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.
Istodax (Romidepsin)
Prescription Required
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Product Details
Description
Istodax is a prescription medication designed to treat specific types of cancer, including cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in adults who have undergone at least one prior systemic therapy. CTCL is a cancer affecting immune system cells.
The active component, romidepsin, is a histone deacetylase inhibitor (HDAC inhibitor). It functions by modifying gene expression, which kills cancer cells.
Fact Table
Formula
C24H36N4O6S2
License
US FDA
Bioavailability
Not applicable (administered intravenously)
Legal status
Prescription only (Rx)
Chemical Name
(1R,4E,7S,10S,16E,21R)-7-ethylidene-4,21-diisopropyl-3,11,18-trioxo-2-oxa-13,20-dithia-3,10,17,19-tetraazabicyclo[17.3.1]tricosa-4,16-diene-8,9,22-trione
Elimination half-life
3 hours
Dosage (Strength)
10 mg (lyophilized powder for injection)
Pregnancy
Contraindicated
Brands
Istodax
Protein binding
92-94%
PubChem CID
5352062
MedlinePlus
a610014
ChEBI
CHEBI:63915
ATC code
L01XX42
DrugBank
DB06830
KEGG
D06427
Routes of administration
Intravenous
Directions
Administer Istodax intravenously under the guidance of a healthcare provider. Istodax is only administered in a controlled healthcare setting.
The typical regimen includes infusions on days 1, 8, and 15 of each 28-day treatment cycle.
This cycle can be repeated depending on the patient's response and tolerance to the medication.
Ingredients
The active ingredient in Istodax is romidepsin.
Interactions
Tell your doctor or pharmacist if you are taking any of the following:
- Apalutamide
- Atazanavir
- Boceprevir
- Carbamazepine
- Clarithromycin
- Cobicistat
- Conivaptan
- Enzalutamide
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Lumacaftor
- Mitotane
- Nefazodone
- Nelfinavir
- Phenytoin
- Posaconazole
- Rifampin
- Ritonavir
- Saquinavir
- St John's Wort
- Telaprevir
- Telithromycin
- Tipranavir
- Voriconazole
Cautions
Note that Istodax can bind to estrogen receptors, potentially reducing the effectiveness of some birth control methods.
Be aware that Istodax may lower blood cell counts, increasing the risk of infections, bleeding, or anemia.
Pregnant or breastfeeding women should avoid Istodax due to potential harm to the baby. Use reliable contraception during treatment.
Before using Istodax, disclose any history of heart issues, liver problems, or electrolyte imbalances to your doctor.
Side Effects
Tell your doctor or healthcare team if you are experiencing any of the following:
- Anemia
- Asthenia
- EKG ST segment changes
- Epstein-Barr virus disease, Reactivation
- Fatigue
- Infectious disease
- Lymphocytopenia
- Loss of appetite
- Nausea
- Neutropenia
- Reactivation of hepatitis B viral hepatitis
- Sepsis
- Supraventricular arrhythmia
- Thrombocytopenia
- Tumor lysis syndrome
- Ventricular arrhythmia
- Vomiting
References
Istodax [package insert]. Cambridge, MA: Gloucester; 2009.
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 : 14617
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