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.
Ponvory (Ponesimod)
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Product Details
Description
Ponvory, known generically as Ponesimod, belongs to a class of medications called sphingosine 1-phosphate receptor modulators. It works by reducing the number of lymphocytes (a type of white blood cell) circulating in the blood, which may decrease inflammatory responses and help control multiple sclerosis (MS). Doctors prescribe Ponvory to adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It's typically administered in tablet form for oral use.
Fact Table
Formula
C23H25ClN2O4S
License
US FDA (2021)
Bioavailability
84%
Legal status
Prescription only (?)
Chemical Name
(Z,Z)-5-[3-Chloro-4-[(2R)-2,3-dihydroxypropoxy]benzylidene]-2-propyl-1-(2-sulfanylphenyl)pyrrolidine-3,4-dione
Elimination half-life
33 hours
Dosage (Strength)
2 mg, 4 mg, 10 mg, 20 mg tablets
Pregnancy
Not recommended (Category X)
Brands
Ponvory
Protein binding
99.9%
PubChem CID
25136894
MedlinePlus
a621037
ChEBI
CHEBI:146043
ATC code
L04AA54
DrugBank
DB15493
KEGG
D11140
Routes of administration
Oral
Directions
Patients typically start treatment with Ponvory by following a 14-day titration schedule, beginning with 2 mg on the first day and gradually increasing to 20 mg. They'll take one pill daily, with or without food. During the initial dosing period, monitoring for symptoms such as slow heart rate, dizziness, or chest pain is important as the body adjusts to the medication.
Ingredients
The active ingredient in Ponvory is Ponesimod. The tablet also contains several inactive ingredients such as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate, among others
Contraindications
If you fall into any of the categories listed below, you should not take Ponvory:
- History of myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or decompensated heart failure requiring hospitalization within the past 6 months
- Diagnosed with Class III or IV heart failure
- Presence of cardiac conduction abnormalities such as Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient is equipped with a functioning pacemaker
Cautions
- Before starting treatment with Ponvory, tell your healthcare provider about:
- Any allergies to medications
- Other medications you are taking
- Other medical conditions you have
- Your plans around pregnancy and breastfeeding
- Ponvory can increase the risk of infections. Before starting treatment, a complete blood count (CBC) is needed to check your overall health. It’s important to monitor for signs of infection during treatment and for 1-2 weeks after stopping the medication. Ponvory should not be started in patients with active infections.
- Ponvory may cause a temporary decrease in heart rate. Because of this, a gradual dose increase is necessary when starting the medication. An electrocardiogram (ECG) should be done beforehand to check for any pre-existing heart conduction issues. If you have heart conduction abnormalities or are taking other medications that affect heart rate, a consultation with a cardiologist might be needed.
- There is a possibility that Ponvory can lead to a decline in lung function. If indicated, tests like spirometry, which measure lung function, may be recommended.
- Significant liver injury, although rare, can occur with Ponvory. Liver function tests should be performed before starting the medication, and Ponvory should be discontinued if significant liver injury is confirmed.
- An increase in blood pressure may occur during treatment with Ponvory. Regular blood pressure monitoring is recommended.
- Periodic skin examinations are advisable as Ponvory might increase the risk of cutaneous malignancies.
- Ponvory can pose risks to an unborn child. Women of childbearing potential should use effective contraception during treatment and for 1 week after stopping Ponvory.
- Before starting Ponvory, an eye exam is recommended, as well as if any changes in vision occur during treatment. Those with diabetes or uveitis have an increased risk of developing macular edema.
Side Effects
Ponvory may cause side effects. The most common Ponvory side effects include upper respiratory tract infections, elevated liver enzymes, and high blood pressure. These are the most frequently reported side effects by patients.
Ponvory can significantly increase the risk of life-threatening infections due to reduced white blood cell counts. Symptoms include fever, body aches, chills, and signs of meningitis like headache, neck stiffness, and confusion. Treatment may be paused or stopped in case of infection. Another serious effect is a slow heart rate (bradycardia), particularly after the first dose. Patients should monitor for symptoms like dizziness, chest pain, and tiredness, and undergo recommended heart tests before starting treatment. Immediate medical attention is advised for any serious symptoms.
References:
- Ponvory (Ponesimod) Product Monograph. Titusville, NJ: Janssen Pharmaceuticals; 2021.
- Ponvory (Ponesimod) Drug Label Information. Titusville, NJ: Janssen Pharmaceuticals; 2021.
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 : 14544
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