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.
Tecfidera (Dimethyl Fumarate)
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Product Details
Description
Tecfidera is a prescription medication used to treat multiple sclerosis (MS). MS is a serious and progressive disease where the immune system attacks the protective layer of the nerve cells. Symptoms are varied and affect every part of the body.
Tecfidera is approved to treat the following relapsing forms of MS:
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
Tecfidera works by activating a cellular pathway called Nrf2, which is involved in the cellular response to oxidative stress. By activating this pathway, Tecfidera helps to treat MS. Tecfidera has been shown to reduce the number of relapses, delay the progression of disability, and slow the development of brain lesions.
Tecfidera should only be prescribed by a physician that specializes in the treatment of MS.
Fact Table
Formula
C6H8O4
License
US FDA, EU EMA
Bioavailability
-
Legal status
Rx-Only
Chemical Name
Dimethyl fumarate
Elimination half-life
12 hours
Dosage (Strength)
120mg, 240mg
Pregnancy
Consult Doctor
Brands
Tecfidera
Protein binding
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PubChem CID
637568
MedlinePlus
a613028
ChEBI
76004
ATC code
L04AX07
DrugBank
DB08908
KEGG
D03846
Routes of administration
By mouth
Directions
The starting dose of Tecfidera is 120 mg by mouth twice daily for seven days. After seven days, the dose is increased to 240 mg by mouth twice daily.
This medication comes as a delayed-release capsule and should not be crushed or chewed. Swallow the capsule whole with or without food.
Ingredients
The active ingredient in Tecfidera is Dimethyl Fumarate, which is the name of the Tecfidera generic.
Interactions
Tecfidera can interact with the following:
- Diroximel Fumarate
- Live vaccines
- Monomethyl Fumarate
Cautions
This medication should be stopped if an allergic reaction or serious swelling occurs.
Tecfidera may cause a condition known as progressive multifocal leukoencephalopathy (PML) and should be stopped at the first sign suggesting this condition.
Your doctor should monitor liver function and blood cell function before and during treatment.
Side Effects
Common adverse reactions to Tecfidera may include:
- Abdominal pain
- Albuminuria
- Diarrhea
- Dyspepsia
- Erythema
- Flushing
- Increased liver enzymes
- Infection
- Lymphocytopenia
- Nausea
- Pruritus
- Skin rash
- Vomiting
References
Tecfidera [package insert]. Cambridge, MA: Biogen; 2021.
Frequently Asked Questions about Tecfidera (Dimethyl Fumarate)
What is Tecfidera (Dimethyl Fumarate)?
Tecfidera is a brand name medication that contains the active ingredient Dimethyl Fumarate. It is used in the treatment of multiple sclerosis (MS) to reduce the frequency of relapses and slow down the progression of the disease.
How does Tecfidera work?
Tecfidera's exact mechanism of action is not fully understood, but it is believed to modulate the immune system and reduce inflammation in the central nervous system, which is involved in the development of MS symptoms.
What types of multiple sclerosis is Tecfidera used to treat?
Tecfidera is approved for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS) in some cases.
Is Tecfidera suitable for all individuals with multiple sclerosis?
No, Tecfidera is not suitable for everyone with MS. Your healthcare provider will assess your specific condition and medical history to determine if Tecfidera is an appropriate treatment option for you.
What are the common side effects of Tecfidera?
Common side effects of Tecfidera may include flushing (warmth and redness of the skin), gastrointestinal symptoms (such as abdominal pain, diarrhea, and nausea), and decreases in white blood cell count. It's important to discuss potential side effects with your healthcare provider.
How is Tecfidera typically taken?
Tecfidera is usually taken as an oral medication. It is typically taken twice daily with or without food. Your healthcare provider will provide specific dosing instructions based on your individual needs.
Can Tecfidera be taken during pregnancy or while breastfeeding?
The safety of Tecfidera during pregnancy and breastfeeding is not well-established. If you are pregnant, planning to become pregnant, or breastfeeding, it's crucial to discuss the potential risks and benefits with your healthcare provider.
How long does it take for Tecfidera to show its effects in managing MS symptoms?
The effectiveness of Tecfidera in managing MS symptoms may vary from person to person. It may take several months to see noticeable benefits, and it is important to continue taking the medication as prescribed.
Can Tecfidera be used in combination with other MS treatments?
Your healthcare provider will determine the most appropriate treatment plan for your specific condition. In some cases, Tecfidera may be used in combination with other MS medications.
Is regular monitoring necessary while taking Tecfidera?
Yes, regular monitoring by your healthcare provider is important while taking Tecfidera to assess its effectiveness and monitor for any potential side effects or changes in your condition.
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 : 13247
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