DARZALEX FASPRO® Side Effects

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

Reactions to the injection

9% of 832 patients

In a safety analysis of patients from clinical studies, 9% of 832 patients taking DARZALEX FASPRO® by itself or in combination with other treatments experienced a reaction related to the injection, with most reactions being mild to moderate and occurring after the first injection.

Signs and symptoms of severe injection-related reactions included:
  • 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

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

3x fewer injection reactions

In a clinical study that compared DARZALEX FASPRO® (monotherapy) to the intravenous (IV) formulation of DARZALEX® (daratumumab) (monotherapy), 13% of the 260 patients who received DARZALEX FASPRO® experienced injection reactions (systemic) as compared to 34% of the 258 patients who received the IV formulation of DARZALEX®.

The most common side effects of DARZALEX FASPRO® are cold-like symptoms (upper respiratory infection). In addition, some patients may have skin reactions at or near the injection site (local). In a safety analysis of patients from clinical studies, 8% of patients had local injection-site reactions with injection site redness (erythema) being the most frequent.

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

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

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