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What is Fampyra (fampridine)?

Ampyra (dalfampridine) in the USA and Fampyra (fampridine) in the EU is an oral medicine used to improve walking ability in adults with multiple sclerosis (MS). Multiple sclerosis (MS) is a neurological disease, where the inflammation destroys the protective sheath around the nerves^[1,2].

How does Ampyra (dalfampridine) or Fampyra (fampridine) work?

In multiple sclerosis (MS), when the protective sheaths around the nerves become destroyed, walking can become difficult as the transmission of electrical impulses along the nerves to the muscles becomes impaired.

Ampyra (dalfampridine) / Fampyra (fampridine) is a potassium channel blocker that works by acting on the damaged nerves, preventing charged potassium particles from leaving the nerve cells, and thus believed to allow electrical impulses to travel along the nerves^[1,2].

Where has Ampyra (dalfampridine) or Fampyra (fampridine) been approved?

Ampyra (dalfampridine) or Fampyra (fampridine) was approved for multiple sclerosis (MS) by:

• The Food and Drug Administration (FDA), US, January 2010, commercialised under the brand name Ampyra (dalfampridine).^[1]
• Therapeutic Goods Administration (TGA), Australia, May 2011, commercialised under the brand name Fampyra (fampridine).^[3]
• European Medicines Agency (EMA), EU, July 2011, commercialised under the brand name Fampyra (fampridine).^[2]
• Health Canada, February 2012, commercialised under the brand name Fampyra (fampridine).^[5]
• Medsafe (New Zealand), November 2011, commercialised under the brand name Fampyra (fampridine).^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Ampyra (dalfampridine) or Fampyra (fampridine) taken?

The recommended dosage is^[1,2]:

• 10 mg (10 mg-tablets) taken orally, 12 hours apart, twice daily.

Adjustment in dose may be required based on symptoms and experienced side effects^[1,2].

Complete information about Ampyra (dalfampridine) or Fampyra (fampridine) dosage and administration can be found in the official prescribing information listed in our references section^[1,2].

Note: Please consult with your treating doctor for personalised dosing. 

Are there any known side effects or adverse reactions of Ampyra (dalfampridine) or Fampyra (fampridine)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^[1,2]:

• urinary tract infection
• dizziness
• headache
• feeling weak and tired
• difficulty sleeping
• anxiety
• minor shaking (tremor)
• numbness or tingling of skin

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^[1,2]:

• seizure
• renal impairment
• allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems

Use in a specific population

The safety and efficacy of Ampyra (dalfampridine) or Fampyra (fampridine) has not been established in patients under the age of 18. There were insufficient numbers of patients aged over 65 to determine whether they respond differently to the younger patients. Ampyra (dalfampridine) or Fampyra (fampridine) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding while taking this medicine^[1,2].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2].

References

1. Summary of Product Characteristics [FDA]: Ampyra (dalfampridine)[PDF] Accorda, January 2010.
2. Summary of Product Characteristics [EMA]: Fampyra (fampridine)[PDF] Biogen, July 2011.
3. Summary of Product Characteristics [TGA]: Fampyra (fampridine)[PDF] Accorda, May 2011.
4. Product Detail [Medsafe]: Fampyra (fampridine)[PDF] Biogen, November 2018.
5. Summary of Product Characteristics [Health Canada]: Fampyra (fampridine)[PDF] Biogen, February 2012.