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.
Gilenya (Fingolimod)
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Product Details
Description
Gilenya is a medication your doctor may prescribe if you have relapsing multiple sclerosis (MS), which is when MS is well-controlled on other medications, but the symptoms start to get worse.
MS is a disease that can affect every major system in the body, including:
- Visual
- Nervous
- Musculoskeletal
- Urinary
- Speech
- Sensory
Gilenya works by binding to S1P receptors on cells of the immune system called lymphocytes. It prevents these cells from emerging from lymph nodes.Fact Table
Formula
C19H33NO2
License
US FDA, EU EMA
Bioavailability
More than 90%
Legal status
Rx-only
Chemical Name
Fingolimod
Elimination half-life
6-9 days
Dosage (Strength)
0.5mg
Pregnancy
Not Recommended
Brands
Gilenya
Protein binding
99.7%
PubChem CID
107970
MedlinePlus
a611006
ChEBI
63115
ATC code
L04AA27
DrugBank
DB08868
KEGG
D10001
Routes of administration
By mouth
Directions
The standard dosage is 0.5 mg by mouth once daily.
Gilenya can slow the heart rate, so the first dose must be administered in a healthcare setting where the patient can be monitored for at least six hours.
Ingredients
The active ingredient in Gilenya is fingolimod.
Interactions
Common drug interactions with this drug are:
- Amiodarone
- Baricitinib
- BCG (Intravesical)
- Bradycardia-Causing Agents
- Ceritinib
- Cladribine
- COVID-19 Vaccine (mRNA)
- Disopyramide
- Dofetilide
- Dronedarone
- Echinacea
- Ibutilide
- Immunosuppressants
- Measles, Mumps, and Rubella Virus Vaccine
- Natalizumab
- Pimecrolimus
- Quinidine
- Rabies Vaccine
- Roflumilast
- Sipuleucel-T
- Sotalol
- Tacrolimus
- Tofacitinib
- Vaccines (Inactivated)
- Vaccines (Live)
- Varicella Virus Vaccine
Cautions
Any vaccines that are needed should be administered before starting Gilenya.
Use caution if you have a history of heart disease. When starting Gilenya, there is a high risk that it can cause a slow heart rate.
You are at an increased risk of infection when taking this drug.
Talk to your doctor and pharmacist about all precautions that can apply to you before starting Gilenya.
Side Effects
Potential Gilenya side effects may include:
- Abdominal pain
- Actinic keratosis
- Alopecia
- Asthenia
- Back pain
- Blurred vision
- Bradycardia
- Cough
- Decreased lung function
- Diarrhea
- Dyspnea
- First-degree atrioventricular block
- Headache
- Herpes virus infection
- Herpes zoster infection
- Hypertension
- Increased gamma-glutamyl transfer
- Increased serum alanine aminotransferase
- Increased serum aspartate transaminase
- Increased serum triglycerides
- Influenza
- Leukopenia
- Lymphocytopenia
- Migraine
- Nausea
- Second-degree atrioventricular block
- Sinusitis
References
- Gilenya [package insert]. Morris Plains, NJ: Novartis; 2012.
Frequently Asked Questions about Gilenya (Fingolimod)
What is Gilenya (Fingolimod)?
Gilenya, with the active ingredient Fingolimod, is a prescription medication used to treat relapsing forms of multiple sclerosis (MS). It is part of a class of drugs known as disease-modifying therapies (DMTs).
How does Gilenya work to treat multiple sclerosis (MS)?
Gilenya works by reducing the immune system's attack on the central nervous system. It does this by trapping certain white blood cells in the lymph nodes, preventing them from entering the brain and spinal cord, where they can cause damage.
Is Gilenya available over the counter (OTC)?
No, Gilenya is not available over the counter. It is a prescription medication, so you will need a doctor's prescription to obtain it.
How is Gilenya taken?
Gilenya is taken orally in the form of a capsule. Your healthcare provider will provide specific dosing instructions, but it is usually taken once daily.
What are the potential side effects of Gilenya?
Common side effects of Gilenya may include headache, diarrhea, cough, back pain, and high blood pressure. More serious but less common side effects can include changes in heart rate, liver problems, and infections. Your healthcare provider will monitor you for side effects.
Can I take other medications while using Gilenya?
It is essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Gilenya. Some drugs, especially those affecting the heart rhythm, may have interactions.
Is Gilenya a cure for multiple sclerosis (MS)?
No, Gilenya is not a cure for MS. It is used to reduce the frequency of relapses and slow the progression of the disease. MS remains a chronic condition that requires ongoing management.
Can I drink alcohol while taking Gilenya?
It is generally safe to consume alcohol in moderation while taking Gilenya. However, it's advisable to discuss alcohol use with your healthcare provider, as excessive alcohol intake can have health implications.
How long will I need to take Gilenya?
The duration of Gilenya treatment will be determined by your healthcare provider based on your individual response to the medication and the progression of your MS. It may be a long-term treatment.
Is it safe to use Gilenya during pregnancy or while breastfeeding?
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the use of Gilenya with your healthcare provider. They can assess the potential risks and benefits and provide guidance on the best course of action.
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 : 12570
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