Amifampridine is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 20, 2026[1]
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
How to take
GBOfficial regulatory label
CACanada· Health Canada
2 products
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations The following situations may affect dosing of RUZURGI (amifampridine) Dosing should be individualized based on disease severity, patient response, and patient population. RUZURGI is extensively metabolized/acetylated by N-acetyltransferase 2 (NAT2).
RUZURGI (amifampridine tablets) Product Monograph Page 5 of 29 Therefore, RUZURGI should be initiated at the lowest recommended starting dose possible in patients who are known NAT2 slow acetylators (see DOSAGE AND ADMINISTRATION (3), Recommended Dose and Dosage Adjustment; WARNINGS AND PRECAUTIONS (6), Hepatic/Billiary/Pancreatic; ACTION AND CLINICAL PHARMACOLOGY (9), Genetic Polymorphism).
RUZURGI can accumulate in patients with renal impairment. In patients with mild and moderate renal impairment, RUZURGI should be initiated at the lowest possible dose and titrated slowly to clinical effect while monitoring for adverse reactions and tolerability.
EUEuropean Union· EMA
2 products
Uses
EUOfficial regulatory label· revised December 18, 2024[3]
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
How to take
EUOfficial regulatory label
Drug interactions
Known interactions involving Amifampridine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB439560005 · revised February 20, 2026
[2]Health Canada (DPD) · 02503034 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/001032 · revised December 18, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Posology Amifampridine should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
No single dose should exceed 20 mg. Tablets are to be taken with food. 2 for further information about bioavailability of amifampridine in the fed and fasted state. If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Renal or hepatic impairment Amifampridine should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function.
For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days.
2). Paediatric population The safety and efficacy of Amifampridine in children aged 0 to 17 years has not been established. No data are available. Method of administration For oral use only.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]
Summary of the safety profile The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain).
The intensity and incidence of most adverse reactions is dose-dependent. Table 1 below lists the adverse reactions reported with amifampridine.
Tabulated list of adverse reactions Frequencies are defined as:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Table 1:
Adverse Reactions Reported with Amifampridine MedDRA System organ class MedDRA Preferred term Frequency Psychiatric disorders Sleep disorders, anxiety Unknown Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache UnknownNervous system disorders Dizziness1, hypoaesthesia1, paraesthesia1 Very common Eye disorders Blurred vision Unknown Cardiac disorders Cardiac rhythm disorders, palpitations Unknown Raynaud's syndrome UnknownVascular disorders Cold extremities1 Common Respiratory, thoracic and mediastinal disorders Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough Unknown Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1 Very common Abdominal pain Common Gastrointestinal disorders Diarrhoea, epigastralgia Unknown Hepatobiliary disorders Elevated liver enzyme levels (transaminases) Unknown Skin and subcutaneous disorders Hyperhidrosis1, cold sweat1 Very common 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]
2). No studies have been conducted in patients with hepatic impairment. In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored. The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function.
2). Seizures Exposure to amifampridine is associated with an increased risk for epileptic seizures. 5). In the event of a seizure, treatment should be discontinued. 3). Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time. Most Schwannomas are benign and asymptomatic. They can present in many locations, therefore the clinical presentation can be varied.
A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy. Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma. Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Cardiac effects Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter. In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
Concomitant diseases Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 20, 2026[1]
4)
This is not medical advice. Consult a qualified healthcare professional.
Additional caution should be exercised when dosing patients with severe renal impairment. No dosing recommendations can be made for patients with end-stage renal disease or those receiving dialysis (see WARNINGS AND PRECAUTIONS (6), Renal; ACTION AND CLINICAL PHARMACOLOGY (9), Renal Impairment).
To avoid the risk of overdose, RUZURGI should not be taken with other forms of amifampridine or with other aminopyridines (see CONTRAINDICATIONS (2)). Caution is advised if administering RUZURGI to patients with risk factors for torsade de pointes or in combination with drugs known to prolong QT interval (see WARNINGS AND PRECAUTIONS (6), Cardiovascular; DRUG INTERACTIONS (8); ACTION AND CLINICAL PHARMACOLOGY (9), Pharmacodynamics).
2 Recommended Dose and Dosage Adjustment Dosing should be individualized based on disease severity, patient response, and patient population. The dose should be gradually titrated to the optimal effective dose with the minimum of side effects.
Once achieved, this optimal dose should be maintained, and dosing frequency should be adjusted, as needed. Patients 6 years of age and older RUZURGI should be initiated at the lowest possible dose and titrated slowly to effect while closely monitoring tolerability and adverse events.
The recommended oral dose is based on body weight (see Table 1). 5 mg* to 5 mg increments, divided in up to 5 doses per day 10 mg 40 mg All patients weighing 45 kg or more 10 mg to 20 mg daily, in divided doses (2 to 3 times per day) Increase daily in 5 mg to 10 mg increments, divided in up to 5 doses per day 20 mg 80 mg Some patients may benefit from a total daily dose of 100 mg.
3) for method to achieve these doses. RUZURGI (amifampridine tablets) Product Monograph Page 6 of 29 Known N-acetyltransferase 2 (NAT2) Slow Acetylators: The recommended starting dosage in patients weighing less than 45 kg who are known NAT2 slow acetylators is 5 mg daily taken orally in divided doses, 2 to 3 times per day.
The recommended starting dose of RUZURGI in patients weighing 45 kg or more who are known NAT2 slow acetylators is 10 mg daily taken orally in divided doses (2 to 3 times per day) (see WARNINGS AND PRECAUTIONS (6), Special Populations; ACTION AND CLINICAL PHARMACOLOGY (9)).
Use in Hepatic Impairment:
RUZURGI has not been studied in controlled clinical trials of patients or volunteers with any degree of hepatic impairment. RUZURGI is extensively metabolized and hepatic impairment can slow its metabolism, resulting in higher plasma drug levels (see WARNINGS AND PRECAUTIONS (6), Hepatic/Biliary/Pancreatic; ACTION AND CLINICAL PHARMACOLOGY (9), Pharmacokinetics).
Initiation and titration of RUZURGI in patients with mild and moderate hepatic impairment should be done cautiously, using the lowest recommended initial single and total daily doses. Additional caution and monitoring of adverse reactions is recommended for patients with severe hepatic impairment (see WARNINGS AND PRECAUTIONS (6), Hepatic/Biliary/Pancreatic).
The recommended starting dose for patients weighing less than 45 kg with mild and moderate hepatic impairment is 5 mg daily taken orally in divided doses (2 to 3 times per day) using the lowest possible total daily dose with a recommended maximum of 20 mg/day.
The recommended starting dose of RUZURGI in patients weighing 45 kg or more with mild or moderate hepatic impairment is 10 mg daily taken orally in divided doses (2 to 3 times per day) using the lowest possible total daily dose with a recommended maximum of 40 mg/day.
No dosage recommendations for RUZURGI can be made for patients with severe hepatic impairment (see WARNINGS AND PRECAUTIONS (6), Special Populations).
Use in Renal Impairment:
RUZURGI has not been studied in controlled trials of patients or volunteers with any degree of renal impairment. RUZURGI should be titrated more slowly, using the lowest dose in patients with moderate or severe renal impairment (see WARNINGS AND PRECAUTIONS (6), Renal).
5 mg daily taken orally in divided doses to a maximum daily dose of 20 mg. The recommended starting dose of RUZURGI in patients weighing 45 kg or more with renal impairment (creatinine clearance 15 to 90 mL/min) is 15 mg daily taken orally in divided doses to a maximum daily dose of 40 mg (see WARNINGS AND PRECAUTIONS (6), Special Populations).
No dosage recommendations for RUZURGI can be made for patients with end- stage renal disease or those undergoing dialysis. 3 Administration RUZURGI can be taken without regard to food intake. However, administration of RUZURGI with food could mitigate paresthesia and abdominal discomfort (see […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 2 times greater than the maximum recommended total daily dose) to 52 healthy adult volunteers (see ACTION AND CLINICAL PHARMACOLOGY (9), Cardiac Electrophysiology).
Adverse reactions that occurred during RUZURGI treatment and with incidence at least 2% greater than placebo treatment are displayed in Table 3. RUZURGI (amifampridine tablets) Product Monograph Page 11 of 29 Table 3 – Adverse Reactions Occurring in ≥1% of Subjects During Ruzurgi Treatment and with at Least 2% Greater Incidence than Placebo System Organ Class (SOC) Adverse Reactions Ruzurgi (n=52) % Placebo (n=49) % Gastrointestinal Disorders Oral dysaesthesia 29 0 Abdominal pain* 25 0 Dyspepsia 17 2 Nausea 10 2 Diarrhea 2 0 General Disorders and Administration Site Conditions Chest discomfort 2 0 Musculoskeletal and Connective Tissue Disorders Back pain 8 2 Muscle spasms 6 2 Pain in extremity 2 0 Nervous System Disorders Dysaesthesia 48 2 Dizziness 12 0 Hypoesthesia 6 0 Dysgeusia 2 0 Paresthesia 2 0 Respiratory, Thoracic and Mediastinal Disorders Hiccups 2 0 Vascular Disorders Hot flush 2 0 Hypotension 2 0 * Includes abdominal pain and upper abdominal pain.
RUZURGI (amifampridine tablets) Product Monograph Page 12 of 29 Subjects classified as slow acetylators based on genotyping for variants of the N- acetyltransferase 2 (NAT2) gene were more likely to experience adverse reactions during RUZURGI treatment than intermediate or rapid acetylators (see ACTION AND CLINICAL PHARMACOLOGY (9), Genetic Polymorphism).
Expanded Access Experience:
In the Expanded Access Programs, 162 patients with LEMS (54% female) were treated with RUZURGI. 4 person years. 7 years). 3 mg/day, respectively. In general, the most frequent adverse reactions observed in the Expanded Access Programs were similar to those observed in the QT study.
Additionally, the following adverse reactions were reported in ≥5% of patients: falls, pneumonia, dyspnea, arthralgia, asthenia, depression, dysphagia, headache, insomnia, vision blurred, anemia, anxiety, constipation, feeling cold, gastroesophageal reflux disease, and pain.
Because these reactions were captured retrospectively from the Expanded Access Programs, it is not possible to reliably estimate their frequency or establish a causal relationship to RUZURGI. 3 Clinical Trial Adverse Reactions (Pediatrics) The safety of RUZURGI was evaluated in 7 pediatric LEMS patients 6 to less than 18 years of age who were treated with RUZURGI in the Expanded Access Programs for at least one year.
Adverse reactions reported in these patients were similar to those seen in adult LEMS patients and included one patient with palpitations.
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
Cardiovascular QTc Interval Prolongation:
RUZURGI can cause QTc interval prolongation in N- acetyltransferase 2 slow acetylators (see ACTION AND CLINICAL PHARMACOLOGY (9), Electrocardiography). Drugs that prolong the QTc increase the risk of torsade de pointes, a polymorphic ventricular tachyarrhythmia.
Generally, the risk of torsade de pointes increases with the magnitude of QTc prolongation produced by a drug. Torsade de pointes can be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures. If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death.
Caution should be observed if RUZURGI is administered to patients who have risk factors for torsade de pointes. , myocardial infarction, heart failure); history of arrhythmias; bradycardia (<50 beats per minute); and electrolyte disorders.
Hypokalemia, hypocalcemia, and hypomagnesemia should be corrected prior to initiation or continuation of RUZURGI. Endocrine and Metabolism Exposure of RUZURGI is increased in patients who are N-acetyltransferase (NAT2) slow acetylators (see ACTION AND CLINICAL PHARMACOLOGY (9)).
Therefore, initiate RUZURGI in patients who are known NAT2 slow acetylators at the lowest recommended starting dose and monitor for adverse reactions. Dose titration should be based on clinical response and tolerability (see DOSAGE AND ADMINISTRATION (3), Recommended Dose and Dosage Adjustment).
Hepatic/Biliary/Pancreatic The effects of RUZURGI have not been studied under controlled conditions in patients or volunteers with any degree of hepatic impairment. Since RUZURGI is extensively metabolized/acetylated by N-acetyltransferase 2 (NAT2), hepatic impairment can cause an increase in exposure.
Therefore, initiate RUZURGI in patients with mild and moderate hepatic impairment using the lowest recommended initial single and total daily doses. Additional caution and monitoring of adverse reactions is recommended for patients with severe hepatic impairment (see DOSAGE AND ADMINISTRATION (3) and ACTION AND CLINICAL PHARMACOLOGY (9), Special Populations and Conditions, Hepatic Impairment).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
RUZURGI (amifampridine) is contraindicated in patients who: Are hypersensitive to this drug or to any ingredient in its formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING (5); Have history of seizures; Are taking other forms of amifampridine or other aminopyridines.
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Posology FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
No single dose should exceed 20 mg. Tablets are to be taken with food. 2 for further information about bioavailability of amifampridine in the fed and fasted state. If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Renal or hepatic impairment FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function.
For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days.
2). Paediatric population 3 The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established. No data are available. Method of administration For oral use only.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised December 18, 2024[3]
Summary of the safety profile 6 The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain).
The intensity and incidence of most adverse reactions is dose-dependent. Table 1 below lists the adverse reactions reported with amifampridine.
Tabulated list of adverse reactions Frequencies are defined as:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Table 1:
Adverse Reactions Reported with FIRDAPSE MedDRA System organ class MedDRA Preferred term Frequency Psychiatric disorders Sleep disorders, anxiety Unknown Nervous system disorders Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache Unknown Dizziness1, hypoaesthesia1, paraesthesia1 Very common Eye disorders Blurred vision Unknown Cardiac disorders Cardiac rhythm disorders, palpitations Unknown Vascular disorders Raynaud's syndrome Unknown Cold extremities1 Common Respiratory, thoracic and mediastinal disorders Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough Unknown Gastrointestinal disorders Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1 Very common Abdominal pain Common Diarrhoea, epigastralgia Unknown Hepatobiliary disorders Elevated liver enzyme levels (transaminases) Unknown Skin and subcutaneous disorders Hyperhidrosis1, cold sweat1 Very common 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised December 18, 2024[3]
2). No studies have been conducted in patients with hepatic impairment. In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored. The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function.
2). Seizures Exposure to amifampridine is associated with an increased risk for epileptic seizures. 5). In the event of a seizure, treatment should be discontinued. 3). Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time. Most Schwannomas are benign and asymptomatic. They can present in many locations, therefore the clinical presentation can be varied.
A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy. Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma. Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Cardiac effects 4 Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter. In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
Concomitant diseases Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised December 18, 2024[3]
4)
This is not medical advice. Consult a qualified healthcare professional.
Neurologic Seizures RUZURGI can cause seizures. Seizures have been observed in patients with and without previous history of seizures taking RUZURGI at the recommended therapeutic doses, and at various times after initiation of treatment.
Seizures may be dose dependent. Patients with history of seizures or tremor were not included in controlled clinical trials of RUZURGI. Some of the patients were taking medications or had comorbid medical conditions that may have lowered the seizure threshold (see DRUG INTERACTIONS (8), Drug-Drug Interactions).
Consider discontinuation or dose-reduction of RUZURGI in patients who have a seizure while on treatment. RUZURGI is contraindicated in patients with a history of seizures. It should be used with caution in combination with drugs that are known to lower seizure threshold (see CONTRAINDICATIONS (2)).
RUZURGI (amifampridine tablets) Product Monograph Page 9 of 29 Renal There is no controlled experience with RUZURGI in patients or volunteers with any degree of renal impairment. Renal clearance is an elimination pathway for RUZURGI and its inactive metabolite, 3-N-acetyl-amifampridine (see ACTION AND CLINICAL PHARMACOLOGY (9), Renal Impairment).
Therefore, in patients with mild or moderate renal impairment, RUZURGI should be initiated at the lowest recommended starting dosage and patients should be closely monitored for adverse reactions. In patients with severe renal impairment, extra caution should be exercised and patients should be monitored for tolerability and adverse reactions.
Consider dose reduction or discontinuation of RUZURGI for patients with renal impairment, as needed, based on clinical effect and tolerability (see DOSAGE AND ADMINISTRATION (3), Renal Impairment). Sensitivity/Resistance In clinical trials, hypersensitivity reactions and anaphylaxis associated with RUZURGI administration have not been reported.
However, since anaphylaxis has been reported in patients taking another aminopyridine it can occur with RUZURGI, as well. If anaphylaxis occurs, RUZURGI should be discontinued and appropriate therapy initiated. 1 Pregnant Women There are no adequate and well-controlled studies of RUZURGI in pregnant women.
Both RUZURGI and its metabolite cross the placenta and enter the fetal circulation and amniotic fluid. Women of childbearing potential should use effective contraception during treatment with RUZURGI (see ADVERSE REACTIONS (7), Expanded Access Experience).
RUZURGI should be used during pregnancy only if potential benefit to the mother justifies the potential risk to the fetus. 2 Breast-feeding There is no reported experience with RUZURGI in nursing mothers. It is not known whether RUZURGI or its metabolite are secreted in human milk or how they affect milk production or what effects they have on the breastfed baby.
Because many drugs are excreted in human milk, a decision should be made to either discontinue nursing or discontinue the drug taking into account the mother’s clinical need for RUZURGI, any potential adverse effects on the breastfed infant from RUZURGI, or from the underlying maternal condition.
3 Pediatrics There is no controlled experience for the safety and efficacy of RUZURGI in pediatric LEMS patients. Seven patients, 9 to 16 years of age, have received RUZURGI in clinical practice. There are no actual pharmacokinetic/exposure data in pediatric LEMS patients 6 to 17 years of age.
Use of RUZURGI in this population is supported by evidence from controlled studies of RUZURGI in adults with LEMS, pharmacokinetic data in adult […]