Skip to main content

Understanding DARZALEX and DARZALEX FASPRO

Page 1


The IMF InfoLine team is here to support you and your loved ones with the most up-to-date information about myeloma

Call the IMF InfoLine at 1.800.452.CURE (toll-free in the U.S. & Canada) or 1.818.487.7455 (worldwide), or email InfoLine@myeloma.org with your questions, or if you wish to discuss the contents of this booklet.

Want answers and don’t want to wait?

Get the answers you need anytime from Myelo® , your 24/7 generative AI assistant that is designed to support you living well with myeloma. Ask Myelo your questions at myeloma.org.

Join the Myeloma Knowledge Platform Visit myprofile.myeloma.org and create your online IMF account to receive the most helpful content recommendations tailored to support your personal myeloma experience.

You are not alone

The International Myeloma Foundation (IMF) is here to help you. We are committed to providing information and support for patients with multiple myeloma (which we refer to simply as “myeloma”) and their care partners, friends, and family members. The IMF supports the myeloma community with a broad range of resources available on our website myeloma.org, and through numerous programs and services such as publications, seminars, webinars, workshops, and the IMF InfoLine.

The IMF InfoLine

The IMF InfoLine responds to your myeloma-related questions and concerns in a compassionate and caring manner. To receive the most up-to-date information about myeloma, call 1.818.487.7455, email InfoLine@myeloma.org, or schedule a convenient time to talk with an IMF InfoLine Coordinator at mmsm.link/infoline.

IMF publications

Myeloma is a cancer that is not known to most patients at the time of diagnosis. If you have been diagnosed with myeloma or if you suspect that you might have myeloma, the IMF can help you become well-informed about this disease so that you can have an active role in your own medical care and make good decisions about it in partnership with your doctor.

We suggest that you read the IMF’s Patient Handbook, an introductory overview of myeloma diagnosis, effects on the body, risk stratification, treatment options, and key supportive care measures. The Patient Handbook will also direct you to other resources that may be helpful to you.

The IMF’s Understanding-series publications are intended to offer more detailed information about a broad range of myeloma-specific topics, including drugs and drug regimens, and the symptoms and side effects that can result from the myeloma itself and from its treatments.

All IMF publications are free-of-charge and can be read, downloaded, or requested in printed format at publications.myeloma.org. If you prefer to access any of the IMF’s publications or resources in electronic format, the light blue links will take you there.

Understanding myeloma vocabulary

Words in bold+blue in IMF publications are explained in a companion booklet, Understanding Myeloma Vocabulary. Myeloma is a complicated disease, but the language that describes it doesn’t have to be hard to understand. Being comfortable with myeloma-related terms is helpful to reading educational materials and to your discussions with your doctor. To read or download the electronic edition of Understanding Myeloma Vocabulary, visit glossary.myeloma.org.

What you will learn from this booklet

This booklet discusses Darzalex® (also known as daratumumab, its generic drug name) and its newer formulation, Darzalex Faspro® (daratumumab + hyaluronidase-fihj). You will learn how this medication works, who can be treated with it, how it is given, how to prevent or minimize potential side effects, and what assistance may be available to patients who are receiving Darzalex or Darzalex Faspro.

Darzalex and Darzalex Faspro

In November 2015, Darzalex became the first monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to target the CD38 protein on the surface of myeloma cells. Darzalex is administered as an intravenous (IV) infusion into a vein. The patient’s first infusion is usually given in a clinic over a period of up to 8 hours. The dose is calculated based on the patient’s weight.

In May 2020, the FDA approved Darzalex Faspro, a formulation that is given as a subcutaneous (SQ) injection under the skin of your abdomen. The injection is given by a healthcare professional at your doctor’s office or in a clinic, and it takes only 3 to 5 minutes. The dose is a fixed amount of medication; Darzalex Faspro does not need to be calculated based on the patient’s weight.

Darzalex and Darzalex Faspro have been shown to be equally effective, but the chances of having a bad reaction to the treatment is different with each formulation. For example, the rate of infusion-related reactions (IRR) demonstrated in clinical trials with Darzalex Faspro is 13%. However, IRR with Darzalex is 34%.

How Darzalex and Darzalex Faspro work

Antibodies, also called immunoglobulins (Ig), are a naturally occurring part of the human immune system. Darzalex is a laboratory-made monoclonal antibody designed to function like a naturally occurring antibody and to target a specific single protein on the surface of myeloma cells. This is called “targeted therapy.” Darzalex enlists the cells of the immune system to help attack and kill myeloma cells. The IMF’s publication, Understanding the Immune System in Myeloma, provides more detailed information about the impact of myeloma on the immune system.

Darzalex targets and binds to the CD38 protein (glycoprotein) on the surface of myeloma cells. “CD” in CD38 stands for “cluster of differentiation,” a system for identifying the various molecules that serve as binding sites. CD38 is found in very high amounts on the surface of myeloma cells but only in very low amounts on healthy cells in the bone marrow. Darzalex mostly attacks the cancer, making it easier for healthy cells to recover after treatment.

Darzalex kills myeloma cells directly, plus it attracts immune system cells that attach to the Darzalex-CD38 complex and kill myeloma cells. In addition, Darzalex recruits complement proteins that boost the killing power of antibodies, which punch holes in the targeted myeloma cells to kill them. Darzalex also inhibits CD38 from functioning as an enzyme that regulates calcium in the cell; blocking the transfer of calcium ions is toxic to cancer cells but spares normal cells.

FDA-approved treatment regimens Regimens with Darzalex IV

Please note that patients who began receiving Darzalex as an IV infusion can be transitioned to Darzalex Faspro SQ by their doctor.

For patients with newly diagnosed multiple myeloma (NDMM):

¡ Darzalex + Velcade® (bortezomib) + thalidomide + dexamethasone [DVTd] in patients with NDMM who are eligible for autologous stem cell transplant (ASCT).

¡ Darzalex + Revlimid® (lenalidomide) + dexamethasone [DRd] in patients with NDMM who are ineligible for ASCT.

¡ Darzalex + Velcade + melphalan + prednisone [DVMP] in patients with NDMM who are ineligible for ASCT.

For patients with relapsed or refractory multiple myeloma (RRMM):

¡ Darzalex + Revlimid + dexamethasone [DRd] in patients with RRMM who have received at least 1 prior therapy.

¡ Darzalex + Velcade + dexamethasone [DVd] in patients with RRMM who have received at least 1 prior therapy.

¡ Darzalex + Kyprolis® (carfilzomib) + dexamethasone [DKd] in patients with RRMM who have received 1 to 3 prior lines of therapy.

¡ Darzalex + Pomalyst® (pomalidomide) + dexamethasone [DPd] in patients with RRMM who have received at least 2 prior therapies including Revlimid + a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro® [ixazomib]).

¡ Darzalex monotherapy – In patients with RRMM who have received at least 3 prior lines of therapy, including a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro) and an immunomodulatory agent (Pomalyst, Revlimid, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

Regimens with Darzalex Faspro SQ

For patients with high-risk (HR) smoldering multiple myeloma (SMM):

¡ Darzalex Faspro monotherapy in adults with HR-SMM.

For patients with newly diagnosed multiple myeloma (NDMM):

¡ Darzalex Faspro + Velcade + Revlimid + dexamethasome [DVRd] in patients with NDMM who are eligible for ASCT, used for induction therapy and consolidation therapy.

¡ Darzalex Faspro + Revlimid + dexamethasome [DRd] in patients with NDMM who are ineligible for ASCT.

¡ Darzalex Faspro + Velcade + melphalan + prednisone [DVMP] in patients with NDMM who are ineligible for ASCT.

¡ Darzalex Faspro + Velcade + thalidomide + dexamethasone [DVTd] in patients with NDMM who are eligible for ASCT.

For patients with relapsed or refractory multiple myeloma (RRMM):

¡ Tecvayli® (teclistamab-cqyv) + Darzalex Faspro [ Tec-Dara] in patients with RRMM who have received at least 1 prior line of therapy.

¡ Darzalex Faspro + Revlimid + dexamethasome [DRd] in patients with RRMM who have received at least 1 prior therapy.

¡ Darzalex Faspro + Velcade + dexamethasone [DVd] in patients with RRMM who have received at least 1 prior therapy.

¡ Darzalex Faspro + Pomalyst + dexamethasone [DPd] in patients with RRMM who have received at least 1 prior line of therapy including Revlimid and a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro).

¡ Darzalex Faspro + Kyprolis + dexamethasone [DKd] in patients with RRMM who have received 1 to 3 prior lines of therapy.

¡ Darzalex Faspro monotherapy in patients with RRMM who have received at least 3 prior lines of therapy, including a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro) and an immunomodulatory agent (Revlimid, Pomalyst, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

Combination therapies

Darzalex IV and Darzalex Faspro SQ are usually used in combination with other drugs. To learn more about these drugs, read the following IMF publications:

¡ Understanding Dexamethasone in the Treatment of Myeloma

¡ Understanding KYPROLIS® (carfilzomib)

¡ Understanding POMALYST® (pomalidomide)

¡ Understanding REVLIMID® (lenalidomide)

¡ Understanding TECVAYLI® (teclistamab-cqyv)

¡ Understanding Thalidomide Therapy

¡ Understanding VELCADE® (bortezomib)

¡ Understanding the VRd Regimen for Newly Diagnosed Myeloma

Clinical trial experience with Darzalex

A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. Each clinical trial is designed to find better ways to prevent, detect, diagnose, or treat a medical problem and to answer scientific questions. A clinical trial is launched only after laboratory studies have demonstrated the potential of a treatment or procedure to be more effective and/or less harmful than previously existing methods. The goal of clinical trials is to improve patient care.

VRd vs. DVRd

In December 2019, at the annual meeting of the American Society of Hematology (ASH), the GRIFFIN phase II clinical trial of VRd vs. DVRd introduced the notion of adding Darzalex to the VRd combination. It did so in induction therapy and for 2 Cycles of consolidation therapy after ASCT.

In June 2022, the post hoc analysis of sustained minimal residual disease (MRD) from the GRIFFIN study was presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Data showed that the addition of Darzalex to VRd induction therapy and consolidation therapy, followed by Revlimid maintenance therapy, may lead to durable MRDnegativity in ASCT-eligible patients with NDMM, high-risk cytogenetics, ISS stage III myeloma, and those who achieve complete response (CR) or stringent complete response (sCR).

In December 2023, at the annual meeting of ASH, the primary results of the PERSEUS phase III study showed that DVRd significantly improved progression-free survival (PFS) in ASCT-eligible patients with NDMM and increased depth of response (DpR) across relevant study subgroups. These results support the use of DVRd followed by maintenance therapy with Darzalex + Revlimid [D-R] as a new standard of care for ASCT-eligible patients with NDMM when compared to VRd alone followed by maintenance with Revlimid.

Prior to the FDA approval, DVRd was included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of myeloma.

Tecvayli + Darzalex Faspro

In March 2026, the FDA approved the combination therapy of Tecvayli + Darzalex Faspro [ Tec-Dara] in patients with RRMM who have received at least 1 prior line of therapy. The application for FDA approval was granted priority review and was expedited. The approval is based on the efficacy of this combination evaluated in the MajesTEC-3 clinical trial.

A total of 587 patients were randomized to receive either Tec-Dara (291 patients) or the study investigator’s choice of treatment (296 patients

received either DPd or DVd). The major outcome measure was PFS, the length of time during and after treatment that a patient lives with the disease but the myeloma does not get worse. The benefit in the Tec-Dara group of patients was dramatic. At 3 years, PFS was 83.4% in the Tec-Dara group vs. 29% in the DPd/DVd group.

Overall survival (OS) was an additional efficacy outcome measure. Median PFS was not reached in the Tec-Dara group and was 18.1 months in the DPd/DVd group. Median OS was not reached in any study group.

Darzalex Faspro monotherapy for HR-SMM

In November 2025, the FDA granted its first approval of a treatment for adult patients with HR-SMM based on data from the AQUILA clinical trial, which compared treatment with Darzalex Faspro for 3 years vs. active monitoring (observation) in 390 patients.

Patients randomized to the Darzalex group were treated once-weekly from weeks 1 to 8, once every 2 weeks from weeks 9 to 24, and once every 4 weeks starting with week 25 until 39 Cycles of treatment or up to 36 months or until diagnosis to myeloma or unacceptable toxicity.

Darzalex Faspro is approved for patients with HR-SMM; it is not approved for other risk categories of SMM. For more information, read the IMF’s publication Understanding MGUS and Smoldering Multiple Myeloma.

Finding a clinical trial to match your needs

Participating in a clinical trial may give you access to treatment that is not yet available outside of a study. If you have an interest in participating in a clinical trial, be sure to discuss with the doctor treating your myeloma all the potential risks and benefits that may apply to your particular case.

Clinical research in myeloma has become a robust field, with many studies enrolling patients. To help myeloma patients with personalized support for identifying and exploring clinical trial options across the U.S., the IMF has partnered with SparkCures. Visit myeloma.org/sparkcures or contact the IMF InfoLine for more information.

The U.S. government maintains the website clinicaltrials.gov, an online database of thousands of research studies from around the world. You may wish to also explore this resource. However, the U.S. government does not review or approve the safety and science of all the studies listed on this website.

For more information about what’s involved in study participation, read the IMF’s publication Understanding Clinical Trials in Myeloma.

Dose and schedule

Regimens with Darzalex Faspro SQ

Darzalex Faspro SQ can be given on the same schedule as Darzalex IV, but it is administered as an abdominal injection that takes only a few minutes. The risk of infusion-related reaction (IRR) is much lower with Darzalex Faspro SQ than with Darzalex IV, but patients are still monitored for a few hours after the first one or two doses.

The recommended dosage of Darzalex Faspro is 1,800 mg Darzalex + 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL) solution in a single-dose vial. Patients are pre-medicated with a corticosteroid, acetaminophen, and a histamine-1 receptor antagonist. Your doctor may also recommend medication you can take after your injection.

Regimens with Darzalex IV

Since the FDA approval of Darzalex Faspro SQ, very few patients are still receiving Darzalex IV. For those who are prescribed Darzalex IV, the first dose of is usually given over a period of up to 8 hours. Especially with the first dose, the slower the rate of infusion, the less likely it is that a patient will experience a severe IRR. If the first dose is well tolerated, subsequent doses may be given more rapidly at your doctor’s discretion.

Medications can be given before and after each Darzalex infusion to help prevent IRR. Splitting the first infusion of Darzalex over 2 consecutive days is called “split-dosing,” which is approved in the United States and in Europe. Split-dosing is not done with Darzalex Faspro SQ.

Special precautions

All treatments for myeloma require close monitoring. As documented in clinical trials with Darzalex or Darzalex Faspro, both drugs have the potential to cause Grade 3 or 4 side effects. A side effect is an unwanted or unexpected effect caused by a drug. In the U.S., the National Cancer Institute (NCI) toxicity is categorized as follows:

• Grade 0 – no symptoms,

• Grade 1 – mild symptoms,

• Grade 2 – moderate symptoms,

• Grade 3 – symptoms requiring treatment,

• Grade 4 – symptoms requiring urgent intervention,

• Grade 5 – symptoms resulting in death.

Infusion-related reaction (IRR) with Darzalex IV

Clinical trial data shows that IRR was documented in approximately 37% of patients during their first infusion of Darzalex IV, then 5% during the second infusion, and 6% during subsequent infusions. In contrast, systemic

administration-related reaction (ARR), a broader term that encompasses IRRs, was documented in approximately 7%–11% of patients receiving injections of Darzalex Faspro SQ.

Monoclonal antibodies, including Darzalex, may cause IRR by the release of cytokines, sometimes called cytokine release syndrome (CRS). Reactions are often flu-like, and include nasal congestion, fever, chills, cough, throat irritation, difficulty breathing, low blood pressure, nausea, and rash.

IRR occurred in 46% of patients in the registration trials for Darzalex. IRR was mostly mild to moderate and occurred mostly during the first infusion or within 4 hours after the first infusion. IRR occurred in 5% of patients during or after the second infusion, and in 4% with subsequent infusions. Severe IRR that required hospitalization occurred in 3% of patients. There were no life-threatening infusion reactions.

Prevention and treatment of IRR

To minimize the risk of IRR, all patients receive medication approximately 1 hour before every infusion of Darzalex IV. If dexamethasone is part of a patient’s treatment regimen, it may serve as pre-medication on days when Darzalex IV is given. If a reaction of any kind occurs during the administration of Darzalex, the infusion will be stopped. All patients also receive post-infusion medication to reduce the risk of delayed IRR.

In 2018, a clinical trial evaluated the use of montelukast as a pre-medication for Darzalex IV therapy. Patients who received montelukast 10 mg as premedication had lower IRR rates during the first infusion and the median duration of the first infusion was shorter. In 2022, a retrospective study evaluating the use of montelukast as a pre-medication for Darzalex IV determined that the rate of IRR was lower in patients receiving montelukast than patients who did not receive it.

Risk of herpes zoster infection

Herpes zoster (“shingles”) is caused by the reactivation of the varicellazoster virus (VZV), the same virus that causes varicella (“chickenpox”). A small percentage of patients in clinical trials with Darzalex developed reactivation of VZV, which frequently affects nerves.

Prevention and treatment of herpes zoster infection

All patients should receive preventive treatment with antiviral medication within 1 week after starting Darzalex and should continue taking an antiviral medication for 3 months following the last dose of treatment with Darzalex.

Risk of hepatitis B virus reactivation

Darzalex IV can cause the hepatitis B virus (HBV) to become active again. Reactivation has been reported in fewer than 1% of clinical trial participants, but there were fatal cases.

Prevention and treatment of HBV reactivation

HBV reactivation can occur at any treatment phase. Regular monitoring is required on a long-term basis. Ask your doctor if prevention strategies are recommended in your particular case.

Neutropenia, lymphopenia, thrombocytopenia

Neutropenia is a reduced level of neutrophils, a type of white blood cell necessary to combat bacterial infection. Lymphopenia (also called lymphocytopenia) is low levels of B cells, T cells, and natural killer (NK) cells.

Thrombocytopenia is a low number of platelets (thrombocytes) in the blood. The “normal” level varies from laboratory to laboratory. For example, at Mayo Clinic the “normal” level is ≥ 150,000 platelets per microliter of circulating blood. If the platelet count is less than 50,000, bleeding problems may occur. Major bleeding is usually associated with a reduction in count to less than 10,000 platelets.

Common abnormalities in laboratory blood tests (≥ 40%) with Darzalex Faspro are decreased leukocytes, decreased platelets, and decreased hemoglobin.

Prevention and treatment of low blood cell counts

Your doctor will use the complete blood count (CBC) test to monitor you during treatment. If your blood cell counts are low, your doctor will either hold your dose of Darzalex until your counts improve or will provide you with supportive care in the form of transfusions or medications that stimulate the formation of new blood cells.

Embryo-fetal toxicity

Females of reproductive potential and males with female partners of reproductive potential must use effective contraception during treatment. Ask your doctor how long to continue using effective contraception after the last dose of treatment is administered.

Interference with blood tests

Darzalex and Darzalex Faspro can interfere with red blood cell (RBC) antibody screening and with blood compatibility testing, including with cross-matching done prior to blood transfusions. If you might need a blood transfusion subsequent to the start of your treatment regimen, your doctor should have screened your blood before treatment and established your blood type. Blood banks should be informed that you have received Darzalex or Darzalex Faspro.

Darzalex has been known to interfere with the results of serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) tests used to monitor myeloma. This can lead to inaccuracies in blood test results for detecting complete response and disease progression. In 2018,

the FDA approved a new test for evaluating M-protein in serum by IFE for myeloma patients treated with Darzalex.

Hypersensitivity

Medication can produce an undesirable hypersensitivity reaction by the immune system. Your doctor will permanently discontinue Darzalex Faspro for life-threatening reactions. A mild hypersensitivity reaction may be uncomfortable, but a severe reaction may be damaging or fatal.

Possible common side effects

Common side effects that occurred in 20% or more of the patients in clinical trials include the following:

Fatigue

In the registration trials for Darzalex, 39% of the patients experienced fatigue, all but 2% of which was mild to moderate and did not limit the patients’ ability to care for themselves. Caution is advised if you are operating machinery, including automobiles. For more detailed information, please see the IMF publication Understanding Fatigue in Myeloma.

Prevention and treatment of fatigue

The effects of fatigue may be minimized by maintaining:

¡ A moderate level of activity.

¡ A healthy diet and proper fluid intake.

¡ A consistent sleeping schedule with enough rest.

¡ Regularly scheduled visits with your doctor or healthcare provider to discuss issues that may contribute to your fatigue.

¡ A careful review of the side effects of any other supplements and medications you are taking to ensure that they are not contributing to your fatigue.

Nausea

Approximately 25% of the patients in the registration trials had mild to moderate nausea. There were no cases of severe nausea.

Prevention and treatment of nausea

Pre- and post-infusion medications help to reduce the occurrence and severity of nausea. Your doctor may order an anti-nausea drug prior to your Darzalex infusion.

Back pain

Treatment-related (rather than myeloma-related) back pain can occur as a result of inflammatory cytokines released in reaction to the monoclonal antibody. Back pain may also occur when a patient receiving Darzalex has low levels of white blood cells (WBC) and develops an infection along

with body aches and pains. Of the 25% of patients who experienced back pain in the Darzalex registration trials, only 2% experienced back pain that was severe enough to limit their ability to care for themselves.

Prevention and treatment of back pain

Pre- and post-infusion medications can reduce or prevent infusion-related back pain. Consult your doctor, who will determine if you require medication.

Fever

An oral temperature greater than 100.4°F (38°C) needs to be further evaluated immediately. Fever can be a sign of the interaction of the monoclonal antibody with the immune system.

Prevention and treatment of fever

You can minimize the effects of fever in the following ways:

¡ Check your temperature twice a day if you feel warm.

¡ Notify your doctor immediately if you have a fever greater than 100.4°F (38°C).

¡ If your doctor’s office is closed and you are not able to reach your healthcare team, go to an emergency room (ER) or urgent care facility.

¡ Take medications to control the fever as directed by your doctor.

¡ To avoid dehydration, drink a lot of non-alcoholic and non-caffeinated liquids.

Your doctor may also do the following:

¡ Recommend medication to treat fever related to flu-like symptoms. Do not take any medication without first consulting a doctor familiar with your medical history.

¡ Prescribe antibiotics if you have a fever as a result of an infection. You may also be given a colony-stimulating factor (CSF) to stimulate the development and growth of white blood cells.

Cough

Cough can be best managed proactively with pre- and post-infusion medications. In general, maintaining good hydration, drinking hot liquids, taking lozenges, avoiding irritants in the air, and breathing warm steam from a shower or humidifier will help relieve your symptoms.

Prevention and treatment of cough

Cough can be best managed proactively with pre- and post-infusion medications. If you develop a cough as a result of an upper respiratory infection, your doctor will recommend medications, if appropriate, to treat the infection.

Respiratory problems

In the registration trials for Darzalex, 20% of the patients experienced an upper respiratory tract infection; all but 1% were mild to moderate. Upper respiratory tract infections can be a bacterial or viral infection of the nose, throat, sinuses, or larynx. Possible respiratory infections include lung problems such as pneumonia (an infection in one or both lungs). Shortness of breath is also a common side effect.

Prevention and treatment of upper respiratory tract infection

Report your symptoms to your doctor immediately. If your infection is serious and your white blood cell count is low, the doctor may hold your Darzalex infusion until you recover or support you with medications to stimulate the production of new white blood cells.

Peripheral neuropathy

Peripheral neuropathy (PN) is a serious condition that affects nerves in the hands, feet, lower legs, and/or arms. Symptoms of PN may include a feeling of numbness, tingling, burning, and/or pain. Myeloma patients may experience PN from the effects of the disease itself or from treatments for myeloma. Velcade, a drug that is part of many myeloma combination therapies, including regimens with Darzalex or Darzalex Faspro, is known to cause PN.

Prevention and treatment of PN

Velcade causes significantly less PN when it is administered as a subcutaneous (SQ) injection under the skin rather than Velcade administered as an intravenous (IV) infusion into a vein. In a French clinical trial that compared Velcade SQ to Velcade IV, only 6% of the patients who received Velcade SQ had PN of Grade 3 or 4, while 16% of the patients who received Velcade IV had Grade 3 or 4 PN.

Diarrhea

Diarrhea is defined as 3 or more loose stools per day. Severe diarrhea is defined as 7 or more loose stools per day. Dizziness, lightheadedness, or fainting may occur due to dehydration caused by either excessive or persistent diarrhea.

Prevention and treatment of diarrhea

Precautions should be taken to prevent dehydration. Ask your doctor how you can maintain an adequate level of hydration. Contact your doctor if you experience dizziness, lightheadedness, or fainting. Your doctor may administer antidiarrheal medication or intravenous fluids on an outpatient basis or may recommend hospitalization if needed.

Constipation

The medical definition of constipation is 3 or fewer bowel movements in 1 week. The stool may be hard, dry, and difficult to pass. You may also have stomach cramps and bloating. Not eating, not drinking enough water, and being less active can contribute to this problem.

Prevention and treatment of constipation

Report your constipation to your doctor and ask for instructions on drinking sufficient fluids and eating high-fiber foods. Try to be active every day, even if you exercise in a chair. Moving your body increases the rhythmic contractions that move food through your intestines.

Patient assistance

If you are prescribed Darzalex or Darzalex Faspro, you can sign up for the “DARZALEX withMe” program. Visit darzalex.com or call 1.833.565.9631

Monday–Friday, 8 a.m.–8 p.m. (ET) for access to a Care Navigator who can help guide you to support solutions throughout your treatment with Darzalex.

In closing

This booklet is not meant to replace the advice of your doctors and nurses who are best able to answer questions about your specific healthcare management plan. The IMF intends only to provide you with information that will guide you in discussions with your healthcare team.

To help ensure a good quality of life through effective treatment, you must play an active role in your own medical care. We encourage you to visit myeloma.org for more information and to join the IMF’s Myeloma Knowledge Platform at myprofile.myeloma.org.

To receive the most up-to-date information about myeloma in a caring and compassionate manner, call the IMF InfoLine at 1.818.487.7455, email InfoLine@myeloma.org, or visit mmsm.link/infoline to schedule a convenient time to talk with an IMF InfoLine Coordinator.

To get answers to your questions without having to wait, ask Myelo® anytime 24/7 at myeloma.org. This generative AI assistant is designed to help you find the right resources.

Use the hyperlinks and web addresses included in this publication for quick access to a variety of resources. Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, as well as alerts about IMF news, events, and actions.

Founded in 1990, the International Myeloma Foundation (IMF) is the world’s leading organization dedicated to multiple myeloma. The IMF is steadfast in its mission: improving the quality of life of myeloma patients while working toward prevention and a cure. The IMF serves people affected by myeloma at every stage of the disease.

The IMF combines world-class research, trusted education, global advocacy, and direct support. A cornerstone of this work is the IMF International Myeloma Working Group® (IMWG®), comprised of more than 350 renowned researchers and clinicians who establish the guidelines that shape how myeloma is diagnosed, treated, and managed worldwide.

The IMF ensures that scientific advances translate into better care and outcomes. Through the IMF InfoLine, educational programs, a global network of support groups, the 24/7 generative-AI myeloma assistant Myelo®, and our advocacy for healthcare access, the IMF helps people living with myeloma and their care partners navigate diagnosis and survivorship.

The IMF is driven by its vision of a world where every myeloma patient can live life to the fullest, unburdened by the disease.

Turn static files into dynamic content formats.

Create a flipbook
Understanding DARZALEX and DARZALEX FASPRO by International Myeloma Foundation - Issuu