Product Description
TECFIDERA contains the active substance Dimethyl Fumarate. It is used for the treatment of relapsing forms of multiple sclerosis, a condition in which the immune system attacks the protective covering of the nerves called myelin, causing disrupted communication between the brain and body.
It belongs to the group of medicines called Nrf2 (nuclear factor erythroid-derived 2) activators.
It works through the Nrf2 pathway to protect cells in your body from oxidative stress and inflammation. This slows progression of disease and reduces the number of attacks in multiple sclerosis.
Inform the doctor if you have any active infection, low leucocyte count, low immune system, stomach issues, diabetes, kidney problems or liver problems.
Inform the doctor about all your medical conditions, prescription and non-prescription drugs, vitamin supplements, herbal medications, since TECFIDERA can interact with them. TECFIDERA can cause an allergic reaction in some patients therefore it is necessary to read the complete composition list and consult the doctor in case of any ingredient that induces allergies.
Consult the doctor if you are planning, on a pregnancy or breastfeeding.
It is advisable to avoid driving and operating heavy machinery during the course of TECFIDERA.
Indications of TECFIDERA
TECFIDERA indicated for the treatment of of relapsing forms of multiple sclerosis, a condition in which the immune system attacks the protective covering of the nerves called myelin, causing disrupted communication between the brain and body.
Therapeutic Effects of TECFIDERA
TECFIDERA belongs to the group of medicines called Nrf2 (nuclear factor erythroid-derived 2) activators. It works through the Nrf2 pathway to protect cells in your body from oxidative stress and inflammation. This slows progression of disease and reduces the number of attacks in multiple sclerosis.
Directions for Use
TECFIDERA should be swallowed whole with water and should not be crushed, chewed, or opened. The medicine can be taken with or without food. Taking these medicines regularly at the same time increases their effectiveness. A dose of this medicine should not be missed as it can affect your recovery. The dosage and duration of treatment will depend on the individual’s condition and response to the medication and should be determined by the doctor.
Your doctor will decide the dose and frequency of administration based on your health condition.
A trained healthcare doctor/Nurse will administer TECFIDERA. So, do not self-administer.
Storage
TECFIDERA should be stored below 30°C temperature at room temperature. Do not freeze.
If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.
Keep the medicine in the original container to protect from light and moisture.
Keep TECFIDERA out of sight and reach of children.
Common:
- Nausea
- Flushing (sense of warmth in the face, ears, neck and trunk)
- Diarrhea
- Rash
- Itching
- Stomach pain
- Indigestion
Serious:
- Allergic reactions
- Low white blood cell count, infections
- Progressive multifocal leukoencephalopathy (PML)
- Infusion reactions
- Liver damage
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Contraindications
TECFIDERA is contraindicated in patients with a known hypersensitivity to TECFIDERA or any of the excipients.
Drug Interactions
TECFIDERA might interact with other medicines. Therefore, it is recommended to inform your doctor about all the prescriptions you have.
Safety Advices for TECFIDERA
Consult Your Doctor
It is unknown whether TECFIDERA interacts with alcohol. However, it is best to avoid alcohol or limit your alcohol consumption while taking any medication. Consult your doctor.
Consult Your Doctor
If you are pregnant or planning to get pregnant during the treatment, please consult your doctor. Your doctor will prescribe any potential risks if the benefits are found to outweigh the risks.
Consult Your Doctor
It is recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk. Consult your doctor if you are breastfeeding before taking this medication.
Unsafe
TECFIDERA may cause dizziness, lightheadedness, or sleepy in some patients. Therefore, avoid driving or operating machines that require mental concentration until you are not alert.
Consult Your Doctor
If you have pre-existing or a history of lung problems, consult your doctor before taking TECFIDERA. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of liver problems, consult your doctor before taking TECFIDERA. It should be used cautiously in liver disease patients as it could further enhance liver damage. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of kidney disease, consult your doctor before taking TECFIDERA. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Unsafe
TECFIDERA is not recommended for use in children below 18 years old as the safety and efficacy are not established.
References
- 1. Tecfidera. Dimethyl fumarate. [Accessed 24 Jan. 2019] (online) Available from: https://www.tecfidera.com/
- 2. Dimethyl fumarate. Cambridge: Biogen Idec Inc; 2013. [Accessed 22 Mar. 2019] (online) Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf
- 3. Central Drugs Standard Control Organisation (CDSCO). [Accessed 22 Mar. 2019] (online) Available from: https://cdscoonline.gov.in/CDSCO/Drugs
- 4. HA Blair; Dimethyl fumarate: A Review in relapsing, remitting MS; [Revised on 2019] [Accessed on 31 August 2023], https://pubmed.ncbi.nlm.nih.gov/31784875/
- 5. Jineane V Venci et al; Dimethyl fumarate (Dimethyl fumarate Capsule): A new oral agent for multiple sclerosis; [Revised on 2013] [Accessed on 31 August 2023], https://pubmed.ncbi.nlm.nih.gov/24259625/

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