CYMEVENE POWDER FOR INFUSION

Active substance: GANCICLOVIR SODIUM

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Patient Information Leaflet

10120155 GB 1004.1077

Cymevene® powder for infusion 500 mg
Ganciclovir

Please read all of this leaflet
carefully before you start having
this medicine.

Taking other medicines

Please tell your doctor or nurse if
you are taking or have recently taken any
other medicines. This includes medicines
that you buy without a prescription and
herbal medicines. This is because
Cymevene can affect the way some
medicines work. Also some medicines can
affect the way Cymevene works.

• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or nurse.
• If any of the side effects become serious
or troublesome, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or nurse.

In particular, tell your doctor or nurse
if you are taking any of the following
medicines:
• Probenecid (used to treat gout).
• Mycophenolate mofetil (used after
an organ transplant).
• Zidovudine, didanosine, cidofovir
or foscarnet (used to treat HIV).
• Imipenem-cilastatin, trimethoprim,
pentamidine, flucytosine, amphotericin
B or dapsone (antibiotics used to treat
infections).
• Doxorubicin, vincristine, vinblastine
or hydroxyurea (used to treat cancer).

In this leaflet:
1. What Cymevene is and what it is
used for
2. Before you are given Cymevene
3. How Cymevene will be given
4. Possible side effects
5. How Cymevene is stored
6. Further information

1. What Cymevene is and what
it is used for

Pregnancy and breast-feeding

Cymevene contains a medicine
called ganciclovir. This belongs to a group
of medicines called ‘anti-virals’.

You must not have Cymevene if you are
pregnant or breast-feeding. Cymevene
will damage an unborn baby.
• If you are a man and your partner
is at an age where she could get
pregnant, you must use condoms
during your treatment with Cymevene
and for 90 days after the end of
treatment.
• If you are a woman at an age where
you could get pregnant, you must use
contraception (birth control) during
your treatment.

Cymevene is used to treat
infections caused by a virus called
cytomegalovirus (CMV).
• The virus can infect any part of the
body. This includes the retina of the eye
where it causes problems with eye
sight.
• The virus can infect anyone. However,
in people who have a poor immune
system because of other diseases or
medicines (people who
are ‘immunocompromised’), it can
lead to serious
infections.

If you are not sure if
you are protected (have
adequate contraception),
talk to your doctor
or nurse before having Cymevene.

Cymevene is also used to prevent
cytomegalovirus (CMV) infection after an
organ transplant.

Driving and using machines

Ganciclovir can make you feel dizzy,
sleepy or confused. It can also cause fits
and loss of co-ordination. If any of these
happen to you, do not drive or use any
tools or machines.

2. Before you are given
Cymevene
You must not be given Cymevene if:
• You are allergic (hypersensitive)
to ganciclovir (the only ingredient
in Cymevene).
• You are allergic to similar medicines
called ‘anti-virals’. These include
valganciclovir, aciclovir and
valaciclovir.
• You are pregnant or breast-feeding
a baby. See the section on ‘Pregnancy
and breast-feeding’.
You must not be given Cymevene if any
of the above apply to you. If you are not
sure, talk to your doctor or nurse before
having Cymevene.

3. How Cymevene will be given
Cymevene will be given to you by a doctor
or nurse. It will be given to you through
a small tube into one of your veins (called
an ‘intravenous infusion’). It usually takes
one hour for the medicine to be given.
• The dose of Cymevene varies from
one patient to another. It depends on
your age, weight, how well your
kidneys are working and what you
need the medicine for. The doctor
will work out how much to give you.
• How often you have Cymevene and
how long you keep having it for also
varies from one patient to another.
You will usually start by having
one infusion every 12 hours for up to
21 days. After that you may have one
infusion a day.
• Your doctor will see how you respond
to this medicine, you may need to have
regular blood tests. If necessary your
dose might be changed or your
treatment stopped.

Take special care with Cymevene

Check with your doctor or nurse before
having Cymevene if:
• You have low numbers of white blood
cells, red blood cells or platelets in your
blood.
• You have had blood problems in the
past that have been caused by
medicines.
• You are having radiotherapy, or have
recently had it.
• You have kidney problems.
• You or your partner might
become pregnant during treatment.
See the section on ‘Pregnancy and
breast-feeding’.
If any of the above apply to you, or if you
are not sure, talk to your doctor or nurse
before you have Cymevene.

If you are given more Cymevene
than you should
• If you are given too much Cymevene
you may get changes to your blood,
problems with your liver or kidneys,
stomach pain, being sick, diarrhoea,
fits and shaking.
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This information is intended for medical or healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Cymevene® powder for infusion 500 mg

Ganciclovir
Please refer to the Summary of Product Characteristics for full prescribing
information.

Posology and method
of administration

Elderly patients

No studies on the efficacy or safety
of Cymevene in elderly patients
have been conducted. Since elderly
individuals often have reduced renal
function, Cymevene should be
administered to elderly patients with
special consideration for their renal
status (see above).

For intravenous infusion following
reconstitution with 10ml Water for
Injections BP. Based on patient weight
the appropriate calculated dose volume
should be removed from the vial
(ganciclovir concentration 50mg/ml) and
added to an acceptable infusion fluid
(typically 100ml) for delivery over the
course of 1 hour. Infusion concentrations
greater than 10mg/ml are not
recommended. (For further information
see Instructions for use/handling and
disposal).

Paediatric patients

There has been limited clinical
experience in treating patients under the
age of 12 years. Reported adverse events
were similar to those seen in adults.

However, the use of Cymevene
in children warrants extreme caution
due to the potential for long-term
carcinogenicity and reproductive
toxicity. The benefits of treatment
should outweigh the risks. Cymevene
is not indicated for the treatment of
congenital or neonatal CMV
infections.

Adults
Treatment of CMV infection
Initial (induction) treatment: 5mg/kg
infused at a constant rate over 1 hour
every 12 hours (10mg/kg/day) for
14 to 21 days.
Long-term (maintenance) treatment:
For immunocompromised patients at
risk of relapse of CMV retinitis a course
of maintenance therapy may be given.
Intravenous infusion of 6mg/kg once
daily 5 days per week, or 5mg/kg once
daily 7 days per week is recommended.

Dosage reductions

For less severe neutropenia or other
cytopenias a reduction in the total daily
dose should be considered. Cell counts
usually normalise within 3 to 7 days after
discontinuing the drug or decreasing the
dose. As evidence of marrow recovery
becomes apparent gradual increases in
dose, with careful monitoring of white
blood cell counts, may be appropriate.

Treatment of disease progression:
Indefinite treatment may be required
in patients with AIDS, but even with
continued maintenance treatment,
patients may have progression of
retinitis. Any patient in whom the
retinitis progresses, either while
on maintenance treatment or because
treatment with Cymevene has been
withdrawn, may be re-treated using
the induction treatment regimen.

Patients with severe
leucopenia, neutropenia, anaemia,
thrombocytopenia and pancytopenia

Severe leucopenia, neutropenia, anaemia,
thrombocytopenia, pancytopenia, bone
marrow depression and aplastic anaemia
have been observed in patients treated
with Cymevene. Therapy should not be
initiated if the absolute neutrophil count
is less than 500 cells/μL, or the platelet
count is less than 25000/μL, or the
haemoglobin level is less than 8g/dL.

Prevention of CMV disease
Induction regimen: 5mg/kg infused every
12 hours (10mg/kg/day) for 7 to 14 days.
Maintenance regimen: Intravenous
infusion of 6mg/kg once daily 5 days per
week, or 5mg/kg once daily 7 days per
week is recommended.

Cymevene should be used with caution in
patients with pre-existing haematological
cytopenia or a history of drug-related
haematological cytopenia and in patients
receiving radiotherapy.

Special dosage instructions
Patients with renal impairment:

If there is a significant deterioration of
blood cell counts during therapy with
Cymevene, treatment with haematopoetic
growth factors and/or dose interruption
should be considered.

Serum creatinine levels or creatinine
clearance should be monitored carefully.
Dosage adjustment is required according
to creatinine clearance as shown in the
table below.

Method of administration

Cymevene is a powder for solution for
intravenous infusion. For directions on
the preparation of the infusion solution,
see Instructions for use/handling, and
disposal.

An estimated creatinine clearance
(ml/min) can be related to serum
creatinine by the following formulae:
(140 – age [years])
For males = x (body weight [kg])
(72) x (0.011 x serum
creatinine [micromol/L])

Cymevene must only be given by
intravenous infusion, preferably via a
plastic cannula, into a vein with
adequate blood flow.

For females = 0.85 x male value

CrCl

Induction dose
of ganciclovir

≥ 70 ml/min

25 – 49 ml/min

5.0mg/kg every
12 hours
2.5mg/kg every
12 hours
2.5mg/kg/day

10 – 24 ml/min

1.25mg/kg/day

< 10 ml/min

1.25mg/kg/day
after haemodialysis

50 – 69 ml/min

Caution - do not administer by rapid or
bolus i.v. injection! The toxicity of
Cymevene may be increased as a result
of excessive plasma levels.
Caution - i.m. or s.c. injection may
result in severe tissue irritation due to the
high pH (~11) of ganciclovir solutions.
The recommended dosage, frequency,
or infusion rates should not be exceeded.

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• If you think you have been given too
much Cymevene, tell your doctor or
nurse.

• Feeling tired, unwell or weak,
high temperature (fever), shivering,
weight loss.
• A reaction where Cymevene was given
into your vein.

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

Uncommon (affect less than
1 in 100 people)

• Changes to your bone marrow (which
may affect how your body produces
some blood cells).
• Disturbances of the mind, including
feeling agitated and losing contact with
reality.
• Shaking or trembling that you cannot
control.
• Infection of the eye (conjunctivitis).
• Deafness.
• Uneven heart beat.
• Low blood pressure. The signs include
feeling dizzy or light-headed.
• Mouth ulcers, swelling of the abdomen
(tummy) and pancreatitis. The signs of
pancreatitis include severe pain in the
stomach which spreads to your back.
• Loss of hair and dry skin.
• Serious kidney disease.
• Blood in your urine (water).
• Infertility in men. Cymevene may stop
men from producing sperm. This can be
temporary or permanent.

4. Possible side effects
Like all medicines, Cymevene can cause
side effects, although not everyone will
get them.
Allergic reactions (uncommon, affect
less than 1 in 100 people)
If you have an allergic reaction,
tell a doctor straight away.
The signs may include:
• A raised itchy skin rash (hives).
• Difficulty breathing or swallowing
caused by sudden swelling of the
throat, face, lips and mouth.
• Sudden swelling of the hands, feet and
ankles.

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

• Low numbers of one type of white blood
cell (called neutrophils). The signs
include infections of the mouth, gums,
throat and lungs. Your doctor may
want you to have blood tests.
• Low numbers of red blood cells
(anaemia). The signs include feeling
tired, pale skin, palpitations
(a fluttering sensation in the heart)
and being short of breath.
• Difficulty breathing.
• Diarrhoea.

If any of the side effects become serious
or troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or nurse.

5. How Cymevene is stored
• Your doctor or pharmacist are
responsible for storing Cymevene.
They are also responsible for disposing
of any unused Cymevene correctly.
• Keep out of the reach and sight
of children.
• Do not store
Cymevene above
30°C.
• Do not use Cymevene
after the expiry date
printed on the pack.

Common (affect less than
1 in 10 people)






















• Infections of the
blood, skin, urinary
tract and mouth. The
signs include high
temperature (fever),
chills, feeling tired,
redness and swelling of the skin, pain
on passing water and creamy white
spots in the mouth.
Low numbers of all types of white
blood cells. The signs include infections
of the mouth, gums, throat and lungs.
Low numbers of platelets in your blood.
The signs include bruising easily and
nose bleeds.
Low numbers of all the types of cells
in your blood. The signs include feeling
tired, bruising easily, being short of
breath and nose bleeds.
Loss of appetite.
Depression, anxiety, feelings of
confusion and abnormal thinking.
Headache.
Difficulty in sleeping.
Changes to the way things taste.
Dizziness.
Fits (‘convulsions’).
Changes in your skin sensitivity
(such as numbness, pins and needles,
burning sensations).
Changes to your eye-sight (vision),
loss of vision or eye pain.
Pain in your ears.
A cough.
Feeling or being sick, pain in your
stomach, constipation, wind and
difficulty swallowing.
Problems with your liver, shown in a
blood test.
Skin rashes (including inflammation,
redness and blistering), itchiness and
sweating at night.
Pain in your back, joints, muscles or
chest or muscle cramps.
Problems with your kidneys. This may
affect the amount of water (urine) that
you pass.

6. Further information
What Cymevene contains

The active substance in Cymevene
powder for infusion is ganciclovir. Each
glass vial contains 500 mg (milligrams)
ganciclovir as ganciclovir sodium
543 mg. Sodium content per vial is 43 mg.
There are no other ingredients in
Cymevene.

What Cymevene looks like and
contents of the pack

Cymevene is a powder, supplied in a glass
vial. Before it is given, Cymevene is made
into a solution by adding sterile water to
the vial. The correct dose is then taken
out of the vial and added to the bag of
infusion solution to be given to the patient.
Vials of Cymevene are supplied in
packs of 5 or 25. Not all packs may be
marketed.

Marketing Authorisation Holder
and Manufacturer:
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom.

This leaflet was last approved in 09/2010

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Instructions for use/handling
and disposal
Caution should be exercised in the
handling of Cymevene.

Since Cymevene is considered a potential
teratogen and carcinogen in humans,
caution should be exercised in its
handling. Avoid inhalation or direct
contact of the powder contained in the
vials or direct contact of the reconstituted
solution with the skin or mucous
membranes. Cymevene solutions are
alkaline (pH approximately 11). If such
contact occurs, wash thoroughly with soap
and water, rinse eyes thoroughly with
sterile water, or plain water if sterile water
is unavailable.

Method of Preparation of Cymevene
solution
1. Lyophilized Cymevene should
be reconstituted by injecting 10ml of
sterile Water for Injections into the
vial. Do not use bacteriostatic
water for injection containing
parabens (para-hydroxybenzoates),
since these are incompatible with
Cymevene sterile powder and may
cause precipitation.
2. The vial should be shaken to dissolve
the drug.
3. Reconstituted solution should
be inspected for particulate matter
prior to proceeding with the admixture
preparation.
4. Reconstituted solution in the
vial is stable at room temperature for
12 hours. It should not be refrigerated.

Preparation and administration of
infusion solution

Based on patient weight the appropriate
calculated dose volume should be
removed from the Cymevene vial
(concentration 50mg/ml) and added to an
acceptable infusion fluid. Normal saline,
dextrose 5% in water, Ringer’s or lactated
Ringer’s solution are determined
chemically or physically compatible with
Cymevene. Infusion concentrations
greater than 10mg/ml are not
recommended.
Cymevene should not be mixed with
other iv products.
Because Cymevene is reconstituted with
nonbacteriostatic sterile water, the
infusion solution should be used as soon
as possible and within 24 hours of
dilution in order to reduce the risk of
bacterial contamination.
The infusion solution should
be refrigerated. Freezing is not
recommended.
Any unused product or waste material
should be disposed of in accordance with
local requirements.

This leaflet was last approved in 09/2010

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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.

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