Darzalex Faspro Side Effects

Generic name: daratumumab / hyaluronidase

Medically reviewed by Drugs.com. Last updated on Nov 8, 2024.

Note: This document provides detailed information about Darzalex Faspro.

Applies to daratumumab / hyaluronidase: subcutaneous solution 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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest pain, chills, cough, dizziness or lightheadedness, fast heartbeat, fever, itching, nausea or vomiting, runny or stuffy nose, sore throat, or trouble breathing after receiving this medicine.

This medicine may cause serious skin reactions at or near the injection site. Tell your doctor right away if you have bruising, itching, redness, or swelling of the skin after you receive the injection. These reactions may occur more than 24 hours after receiving this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause serious heart problems (eg, cardiac toxicity) in patients with light chain amyloidosis (AL). Check with your doctor right away if you have chest pain or discomfort, fast or irregular heartbeat, swelling of the feet or lower legs, or trouble breathing.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor who treats you knows that you are receiving daratumumab and hyaluronidase-fihj combination injection. This medicine may affect the results of certain medical tests (eg, tests to determine your blood type). These effects may last up to 6 months after your last dose. Tell your doctor or other trained health professional that you are receiving this medicine before you receive a blood transfusion.

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:

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:

For healthcare professionals

Applies to daratumumab / hyaluronidase: subcutaneous solution.

General adverse events

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer