Darzalex Faspro Side Effects

Generic name: daratumumab / hyaluronidase

Medically reviewed by Drugs.com. Last updated on Nov 1, 2023.

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

Applies to daratumumab / hyaluronidase: subcutaneous solution.

Serious side effects of Darzalex Faspro

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

Other side effects of Darzalex Faspro

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): Decreased hemoglobin (42%), decreased leukocytes (65%), decreased lymphocytes (59%), decreased platelets (43%), neutropenia, thrombocytopenia^[Ref]

Hypersensitivity

Common (1% to 10%): 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, dehydration, hyperglycemia, hypocalcemia^[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

Upper respiratory tract infections included acute sinusitis, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, and upper respiratory tract infection.

Cough included cough and productive cough.

Pneumonia included lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, and pneumonia.

Dyspnea included dyspnea and dyspnea exertional.^[Ref]

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

Common (1% to 10%): Bronchitis, cough, dyspnea, pneumonia, pulmonary edema^[Ref]

Other

Fatigue included asthenia and fatigue.^[Ref]

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

Common (1% to 10%): Chills, herpes zoster, influenza, sepsis

Postmarketing reports: Cytomegalovirus, listeriosis^[Ref]

General

The most frequently reported side effect was upper respiratory tract infection.

Consult the manufacturer's prescribing information for information on side effects reported when using this drug in different drug combinations.^[Ref]

Nervous system

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

Cardiovascular

Serious cardiac disorders included arrhythmia, cardiac arrest, and cardiac failure.

Fatal cardiac disorders included cardiac arrest, cardiac failure, and sudden death.^[Ref]

Common (1% to 10%): Arrhythmia, atrial fibrillation, cardiac arrest, cardiac failure, fatal cardiac disorder, hypertension, hypotension, sudden death^[Ref]