Tecfidera

Tecfidera is an effective oral medication for managing relapsing forms of multiple sclerosis (MS). It modulates the immune system and reduces inflammation to protect nerve cells, which helps decrease flare-ups and slow disease progression. Starting with a dose of 120 mg twice daily, which increases to 240 mg, Tecfidera is known for its ability to reduce the frequency of MS symptoms and physical disabilities. While generally well-tolerated, it requires monitoring for potential side effects like liver damage and low white blood cell counts. Always taken under medical supervision, Tecfidera is a pivotal treatment in managing MS.

Tecfidera (dimethyl fumarate) is a leading oral medication for treating relapsing forms of multiple sclerosis (MS), created to modulate the immune system and lower inflammatory responses that can damage nerve cells in the brain and spinal cord. This medication is primarily used to decrease the frequency of flare-ups & slow the progression of physical disabilities associated with MS. The typical recommended dosage for adults starts with 120 mg twice daily during the first week, increasing to 240 mg daily. Patients must follow their healthcare provider’s instructions carefully and undergo regular monitoring to manage side effects and ensure effectiveness.

Tecfidera can be taken with or without food, although consuming it with food may help mitigate some gastrointestinal side effects, such as flushing and stomach discomfort. Tecfidera works by activating the Nrf2 pathway, which helps protect nerve cells from oxidative stress & inflammation, potentially reducing flare-ups and delaying disease progression. However, it can cause multiple side effects, from flushing and gastrointestinal issues to more severe conditions like low white blood cell counts and liver damage.

Regular blood tests are recommended for patients to monitor their health, especially liver function and lymphocyte counts. Safety precautions with Tecfidera include avoiding live vaccines and minimizing exposure to infections due to the drug’s impact on the immune system. Women should discuss pregnancy plans with their healthcare provider due to the unknown risks of taking Tecfidera during pregnancy. Patients considering Tecfidera should be aware of potential interactions with other medications and supplements, particularly those that affect the immune system or liver enzyme levels. Alternatives to Tecfidera include other oral treatments, injectable medications, and infusion therapies, which may be preferable depending on individual patient needs and medical histories.

Uses of Tecfidera?

• Relapsing varieties of multiple sclerosis (MS)

What Are the Forms & Strengths of Tecfidera?

Tecfidera is available in the following forms and strengths:

• Oral delayed-release capsules: 120 mg and 240 mg.

What Are the Recommended Dosage of Tecfidera?

The recommended dosage of Tecfidera (dimethyl fumarate) for adults, including those newly starting the medication and those continuing treatment, generally follows this protocol:

• Initial Dose:
  • Start with 120 mg twice daily (morning and evening).
  • This initial dose is usually maintained for the first 7 days.
• Maintenance Dose:
  • After the first week, increase the dose to 240 mg twice daily.
  • This dose is then continued as the standard treatment regimen.

Special Considerations:

• Kidney or Liver Impairment: No dosage adjustment is typically required for patients with kidney or liver impairment, but monitoring may be more frequent.
• Elderly Patients: While no specific dosage adjustment is recommended for elderly patients, they may be more sensitive to the effects of Tecfidera and require close monitoring.

Pediatric Use:

• The safety and effectiveness of Tecfidera in pediatric patients who are under 18 years of age have not been established yet.

[Note: Remember, these dosage recommendations of Tecfidera may vary from person to person. Discuss it with your medical professional, and they’ll customize your dosage accordingly.]

• Dosage: Typically, start with a lower dose to improve gastrointestinal tolerability and gradually increase to the full dosage as directed by your healthcare provider.
• Administration: Take Tecfidera capsules orally with or without food. Swallow the tablets whole; do not crush, chew, or sprinkle on food.
• With Food: Taking Tecfidera with food, especially protein-rich food, can help minimize common side effects like flushing and stomach upset.
• Timing: It’s usually taken twice a day, roughly 12 hours apart; maintaining a consistent schedule helps maintain steady medication levels in your body.
• Flushing Management: If flushing occurs, over-the-counter aspirin (taken 30 minutes before Tecfidera) may help, but first discuss this with your healthcare provider.
• Monitoring: Routine blood tests may be required to monitor your white blood cell counts and other parameters, as Tecfidera can decrease immune cell levels, increasing infection risk.

[Note: Your healthcare specialist will decide the right amount for you as per your condition, following medicine guidelines & studies on the drug. They’ll adjust it as needed over time.]

Tecfidera (dimethyl fumarate) modulates the immune system, although its exact mechanism in treating multiple sclerosis (MS) isn’t fully understood. It’s believed to protect nerve cells from damage and reduce inflammation, key factors in MS. Tecfidera activates the Nrf2 pathway. This protective response helps cells defend against oxidative stress, which can damage or kill cells. By decreasing inflammation and protecting against cell damage, Tecfidera helps to slow the progression of MS and decrease the frequency of flare-ups. This action makes it effective in managing both relapsing-remitting MS & other forms of the disease, helping to maintain nerve function and reduce overall disability.

Tecfidera may cause side effects that are generally temporary, lasting from a few days to weeks. If these side effects persist, become bothersome, or intensify, you must seek advice from your doctor or pharmacist. Common side effects of Tecfidera include:

• Flushing: Warmth, redness, itching, or burning sensation of the skin, typically on the face and upper body.
• Gastrointestinal issues:
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Indigestion
• Skin reactions:
  • Rash
  • Itching
  • Hives
• Elevated liver enzymes: This may be detected in blood tests and usually doesn’t cause symptoms.
• Decreased white blood cell count: This can increase the risk of infections.
• Headache
• Fatigue
• Back pain
• Proteinuria: Increased protein in urine, which may be detected in tests.
• Upper respiratory tract infections

Serious side effects of Tecfidera include: While Tecfidera is generally well-tolerated, it can potentially result in severe side effects of this medication that need immediate medical attention. Here are the most significant ones:

• Progressive Multifocal Leukoencephalopathy (PML): A rare but severe brain infection due to the John Cunningham (JC) virus. Symptoms may include progressive weakness on one side of the body, clumsiness, vision problems, and changes in thinking, memory, and orientation.
• Severe allergic reactions, including anaphylaxis, angioedema, and difficulty breathing.
• Severe lymphopenia: A significant decrease in lymphocyte (white blood cell) count can heighten the risk of serious infections.
• Liver injury: Characterized by significant elevations in liver enzymes or symptoms like jaundice, dark urine, nausea, vomiting, and abdominal pain.
• Herpes zoster infections (shingles): Tecfidera may increase the risk of developing shingles.
• Severe flushing reactions: While flushing is common, severe cases can cause significant discomfort and may be accompanied by other symptoms.
• Gastrointestinal disorders: In rare cases, severe stomach pain, persistent nausea, vomiting, or diarrhea may occur.
• Kidney problems: Including proteinuria and increased serum creatinine.
• Opportunistic infections: Due to the medication’s effects on the immune system.
• Malignancies: There’s a potential increased risk of certain cancers, although this is still being studied.

[Note: Remember, this list does not cover all Tecfidera side effects. Always consult with your healthcare specialist for medical advice about side effects.]

Tecfidera may lead to significant health risks, especially for certain individuals. If you have concerns, consult your healthcare expert for alternative treatments.

• Severe Allergic Reactions: Dimethyl fumarate may trigger critical allergic reactions, including anaphylaxis, manifesting as facial or neck swelling, difficulty breathing, or swelling of the throat or tongue. Seek emergency medical attention if you see these symptoms.
• Serious Infections: This medication can suppress your immune system, increasing susceptibility to serious opportunistic infections, such as herpes zoster, progressive multifocal leukoencephalopathy (PML), and tuberculosis. Before starting treatment, disclose your full medical history to your care team and immediately report any symptoms like fever or cough.
• Low White Blood Cell Count (Lymphopenia): Treatment with dimethyl fumarate can reduce lymphocyte levels, heightening the risk of infection. Routine blood tests are important to monitor your lymphocyte count. If lymphocyte levels drop significantly, treatment may need to be paused.
• Liver Damage: Reports of liver damage, some requiring hospitalization, have been noted, particularly within the first few months of treatment. Liver health will be monitored through regular lab tests, and treatment may be halted if liver injury is detected. Liver damage symptoms comprise of yellowing of the skin or eyes, stomach pain, and nausea.
• Flushing: Flushing, characterized by warmth, redness, and itching, is a common side effect but generally not harmful. To reduce flushing, taking aspirin before your dose and consuming food with your medication might help.
• Gastrointestinal Issues: Severe gastrointestinal problems, such as ulcers and perforations, have been reported in rare cases. If you experience intense stomach pain, nausea, or vomiting, immediate medical attention is advised.

• Inform your medical specialist if you are allergic to dimethyl fumarate, diroximel fumarate, monomethyl fumarate, or have other allergies. Inactive ingredients in this product may cause reactions.
• Discuss your medical history, especially concerning low white blood cell counts, liver disease, and current or past infections.
• Dimethyl fumarate increases susceptibility to infections. Avoid contacting individuals with infectious diseases like chickenpox, COVID-19, measles, or flu.
• Inform your doctor of your use of dimethyl fumarate before receiving any immunizations/vaccinations, particularly live vaccines.
• Ensure your doctor or dentist has been informed of all the products you use, including prescription or nonprescription drugs & herbal products, before surgery.
• Use this medication during pregnancy only if needed after discussing the risks & benefits with your doctor.
• It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding.

The contraindications for using Tecfidera include:

• Known hypersensitivity to Tecfidera or any of the excipients in the formulation. Reactions can include rash, itching, or more severe allergic reactions.
• Patients with severe kidney impairment (GFR <30 mL/min/1.73 m²) have not been studied, and therefore, Tecfidera is not recommended in these patients due to potential increased risk and lack of data.
• While not strictly contraindicated, the use of Tecfidera during pregnancy is generally advised against unless the potential benefit showcases the potential risk to the fetus. This is due to the lack of sufficient data on the drug’s safety during pregnancy.

If you miss a dose of Tecfidera, take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed dose & continue with your regular dosing schedule. Do not take two doses simultaneously to make up for a missed dose. Maintaining a regular schedule to ensure effective treatment is important, so setting reminders might help you avoid missing doses in the future. Discuss this with your healthcare provider for additional guidance if you frequently miss doses.

[Note: If you have missed a Tecfidera dosage and are unsure about the next one, immediately consult your doctor or pharmacist.]

If you suspect an overdose of Tecfidera, it’s crucial to seek immediate medical attention. Overdosing on Tecfidera can lead to severe health issues. Symptoms of an overdose might include increased flushing and stomach discomfort, which are common side effects of the medication but can be more severe in cases of overdose. Contact your healthcare expert or local poison control center, or head to the nearest emergency room. Remember to provide all relevant information about the dose taken and any symptoms experienced to ensure prompt and appropriate treatment.

[Note: If you have consumed more than the recommended dose of Tecfidera, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Tecfidera should be stored properly to maintain its effectiveness. Here are general guidelines for storing Tecfidera:

• Keep Tecfidera at room temperature, ideally between 20°C to 25°C.
• Store the capsules in their original container until ready to use.
• Keep the medicine container tightly closed to protect it from moisture.
• Store in a dry place, away from direct heat and light.
• Keep out of reach of children and pets.

[Note: Discuss with your healthcare expert about the proper disposal of any unused medication and any questions you may have related to its storage.]

Tecfidera can interact with several types of medications. Here are some fundamental interactions to be aware of:

• Other Immune System Modifiers: Combining dimethyl fumarate with other drugs that affect the immune system, such as other MS therapies like natalizumab (Tysabri) or fingolimod (Gilenya), can increase the risk of severe immune suppression.
• Vaccines: Live vaccines may pose a higher risk of causing infection when taken alongside dimethyl fumarate due to their immune system effects. It’s important to consult with your healthcare provider before receiving any vaccinations.
• Strong CYP Inducers: Drugs that strongly induce certain liver enzymes (particularly CYP enzymes), such as rifampin or St. John’s Wort, might decrease the effectiveness of dimethyl fumarate by increasing its metabolism.
• Nephrotoxic Drugs: Medications that can lead to kidney damage might increase the risk of similar side effects when taken with dimethyl fumarate due to potential additive effects on kidney stress.
• Antifungal and Antibiotics: Certain antifungal medications and antibiotics can affect liver enzyme levels, altering how dimethyl fumarate is metabolized, potentially leading to changes in its effectiveness and side effects.

What Are the Other Tecfidera Interactions?

In addition to medications, Tecfidera can interact with various other substances:

• Supplements and Vitamins: Some dietary supplements, especially those affecting the immune system or liver enzyme levels, could interact with dimethyl fumarate. For example, high doses of Vitamin B7 (biotin) can interfere with certain laboratory tests used in monitoring Tecfidera treatment.
• Foods: No specific foods have been shown to interact with Tecfidera. Still, it’s generally suggested that the medication be taken with food to help minimize gastrointestinal side effects like flushing and stomach discomfort.
• Herbal Products: Herbs such as St. John’s Wort may decrease the effectiveness of Tecfidera by inducing liver enzymes that enhance drug metabolism, leading to reduced drug levels in the body.
• Alcohol: While not directly interacting, consuming alcohol during Tecfidera treatment may exacerbate certain side effects such as liver stress or gastrointestinal discomfort. It’s wise to discuss alcohol consumption with your healthcare provider.

[Note: This is not a complete list of all the medications that potentially interact with Tecfidera. Make sure to tell your doctor about any prescription or over-the-counter medicines & herbal products you’re taking.]

Here are several alternative medications for treating relapsing forms of multiple sclerosis (MS), including their generic names:

Injectable Medications:

• Avonex (interferon beta-1a)
• Rebif (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Plegridy (peginterferon beta-1a)
• Copaxone (glatiramer acetate)
• Glatopa (glatiramer acetate)

Oral Medications:

• Gilenya (fingolimod)
• Mayzent (siponimod)
• Aubagio (teriflunomide)
• Mavenclad (cladribine)
• Zeposia (ozanimod)
• Ponvory (ponesimod)

Infusion Treatments:

• Tysabri (natalizumab)
• Ocrevus (ocrelizumab)
• Lemtrada (alemtuzumab)
• Kesimpta (ofatumumab)

Newer Options:

• Vumerity (diroximel fumarate) – similar to Tecfidera but may have fewer gastrointestinal side effects.
• Bafiertam (monomethyl fumarate) – another fumarate option

[Note: Your doctor will choose the best Tecfidera alternative for you. We advise against taking any of these alternative medications without consulting your healthcare specialist. Taking them on your own may cause serious side effects.]

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