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.
Zeposia (Ozanimod)
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Product Details
Description
Zeposia, known by the generic name Ozanimod, is a sphingosine 1-phosphate receptor modulator. This oral medication targets specific white blood cells to reduce their movement into the central nervous system. By restricting their travel, Zeposia helps lower inflammation and damage to nerve cells in patients. Zeposia uses include the treatment of relapsing forms of multiple sclerosis (MS), such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It's also indicated for treating moderately to severely active ulcerative colitis (UC).
F act Table
Formula
C23H24N4O3
License
US FDA (2020)
Bioavailability
~68% (oral)
Legal status
Prescription only (?)
Chemical Name
(S)-[2-(3-chlorophenyl)-2-hydroxyethyl]-1,1-dioxo-6-(2H-1,2,3,4-tetrazol-5-yl)-3,1-benzoxathiol-3-yl]-1-methyl-1H-indole-5-carboxamide
Elimination half-life
~19 hours (Ozanimod), ~11 days (active metabolite)
Dosage (Strength)
0.23 mg, 0.46 mg, 0.92 mg capsules
Pregnancy
Not recommended (Category D)
Brands
Zeposia
Protein binding
98.2% (Ozanimod), 99.8% (active metabolite)
PubChem CID
57379336
MedlinePlus
a620008
ChEBI
CHEBI:145849
ATC code
L04AA42
DrugBank
DB12364
KEGG
D10833
Routes of administration
Oral
Directions
Zeposia is taken orally with or without food. The usual approach to starting Zeposia involves a titration period, meaning the dose gradually increases over the first week to reach the maintenance dose. Patients usually begin with a lower dose and, over seven days, incrementally work their way up to the standard dosage of 0.92 mg daily. Always follow the instructions from a healthcare provider before starting treatment.
Ingredients
Zeposia capsules contain the active ingredient Ozanimod.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Individuals with a recent history of certain cardiovascular events, including myocardial infarction or stroke
- People who have experienced episodes of unstable angina or transient ischemic attack in the past six months
- Patients with hypersensitivity to Ozanimod or any component of the formulation
- Anyone currently taking monoamine oxidase inhibitors (MAOIs), as interactions can be severe
- Untreated sleep apnea
Cautions
- Before taking Zeposia, tell a healthcare provider about the following:
- Other medical conditions you may have
- All medications you are currently taking
- Any allergies you have
- If you are pregnant or breastfeeding
- Zeposia can make you more likely to get infections. Before starting treatment, you'll need a blood test to check your overall health. While on Zeposia, and for three months after stopping, watch out for signs of infection and report them to your doctor. It's best not to start Zeposia if you're currently fighting an infection.
- If you experience symptoms that might suggest a rare brain infection called PML (like unusual weakness, vision changes, or confusion), stop taking Zeposia and contact your doctor immediately.
- Zeposia can temporarily slow down your heart rate, especially when you first start taking it. Your doctor will check your heart with an ECG test before you begin Zeposia to make sure there aren't any pre-existing conditions that could be worsened. Sometimes, a heart specialist might need to be consulted.
- If there's significant liver damage while on Zeposia, the medication should be stopped. Liver function tests will be done before you start Zeposia to ensure your liver is healthy.
- If you're able to become pregnant, you should use effective birth control during your Zeposia treatment and for three months after the last dose because Zeposia could harm an unborn baby.
- Your blood pressure should be checked regularly while you're on Zeposia, as it may cause an increase in blood pressure.
- Zeposia might affect your lung function. If you have breathing issues or your doctor thinks it's necessary, you might undergo tests to check your lung function.
- If you notice any changes in your vision, an eye exam should be scheduled promptly. People with diabetes or a history of uveitis (eye inflammation) are at higher risk for a condition called macular edema and should have a thorough eye exam before starting Zeposia.
Side Effects
People taking Zeposia might catch more colds, feel dizzy when standing up too fast, experience back pain, headaches, or have higher liver enzyme levels which could indicate liver irritation. It can also cause symptoms of a urinary tract infection, like painful or frequent urination, and raise your blood pressure.
Serious Zeposia side effects include liver issues, with doctors monitoring liver function closely. Look out for symptoms like nausea, yellowing of the skin or eyes, and stomach pain. High blood pressure, breathing difficulties, and macular edema affecting vision are also risks. A rare but serious condition, PRES, involves swelling in the brain and could lead to a stroke if untreated. Additionally, stopping Zeposia might worsen MS symptoms, so always consult a doctor before discontinuing.
References:
- Zeposia (Ozanimod) Product Monograph. Princeton, NJ: Bristol-Myers Squibb; 2023.
- Zeposia (Ozanimod) Drug Label Information. Princeton, NJ: Bristol-Myers Squibb; 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 : 13853
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