Dalfampridine

Dalfampridine is part of the drug class:

• OTHER NERVOUS SYSTEM DRUGS

Dalfampridine may cause serious side effects, including:

• kidney or bladder infections
• Dalfampridine can cause seizures. See below for more information.
• serious allergic reactions, including anaphylactic reactions

Dalfampridine can cause seizures.

• You could have a seizure even if you never had a seizure before.
• Your chance of having a seizure is higher if you take too much dalfampridine or if with mild kidney dysfunction, which is common after age 50.
• Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking dalfampridine.
• Before taking dalfampridine tell your doctor if you have kidney problems.
• Take dalfampridine exactly as prescribed by your doctor.

Stop taking dalfampridine and call your doctor right away if you have a seizure while taking dalfampridine.

Do not take dalfampridine if you:

• have ever had a seizure
• have certain types of kidney problems

Dalfampridine comes as a tablet to be taken by mouth with or without food. It is usually taken 2 times each day about 12 hours apart. Dalfampridine tablets should be taken whole. Do not break, crush, chew or dissolve dalfampridine tablets.

If you miss a dose of dalfampridine, do not make up the missed dose. Do not take 2 doses at the same time. Take your next dose at your regular scheduled time.

If you take too much dalfampridine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dalfampridine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause confusion, problems with thinking or memory, tremors, sweating, or seizures.

Dalfampridine was formerly known as fampridine (4-aminopyridine; 4-AP);1 13 14 broad spectrum potassium channel blocker.1 13 14 22

In the U.S.

• Ampyra

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Potassium Channel Blocker

• If you have an allergy to dalfampridine or any other part of dalfampridine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had a seizure.
• If you have kidney disease.
• If you are taking or will be taking another drug like this one.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dalfampridine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Potassium Channel Blocker

Nonspecific potassium channel blocker which improves conduction in focally demyelinated axons by delaying repolarization and prolonging the duration of action potentials. Enhanced neuronal conduction is thought to strengthen skeletal muscle fiber twitch activity, thereby, improving peripheral motor neurologic function.

Absorption

Rapid and complete

Distribution

Vd: 2.6 L/kg

Metabolism

Limited metabolism; in vitro data suggests hepatic metabolism to 3-hydroxy-4-aminopyridine occurs primarily via CYP2E1; further conjugated to 3-hydroxy-4-aminopyridine sulfate; metabolites are inactive

Excretion

Urine (96%; 90% of total dose as unchanged drug); feces (0.5%)

Time to Peak

Plasma: 3-4 hours

Half-Life Elimination

5.2-6.5 hours; prolonged in severe renal impairment (~3 times longer)

Protein Binding

Negligible; predominantly unbound to plasma proteins

Clearance modestly decreased with increasing age, but not significantly enough to necessitate a dose modification.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Adverse events have been observed in animal reproduction studies, including decreased growth and death.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, headache, loss of strength and energy, insomnia, back pain, rhinitis, pharyngitis, or constipation. Have patient report immediately to prescriber signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), severe dizziness, passing out, severe loss of strength and energy, seizures, change in balance, shortness of breath, or burning or numbness feeling (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Commonly reported side effects of dalfampridine include: urinary tract infection. Other side effects include: equilibrium disturbance, insomnia, and nausea. See below for a comprehensive list of adverse effects.

Dosage Information

The maximum recommended dosage of Dalfampridine extended-release tablets is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart.

There is no evidence of additional benefit at doses greater than 10 mg twice daily. Adverse reactions, including seizures, and discontinuations because of adverse reactions were more frequent at higher doses. 

Administration Instructions

Dalfampridine extended-release tablets can be taken with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve Dalfampridine extended-release tablets.

If a dose is missed, patients should not take double or extra doses.      

Renal Monitoring Prior to and During Treatment

Estimated creatinine clearance (CrCl) should be known before initiating treatment with Dalfampridine extended-release tablets, and monitored at least annually during treatment with Dalfampridine extended-release tablets. CrCl can be estimated using the following equation (multiply by 0.85 for women):

Dosage in Patients with Renal Impairment

In patients with mild renal impairment (CrCl 51 to 80 mL/min), Dalfampridine plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that is 1.5 times the maximum recommended dose and may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of Dalfampridine extended-release tablets should be carefully considered against the risk of seizures in these patients [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.4)].           

Dalfampridine extended-release tablets are contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min).

Dalfampridine Extended-Release Tablets, 10 mg are white to off-white, biconvex, oval shaped, film-coated tablets with flat edge, debossed with ‘J’ on one side and ‘76’ on the other side.

Bottles of 60                                       NDC 65862-863-60
Bottles of 100                                     NDC 65862-863-01
Bottles of 500                                     NDC 65862-863-05

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Seizures

Inform patients that Dalfampridine extended-release tablets can cause seizures, and that they must discontinue use of Dalfampridine extended-release tablets if they experience a seizure [see Warnings and Precautions (5.1)].

Dalfampridine extended-release tablets dosing

Instruct patients to take Dalfampridine extended-release tablets exactly as prescribed. Instruct patients not to take a double dose after they miss a dose, as this would increase their risk of seizure. Instruct patients not to take more than 2 tablets in a 24-hour period and to make sure that there is an approximate 12-hour interval between doses [see Dosage and Administration (2.1,2.2)].  

Anaphylaxis

Advise patients to discontinue Dalfampridine extended-release tablets and seek medical care if they develop signs and symptoms of anaphylaxis [see Warnings and Precautions (5.4)].

Drug Interactions

Instruct patients to notify their healthcare provider prior to starting any new medication, including over-the-counter drugs.    

Storage

Advise patients to store Dalfampridine extended-release tablets at 20° to 25°C (68° to 77°F). Advise patients to safely throw away Dalfampridine extended-release tablets that is out of date or no longer needed.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides