Medication Guide App

FOSCAVIR 24 MG/ML SOLUTION FOR INFUSION

Active substance: FOSCARNET SODIUM HEXAHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
M088729-04 UK

Package leaflet: Information for the user

Foscavir®
24 mg/ml Solution for Infusion
foscarnet

Read all of this leaflet carefully
before you start having this medicine
because it contains important
information for you.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or nurse.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or nurse. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Foscavir is and what it is used
for
2. What you need to know before you
have Foscavir
3. How to have Foscavir
4. Possible side effects
5. How to store Foscavir
6. Contents of the pack and other
information
1. What Foscavir is and what it is
used for
Foscavir contains a medicine called
foscarnet. This belongs to a group of
medicines called anti-virals. It works
by stopping viruses from multiplying in
number.
Foscavir is used to treat the following
infections that are caused by viruses:
• An eye infection caused by a virus
in people with AIDS. The virus is
called cytomegalovirus (CMV) and the
infection is known as CMV retinitis.
Foscavir stops the infection from
getting worse but it cannot repair the
damage that has already happened.
• Herpes Simplex Virus (HSV). Foscavir
is given to people with HSV who
have a weakened immune system.
It is given to people who have not
got better from HSV after having a
medicine called aciclovir.
2. What you need to know before
you have Foscavir
Do not have Foscavir:
• If you are allergic (hypersensitive)
to foscarnet or any of the other
ingredients of this medicine (listed in
section 6).

Pregnancy and breast-feeding
• Foscavir is not recommended during
pregnancy.
• Trying to become pregnant during
Foscavir therapy is not recommended
so you should use effective
contraception methods.
• Men treated with Foscavir should not
father a child during or up to 6 months
after therapy.
• Do not have Foscavir if you are breastfeeding.
Driving and using machines
Foscavir may affect you being able to
drive or use tools or machines. Talk to
your doctor before you do any of these
activities.
Tests before and during your
treatment with Foscavir
Your doctor may do blood and urine
tests before and during your treatment
with Foscavir. This is to check how well
your kidneys are working and the level
of minerals in your blood.
Foscavir contains sodium
Foscavir contains 240 micromoles
(5.5 mg) of sodium per ml. This should
be taken into consideration by patients
on a controlled sodium diet, so please
tell your doctor or nurse if you are on a
low sodium (salt) diet.
3.

How to have Foscavir

• Foscavir will be given to you by a
doctor or nurse. It will be given to you
as an infusion (drip) into a vein. It may
be given into a central line in your
chest if you already have one in place.
• Each infusion will take at least 1 hour.
Do not interfere with your drip during
the infusion.
• The amount of Foscavir that you
are given depends on how well your
kidneys are working. It also depends
on your weight.
• It is important to have plenty of fluid
with the infusion. This will help to
prevent kidney problems. If you need
fluid, the doctor or nurse will give it to
you at the same time as Foscavir.
Having Foscavir for CMV retinitis
If you are having Foscavir for CMV
retinitis, there will be two stages to
your treatment. The first stage is called
induction therapy and the second stage
is called maintenance therapy.

If you are not sure, talk to your doctor or
nurse before having Foscavir.

Induction therapy
• During induction therapy, you will be
given an infusion every 8 hours. This
will usually happen for 2 or 3 weeks.

Warnings and precautions
Talk to your doctor or nurse before you
have Foscavir.

• The usual dose for induction therapy
is 60 mg of Foscavir for every kilogram
that you weigh (60 mg/kg).

Check with your doctor or nurse before
having Foscavir if:

• Your doctor will tell you when you
are ready to change to maintenance
therapy.

• You have problems with your kidneys.
If you are not sure if this applies to
you, talk to your doctor or nurse before
having Foscavir.
Other medicines and Foscavir
Tell your doctor or nurse if you are
taking, have recently taken or might
take any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines.
This is because Foscavir can affect
the way some medicines work and
some medicines can have an effect on
Foscavir.
In particular, tell your doctor or nurse
if you are already having any of the
following medicines:
• Pentamidine (for infections).
• Amphotericin B (for fungal infections).
• Aciclovir (for viral infections).
• Antibiotics called aminoglycosides,
such as gentamicin and streptomycin
(for infections).
• Ciclosporin A, methotrexate or
tacrolimus (used to suppress the
immune system).
• Medicines called protease inhibitors,
such as ritonavir and saquinavir.
• Laxatives.

Maintenance therapy
• During maintenance therapy, you will
be given an infusion once a day.
• The usual dose for maintenance
therapy is 60 to 120 mg of Foscavir for
every kilogram that you weigh (60 to
120 mg/kg).
Your doctor will tell you if you need to
have more or less Foscavir and how
often you should have it. This is so that
you have the dose that is right for you.
Sometimes your doctor may ask you to
have a medicine called ganciclovir as
well. This is to make sure that you have
the treatment that is right for you.
Having Foscavir for Herpes Simplex
Virus
• If you are being given Foscavir to treat
Herpes Simplex Virus, there is only
one stage.
• You will be given an infusion every 8
hours.
• Your wounds (lesions) may start to
heal after about 1 week. However, you
may need to keep having Foscavir
for 2 to 3 weeks or until your wounds
have healed.
• The usual dose is 40 mg of Foscavir
for every kilogram that you weigh
(40 mg/kg).

Personal hygiene
Wash your genitals carefully after
passing water (urine). This will help to
prevent any sores from developing.
If you get Foscavir solution on your
skin or in your eyes
If you get Foscavir solution on your skin
or in your eyes by mistake, rinse your
skin or your eyes straight away with
water.
If you think you have been given too
much Foscavir
If you think you have been given too
much Foscavir, talk to your doctor
straight away.
If you forget to have Foscavir
If you think you have missed a dose, talk
to your doctor straight away.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
The following side effects may happen
with this medicine.
Very common
(affects more than 1 in 10 people)
• Loss of appetite.
• Diarrhoea.
• Feeling or being sick.
• Feeling weak or tired.
• High temperature or chills.
• Feeling dizzy.
• Headache.
• Pins and needles.
• Skin rash.
• Changes in how well your kidneys are
working (shown in blood tests).
• Low levels of white blood cells. The
signs include infections and high
temperature (fever).
• Changes to red blood cells (shown in
blood tests). This may make you feel
tired or look pale.
• An imbalance of salts and minerals
in your blood. The signs include
weakness, cramps, thirst, tingling or
itching of the skin and twitching of
muscles.
Common
(affects less than 1 in 10 people)
• Pain in the tummy (abdomen),
constipation and indigestion.
• Inflamed pancreas (pancreatitis). The
signs include severe stomach pain.
• Feeling anxious, nervous, depressed,
agitated, aggressive or confused.
• Problems with your co-ordination.
• Fits (convulsions).
• Reduced feeling in the skin.
• Itchy skin.
• Generally feeling unwell.
• Swelling of the feet and legs.
• Pounding heart beat (palpitations).

The following side effects have also
been reported (frequency not known)
• Unusual heart beat.
• An ulcer in your oesophagus (the
passage where food travels from the
throat to the stomach). This may be
painful.
• Severe muscle problems with a
breakdown of your muscle tissue
(rhabdomyolysis). The signs include
abnormal urine colour and severe
muscle weakness, tenderness or
stiffness.
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store Foscavir
• 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
label. The expiry date refers to the last
day of that month.
• Do not store unopened bottles of
Foscavir above 30°C. Do not put them
in the fridge.
• Foscavir may be mixed with another
liquid by a pharmacist. This is to give
you a medicine ready to use. The
pharmacist will tell you how to store it
and when to use it by.
• Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What Foscavir contains
• The active substance is foscarnet.
There is 24 mg of foscarnet in each
millilitre (ml) of solution.
• The other ingredients are water for
injection and hydrochloric acid (E507).
What Foscavir looks like and contents
of the pack
Foscavir is a sterile solution for infusion.
The solution is clear and colourless.
Foscavir comes in bottles containing
250 ml.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for Foscavir
is held by Clinigen Healthcare Ltd.,
Pitcairn House, First Avenue,
Burton-on-Trent, Staffordshire,
DE14 2WW, UK.
Foscavir is manufactured by Fresenius
Kabi Austria GmbH, Hafnerstrasse 36,
A-8055 Graz, Austria.

• High blood pressure.
• Low blood pressure. This may make
you feel dizzy.
• Changes in tests that show how well
your heart is working (ECGs).
• Muscle problems. These include
changes that are shown in blood tests
and painful, sore, weak or twitching
muscles.
• Shaking (tremors).
• Nerve damage that may cause
changes in sensation or muscle
weakness (neuropathy).
• Swelling and redness along a vein.
• Genital sores.
• Changes in how well your liver is
working (shown in blood tests).
• Low levels of platelets in your blood.
This may make you bruise more easily.
• Infection of the blood.

To listen to or request
a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Foscavir
Reference number
31644/0001
This is a service provided
by the Royal National
Institute of Blind People.

• Kidney problems. These include pain
in your kidneys (you may feel this in
your lower back) and kidney failure.

This leaflet was last revised in
January 2014.

• Pain when you pass water (urine).

© Clinigen Healthcare Ltd.

• Passing water (urine) more often than
normal. Rarely, you may also feel very
thirsty.

Foscavir is a trademark of Clinigen
Healthcare Ltd.

Uncommon
(affects less than 1 in 100 people)
• Too much acid in the blood. This may
make you breathe more quickly.
• Changes in how well your pancreas is
working (shown in blood tests).

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)