Learn about DARZALEX FASPRO® + VRd, the latest FDA-approved quad treatment combination for people with newly diagnosed multiple myeloma who are not eligible to receive a stem cell transplant

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DARZALEX FASPRO ® is now FDA approved as the first therapy for use alone to treat adults with high-risk smoldering multiple myeloma.

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Staying on TreatmentTreatment Side Effects

Treatment side effects

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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®. Your healthcare provider may temporarily stop or completely stop treatment with DARZALEX FASPRO® if you have a serious reaction. 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®. Signs and symptoms of serious allergic reactions include:

  • 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 or irritation
  • Runny or stuffy nose
  • Headache
  • Itching
  • High blood pressure
  • Eye pain
  • Nausea
  • Vomiting
  • Chills
  • Fever
  • Chest pain
  • Blurred vision

Skin reactions at or near the injection site (local), including injection-site reactions, can happen with DARZALEX FASPRO®. Symptoms may include:

  • Itching
  • Swelling
  • Bruising
  • Pain
  • Rash
  • Bleeding
  • Redness of the skin

These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.

In a safety analysis of patients from clinical studies, 8% of patients had local injection-site reactions with injection site redness (erythema) and injection site rash being the most frequent.

The most common side effects of DARZALEX FASPRO® when used alone include:

  • Cold-like symptoms (upper respiratory tract infection)
  • Muscle, bone, and joint pain
  • Tiredness
  • Diarrhea
  • Rash
  • Trouble sleeping, including sleep apnea and restless legs
  • Nerve problems, including increased or decreased sensitivity to touch, temperature, or pain; loss of smell; and numbness, tingling, or burning sensations
  • Injection site reactions

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

  • Tiredness
  • Nausea
  • Diarrhea
  • Shortness of breath
  • Trouble sleeping
  • Headache
  • Rash
  • Fever
  • Cough
  • Muscle spasms
  • Back pain
  • Vomiting
  • High blood pressure
  • Muscle, bone, and joint pain
  • Cold-like symptoms (upper respiratory infection)
  • Nerve damage causing tingling, numbness, or pain
  • Constipation
  • Lung infection (pneumonia)
  • Swollen hands, ankles, or feet
  • Decreased red blood cell counts

Tell your healthcare provider if you have any side effects that are bothersome or that do not go away.

These are not all of the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about side effects.

Have questions about treatment with DARZALEX FASPRO® ? See our FAQs.

Infections. DARZALEX FASPRO® can cause serious life-threatening infections that can lead to death. Tell your healthcare provider right away if you develop a fever, trouble breathing, cough, burning or pain when you urinate, or any other signs and symptoms of infection during treatment.

DARZALEX FASPRO® and DARZALEX® can also cause:

Changes in blood tests

DARZALEX FASPRO® and DARZALEX® 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®or DARZALEX®. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® or DARZALEX® before receiving blood transfusions.

Decreases in blood cell counts

DARZALEX FASPRO® and DARZALEX® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Decreases in blood cell counts are common with DARZALEX FASPRO® and DARZALEX® but can be severe. Your healthcare provider will check your blood cell counts during treatment. Tell your healthcare providers if you develop fever or have signs of bruising or bleeding.

You can watch real people who are being treated with DARZALEX FASPRO® or DARZALEX® talk about their experiences here.

See their stories
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