Dimethyl Fumarate (Tecfidera) Mechanism of Action |Side Effects |Nursing Implications |Patient Teachings

Introduction

In this article, you’ll learn about the Dimethyl Fumarate (Tecfidera) mechanism of action (MOA), side effects, and nursing implications. Also, its dosage, indication, contraindications, interactions, nursing assessment, nursing interventions, and patient teachings.

Dimethyl Fumarate is commonly known as its brand name Tecfidera is used to treat relapsing forms of multiple sclerosis (MS). It also helps to delay the progression of disability.

Generic Name: Dimethyl Fumarate

Brand Name(s): Tecfidera

Dimethyl Fumarate (Tecfidera) Class and Category

Pharmacologic class: Fumaric acid agent

Therapeutic class: Multiple sclerosis agent; immunomodulating agent

Pregnancy category: C

Dimethyl Fumarate (Tecfidera) Dosage

Multiple Sclerosis Dosage

  • Adults: PO: initial dose 120mg; BD; for 7 days. Then maintenance dose 240 mg; BD.

Dimethyl Fumarate (Tecfidera) Pharmacokinetics and Pharmacodynamics

RouteOnsetPeakDuration
PO24 weeks60 weeksunknown
Dimethyl Fumarate (Tecfidera) Pharmacokinetics and Pharmacodynamics

Absorption: When Tecfidera is given orally, enzymes in the GI tract, blood, and tissue rapidly convert it to the active metabolite monomethyl fumarate (MMF).

Distribution: Unknown

Metabolism: Protein binding is 27 – 45 percent.

Half-life: 1 hr

Excretion: Mainly eliminated as exhaled carbon dioxide (approx. 60%). Also, small amounts are excreted via renal and fecal routes.  

Dimethyl Fumarate (Tecfidera) Mechanism of Action

The exact mechanism through which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is NOT known.

DMF and its metabolite, monomethyl fumarate (MMF), have been proven to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway.

The Nrf2 pathway is a critical cellular defense system that responds to oxidative stress through the up-regulation of antioxidant response genes.

Therapeutic Effects: Reduces the occurrence and severity of relapse and inhibit disease progression.

What are the indications of Dimethyl Fumarate (Tecfidera)?

Dimethyl Fumarate (Tecfidera) indications are as follows. 

What are the contraindications of Dimethyl Fumarate (Tecfidera)?

The contraindications of Dimethyl Fumarate (Tecfidera) are:

  • Hypersensitivity to Dimethyl Fumarate and any of its components.

Caution: Serious infections; lymphopenia; hepatic impairment.

Dimethyl Fumarate (Tecfidera) Interactions

  • Drug to drug interactions not known.
  • Live vaccines are not recommended during Tecfidera therapy since the potential risks have not been evaluated in clinical trials.
  • May increase LFT levels.
  • May increase urine albumin and protein levels.
  • May decrease lymphocyte counts

Herbal/food interactions

  • Tecfidera interactions with food or herbs is unknown.

What are the side-effects of Dimethyl Fumarate (Tecfidera)?

Dimethyl Fumarate (Tecfidera) side effects include:

  • Flushing / Hot flush
  • Gastroenteritis
  • Diarrhea
  • Nausea
  • Upper abdominal pain
  • Gastritis
  • Lymphopenia
  • Leucopenia
  • Burning sensation
  • Pruritus
  • Rash
  • Erythema
  • Proteinuria

Life-threatening adverse effects Dimethyl Fumarate (Tecfidera)  

  • Progressive multifocal leukoencephalopathy
  • Hepatotoxicity
  • Anaphylaxis

Dimethyl Fumarate (Tecfidera) Nursing Implications [Nursing Considerations]

Dimethyl Fumarate (Tecfidera) nursing implications are divided into nursing assessment, nursing diagnosis, nursing interventions, and evaluation. 

Dimethyl Fumarate (Tecfidera) nursing assessment

  • Obtain detailed clinical history including hypersensitivity, chronic or recurrent infection, pregnancy, and lactation.
  • Assess for underlying conditions that may predispose patient to infection.
  • Assess number and severity of spasms, chronic pain, fatigue and weakness, balance and dizziness
  • Obtain baseline CBC, LFTs, urinalysis.

Dimethyl Fumarate (Tecfidera) nursing diagnosis

Dimethyl Fumarate (Tecfidera) nursing interventions/ actions

  • Monitor patient for any sign or symptoms of infection (such as fever, flulike symptoms). Tecfidera therapy may need to withhold until severe infections are resolved.
  • Observe the patient for anaphylactic reaction, especially after the first dose and throughout the treatment.
  • Observe the patient for progressive multifocal leukoencephalopathy (PML) such as ataxia, vision changes, weakness, trouble using arms/legs, confusion. Tecfidera therapy should be discontinued at first sign of PML.
  • Monitor CBCs annually or as clinically indicated. Because Tecfidera is associated with decreased lymphocyte counts.
  • Monitor patient’s LFTs. Tecfidera is associated with increased liver enzymes.
  • Repeat urinalysis annually. Tecfidera is associated with proteinuria and microalbuminuria.
  • Monitor the patient for reduced frequency and intensity of spasms and chronic pain.
  • Monitor patient for improvement in generalized weakness, fatigue, balance, and dizziness.

Evaluation

Evaluate the effectiveness of the Dimethyl Fumarate (Tecfidera):

Pregnancy/breastfeeding considerations for Dimethyl Fumarate (Tecfidera)

  • Dimethyl Fumarate effects on fetus in unknown. Consult with the prescriber if you are pregnant or planning pregnancy.
  • It is unknown whether Dimethyl Fumarate is excreted in breastmilk. Consult with the prescriber before starting lactation.

What is the nurse patient teachings for Dimethyl Fumarate (Tecfidera)?

Nurse patient teaching for Dimethyl Fumarate (Tecfidera) should include the following points.

  • Teach the patient sign and symptoms of anaphylactic reaction (such as dyspnea, swelling of the throat and tongue) and instruct to seek immediate medical treatment.
  • Instruct the patient that he or she should take the missed dose as soon as possible. The next dose should be taken at the regularly scheduled time.
  • Advise the patient to take Tecfidera dose regularly on time with or without food. If the patient experiences GI irritation, tell them to take the Tecfidera capsule with food.
  • Inform the patient that Tecfidera capsule should be taken as a whole. It should NOT be split, crushed, chewed, dissolved or mixed with food.
  • Instruct the patient to keep Tecfidera capsules at 15°C to 30°C (59 to 86°F) and to protect from light.
  • Also, instruct the patient to keep Tecfidera capsules in their original container and to discard them 90 days after opening.
  • Teach the patient signs of progressive multifocal leukoencephalopathy (PML) such as ataxia, vision changes, weakness, difficulty using limbs, disorientation. Instruct the patient to notify the prescriber promptly if they exhibit any symptoms of PML.
  • Instruct the patient to report yellowing of skin or eyes, upper abdominal pain, bruising, dark-colored urine, fever, body aches, cough, dehydration to the prescriber as soon as possible.

Treatment for Dimethyl Fumarate (Tecfidera) Overdose

Dimethyl Fumarate (Tecfidera) overdosage does not have a specific treatment. Symptomatic treatment should be given to the patient.  Also, closely observe for adverse effects.

Conclusion

You’ve learned about the Dimethyl Fumarate (Tecfidera) mechanism of action (MOA), side effects, and nursing implications in this article.

In addition, you’ve learned about Dimethyl Fumarate’s pharmacokinetics, dosage and administration, indications, contraindications, nursing assessment, nursing diagnoses, nursing interventions, and patient teaching.

Recommended Readings & Reference

Australian TGA Dimethyl Fumarate (Tecfidera) Information

FDA Dimethyl Fumarate (Tecfidera) Information

Herdman, T., Kamitsuru, S. & Lopes, C. (2021). NURSING DIAGNOSES: Definitions and Classifications 2021-2023 (12th ed.). Thieme.

Kizior, R., & Hodgson, K. (2021). SAUNDERS NURSING DRUG HANDBOOK 2021. Elsevier Inc.

Skidmore-Roth, L. (2021). MOSBY’S 2021 NURSING DRUG REFERENCE (34th ed.). Elsevier Inc.

Vallerand, A., Sanoski, C., & Quiring, C. (2019). Davis’s Drug Guide for Nurses (19th ed.). F.A. Davis Company.

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