Darzalex Faspro: Dosage, side effects, uses, interactions, and more

Specifically, the Food and Drug Administration (FDA) has approved Darzalex Faspro to treat multiple myeloma and amyloid light chain (AL) amyloidosis in certain adults. Multiple myeloma is a form of bone marrow cancer. AL amyloidosis is a condition in which abnormal proteins build up in your body. It’s sometimes associated with multiple myeloma.

Darzalex Faspro is a biologic medication that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Biologic drugs are made using living cells. It’s not possible to copy these drugs exactly, but biosimilar drugs can sometimes be made. A biosimilar is a drug that’s similar to a brand-name biologic drug (the reference drug). Biosimilars are considered to be as safe and effective as their reference drug.

A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active ingredient in a brand-name medication that’s made from chemicals.

Generics and biosimilars tend to cost less than brand-name medications.

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

Darzalex Faspro comes as a solution in a single dose vial. It’s given by subcutaneous injection (shot just under the skin).

Darzalex Faspro is available in one strength only. Each vial contains 1,800 milligrams (mg) daratumumab and 30,000 units hyaluronidase.

The recommended dose of Darzalex Faspro for multiple myeloma is 1,800 mg daratumumab and 30,000 units hyaluronidase (one injection). How often you’ll receive the injection depends on your situation and what other treatments you are having.

If you’re not having a stem cell transplant as part of your treatment, you’ll likely receive one injection of Darzalex Faspro weekly to begin with, followed by one injection once every 2 or 3 weeks. Then after a period of time, in most cases you’ll receive one injection once every 4 weeks as an ongoing treatment.

If you’re having a stem cell transplant as part of your treatment, you’ll typically receive a fixed number of doses of Darzalex Faspro. You’ll likely receive one injection of Darzalex Faspro weekly for 8 weeks, followed by one injection once every 2 weeks for 8 weeks. At this point you’ll usually receive your stem cell transplant. Then after the transplant you’ll likely receive one injection of Darzalex Faspro once every 2 weeks for a further 8 weeks.

Your doctor will prescribe the dosing schedule that’s right for you.

The recommended dose of Darzalex Faspro for AL amyloidosis is 1,800 mg daratumumab and 30,000 units hyaluronidase (one injection). You’ll typically receive one injection weekly for 8 weeks, then one injection every 2 weeks for 16 weeks. After this you’ll likely receive one injection once every 4 weeks.

Darzalex Faspro is given by subcutaneous injection into your abdomen. Your doctor or another healthcare professional will typically administer your injection over about 3 to 5 minutes. You’ll likely receive your injections in your doctor’s clinic or an infusion center.

Before and after each injection of Darzalex Faspro, you’ll also be given other medications. These help prevent reactions that can occur with the injection. For example, you’ll likely be given:

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

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

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Darzalex Faspro and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

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

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

For some people, Darzalex Faspro can cause an allergic reaction.

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

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 Faspro, your doctor may recommend a different medication instead.

The Food and Drug Administration (FDA) approves prescription drugs such as Darzalex Faspro to treat certain conditions. Darzalex Faspro 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 Faspro 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, abnormal plasma cells, called myeloma cells, develop in your bone marrow.

Myeloma cells multiply quickly and form tumors that prevent your bone marrow from making enough healthy blood cells. The myeloma cells also produce abnormal antibodies that don’t work to fight infections. These abnormal antibodies, called M proteins, can damage your bones and kidneys.

Darzalex Faspro 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. It can also be used to treat high-risk smoldering multiple myeloma. This is an early form of multiple myeloma that doesn’t usually have symptoms, but has a high risk of progressing to active multiple myeloma.

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

The specific treatment regimen your doctor prescribes will depend on your individual situation.

You can learn more about multiple myeloma and its treatment by visiting our cancer hub.

Darzalex Faspro is FDA-approved to treat amyloid light chain (AL) amyloidosis in adults. AL amyloidosis is a condition in which abnormal proteins build up in your body.

With AL amyloidosis, abnormal plasma cells (a type of white blood cell) develop in your bone marrow. These abnormal cells produce abnormal proteins called amyloids. The amyloid proteins build up and form deposits in organs such as the kidneys, liver, heart, spleen, nerves, or digestive system. The deposits can prevent these organs from working correctly.

AL amyloidosis is not a form of cancer, but it can sometimes be associated with multiple myeloma.

Darzalex Faspro can be used to treat AL amyloidosis that’s newly diagnosed. For this purpose, Darzalex Faspro is prescribed with other drugs for AL amyloidosis, called bortezomib (Velcade), cyclophosphamide, and dexamethasone.

Note that your doctor likely won’t prescribe Darzalex Faspro if you have certain forms of heart disease, unless this is part of a clinical trial.

Darzalex Faspro is not FDA-approved for any uses in children under 18 years old. It’s not known if the drug is safe or effective in this age group.

Darzalex Faspro 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 Faspro.

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

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

Alcohol is not known to interact with Darzalex Faspro. However, alcohol and Darzalex Faspro can cause some similar side effects, such as nausea, headache, and diarrhea. So if you drink alcohol while receiving Darzalex Faspro, 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 receiving Darzalex Faspro, talk with your doctor or pharmacist.

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

Financial and insurance assistance: If you need financial support to pay for Darzalex Faspro or help understanding your insurance coverage, help is available. A program called Darzalex withMe is available for Darzalex Faspro. For more information and to find out if you’re eligible for support, call 833-565-9631 or visit the program website.

Generic or biosimilar version: Darzalex Faspro is a brand-name biologic drug. It’s not available in a generic or biosimilar form. A generic drug is an exact copy of the active ingredient in a brand-name medication. A biosimilar is similar to a brand-name biologic drug (the reference drug). Generics and biosimilars tend to cost less than brand-name drugs.

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 Faspro, talk with your doctor. They can tell you about other medications that may work well for you.

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

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

In some cases, Darzalex Faspro may be used with other medications called thalidomide (Thalomid), lenalidomide (Revlimid), or pomalidomide (Pomalyst). However, 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 Faspro.

Darzalex Faspro is 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 options while you’re receiving treatment with Darzalex Faspro.

Note: The use of binary terms such as “male” and “female” or “men” and “women” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.

If you are able to become pregnant, your doctor will likely recommend that you use birth control during treatment with Darzalex Faspro and for 3 months after your last dose.

The manufacturer of Darzalex Faspro doesn’t give birth control recommendations for males receiving this treatment. 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 Faspro treatment.

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

Darzalex is used to treat multiple myeloma and amyloid light chain (AL) amyloidosis. Multiple myeloma is a type of cancer that affects plasma cells (a type of white blood cell) made in your bone marrow. AL amyloidosis is a condition in which abnormal proteins build up in your body. These conditions are sometimes related.

With both multiple myeloma and AL amyloidosis, your bone marrow makes abnormal plasma cells. These cells have large amounts of a protein called CD38 on their surface.

With multiple myeloma, the cancerous plasma cells multiply quickly and form tumors that prevent your bone marrow from making enough healthy blood cells.

With AL amyloidosis, the abnormal plasma cells produce abnormal proteins called amyloids. These build up and form amyloid deposits in organs such as the kidneys, liver, heart, spleen, nerves, or digestive system. The deposits prevent the organs from working correctly.

The way Darzalex Faspro works (its mechanism of action) is by attaching to and blocking the CD38 protein on the abnormal plasma cells. This action has effects that directly kill the abnormal plasma cells. It also helps your immune system to find and kill these abnormal cells.

By killing the abnormal plasma cells, Darzalex Faspro helps slow or stop multiple myeloma from spreading and worsening. With AL amyloidosis, killing the abnormal plasma cells stops them producing abnormal proteins. This reduces the build up of amyloid deposits and helps prevent organ damage.

Here are answers to some frequently asked questions about Darzalex Faspro.

Darzalex and Darzalex Faspro are both treatments for multiple myeloma. Darzalex Faspro is also used to treat amyloid light chain (AL) amyloidosis.

Darzalex is given by intravenous infusion (injection into a vein that’s given over a period of time). Darzalex Faspro is given by subcutaneous injection (injection just under the skin).

The active ingredient in both Darzalex and Darzalex Faspro is called daratumumab. Darzalex Faspro also contains another active ingredient called hyaluronidase-fihj. This ingredient is an enzyme (type of protein) that helps your body absorb daratumumab from under your skin.

Darzalex Faspro injections take much less time to administer than Darzalex infusions. They are also less likely to cause administration reactions (side effects that happen during or after the injection). Both medications are similarly effective at treating multiple myeloma.

To learn more about the difference between Darzalex and Darzalex Faspro, talk with your doctor.

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

Chemotherapy is a cancer treatment that kills all cells that are multiplying quickly in your body, including healthy cells as well as cancer cells. Targeted therapy, by contrast, blocks specific processes or proteins that help cancer cells multiply quickly. As a result, targeted therapy has less effect on healthy cells in your body.

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

Keep in mind that you may receive chemotherapy with Darzalex Faspro. The specific treatment regimen that your doctor prescribes will depend on your individual situation.

Darzalex Faspro is a type of targeted cancer therapy (see just above). But it also has some immunotherapy effects. Immunotherapy is a type of cancer treatment that helps your immune system to find and kill cancer cells.

Darzalex targets abnormal blood cells that have large amounts of a protein called CD38 on their surface. By attaching to the CD38 protein, Darzalex Faspro kills the abnormal cells. But it also marks the abnormal cells so that your immune system can more easily find and destroy them.

Before taking Darzalex Faspro, discuss your health history with your doctor. Darzalex Faspro 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 Faspro, see the “Darzalex Faspro side effects” section.

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.