Levetiracetam Hospira - Levetiracetam uses, dose and side effects

as the sole treatment in adults and adolescents from the age of 16 with newly diagnosed epilepsy , to treat a certain type of epilepsy . Epilepsy is a condition in which patients have repeated seizures (seizures). Levetiracetam is used for the form of epilepsy where the seizures initially affect only one side of the brain, but can then spread to larger areas on both sides of the brain ( partial seizures with or without secondary generalization). Your doctor has given you levetiracetam to reduce the number of seizures.
in addition to other antiepileptic medicines to treat:
- partial seizures with or without generalization in adults, adolescents and children from 4 years of age
- myoclonic seizures (short, sudden twitching of any muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
- primarily generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with generalized epilepsy of unknown origin (the type of epilepsy considered hereditary).

Levetiracetam Hospira concentrate for solution for infusion is an alternative for patients when oral administration of antiepileptic levetiracetam drugs orally is not possible.

What you need to know before you use Levetiracetam Hospira

Do not use Levetiracetam Hospira

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

Warnings and cautions

Talk to your doctor before receiving Levetiracetam Hospira:

If you have kidney problems, follow your doctor’s instructions. He / she decides if your dose needs to be adjusted.
If you notice that growth slows down or that puberty develops in your child unexpectedly, contact your doctor.
A small number of people who have been treated with antiepileptic drugs , such as Levetiracetam Hospira, have also had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and / or suicidal ideation, consult your doctor.
If you or someone in your family has a history of irregular heartbeat (seen on electrocardiogram , ECG ) or if you have a disease and / or receive treatment that increases the tendency for irregular heartbeat or salt balance disorders.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts for more than a couple of days:

Abnormal thoughts, irritability or unusually aggressive reactions, or if you or your family and friends notice significant changes in your mood or behavior.
Exacerbated epilepsy
In rare cases, your seizures may worsen or occur more often, mainly during the first month after starting treatment or increasing the dose . See a doctor as soon as possible if you experience any of these new symptoms while taking Levetiracetam Hospira.

Children and young people

Levetiracetam Hospira should not be used in children and adolescents under 16 years of age as single treatment ( monotherapy ).

Other medicines and Levetiracetam Hospira

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

Do not take macrogol (a medicine used as a laxative ) one hour before and one hour after taking levetiracetam as it may result in levetiracetam losing its effect.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Levetiracetam Hospira can be used during pregnancy, but only if the doctor, after careful consideration, deems it necessary. You should not stop your treatment without first discussing this with your doctor.

The risk of birth defects in your unborn baby can not be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Hospira may impair your ability to drive or use tools or machines as it may make you drowsy. This is more likely at the beginning of treatment or after a dose increase. You should not drive or use machines until it has been determined that your ability to perform such activities is not affected.

Levetiracetam Hospira contains sodium

A maximum single dose of Levetiracetam Hospira concentrate contains 57 mg of sodium (19 mg of sodium per vial ). This corresponds to 2.85% of the maximum recommended daily sodium intake for adults. This should be considered if you have been prescribed a low-salt diet.

How Levetiracetam Hospira is given

A doctor or nurse will give you Levetiracetam Hospira as an intravenous infusion.

Levetiracetam Hospira should be given twice a day, once in the morning and once in the evening, at approximately the same time each day.

The intravenous formulation is an alternative to your oral administration. You can switch from film-coated tablets or oral solution to intravenous administration or vice versa, directly without dose adjustment. Your total daily dose and number of dosing times remain identical.

Alone treatment

Dose for adults and adolescents (from 16 years):

Usual dose: Between 1,000 mg and 3,000 mg every day.

When you start taking Levetiracetam Hospira, your doctor will prescribe a lower dose for 2 weeks before you receive the lowest standard dose.

Additional treatment

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

Usual dose: Between 1,000 mg and 3,000 mg every day.

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

Usual dose: Between 20 mg / kg body weight and 60 mg / kg body weight every day.

Method of administration:

Levetiracetam Hospira is for intravenous use.

The recommended dose must be diluted in at least 100 ml of compatible diluent and infused over 15 minutes.

For physicians and nurses, see section 6 for more detailed instructions for the proper use of Levetiracetam Hospira.

Processing time:

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

If you stop using Levetiracetam Hospira

If treatment with Levetiracetam Hospira should be discontinued, just as with other medicines to treat epilepsy, done gradually to avoid an increase of seizures. If your doctor decides to stop your treatment with Levetiracetam Hospira, he/she will instruct you on how to stop the treatment gradually.

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

Possible side effects

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

Talk to your doctor immediately or see your nearest emergency department if you experience:

weakness, dizziness or feeling dizzy or having difficulty breathing as this may be a sign of a severe allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat ( Quincke’s edema )
flu-like symptoms and rash on the face followed by a widespread rash with fever, elevated levels of liver enzymes seen in blood samples and an increase in the type of white blood cells ( eosinophilia ) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms “DRESS”)
symptoms such as small urine volume, fatigue, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden renal impairment
skin rash that can form blisters and look like small targets (central dark spots surrounded by a paler area with a dark ring around the edge) ( erythema multiforme )
extensive skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome )
a more severe form of skin rash that causes skin detachment on more than 30% of the body surface ( toxic epidermal necrolysis )
signs of severe mental changes or if someone around you detects signs of confusion, drowsiness (drowsiness), amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy .

The most commonly reported side effects are inflammation of the nose and/or throat, somnolence (drowsiness), headache, fatigue, and dizziness. At the beginning of treatment or when increasing the dose, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

inflammation of the nose or throat
somnolence (drowsiness), headache

Common: may affect more than 1 in 10 people

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
cramps, balance disorders, dizziness (feeling of instability), drowsiness (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (feeling of rotation)
cough
abdominal pain, diarrhea, dyspepsia (stomach upset), vomiting, nausea
rash
weakness / fatigue (fatigue)

Uncommon: may affect up to 1 in 100 people

decreased platelet count , decreased white blood cell count
weight loss, weight gain
suicide attempts and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability / mood swings, agitation
amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination / ataxia (impaired coordination of movements), paresthesia (tingling), disturbance of attention (impaired ability to concentrate)
diplopia (double vision), blurred vision
elevated / abnormal values on liver function tests
hair loss, eczema , itching
muscle weakness, myalgia (muscle pain)
damage

Rare: may affect up to 1 in 1,000 people

infection
decreased number of all types of blood cell s
severe allergic reactions (DRESS, anaphylactic reaction [severe and severe allergic reaction ], angioedema [swelling of the face, lips, tongue and throat])
low levels of sodium in the blood
suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, inability to concentrate)
delirium
encephalopathy (see section “Talk to your doctor immediately” for a detailed description of the symptoms)
the attacks may worsen or occur more often
uncontrollable muscle spasms affecting the head, torso, arms and legs, difficulty controlling movement, hyperkinesia (hyperactivity)
altered heart rhythm ( electrocardiogram )
pancreatitis ( inflammation of the pancreas)
liver failure, hepatitis
rapidly impaired renal function
skin rash, which can 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 large skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes skin detachment on more than 30% of the body surface ( toxic epidermal necrolysis )
rhabdomyolysis (degradation of muscle tissue) associated with elevated creatine phosphokinase in the blood. The incidence is significantly higher in Japanese patients compared to non-Japanese patients
lame gait or difficulty walking.

How to store Levetiracetam Hospira

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 carton and bottle after EXP.

The expiration date is the last day of the specified month.

No special storage instructions.

Contents of the pack and other information

Content declaration

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
The other ingredients are: Sodium acetate trihydrate, concentrated acetic acid, sodium chloride, water for injections (see section 2 “Levetiracetam Hospira contains sodium”).

What the medicine looks like and contents of the pack

Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colorless, solution.

Levetiracetam Hospira concentrate for solution for infusion is packed in cardboard boxes containing 10 or 25 vials of 5 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BVBA

High Road 10

1930 Zaventem