Darzalex Side Effects
Generic name: daratumumab
Note: This document provides detailed information about Darzalex.
Applies to daratumumab: intravenous solution Side Effects associated with daratumumab. Some dosage forms listed on this page may not apply specifically to the brand name Darzalex.
Applies to daratumumab: intravenous solution.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that the 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 an infusion reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest tightness, chills, cough, dizziness or lightheadedness, fast heartbeat, headache, hoarseness, itching, nausea or vomiting, runny or stuffy nose, a rash or hives, sore throat, swelling of the eyes, hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness while you are 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).
Daratumumab 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 using daratumumab (the active ingredient contained in Darzalex) This medicine may affect the results of certain medical tests including tests to determine your blood type. These effects may last up to 6 months after your last dose. Tell all of your healthcare providers that you are receiving this medicine before you receive a blood transfusion.
Serious side effects of Darzalex
Along with its needed effects, daratumumab 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:
More common side effects
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- body aches or pain
- chest pain or tightness
- chills
- confusion
- cough
- difficulty swallowing
- dizziness
- ear congestion
- facial swelling
- fast heartbeat
- fever
- headache
- hoarseness
- loss of voice
- nausea
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, lips, or tongue
- rapid, shallow breathing
- skin rash, hives, or itching
- slow or fast heartbeat
- sneezing
- sore throat
- stuffy or runny nose
- tingling of the hands or feet
- trouble breathing
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Less common side effects
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- painful blisters on the trunk of body
- sweating
Incidence not known
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- constipation
- coughing that sometimes produce a pink frothy sputum
- darkened urine
- lower back or side pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- swelling in the legs and ankles
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- yellow eyes or skin
Other side effects of Darzalex
Some side effects of daratumumab 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 side effects
- back pain
- burning, numbness, tingling, or painful sensations
- diarrhea
- difficulty with moving
- joint pain
- loss of appetite
- muscle pain or stiffness
- pain in the arms or legs
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
For healthcare professionals
Applies to daratumumab: intravenous solution.
Cardiovascular adverse events
- Very common (10% or more): Hypertension (10%)[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (27%), diarrhea (16%), constipation (15%), vomiting (14%)[Ref]
Hematologic
- Very common (10% or more): Lymphopenia (72%), neutropenia (60%), thrombocytopenia (48%), anemia (45%)[Ref]
Immunologic
- Common (1% to 10%): Pneumonia (e.g., streptococcal pneumonia, lobar pneumonia), herpes zoster reactivation[Ref]
Local
- Very common (10% or more): Infusion reaction (48%)[Ref]
Metabolic
- Very common (10% or more): Decreased appetite (15%)[Ref]
Musculoskeletal
- Very common (10% or more): Back pain (23%), arthralgia (17%), pain in extremity (15%), musculoskeletal chest pain (12%)[Ref]
Nervous system
- Very common (10% or more): Headache (12%)[Ref]
Respiratory
- Very common (10% or more): Cough (21%), upper respiratory tract infection (20%), nasal congestion (17%), dyspnea (15%), nasopharyngitis (15%), vomiting (14%)
- Common (1% to 10%): Bronchospasm, dyspnea, hypoxia
- Uncommon (0.1% to 1%): Allergic rhinitis allergic, throat irritation[Ref]
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References
1. (2015) "Product Information. Darzalex (daratumumab)." Janssen Biotech, Inc.
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Further information
Darzalex 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.