What is the recommended dosage and usage of Dalfampridine (generic name) for patients with multiple sclerosis?

Dalfampridine Dosage and Usage for Multiple Sclerosis

The recommended dosage of dalfampridine for patients with multiple sclerosis is 10 mg twice daily (approximately 12 hours apart), taken with or without food, with tablets administered whole. 1

Dosage Guidelines

• The maximum recommended dosage is 10 mg twice daily, with no evidence of additional benefit at higher doses 1
• Higher doses are associated with increased risk of adverse reactions, particularly seizures 1, 2
• Tablets should be taken whole; do not divide, crush, chew, or dissolve 1
• Patients should not take double or extra doses if they miss a dose 1
• Dalfampridine can be taken with or without food 1

Renal Function Considerations

• Estimated creatinine clearance (CrCl) should be known before initiating treatment 1
• Dalfampridine is contraindicated in patients with moderate or severe renal impairment (CrCl ≤50 mL/min) 1, 2
• In patients with mild renal impairment (CrCl 51-80 mL/min), dalfampridine may reach plasma levels associated with greater seizure risk 1
• Approximately 96% of dalfampridine is eliminated unchanged in urine, making renal function assessment critical 2

Efficacy and Clinical Outcomes

• Dalfampridine is indicated to improve walking in adult patients with multiple sclerosis 1
• Clinical trials demonstrated that approximately 35-43% of patients respond to treatment (compared to 8-9% with placebo) 3, 4
• Among responders, walking speed improved by approximately 25% 4
• The effect on walking speed is maintained throughout the interdosing period 4

Safety Considerations

• Contraindicated in patients with history of seizures 1
• Contraindicated in patients with moderate to severe renal impairment 1
• Contraindicated in patients with history of hypersensitivity to dalfampridine 1
• Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine) 1
• Use caution with OCT2 inhibitors as concomitant use may increase exposure and seizure risk 1

Common Adverse Effects

• Most common adverse events (incidence ≥2% and greater than placebo) include: 1, 2
  • Urinary tract infection
  • Insomnia
  • Dizziness
  • Headache
  • Nausea
  • Asthenia
  • Back pain
  • Balance disorder
  • Multiple sclerosis relapse
  • Paresthesia
  • Nasopharyngitis
  • Constipation
  • Dyspepsia
  • Pharyngolaryngeal pain

Monitoring and Duration of Treatment

• Patients should be monitored for improvement in walking ability 4
• Long-term studies have shown sustained improvements in walking speed for up to 2.5 years of continuous treatment in responders 5
• If a seizure occurs, discontinue dalfampridine and do not restart 1

Special Populations

• Pregnancy: Based on animal data, may cause fetal harm 1
• Geriatric use: Elderly patients are more likely to have decreased renal function, making assessment of creatinine clearance particularly important before initiating treatment 1