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.
Xospata (Gilteritinib)
Prescription Required
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Product Details
Description
Xospata (gilteritinib) is a medication prescribed to treat adults with relapsing or refractory acute myeloid leukemia.
Xospata is available in 40 mg oral tablets.
Fact Table
Formula
C29H44N8O3
License
US FDA, EMA
Bioavailability
67.8%
Legal status
Prescription only (Rx)
Chemical Name
Gilteritinib
Elimination half-life
113 hours
Dosage (Strength)
40 mg tablets
Pregnancy
Consult a doctor
Brands
Xospata
Protein binding
~94%
PubChem CID
56965905
MedlinePlus
a618028
ChEBI
CHEBI:133015
ATC code
L01XE56
DrugBank
DB12054
KEGG
D10340
Routes of administration
Oral
Directions
Take Xospata exactly as prescribed by your doctor. Your doctor will determine an appropriate treatment regimen for you.
The recommended dose is 120 mg by mouth one time a day.
Carefully read the medication guide that comes with your prescription for product use information. Talk to your doctor or pharmacist about any questions or concerns you may have.
Ingredients
The active ingredient in Xospata is gilteritinib.
Inactive ingredients include ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, mannitol, magnesium stearate, polyethylene glycol, talc, and titanium dioxide.
Contraindications
Patients with an allergy to gilteritinib or to any of the other ingredients in Xospata should not take it, as anaphylaxis has occurred during clinical trials.
Cautions
- Xospata contains the following FDA Boxed Warning:
- Symptoms of differentiation syndrome can occur and can result in death if left untreated. Corticosteroid therapy and hemodynamic monitoring should be started if differentiation syndrome is suspected.
- Before you begin treatment with Xospata, tell your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Xospata is associated with the following warnings and precautions:
- Posterior reversible encephalopathy syndrome
- Prolonged QT interval, which is an abnormal heart rhythm
- Pancreatitis
- Harm to an unborn baby; effective contraception is recommended for females of childbearing potential during treatment with Xospata and for 6 months after taking the final dose. Males with female partners who are of childbearing potential are recommended to use effective contraception during treatment with Xospata and for 4 months after the final dose.
- Breastfeeding is not recommended.
Side Effects
Increased liver enzymes, muscle and joint pain, fatigue, general discomfort, fever, sore and inflamed mouth or gut, swelling, rash, noninfectious diarrhea, shortness of breath, nausea, cough, constipation, eye disorders, headache, dizziness, low blood pressure, vomiting, and kidney problems are common Xospata side effects; however, other side effects may also occur. Immediately inform your doctor of any side effects that bother you or won’t go away.
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Reference
Xospata. Northbrook, IL: Astellas Pharma US, Inc.; 2022.
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 : 14606
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