Skip to Content

CIDOFOVIR EMCURE PHARMA 75 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CIDOFOVIR DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
5 mm

80 mm

5 mm

80 mm

5 mm

5 mm

180 mm

5 mm
30 mm

Package leaflet: Information for the user

Cidofovir
75 mg/ml concentrate for solution for infusion
1644

qThis medicine is subject to additional monitoring. This will
allow quick identification of new safety information. You can
help by reporting any side effects you may get. See the end of
section 4 for how to report side effects

Other medicines and cidofovir
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription, as these
may interact with cidofovir or probenecid.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for
you.

It is very important to tell your doctor if you are receiving
other medicines that may damage your kidneys.
These include:
! tenofovir containing medicines, used to treat HIV-1
infection and/or chronic hepatitis B
infectionaminoglycosides, pentamidine or vancomycin
(for bacterial infections)
! amphotericin B (for fungal infection)
! foscarnet (for viral infection)
! adefovir (for HBV infection)

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist 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, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

These medicines must be stopped at least 7 days before
taking cidofovir.
Probenecid may interact with other medicines commonly
used in the treatment of AIDS and AIDS-related illnesses, such
as zidovudine (AZT). If you are taking zidovudine, you should
discuss with your doctor whether to temporarily stop taking
zidovudine or decrease the dose of zidovudine by 50% on
days when cidofovir and probenecid are given.
The potential for interactions between cidofovir and anti-HIV
protease inhibitors has not been studied.

What is in this leaflet:
1 What Cidofovir is and what it is used for
2 What you need to know before you use Cidofovir
3 How to use Cidofovir
4 Possible side effects
5 How to store Cidofovir
6 Contents of the pack and other information

Cidofovir with food and drink
Food should be taken before you are given cidofovir. Your
doctor may instruct you to drink plenty of fluids before
receiving cidofovir.

1 What Cidofovir is and what it is used for
Cidofovir is used to treat an eye infection called CMV
retinitis in patients with AIDS (Acquired
Immunodeficiency Syndrome). Cidofovir will not cure CMV
retinitis but may improve your condition by delaying
progression of the disease.
The safety and efficacy of cidofovir has not been
demonstrated in diseases other than CMV retinitis in patients
with AIDS.
Cidofovir must be administered by a healthcare professional
(doctor or nurse) in a hospital setting.

Pregnancy and breast-feeding
You should not be given cidofovir if you are pregnant. If
you become pregnant while receiving this medication, you
must inform your doctor immediately. Cidofovir has been
shown to cause damage in unborn animals and should not be
used during pregnancy unless the potential benefits justify
the risks to the foetus. If you could get pregnant, you must
use an effective method of contraception to stop you
getting pregnant during treatment with cidofovir and for 1
month afterwards.
You should not be given cidofovir if you are breastfeeding. It is not known whether cidofovir is passed on to the
baby in human milk. Because many medicines are passed
through to human milk, nursing mothers should stop
cidofovir or stop breast-feeding if they continue to receive
cidofovir.
In general, women with HIV should not breast-feed in
order to avoid passing HIV to their infant through the milk.

470 mm

What is CMV retinitis?
CMV retinitis is an eye infection caused by a virus named
cytomegalovirus (CMV). CMV attacks the retina of the eye and
may cause loss of vision, and eventually lead to blindness.
Patients with AIDS are at high risk of developing CMV retinitis
or other forms of CMV disease such as colitis (an inflammatory
bowel disease). Treatment for CMV retinitis is necessary to
reduce the potential for blindness.
Cidofovir is an antiviral medicine which blocks the replication
of CMV by interfering with viral DNA production.

Driving and using machines
Cidofovir may cause short-term side effects such as fatigue or
weakness. If you drive or operate machinery, discuss this with
your doctor to get advice about stopping these activities
based upon your disease and your tolerance of the medicine.

2 What you need to know before you use Cidofovir
Do not use cidofovir
! If you are allergic to cidofovir or any of the other
ingredients of this medicine (listed in section 6).
! If you have ever had kidney disease.
! If you cannot take the medicine probenecid because of a
serious allergy to probenecid or other sulfa-containing
medicines (e.g. sulfamethoxazole).
If any of these apply to you, talk to your doctor. You are not to
be given cidofovir.

Cidofovir 75 mg/ml concentrate for solution for infusion
contains sodium
This medicine contains 2.5 mmol (or 57 mg) sodium per vial
which should be taken into consideration if you are on a
controlled sodium diet.
3 How to use Cidofovir

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using
cidofovir.
! Kidney damage is the major side effect of cidofovir
treatment. Therefore, your doctor may need monitor
carefully, particularly if you already have kidney problems
or are on haemodialysis.
! If you have diabetes mellitus. cidofovir should be used
with caution in diabetic patients due to the potential
increased risk of developing low pressure in the eye (ocular
hypotony).
During treatment with cidofovir you should receive
regular follow-up eye examinations for possible eye
irritation, inflammation or swelling. If you get pain, redness
or itching of the eye or changes in your vision, tell your
doctor promptly.
Cidofovir caused reduced testes weight and low sperm count
(hypospermia) in animals. Although not observed in human
studies of cidofovir, such changes may occur in humans and
cause infertility. Men should practice barrier birth control
methods during and for 3 months after treatment with
cidofovir.
Cidofovir is not used for the treatment of HIV infection.
Cidofovir will not stop you passing HIV infection onto other
people so you should continue to take precautions to
avoid infecting others.
Children
Cidofovir has not been studied in children. Therefore, this
medicine should not be used in children.

Cidofovir 75 mg/ml concentrate for solution for infusion is
given by intravenous infusion (a drip into a vein). It must
not be administered by other methods including intraocular
injection (direct injection into the eye) or topically (on the
skin). Cidofovir must be given by a doctor or nurse with
appropriate experience in treating people with AIDS.
The doctor or nurse will transfer the appropriate dose of
cidofovir from the vial to an infusion bag containing 100 ml
0.9% (normal) saline solution. The entire volume of the bag
will be infused into your vein at a constant rate over a period of
1 hour using a standard infusion pump. The recommended
dose, frequency of use, or rate of infusion must not be
exceeded. At the end of this leaflet, there is further
information for healthcare professionals on how to administer
cidofovir.
To lower the risk of kidney damage, probenecid tablets
and intravenous fluids (saline solution) must be given on
the day of each cidofovir (See sub-sections “How to take
probenecid with cidofovir” and “How IV fluids are given before
cidofovir” below.)
Dose in adults
The dose you will need is calculated based on your body
weight.
Starting (induction) treatment
The recommended dose of cidofovir in patients with normal
kidney function is 5 mg per kg of body weight given once
weekly for two consecutive weeks.

The following information is intended for medical or healthcare professionals only:
Cidofovir vials should be inspected visually prior to use. If visible particles or discolouration are observed, the vial should not be used.
Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and
disposal of cidofovir. The preparation of cidofovir diluted solution should be done in a laminar flow biological safety cabinet.
Personnel preparing the solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs. If
cidofovir contacts the skin, wash membranes and flush thoroughly with water.
The appropriate dose of cidofovir should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline
solution. The entire volume of the bag should be infused into the patient's vein at a constant rate over a period of 1 hour using a
standard infusion pump. The recommended dose, frequency of use, or rate of infusion must not be exceeded.
The chemical stability of cidofovir mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of
5 mm
V2G
030616

Front

180 mm
5 mm

80 mm

5 mm

5 mm

5 mm

80 mm

5 mm

Maintenance treatment
Beginning two weeks after completion of induction
treatment, the recommended maintenance dose of cidofovir
in patients with normal kidney function is 5 mg per kg of body
weight given once every two weeks.

safety of probenecid. You should also read the probenecid
package leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist 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 at www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the
safety of this medicine.

Dose adjustment
If you have kidney problems, cidofovir may not be appropriate
treatment for you. Samples of your urine and/or blood will be
taken before each infusion of cidofovir and used for testing
kidney function. For patients with evidence of decreased
kidney function, your cidofovir dose may be interrupted or
stopped depending on your individual case.

5 How to store Cidofovir
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.
Do not store above 25°C. Do not refrigerate or freeze.
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

If you use more cidofovir than you should
If you have accidentally been given more cidofovir than
prescribed for you, tell your doctor immediately.
How to take probenecid with cidofovir
Probenecid tablets are given to lower the risk of kidney
damage. You must take 3 doses of probenecid tablets orally
on the same day as cidofovir as shown in the following table:
Time
3 hours before start of cidofovir
2 hours after end of cidofovir
8 hours after end of cidofovir
Total

6 Contents of the pack and other information

Dose
2 g probenecid
1 g probenecid
1 g probenecid
4 g probenecid

What Cidofovir 75 mg/ml concentrate for solution for
infusion contains
The active substance is cidofovir. Each ml contains 75 mg
cidofovir anhydrous. Each vial contains 375 mg/5 ml cidofovir
anhydrous.
The other ingredients are sodium hydroxide, hydrochloric
acid, water for injections

Probenecid is only taken on the same day that cidofovir is
given.

What Cidofovir looks like and contents of the pack
Cidofovir is supplied as a sterile concentrate for solution for
infusion in clear, glass vials containing 375 mg of the active
ingredient, anhydrous cidofovir, formulated in 5 ml water for
injections at a concentration of 75 mg/ml. The formulation is
pH-adjusted with sodium hydroxide (and hydrochloric acid if
needed) and contains no preservatives.

How IV fluids are given before cidofovir
Normal saline is given to lower the risk of kidney damage.
You should receive a total of one litre of 0.9% (normal) saline
solution intravenously (as a drip into a vein) before each
cidofovir dose. The saline solution should be infused over a 1
hour period immediately before the cidofovir. If you can
tolerate the additional fluid load, your doctor may administer
a second litre of fluid. If administered, the second litre of saline
should be given either at the start of the cidofovir or
immediately afterwards, and infused over a 1 to 3 hour period.
Your doctor may also tell you to drink plenty of fluids.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist or nurse.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Emcure Pharma UK LTD,
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire, PE19 8ET,
United Kingdom

4 Possible side effects

Manufacturer:
Emcure Pharma UK Ltd
Basepoint Business Centre
110 Butterfield
Great Marlings
Luton, LU2 8DL
United Kingdom
This medicinal product is authorised in the Member States
of the EEA under the following names:

Very common side effects
(These can affect more than 1 user in 10)
low white blood cell counts, headache, nausea, vomiting,
protein in the urine, increase in blood creatinine (a measure of
kidney function), hair loss, rash, weakness/fatigue and fever.

United Kingdom
Belgium

Common side effects
(These can affect 1 to 10 users in 100)
inflammation of the eye, reduced pressure in the eyes, difficult
or laboured breathing, shortness of breath, diarrhoea and
chills.
Any pain, redness or itching of the eye or changes in your
vision should be promptly reported to your doctor so that
your treatment can be reviewed.
Additional reactions reported from post-marketing
experience include kidney failure, damage to kidney tubule
cells, inflammation of the pancreas and hearing impairment.

Germany

Spain

Cidofovir Emcure Pharma 75 mg/ml
concentrate for solution for infusion
Cidofovir Emcure Pharma 75 mg/ml
solution à diluer pour perfusion
Cidofovir Emcure Pharma 75 mg/ml
Konzentrat zur Herstellung einer
Infusionslösung
Cidofovir Emcure Pharma 75 mg/ml
concentrado para solución para perfusión
EFG

This leaflet was last approved on 05/2016

Possible side effects of taking probenecid
Very common side effects possibly related to probenecid
(These can affect more than 1 user in 10)
nausea, vomiting, rash and fever.
Common side effects possibly related to probenecid
(These can affect 1 to 10 users in 100)
headache, weakness/fatigue, chills and allergic reactions.
To reduce the risk of nausea and/or vomiting associated with
taking probenecid, you should eat food before each dose.
Your doctor might instruct you to take other medicines such
as anti-emetics (anti sickness medicines), antihistamines
and/or paracetamol to decrease the side effects of
probenecid.
Probenecid may also cause other side effects including loss of
appetite, sore gums, flushing, hair loss, dizziness, reduced red
blood cell count and increased frequency of passing water
(urinating). Allergic reactions, with skin inflammation, itching,
hives and, rarely, severe allergic reactions, and serious skin
reaction have occurred. There have been reports of reduced
white blood counts, liver toxicity, kidney toxicity and
destruction of red blood cells. Reductions in blood cell and
platelet counts have also occurred.
Therefore before giving you probenecid your doctor should
consult the current prescribing information regarding the

either polyvinyl chloride (PVC) composition or ethylene/propylene copolymer, and in PVC based vented IV administration sets.
Other types of IV set tubing and infusion bags have not been studied.
Compatibility of cidofovir with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
From a microbiological point of view, the product must be used immediately.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8ºC when dilution is
performed under controlled and validated aseptic conditions. Storage beyond 24 hours or freezing is not
recommended. Refrigerated infusion bags should be allowed to warm to room temperature prior to use.
Cidofovir is supplied in single-use vials. Partially used vials must be discarded.

Back

1644

510008690GB01

470 mm

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
These side effects usually disappear when treatment with
cidofovir is stopped. If any of the side effects gets serious, or
if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist immediately.
The most common side effect observed with cidofovir is
damage to the kidneys.

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