Darzalex (Daratumumab)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Darzalex (daratumumab) is used to treat adults with multiple myeloma.
Fact Table
Formula
C6448H9964N1720O2016S40
License
US FDA, EMA
Bioavailability
Not applicable (IV and SC only)
Legal status
Prescription only (Rx)
Chemical Name
Daratumumab
Elimination half-life
18 days (range 5–23 days)
Dosage (Strength)
100 mg/5 mL or 400 mg/20 mL vials; SC: 1800 mg/15 mL (fixed dose)
Pregnancy
Consult a doctor (Category not assigned; potential risk)
Brands
Darzalex, Darzalex Faspro
Protein binding
Monoclonal antibody – IgG1? (specific binding)
PubChem CID
71245173
MedlinePlus
a616033
ChEBI
90841
ATC code
L01XC24
DrugBank
DB09302
KEGG
D10583
Routes of administration
Intravenous (IV), Subcutaneous (SC)
Directions
Your healthcare provider will determine a dose and treatment duration that’s appropriate for you.
Darzalex is administered via an intravenous infusion by your healthcare provider.
Tell your healthcare provider about any questions or concerns you may have.
Ingredients
Daratumumab is the active ingredient in Darzalex. Inactive ingredients may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.
Contraindications
Patients with an allergy to Darzalex should avoid its use.
Cautions
- Before you begin treatment with Darzalex, talk to your healthcare provider about:
- All the prescription and nonprescription medications you take
- Your allergies
- Your current health problems and past medical history
- If you are pregnant or breastfeeding
- Darzalex may cause the following:
- Infusion-related reactions
- Interference with cross-matching and red blood cell antibody screening
- A reduction in a type of white blood cell called neutrophils
- A reduction in platelet count
- Harm to an unborn baby: women are recommended to use effective contraceptive methods
Side Effects
Upper respiratory infection, low neutrophil count, infusion-related reactions, low platelet count, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, swelling, nausea, cough, fever, shortness of breath, and weakness are some common Darzalex side effects. Other side effects can also occur. Tell your healthcare provider right away if you have side effects that bother you or won’t go away.
Ask your healthcare provider about Darzalex.
Reference
Darzalex. Horsham, PA: Janssen Biotech, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14392
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