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Daratumumab / hyaluronidase Side Effects

For the Consumer

Applies to daratumumab/hyaluronidase: subcutaneous solution

Warning

This medicine may harm an unborn baby. Use effective birth control to prevent pregnancy while using daratumumab and hyaluronidase and for at least 3 months after your last dose.

Carefully follow all instructions about the use of birth control while you are using daratumumab and hyaluronidase in combination with other medicines.

Get emergency medical help if you have signs of an allergic reaction: itching, hives; runny or stuffy nose, fever, chills, headache, nausea, vomiting; throat irritation, cough, chest pain, fast heartbeats, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • easy bruising, unusual bleeding, purple or red spots under your skin;

  • right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;

  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

  • a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • itching, swelling, bruising, or redness where the medicine was injected;

  • nausea, vomiting, diarrhea, constipation;

  • fever, low blood cell counts;

  • trouble breathing, lung infection;

  • numbness, tingling, or burning pain in your hands or feet;

  • feeling tired;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • muscle spasm, back pain; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to daratumumab / hyaluronidase: subcutaneous solution

Hematologic

Very common (10% or more): Neutropenia, thrombocytopenia[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity and systemic administration reactions (11%)

Postmarketing reports: Anaphylactic reaction[Ref]

Local

Common (1% to 10%): Injection-site reaction, peripheral edema[Ref]

Musculoskeletal

Very common (10% or more): Back pain (10%)

Common (1% to 10%): Arthralgia, musculoskeletal chest pain, muscle spasms[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, hyperglycemia, hypocalcemia, dehydration[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Common (1% to 10%): Hepatitis B reactivation[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (24%)

Common (1% to 10%): Cough, pneumonia, dyspnea, pulmonary edema, bronchitis[Ref]

Other

Infectious:

Common (1% to 10%): Influenza, herpes zoster, sepsis[Ref]

General

Very common (10% or more): Fatigue (15%), pyrexia (13%)

Common (1% to 10%): Chills[Ref]

Nervous system

Common (1% to 10%): Dizziness, peripheral sensory neuropathy, paresthesia[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, atrial fibrillation[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (15%)

Common (1% to 10%): Nausea, constipation, vomiting, abdominal pain,

Postmarketing reports: Pancreatitis[Ref]

References

1. "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc., Horsham, PA, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.