AMIFAMPRIDINE Drug Interactions: What You Need to Know

INTERACTIONS Drugs that lower seizure threshold: Concomitant use may lead to an increased risk of seizures. ( 7.1 ) Drugs with cholinergic effects (e.g., direct or indirect cholinesterase inhibitors): Concomitant use may increase the cholinergic effects of FIRDAPSE and of those drugs and increase the risk of adverse reactions. ( 7.2 )

7.1 Drugs that Lower Seizure Threshold The concomitant use of FIRDAPSE and drugs that lower seizure threshold may lead to an increased risk of seizures <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.1 )]</span>. The decision to administer FIRDAPSE concomitantly with drugs that lower the seizure threshold should be carefully considered in light of the severity of the associated risks.

7.2 Drugs with Cholinergic Effects The concomitant use of FIRDAPSE and drugs with cholinergic effects (e.g., direct or indirect cholinesterase inhibitors) may increase the cholinergic effects of FIRDAPSE and of those drugs and increase the risk of adverse reactions.

FIRDAPSE is contraindicated in patients with: A history of seizures [see Warnings and Precautions ( 5.1 )] Hypersensitivity to amifampridine phosphate or another aminopyridine [see Warnings and Precautions ( 5.2 )] FIRDAPSE is contraindicated in patients with: A history of seizures ( 4 ) Hypersensitivity to amifampridine or another aminopyridine ( 4 )

AND PRECAUTIONS Seizures: FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. ( 5.1 ) Hypersensitivity reactions: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated. ( 5.2 )

5.1 Seizures FIRDAPSE can cause seizures. Seizures have been observed in patients without a history of seizures taking FIRDAPSE at the recommended doses, at various times after initiation of treatment, at an incidence of approximately 2%. Many of the patients were taking medications or had comorbid medical conditions that may have lowered the seizure threshold <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 )]</span>. Seizures may be dose-dependent. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. FIRDAPSE is contraindicated in patients with a history of seizures.

5.2 Hypersensitivity In clinical trials, hypersensitivity reactions and anaphylaxis associated with FIRDAPSE administration have not been reported. Anaphylaxis has been reported in patients taking another aminopyridine; therefore, it may occur with FIRDAPSE. If anaphylaxis occurs, administration of FIRDAPSE should be discontinued and appropriate therapy initiated.