DARZALEX contains the active ingredient daratumumab, an IgG1κ human monoclonal antibody that targets the CD38 antigen. It comes as an intravenous injectable solution in single-dose vials with various strengths: a 20 mL vial containing 400 mg and a 5 mL vial with 100 mg of daratumumab. Key inactive ingredients include glacial acetic acid, mannitol, and polysorbate 20.
How should I use this medication?
This medication is injected into a vein. It is given by your care team in a hospital or clinic setting. Talk to your care team about the use of this medication in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.
Where should I keep my medication?
This medication is given in a hospital or clinic. It will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
What side effects may I notice from receiving this medication?
Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell -Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded -Unusual bruising or bleeding Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Diarrhea -Fatigue -Nausea -Pain, tingling, or numbness in the hands or feet -Swelling of the ankles, hands, or feet
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What should I tell my care team before I take this medication?
They need to know if you have any of these conditions: -Hereditary fructose intolerance -Infection, such as chickenpox, herpes, hepatitis B -Lung or breathing disease, such as asthma, COPD -An unusual or allergic reaction to daratumumab, sorbitol, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding
What may interact with this medication?
Interactions have not been studied.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medication?
Your condition will be monitored carefully while you are receiving this medication. This medication can cause serious allergic reactions. To reduce your risk, your care team may give you other medication to take before receiving this one. Be sure to follow the directions from your care team. This medication can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after the final dose. Your care team will do blood tests to match your blood type before you start treatment. Tell all of your care team that you are being treated with this medication before receiving a blood transfusion. This medication can affect the results of some tests used to determine treatment response; extra tests may be needed to evaluate response. Talk to your care team if you wish to become pregnant or think you are pregnant. This medication can cause serious birth defects if taken during pregnancy and for 3 months after the last dose. A reliable form of contraception is recommended while taking this medication and for 3 months after the last dose. Talk to your care team about effective forms of contraception. Do not breast-feed while taking this medication.
Source: This information is sourced from Elsevier Inc.
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Prescription medications affect individuals differently, and what works for one person may not work for another. Always consult your doctor, pharmacist, or other qualified healthcare provider to ensure the information displayed applies to your personal circumstances. Only a licensed healthcare provider can advise you on what is safe and effective for you.
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