Fampridine

HOS-095824 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting. Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia. This is consistent with fampridine’s pharmacological activity. The highest incidence of adverse reactions identified from placebo- controlled trials in multiple sclerosis patients with fampridine given at the recommended dose, are reported as urinary tract infection (in approximately 12 % of patients). Tabulated list of adverse reactions Adverse reactions are presented below by system organ class and absolute frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1: Tabulated list of adverse reactions MedDRA System Organ Adverse reaction Frequency category Class (SOC) Infections and infestations Urinary tract infection1 Very Common Influenza1 Common Nasopharyngitis1 Common Viral infection1 Common Immune system disorders Anaphylaxis Uncommon Angioedema Uncommon Hypersensitivity Uncommon Psychiatric disorders Insomnia Common Anxiety Common Nervous system disorders Dizziness Common Headache Common Balance disorder Common Vertigo Common Paraesthesia Common Tremor Common Seizure2 Uncommon

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095820 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to fampridine or to any of the excipients listed in section 6.1. Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine). Patients with prior history or current presentation of seizure. Patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min). Concomitant use of Fampyra with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.

HOS-095819 · has-indication-information · PDF-Seite 2

Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).

HOS-095822 · has-interaction-information · PDF-Seite 4

Interaction studies have only been performed in adults. Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3). Fampridine is eliminated mainly via the kidneys with active renal secretion accounting for about 60% (see section 5.2). OCT2 is the transporter responsible for the active secretion of fampridine. Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine are contraindicated (see section 4.3) and concomitant use of fampridine with medicinal products that are substrates of OCT2 for example, carvedilol, propranolol and metformin is cautioned (see section 4.4.) Interferon: fampridine has been administered concomitantly with interferon-beta and no pharmacokinetic medicinal product interactions were observed. Baclofen: fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.

HOS-095823 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are limited amount of data from the use of fampridine in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure it is preferable to avoid the use of fampridine in pregnancy. 4 Breast-feeding It is unknown whether fampridine is excreted in human or animal milk. Fampyra is not recommended during breast-feeding. Fertility In animal studies no effects on fertility were seen.

HOS-095821 · has-warning-information · PDF-Seite 3

Seizure risk Treatment with fampridine increases seizure risk (see section 4.8). This medicinal product should be administered with caution in the presence of any factors which may lower seizure threshold. Fampridine should be discontinued in patients who experience a seizure while on treatment. Renal impairment Fampridine is primarily excreted unchanged by the kidneys. Patients with renal impairment have higher plasma concentrations which are associated with increased adverse reactions, in particular neurological effects. Determining renal function before treatment and its regular monitoring during 3 treatment is recommended in all patients (particularly in the elderly in whom renal function might be reduced). Creatinine clearance can be estimated using the Cockroft-Gault formula. Caution is required when Fampyra is prescribed in patients with mild renal impairment or in patients using medicinal products that are substrates of OCT2 for example, carvedilol, propranolol and metformin. Hypersensitivity reactions In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment. Particular attention should be given to patients with a previous history of allergic reactions. If an anaphylactic or other serious allergic reaction occurs, this medicinal product should be discontinued and not restarted. Other warnings and precautions Fampridine should be administered with caution to patients with cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose). There is limited safety information in these patients. The increased incidence of dizziness and balance disorder seen with fampridine may result in an increased risk of falls. Therefore, patients should use walking aids as needed. In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo. Infections were seen in the clinical studies (see section 4.8) and increased infection rate and impairment of the immune response cannot be excluded.