Darzalex Faspro Side Effects

Generic name: daratumumab / hyaluronidase

Medically reviewed by Drugs.com. Last updated on Jan 28, 2024.

Note: This document provides detailed information about Darzalex Faspro Side Effects associated with daratumumab / hyaluronidase. Some dosage forms listed on this page may not apply specifically 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.

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]

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

• Very common (10% or more): Upper respiratory tract infection (24%)
• Common (1% to 10%): Bronchitis, cough, dyspnea, pneumonia, pulmonary edema^[Ref]

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]

Other

• 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]

Fatigue included asthenia and fatigue.^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (42%), decreased leukocytes (65%), decreased lymphocytes (59%), decreased platelets (43%), neutropenia, thrombocytopenia^[Ref]

Nervous system

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

Cardiovascular

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

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

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

Dermatologic

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

Gastrointestinal

• Very common (10% or more): Diarrhea (15%)
• Common (1% to 10%): Abdominal pain, constipation, nausea, vomiting
• Postmarketing reports: Pancreatitis^[Ref]

Further information

Darzalex Faspro side effects can vary depending on the individual. 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.

Medical Disclaimer