KEVESY 5 MG / ML SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

WHAT KEVESY IS AND WHAT IT IS USED FOR

Kevesy is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Kevesy is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the numbers of fits.
• as an add-on to other antiepileptic medicines to treat:

• - partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age

• - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

• - primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).

Kevesy is an alternative for patients when administration of antiepileptic oral medicine is temporarily not feasible.

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KEVESY

Do not use Kevesy

• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given Kevesy

• if you suffer from kidney problems, follow your doctor’s instruc­tions.

He/she may decide if your dose should be adjusted.

• if you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• A small number of people being treated with anti-epileptics such as Kevesy have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
• Aggravation of epilepsy

Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Kevesy, see a doctor as soon as possible.

Children and adolescents

Kevesy is not indicated in children and adolescents below 16 years on it’s own (monotherapy).

Other medicines and Kevesy

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Kevesy with food, drink and alchohol

Kevesy may be used with or without food. As a safety precaution, do not use Kevesy with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.

You should not stop your treatment without discussing this with your doctor. A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.

Driving and using machines

Kevesy may impair your ability to drive or operate any tools or machinery, as Kevesy may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Kevesy contains sodium

Kevesy 5 mg/ml contains 3.50 mg of sodium (main component of cooking/table salt) per ml.

This is equivalent to 17.5% of the recommended maximum daily dietary intake of sodium for an adult.

Kevesy 10 mg/ml contains 3.23 mg of sodium (main component of cooking/table salt) per ml.

This is equivalent to 16.15% of the recommended maximum daily dietary intake of sodium for an adult

Kevesy 15 mg/ml contains 2.40 mg of sodium (main component of cooking/table salt) per ml.

This is equivalent to 12% of the recommended maximum daily dietary intake of sodium for an adult.

A doctor or a nurse will administer Kevesy as an intravenous infusion.

Kevesy must be administered twice a day, once in the morning and once in the evening, at about the same time each day.

The intravenous formulation is an alternative to oral administration (as film-coated tablets or oral solution). Your doctor may decide to switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.

Monotherapy

• Dose in adults and adolescents (from 16 years of age):

Recommended dose: between 1000 mg and 3000 mg each day.

When you will first start taking Kevesy, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

• Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1000 mg and 3000 mg each day.

• Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Method and route of administration:

Kevesy is for intravenous use. The solution for infusion should be administered over 15-minutes.

Duration of treatment:

There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Kevesy

If stopping treatment, as with other antiepileptic medicines, Kevesy should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Kevesy treatment, he/she will instruct you about the gradual withdrawal of Kevesy.

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If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

• Weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
• Swelling of the face, lips, tongue and throat (Quincke’s oedema);
• Flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
• Symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
• A skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• A more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• Signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. Atthe beginning ofthe treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common side effects (may affect more than 1 in 10 people):

• nasopharyngitis;
• somnolence (sleepiness), headache.

Common side effects (may affect up to 1 in 10 people):

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon side effects (may affect up to 1 in 100 people):

• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), vision blurred;
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare side effects (may affect up to 1 in 1,000 people):

• infection;
• decreased number of all blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• delirium;
• encephalopathy (see sub-section “Tell you doctor immediately” for detailed description of symptoms);
• seizures may become worse or happen more often
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• change of the heart rhythm (Electrocardiogram)
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
• limp or difficulty walking.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE KEVESY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the overwrap, bag and carton after EXP:.

The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

This medicinal product is for single use only, any unused solution should be discarded. Medicinal product with particulate matter or discoloration should not be used. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Kevesy contains

The active substance is levetiracetam.

• ■ Each ml contains 5 mg of levetiracetam.

Each 100 ml bag contains 500 mg of levetiracetam.

• ■ Each ml contains 10 mg of levetiracetam.

Each 100 ml bag contains 1000 mg of levetiracetam.

• ■ Each ml contains 15 mg of levetiracetam.

What Kevesy looks like and contents of the pack

Kevesy is a clear, colourless to light yellow solution for infusion that is available in a single-use, ready-to-use 100 ml dual port bag with an aluminum over wrap. It is available in three different concentrations in cartons of 10 bags

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

STRAGEN UK Ltd

Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ

Phone: +44 (0) 173 773 5029, Email:

Manufacturer

Infomed Fluids SRL

50 Theodor Pallady Blvd, District 3, 032266 Bucharest, Romania

This leaflet was last revised in 12.2020

stragen