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Darzalex Faspro Side Effects

Generic name: daratumumab / hyaluronidase

Medically reviewed by Drugs.com. Last updated on Apr 11, 2021.

Note: This document contains side effect information about daratumumab / hyaluronidase. Some of the dosage forms listed on this page may not apply to the brand name Darzalex Faspro.

For the Consumer

Applies to daratumumab/hyaluronidase: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, daratumumab / hyaluronidase may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking daratumumab / hyaluronidase:

More common

  • Bladder pain
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blue lips and fingernails
  • blurred vision
  • body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chest pain, discomfort, or tightness
  • confusion
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness or lightheadedness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • facial swelling
  • fainting
  • fast or irregular heartbeat
  • fever or chills
  • frequent urge to urinate
  • headache
  • increased sweating
  • itching
  • loss of voice
  • nausea or vomiting
  • nervousness
  • painful blisters on the trunk of the body
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • runny or stuffy nose
  • sore throat
  • swelling in the legs, ankles, or feet
  • tingling of the hands or feet
  • trouble breathing
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss

Incidence not known

  • Bloating
  • darkened urine
  • difficulty swallowing
  • hives
  • indigestion
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of daratumumab / hyaluronidase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • constipation
  • diarrhea
  • difficulty in moving
  • loss of appetite
  • muscle pain or stiffness
  • pain in the joints
  • rash
  • sleeplessness
  • stomach pain
  • trouble sleeping
  • unable to sleep

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.