approved Darzalex to treat multiple myeloma in certain situations in adults. Multiple myeloma is a type of bone marrow cancer.

Drug details

The following list highlights key information about Darzalex.

Darzalex vs. Darzalex Faspro

Darzalex and Darzalex Faspro both contain the active ingredient daratumumab. But Darzalex Faspro also contains hyaluronidase-fihj. Darzalex is an IV infusion, while Darzalex Faspro is a subcutaneous injection.

Both medications are used to treat certain types of multiple myeloma, but Darzalex Faspro is also used to treat light chain amyloidosis.

This article focuses on Darzalex, not Darzalex Faspro. For more information about Darzalex Faspro, talk with your doctor or pharmacist.

Darzalex is a biologic medication (a drug made using living cells). It’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

A generic is an exact copy of the active ingredient in a brand-name medication that’s made from chemicals. A biosimilar is a similar version of the active ingredient in a brand-name biologic medication. It’s not possible to make exact copies of biologics. But biosimilars are considered to be just as safe and effective as their parent drug.

Like generics, biosimilars tend to cost less than brand-name medications.

Darzalex can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Darzalex. These lists do not include all possible side effects.

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Darzalex, you can do so through MedWatch.

Mild side effects

This section contains a partial list of mild side effects of Darzalex. To learn about other mild side effects, talk with your doctor or pharmacist or view Darzalex’s prescribing information.

Mild side effects of Darzalex can include:

  • upper respiratory infections, such as the common cold
  • cough
  • fever
  • shortness of breath
  • nausea and vomiting
  • diarrhea or constipation
  • fatigue or weakness
  • mild infusion reactions, such as nausea, stuffy nose, rash, or fever
  • peripheral edema (fluid buildup that causes swelling of the ankles, feet, or hands)
  • peripheral sensory neuropathy (nerve damage that causes tingling, numbness, or pain in the legs, feet, arms, or hands)

Most of these side effects may go away within a few days to a couple of weeks. However, if they become 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 or your local emergency number if your symptoms feel life threatening, or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • severe infusion reactions, which may include symptoms such as:
    • trouble breathing
  • neutropenia (low level of white blood cells), which may include symptoms such as:
    • fever
    • frequent infections
  • thrombocytopenia (low level of platelets, which are cells that help blood form clots), which may include symptoms such as:
    • bruising easily
    • unusual bleeding
  • serious infections such as pneumonia or sepsis, which may include symptoms such as:
    • trouble breathing
    • cough
    • fever or chills
ALLERGIC REACTION

For some people, Darzalex can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Darzalex, your doctor may recommend taking a different medication instead.

As with all medications, the cost of Darzalex can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons: You can visit Optum Perks for price estimates of Darzalex. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

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.

A program called Darzalex withMe is available for Darzalex. For more information and to find out if you’re eligible for support, call 833-565-9631 or visit the program website.

Learn more about saving money on prescriptions.

Generic or biosimilar version: Darzalex is a biologic medication (a drug made using living cells). It’s not available in a generic or biosimilar form.

A generic is an exact copy of the active ingredient in a brand-name medication that’s made from chemicals. It’s not possible to make exact copies of biologics. A biosimilar is similar to the active ingredient in a brand-name biologic medication. It’s considered to be just as safe and effective as the parent drug.

Like generics, biosimilars tend to cost less than brand-name medications.

The Food and Drug Administration (FDA) approves prescription drugs such as Darzalex to treat certain conditions. Darzalex may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Darzalex for multiple myeloma

Darzalex is FDA approved to treat multiple myeloma in certain situations in adults.

Multiple myeloma is a type of cancer that affects plasma cells (a type of white blood cell) in your bone marrow. Plasma cells usually produce antibodies that help your body fight infections. But with multiple myeloma, cancerous plasma cells develop. These are called myeloma cells.

Myeloma cells multiply rapidly, forming tumors and crowding out healthy blood cells from your bone marrow. They also make abnormal antibodies, called M proteins, that don’t work to fight infections and can damage your kidneys and bones.

Symptoms of multiple myeloma can include:

  • bone pain, especially in your back, hips, or ribs
  • fatigue
  • shortness of breath
  • frequent infections
  • unusual bruising or bleeding
  • dizziness
  • headache
  • weak bones that fracture easily

Darzalex can be used to treat multiple myeloma that’s newly diagnosed, hasn’t responded to (improved with) other treatments, or has relapsed (come back) after other treatments.

For this purpose, Darzalex may be prescribed by itself or with other drugs for multiple myeloma. Examples of other drugs that may be used with Darzalex include:

The specific treatment used depends on your personal situation. You can learn more in this Darzalex for multiple myeloma article. You can also learn more by visiting our cancer hub.

Darzalex and children

Darzalex is not FDA-approved for use in children. It’s not known if the drug is safe or effective in this age group.

Before starting Darzalex treatment, talk with your doctor and pharmacist. Tell them 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.

Interactions with medications, foods, and supplements

Darzalex is not known to interact with other medications, herbs, supplements, or foods. The manufacturer did not list any of these interactions in the drug’s prescribing information.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Darzalex.

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

Below is a list of lab tests and vaccines that can interact with Darzalex. This list does not contain all lab tests and vaccines that may interact with Darzalex. If you have questions about interactions that may affect you, ask your doctor or pharmacist.

Lab tests or vaccines that can interact with Darzalex include:

  • Live vaccines such as the chickenpox vaccine (Varivax), measles, mumps, and rubella (MMR), or nasal spray flu vaccine (FluMist).
  • Certain blood tests for M protein (a protein made by myeloma cells) used to monitor multiple myeloma.

Alcohol interaction

Alcohol is not known to interact with Darzalex. However, alcohol and Darzalex can cause some similar side effects, such as nausea, dizziness, and dehydration. So if you drink alcohol during your Darzalex treatment, you may be more likely to have these side effects or they may worsen.

If you have questions about the safety of drinking alcohol while taking Darzalex, talk with your doctor or pharmacist.

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

  • your body weight
  • past treatments you have had for multiple myeloma
  • if you are having or have had an autologous stem cell transplant
  • other multiple myeloma treatments you’re having with Darzalex
  • other medical conditions you may have

The following information describes doses that are commonly used or recommended. However,your doctor will determine the best dosing schedule to fit your needs.

Drug forms and strengths

Darzalex comes as a liquid solution in single-dose vials. It’s given by intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time.

Two strengths of Darzalex are available:

  • 100 milligrams in 5 milliliters of solution (100 mg/ 5mL)
  • 400 mg/20 mL

Dosage for multiple myeloma

The recommended dose of Darzalex is usually 16 mg per kilogram (mg/kg) of body weight. (1 kg is about 2.2 pounds [lb].)

For example, a typical dose for a person weighing 70 kg (about 154 lb) would be 1,120 mg.

You’ll likely receive a dose of Darzalex weekly to begin with, followed by a dose every 2, 3, or 4 weeks, depending on your situation. Your doctor will prescribe the dosing schedule that’s right for you.

For more about recommended dosing schedules in specific situations, see this Darzalex dosage article.

How it’s given

A healthcare professional will administer Darzalex by IV infusion. You’ll typically receive your infusions in your doctor’s clinic or an infusion center.

You’ll be given other medications before and after each Darzalex infusion. These help prevent infusion reactions (side effects that can occur during or after the infusion). For example, you’ll likely be given:

If you have an infusion reaction, your doctor may slow down, pause, or stop your infusion, depending on the severity of your symptoms.

Darzalex infusions usually take about 7 hours to begin with. But later infusions may take less time, usually 3 to 5 hours, depending on whether you have reactions with your first infusions.

About receiving Darzalex

The following list highlights information about key dosage issues.

  • If you miss a dose: If you miss an appointment to receive a dose, call your doctor’s office right away to reschedule.
  • Length of use: Darzalex is meant to be used as a long-term treatment. If you and your doctor determine that Darzalex is safe and effective for you, you’ll likely take it long term.
  • Length of time to work: Darzalex starts working right away, but you might not notice this. Your doctor may order tests to check if Darzalex is working for you. In clinical trials, the average time it took for multiple myeloma to respond to Darzalex was about 1 month. Respond means signs of multiple myeloma are reduced or gone.

Darzalex is used to treat multiple myeloma, which is a type of cancer that affects plasma cells (a type of white blood cell) made in your bone marrow. The way Darzalex works is called its mechanism of action.

What happens with multiple myeloma

With multiple myeloma, cancerous plasma cells, called myeloma cells, develop in the bone marrow. These cells have large amounts of a protein called CD38 on their surface.

Myeloma cells multiply rapidly, forming tumors and crowding out healthy blood cells from your bone marrow.

What Darzalex does

Darzalex is a type of drug called a monoclonal antibody, which is a type of targeted cancer therapy. It works by attaching to the CD38 protein on myeloma cells.

When Darzalex attaches to the CD38 protein, it produces effects in the cells that directly kill them. It also acts as a marker that helps your immune system find and kill the myeloma cells.

By killing the myeloma cells, Darzalex helps slow or stop multiple myeloma from spreading and worsening.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Darzalex, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs may be alternatives to Darzalex:

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Darzalex and pregnancy

Darzalex may cause fetal harm. Your doctor will likely not prescribe Darzalex if you are or could be pregnant.

Darzalex is sometimes used with other medications called lenalidomide (Revlimid), thalidomide (Thalomid), or pomalidomide (Pomalyst). If you are pregnant, your doctor will not prescribe Darzalex with these medications. These drugs have a boxed warning about the risk of severe and life threatening congenital anomalies (commonly called birth defects). A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication. Your doctor may suggest birth control options to use during treatment with Darzalex.

Darzalex and birth control

Darzalex is likely not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Darzalex.

Note: Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.

For females using Darzalex

If you’re able to become pregnant, you should use birth control throughout your Darzalex treatment and for 3 months after your last dose.

For males using Darzalex

Drazalex’s manufacturer doesn’t give birth control recommendations for males receiving Darzalex. If you have a sexual partner who’s able to become pregnant, talk with your doctor about whether you should use birth control during Darzalex treatment.

Darzalex and breastfeeding

You should not breastfeed while taking Darzalex. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication. Your doctor may recommend other ways to feed a child who is breastfed during treatment with Darzalex.

Here are answers to some frequently asked questions about Darzalex.

Is Darzalex chemotherapy?

No, Darzalex is not chemotherapy. Instead, it’s a type of targeted cancer therapy.

Chemotherapy is a cancer treatment that kills all rapidly multiplying cells in your body, including healthy cells and cancer cells. Targeted therapy, on the other hand, blocks specific proteins or processes that help cancer cells multiply rapidly, so it has less effect on healthy cells in your body.

Targeted therapies may cause fewer side effects than chemotherapy. But serious side effects are still possible with these drugs.

Keep in mind that you may receive Darzalex with chemotherapy to treat multiple myeloma. The specific regimen used depends on your personal situation. You can learn more in this Darzalex for multiple myeloma article.

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

Darzalex commonly causes infusion reactions, which are side effects that can occur during or soon after the infusion. They can be mild, serious, or even life threatening. Symptoms can include dizziness, fast heart rate, throat tightness, difficulty breathing, headache, itchiness, eye pain, and blurry vision.

You’ll be given other medications before and after each Darzalex infusion to help prevent infusion reactions or reduce their severity. For example, you likely be given:

If you have questions about other medications you receive at your appointments for Darzalex, talk with your doctor.

Does Darzalex cure multiple myeloma?

No, Darzalex doesn’t cure multiple myeloma. At this time, there isn’t a cure for this type of cancer.

Darzalex helps slow or stop multiple myeloma from spreading and getting worse. And some people may have a complete response to Darzalex. With a complete response, you have no symptoms of multiple myeloma, and blood and bone marrow tests show no signs of the disease. However, even with a complete response (which is also called remission), it is still possible for the multiple myeloma to come back.

In clinical trials, Darzalex was shown to increase the length of time you may live without your multiple myeloma getting worse or coming back.

Keep in mind that the results you have with Darzalex depend on many individual factors. These include whether your cancer is newly diagnosed or has come back, what other treatments you have, and whether you have side effects with the treatments.

Talk with your doctor to learn more about what to expect from Darzalex treatment.

Before taking Darzalex, discuss your health history with your doctor. Darzalex may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Darzalex, see the “Darzalex side effects” section or this Darzalex side effects article.

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.