Caring for Yourself or a Loved One

Advice for caregivers

Giuseppe’s story

Watch how Giuseppe, a patient on DARZALEX FASPRO®, and his wife, Bernadette, handle living with multiple myeloma.

What is DARZALEX FASPRO®?

DARZALEX FASPRO® is a prescription medicine used to treat adult patients with multiple myeloma:

  • in combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
  • in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma
  • in combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
  • alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

It is not known if DARZALEX FASPRO® is safe and effective in children.

SELECT IMPORTANT SAFETY INFORMATION

Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX FASPRO®.

DARZALEX FASPRO® may cause serious reactions, including: serious allergic reactions and other severe injection-related reactions, injection site reactions, decreases in blood cell counts, and changes in blood tests.

Please see additional Important Safety Information at the end of this video.

The following is a testimonial from a patient successfully receiving DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). This patient received DARZALEX FASPRO® as monotherapy, which is indicated for patients who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.

Individual results may vary. Please talk to your doctor if you have any questions or think DARZALEX FASPRO® may be right for you.

VO: If you have recently been diagnosed with multiple myeloma, this is the start of your journey.

VO: Every journey with multiple myeloma is unique. It is important to discuss treatment with your doctor. A strong foundation and support system can help you get the most out of treatment.

VO: Giuseppe’s journey with multiple myeloma started when he was diagnosed after experiencing intense pain across his upper body.

GIUSEPPI: They did the test, and he said multiple myeloma, it’s a cancer. Cancer. It’s something you don’t want to hear, and you got to deal with it.

VO: A multiple myeloma diagnosis can be a difficult time for a patient and their family.

VO: Giuseppe and his wife, Bernadette, knew establishing a support system was critical to their treatment journey.

BERNADETTE: You need to have someone with you of support, because you may not understand, and you’re just so upset and not understanding everything that you need someone there for you to help explain it to you.

VO: Treatment is a shared decision. Giuseppe, Bernadette, and Giuseppe’s doctor were determined to find the appropriate course of action to treat his multiple myeloma.

VO: Giuseppe's doctor talked to him about the risks and benefits of his different options and recommended he join a clinical study for DARZALEX FASPRO®.

BERNADETTE: Our doctor told us about a clinical study for DARZALEX FASPRO® and said Giuseppe could be in it. He said it was an injection, and it was only 3 to 5 minutes. We thought that was great.

VO: DARZALEX FASPRO® is a prescription medicine used to treat a wide range of adult patients with multiple myeloma.

VO: Ask your doctor if DARZALEX FASPRO® may be right to treat your multiple myeloma.

VO: DARZALEX FASPRO® is given as an injection under the skin in your stomach area by a member of your healthcare team.

The injection takes approximately three to five minutes.

3 to 5 minutes refers to the time it takes to administer DARZALEX FASPRO® and does not account for all aspects of treatment.

VO: Your dosing schedule for DARZALEX FASPRO® depends on the regimen your doctor believes is right for you.

VO: When you first start treatment, you will receive DARZALEX FASPRO® every week. Over time, DARZALEX FASPRO® treatments are given once every 4 weeks.

VO: Your healthcare provider will give you medications before and after each dose to help reduce the risk of serious allergic reactions and other reactions due to the release of certain substances by your body, which are also known as systemic reactions.

After the injection, contact your doctor if you experience any side effects.

DARZALEX FASPRO® may cause serious reactions, including: serious allergic reactions and other severe injection-related reactions, injection site reactions, decreases in blood cell counts, and changes in blood tests.

VO: If you have multiple myeloma, ask your doctor today about how DARZALEX FASPRO® may be right for your treatment plan.

VO: A study confirmed that DARZALEX FASPRO®️ gave patients results comparable to intravenous daratumumab in treating multiple myeloma when used as monotherapy (by itself).

This study compared treatments in patients with multiple myeloma who received at least 3 prior medicines.

VO: Giuseppe responded well to treatment with DARZALEX FASPRO®.

Giuseppe: When I went to see the doctor after the injection, he said it was working.

VO: You may experience side effects from treatment. Side effects are an unwanted or unexpected reaction to a drug that can occur anywhere in the body due to the administration of treatment.

Among all patients who participated in DARZALEX FASPRO® clinical studies, 11% of the 490 patients taking DARZALEX FASPRO® by itself or in combination with other multiple myeloma treatments experienced a reaction related to the injection, with most reactions being mild to moderate and occurring after the first injection.

In these studies, 1.4% of the 490 patients experienced a severe injection-related reaction with DARZALEX FASPRO®. Signs and symptoms included: shortness of breath or trouble breathing, dizziness or lightheadedness (hypotension), cough, wheezing, throat tightness, runny or stuffy nose, headache, itching, nausea, vomiting, chills or fever, and chest pain.

In addition, some patients may have skin reactions at or near the injection site (local). In the pooled safety clinical trial, 8% of patients had local injection-site reactions with injection site redness (erythema) being the most frequent

DARZALEX FASPRO® may cause serious reactions including: serious allergic reactions and other severe injection-related reactions, injection site reactions, decreases in blood cell counts, and changes in blood tests.

VO: The most common side effects of DARZALEX FASPRO® when used alone include cold-like symptoms (upper respiratory infection).

The most common side effects of DARZALEX FASPRO® used in combination therapy include:
tiredness; nausea; diarrhea; shortness of breath; trouble sleeping; fever; cough; muscle spasms; back pain; vomiting; cold-like symptoms (upper-respiratory infection); nerve damage causing tingling, numbness, or pain; constipation; and lung infection (pneumonia).

VO: Giuseppe was able to find a treatment that was right for him.

Your journey with multiple myeloma is unique. Talk to your doctor today to see if DARZALEX FASPRO® is right for your treatment journey.

INDICATIONS

What is DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)?

DARZALEX FASPRO® is a prescription medicine used to treat adult patients with multiple myeloma:

  • in combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
  • in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma
  • in combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
  • alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

It is not known if DARZALEX FASPRO® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX FASPRO®.

Before you receive DARZALEX FASPRO®, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems
  • have had shingles (herpes zoster)
  • have ever had or might now have a hepatitis B infection as DARZALEX FASPRO® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX FASPRO®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of of your eyes
  • are pregnant or plan to become pregnant. DARZALEX FASPRO® may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX FASPRO®.
    • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of DARZALEX FASPRO®. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Before starting DARZALEX FASPRO® in combination with lenalidomide and dexamethasone, females and males must agree to the instructions in the lenalidomide REMS programs.
    • The lenalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
    • For males who have female partners who can become pregnant, there is information in the lenalidomide REMS about sperm donation and how lenalidomide can pass into human semen.
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO® passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

DARZALEX FASPRO® may cause serious reactions, including:

  • Serious allergic reactions and other severe injection-related reactions. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX FASPRO®. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of DARZALEX FASPRO®.
    • shortness of breath or trouble breathing
    • dizziness or lightheadedness (hypotension)
    • cough
    • wheezing
    • heart beating faster than usual
    • low oxygen in the blood (hypoxia)
    • throat tightness
    • runny or stuffy nose
    • headache
    • itching
    • high blood pressure
    • nausea
    • vomiting
    • chills
    • fever
    • chest pain
  • Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO®. Symptoms may include itching, swelling, bruising, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.
  • Decreases in blood cell counts. DARZALEX FASPRO® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with DARZALEX FASPRO®. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
  • Changes in blood tests. DARZALEX FASPRO® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX FASPRO®. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX FASPRO®. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® before receiving blood transfusions.

The most common side effects of DARZALEX FASPRO® when used alone include cold-like symptoms (upper respiratory infection).

The most common side effects of DARZALEX FASPRO® used in combination therapy include:

  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • trouble sleeping
  • fever
  • cough
  • muscle spasms
  • back pain
  • vomiting
  • cold-like symptoms (upper-respiratory infection)
  • nerve damage causing tingling, numbness, or pain
  • constipation
  • lung infection (pneumonia)

These are not all the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX FASPRO®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX FASPRO® that is written for health professionals.

Active ingredient: daratumumab and hyaluronidase-fihj

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, water for injection

Please click here to see the Product Information.

cp-143282v2

Talking to your family and friends

There’s no one “right” way to tell your family and friends that you have multiple myeloma. Here are some tips to help guide you:

Most people need and want to talk to someone when they find themselves dealing with cancer. Only you can decide when and how to tell your family and friends.

Before you talk to others, think through your own feelings, your reasons for telling them, and what you expect of them.

Telling those closest to you can help you take in the reality of what’s happening. As you talk, you may come up with other concerns that need to be addressed. Write down the questions that come up and discuss them with your healthcare team. Use our conversation starter to create a list of questions for your next appointment.

Some people are empowered by information, while it can make others feel anxious and overwhelmed. Keep this in mind as you share.

It might be helpful to explain what multiple myeloma is, what treatments you might need, and how to plan for the future.

It can get tiring to tell a lot of people details about your illness over and over again. There are websites specifically designed to help keep family and friends updated so you don’t have to spend hours phoning, texting, or emailing if you don’t want to.

You’ll probably have many different emotions when you hear your diagnosis and go through treatment. It’s normal to wonder, “Why me?” or to feel sad, angry, or afraid. Physical and chemical changes from the treatment or the cancer itself can also affect your emotions. So allow yourself to have those feelings.

Sometimes you may not want to talk about your feelings. You can tell others just by saying something like, “You know, I’m usually okay talking about this but just not today. I’m sure you understand.”

Many people have found that a counselor or support group can be a tremendous help during this difficult time.

Living with multiple myeloma and its treatment can affect family roles and routines. Talk with your family about the support you need. This way, you can make decisions as a team and work together.

Try not to put on a “happy face” if you don’t feel that way. Although you want to protect your loved ones by acting cheerful, it will help you and them more if you share how you feel.

If you’re afraid you’ll become a burden, talk with your doctor about what you can do, and try to keep up with your regular activities. You and your family should keep doing things you always enjoyed together. There are real benefits to keeping up your daily routine.

When people ask how they can help, you might respond, out of courtesy, “Oh, nothing right now. I’m just fine.” Remember that most people really do want to help, and it’s okay to ask for support.

When you do ask, be as specific as possible about the support you need. For example, tell them when you need a ride to the doctor, or ask if they might be able to help around the house, run errands, or walk the dog. There will also be times when you don’t know what you need, but even just saying that can provide perspective of how you’re feeling.

Make a comprehensive plan

It takes more than medicine to manage multiple myeloma. A holistic plan addresses more than just the symptoms and disease and takes care of your mind, body, and spirit. Here are some ideas that can help you get started:

There’s a powerful mind-body connection that may affect our health. In fact, research has shown that mindfulness meditation may help relieve anxiety, stress, fatigue, and sleep disturbances, and improve general mood and quality of life for people who suffer from cancer symptoms and treatment side effects. Mindfulness meditation is the practice of being in the present moment and can be learned on your own.

You should find a quiet space to meditate. You don’t need an entire room or a completely empty area. Just make sure there are no distractions such as the television, phone, or computer. Sit comfortably with your feet supported, your back comfortably straight (not rigid), and your hips higher than your knees. Allow your gaze to fall at a point a few feet in front of you, but do not focus on a particular object.

As you experience the moment, thoughts will come into your mind. They should be allowed to flow freely. If the thoughts become a central focus, gently bring your mind back to the moment. One way of doing this is to be aware of the sensation of your breathing and using this as an anchor for your mind to come back to should it wander. In the beginning of your practice, aim to sit for 10 to 15 minutes and build up to sitting for 45 minutes to 1 hour.

Taking care of your body

There is no “multiple myeloma diet.” However, a nutritious, well-balanced diet can help you stay as healthy as possible for as long as possible. Fresh fruits, vegetables, whole grains, and lean proteins, such as fish, poultry, or beans, are recommended. Limit your use of cream-based sauces, dressings, and dips, and avoid refined carbohydrates, such as pastries and sweetened breakfast cereals. Drink about 8 to 10 glasses of water a day.

It may be good to also discuss general diet with your doctor, even if there are no changes.

Regular exercise can help you reduce stress and relieve fatigue. Talk to your doctor before you start a new exercise program. Set goals to slowly increase your activity level. You may want to take a walk, do yoga, or try range-of-motion exercises to help reduce tiredness, relieve stress, and improve your sense of well-being.

Sleep problems are common during treatment for multiple myeloma. Experts say you should try to sleep 7 to 8 hours each night. Here are some tips that can help:

  • Avoid caffeine in coffee, tea, soda, or chocolate
  • Don’t exercise too late in the evening
  • If you nap, make it less than 30 minutes and do it early in the day
  • Avoid too much time in bed. It can make you weak

If you have trouble sleeping, talk to your doctor.

Understanding your emotions

Depending on how long you’ve been living with multiple myeloma and its treatment, you could feel anxious, afraid, uncertain, angry, or depressed. It’s normal to have any and all of these feelings. Your feelings may also change over time. That’s normal, too. Here are some things you can do to deal with your emotions:

  • Talk about your feelings with your family or friends
  • Keep a diary or journal
  • See a counselor and/or join a support group
  • Express your feelings in other ways, such as music, painting, or creative writing
  • Try meditation, deep breathing, and other relaxation exercises

Keeping up your daily routine

There’s no doubt that having multiple myeloma and going for treatments is going to disrupt your schedule. Try to live each day as normally as you can.

Think about how you want to spend your time. What makes you happy? What types of things do you enjoy the most? What gives you “purpose”? If you feel well enough, and with a doctor’s guidance, you may be able to continue to do what you did before your diagnosis and treatment, including:

  • Going to work
  • Spending time with family and friends
  • Taking part in activities
  • Going on trips

Working with your doctor: Shared decision making

Taking part in the decision-making process is one way to ensure that you get the best care for you. Studies have shown that shared decision making has numerous benefits. Among them:

  • Increased confidence and satisfaction with your treatment
  • Enhanced trust in your healthcare team
  • Decreased stress and anxiety regarding decisions

The key to shared decision making is having open discussions with your healthcare team. Here’s how you can start:

  • Express your desire to be involved in treatment decisions
  • Ask questions to understand your options
  • Let the doctor know your goals, values, and preferences
  • Ask for time if you need it (and if it’s appropriate)
  • Arrive at a treatment decision together

Remember, you are your own best advocate.