Drug Guide
Monomethyl Fumarate
Classification
Therapeutic: Multiple sclerosis agent
Pharmacological: Immunomodulator / Fumarate derivative
FDA Approved Indications
- Relapsing forms of multiple sclerosis
Mechanism of Action
The exact mechanism is unknown, but it is thought to have immunomodulatory effects that reduce inflammation by activating the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, leading to antioxidant effects and neuroprotection.
Dosage and Administration
Adult: Bafiertam is typically administered orally at a dose of 96 mg twice daily.
Pediatric: Safety and efficacy in pediatric patients have not been established.
Geriatric: No specific dose adjustment required but monitor for adverse effects in elderly patients.
Renal Impairment: No specific adjustments required, but caution advised.
Hepatic Impairment: No specific adjustments established; use with caution.
Pharmacokinetics
Absorption: Rapidly absorbed after oral administration.
Distribution: Widely distributed across body tissues.
Metabolism: Metabolized to fumarate and possibly to other metabolites.
Excretion: Mainly excreted in urine as metabolites.
Half Life: Approximately 1 hour for monomethyl fumarate.
Contraindications
- Hypersensitivity to fumarates or any components of the formulation
Precautions
- Monitor for lymphopenia, now associated with progressive multifocal leukoencephalopathy (PML)
- Assess for history of hypersensitivity reactions.
- Use caution in patients with renal or hepatic impairment.
Adverse Reactions - Common
- Flushing (Frequent)
- Nausea (Common)
- Abdominal pain (Common)
- Diarrhea (Common)
Adverse Reactions - Serious
- Progressive multifocal leukoencephalopathy (PML) (Rare, serious)
- Lymphopenia (Monitor regularly)
- Elevated liver enzymes (Monitor liver function tests)
Drug-Drug Interactions
- Other immunomodulators, immunosuppressants, or drugs causing lymphopenia
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor complete blood counts, liver function, and renal function before and during therapy. Assess patient response and adverse effects.
Diagnoses:
- Risk for infection due to immunosuppression
- Altered skin integrity related to flushing or rash
Implementation: Administer with meals to reduce gastrointestinal discomfort. Educate patient on reporting signs of infections or neurological symptoms.
Evaluation: Evaluate for reduction in multiple sclerosis relapses and management of side effects.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report symptoms such as weakness, vision changes, or neurological issues immediately.
- Inform about common side effects like flushing and gastrointestinal disturbances.
- Maintain regular blood tests as scheduled.
Special Considerations
Black Box Warnings:
- Progressive multifocal leukoencephalopathy (PML) — a rare brain infection that can be fatal.
Genetic Factors: None established.
Lab Test Interference: May cause lymphopenia, which necessitates monitoring blood counts.
Overdose Management
Signs/Symptoms: Severe gastrointestinal symptoms, hypotension, and neurological symptoms possible.
Treatment: Supportive care; no specific antidote. Hemodialysis is unlikely to be effective due to high protein binding.
Storage and Handling
Storage: Store at controlled room temperature (20°C to 25°C).
Stability: No special stability concerns if stored properly.