Foscarnet sodium 24 mg/ml – patient leaflet, side effects, dosage

1. What Foscarnet is a

nd what it is used for

group of medicines called

certain viruses [all viruses

group and certain retroviruses

s (CMV)]. It stops the virus

ells.

ndividuals with a weakened

• To treat CMV retinitis i

  f you have AIDS.

• To treat herpes infectio

  n (of the lips, nose, eyes and

  genitalia).

• Foscarnet is given to i

  ndividuals with CMV infection

  following a bone mar

  row transplant. This is also

  known as a haemat

  opoietic stem cell transplant

  (HSCT). The infection

  can sometimes be detected

  before the patient star

  ts to have symptoms. This is

  known as CMV viraem

  ia.

2. What you need to

know before you are given

Foscarnet

Do not use foscarnet:

• If you are allergic to f

  oscarnet or any of the other

  ingredients of this med

  icine (listed in section 6).

CHECK WITH YOUR D

OCTOR OR PHARMACIST IF

YOU ARE NOT SURE.

Warnings and precauti

ons

Talk to your doctor or nu

rse before using foscarnet:

• If you have kidney prob

  lems. In this case, your doctor

  may be able to adapt t

  he dose to your condition.

• If you have low blood c

  alcium levels before receiving

  this medicine, and if yo

  u are taking a medicine which

  lowers blood calcium l

  evels.

• If you have heart probl

  ems.

• If you have tingling in y

  our hands or lips, and nausea.

  In this case, your nurs

  e will reduce the infusion rate.

• In case of accidental c

  ontact with the product, rinse

  the exposed skin or m

  ucous membranes

• (inside the mouth, nos

  e, ears or genitalia) with water.

Close attention to perso

nal hygiene is recommended

after passing urine: wa

sh the penis (or vulva) with

running water to avo

id genital lesions (genital

ulceration).

Blood tests

Before and during trea

tment, your doctor may ask

you to have blood and u

rine tests. These tests aim to

check your kidney funct

ion and the mineral levels in

your blood.

Children and adolescent

s

Not applicable.

Other medicines and fo

scarnet

Tell your doctor or nurse i

f you are taking, have recently

taken or might take any o

ther medicines. This includes

medicines that you buy

without a prescription and

herbal medicines. This is

because foscarnet can affect

the way some medicine

s work and some medicines

can have an effect on fo

scarnet.

In particular, tell your doc

tor or nurse if you are already

having any of the followi

ng medicines:

• Pentamidine (for infec

  tions).

• Amphotericin B (for fu

  ngal infections).

• Aciclovir (for viral infec

  tions).

• Antibiotics called

  aminoglycosides, such as

  gentamicin and strepto

  mycin (for infections).

• Ciclosporin A, methot

  rexate or tacrolimus (used to

  suppress the immune

  system).

• Medicines called pr

  otease inhibitors, such as

  ritonavir and saquinav

  ir.

• Quinidine, amiodaro

  ne, sotalol or any other

  medicines which ma

  y affect your heart rate or

  rhythm.

• Anxiolytics (neurolepti

  cs).

Pregnancy and breast-

feeding

• Foscarnet is not recom

  mended during pregnancy.

• You should avoid

  becoming pregnant during

  foscarnet therapy

  and should therefore use

  effective birth control

  methods while being treated

  with foscarnet and for

  7 months following completion

  of treatment.

• Men treated with fos

  carnet recommended to use

  effective contraceptiv

  e measures and should not

  father a child during treatment or up to 4 months following completion of treatment.

  • Do not take foscarnet while breast-feeding.

Driving and using machines

Foscarnet may affect you being able to drive or use tools or machines. This is due to the risk of seizures, abnormal movements and dizziness reported with this medicine. Talk to your doctor before you do any of these activities.

Foscarnet contains sodium

Foscarnet 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.

The maximum recommended daily dose of this medicinal product contains 2.89 grams sodium (found in table salt). This is equivalent to 144.5% of the adult recommended maximum daily dietary intake for sodium.

Talk to your pharmacist or do

ctor if you need foscarnet on a daily basis for a pro

longed period of time, especially if you have been a

dvised to have a low salt diet.

3. How to use Foscarnet

• Always use this medicine e

  xactly as your doctor has told you. Check with your d

  octor if you are not sure.

• Foscarnet will be given to y

  ou by a doctor or nurse. It will be given to you as an i

  nfusion (drip) into a vein.

  It may be given into a centr

  al line in your chest if you already have one in place.

• Each infusion will take a

  t least 1 hour. Do not interfere with your drip duri

  ng the infusion.

• The dose of foscarnet a

  dministered depends on your weight and how well y

  our kidneys are working.

• It is important to keep u

  p adequate fluid intake during the infusion, which

  will also help prevent kidney problems. If necess

  ary, your doctor or nurse will administer the necess

  ary hydration regimen at the same time as your fosc

  arnet infusion.

Personal hygiene

Wash your genitals carefully a

fter passing water (urine).

This will help to prevent any s

ores from developing.

If you get foscarnet soluti

on on your skin or in your eyes

If you get foscarnet solution

on your skin or in your eyes by mistake, rinse your s

kin or your eyes straight away with water.

If you take more foscarnet

If you are given an extremely

than you should:

large dose of foscarnet, tell your doctor or pharmacist Cases of overdose have be

immediately.

en reported. The highest dose was 20 times the norma Symptoms resemble acut

l dose.

e hypocalcaemia, with tingling sensations, and oc

casionally seizures and functional renal failure. Haemodialysis increases fo

scarnet elimination and may be of benefit in some ca

If you forget to take foscarn

Not applicable.

If you stop taking foscarne

Not applicable.

4. Possible side effects

Like all medicines, this m

ses.

et

t

edicine can cause side effects, although not everybo

dy gets them.

Some side effects can

be serious and need immediate medical attentio

n:

• Severe allergic reaction

  s including a fall in blood pressure, shock a

  nd swelling of the skin

  (angioedema). They are k

  nown as hypersensitivity, anaphylactic or anaphylact

  oid reactions.

• Severe skin rashes. These

  types of rashes can be associated with redness,

  swelling, and blisters of the skin, mouth, throat, eye

  s and other places inside the body and can sometim

  es result in death. They are called erythema multi

  forme, Stevens-Johnson syndrome and toxic epider

  mal necrolysis.

If you get any of the above,

tell your doctor straight away or go to the nearest e

mergency unit.

Other side effects include:

Very common: may affect m

ore than 1 in 10 people

• Reduced red blood cell cou

  nt (shown in blood tests).

  You may feel tired or look p

  ale.

• Low levels of white blood

  cells (granulocytopenia).

  The signs include infectio

  ns and high temperature

  (fever).

• Loss of appetite.

• Reduced potassium level i

  n the blood.

• Reduced magnesium level

  in the blood.

• Reduced calcium level in t

  he blood.

• Dizziness.
• Headache.
• Tingling.
• Diarrhoea.
• Nausea, vomiting.
• Feeling weak or tired.
• High temperature or chills.
• Skin rash.

• Changes in how well yo

  ur kidneys are working

  (shown in blood tests)

  : e.g. elevated blood creatinine, reduced haemo

  globin.

  M0xxxxx/02 UK The following infor

mation is intended for

healthcare professiona

ls only:

Take special care with F

oscarnet

• In patients with impair

  ed renal function:

  • Serum creatine sho

    uld be regularly monitored.

  • Dose adjustment sh

    ould be envisaged in patients

    with impaired renal

    function. To prevent changes

    in renal function tha

    t may occur during treatment,

    adequate hydration should be maintained.

• Do not use solutions which may contain calcium.
• In case of accidental contact, rinse the exposed skin or mucous membranes with water.

Method of administration

Foscarnet should be administered by the intravenous route only, either by a central venous line (catheter) or in a peripheral vein.

Caution: Do not administer foscarnet by rapid intravenous injection.

Do not administer foscarnet without a hydration regimen.

Do not use solutions which may contain calcium, 30% glucose, amphotericin B, acyclovir sodium, ganciclovir, pentamidine isethionate, trimethoprim-sulfamethoxazole and vancomycin hydrochloride.

As with all infusions, compli

ance with strictly aseptic conditions is required during

handling.

When peripheral veins are

used, the solution of foscarnet 24 mg/ml must

be diluted. Individually dispensed doses of foscarn

et should be aseptically transferred to plastic infusio

n bags by the hospital pharmacy and diluted with eq

ual parts of 0.9% sodium chloride (9 mg/ml) or 5% de

xtrose (50 mg/ml) by the hospital pharmacy. The phy

sico-chemical stability of foscarnet and dilutions foscarnet and dilutions thereof in PVC bags is 9 days. The diluted solutions should be used as soon as possible after preparation but can be stored for up to 24 hours if kept refrigerated.

Renal toxicity of foscarnet can be reduced by adequate hydration of the patient. See “Hydration” section below.

If a Y-infusion system is used, simultaneously infuse 0.5 to 1 litre of 0.9% NaCl or 5% glucose.

Do not administer other products in the same infusion. When the product is administered by infusion into a peripheral vein, simultaneous intravenous hydration serves as dilution (see “Hydration”).

Common: may affect u

• Low levels of white bl neutropenia). The sign temperature (fever).
• Reduced levels of plat make you bruise more
• Infection of the blood (
• Increased or reduced
• Reduced sodium level
• Increased calcium lev
• Dehydration.
• Abnormal liver functio
• Elevated liver enzy aminotransferase, a LDH).
• Change in your me agitation, anxiety, nervousness.
• Coordination problems
• Seizures.
• Reduced feeling in the
• Unusual heartbeat (he
• Rapid heart rate (tach

• Nervous disorders liab

  p to 1 in 10 people

  ood cells (leukopenia and/or s include infections and high elets in your blood. This may easily.

  sepsis).

  phosphate level in the blood. in the blood.

  el in the blood.

  n.

  mes (gamma-GT, alanine spartate aminotransferase, ntal state. e.g. aggression, confusion, depression,

  .

  skin.

  art palpitations).

  ycardia).

  le to cause sensory changes or muscle weakness (

• Tremor.
• Hypertension.
• Hypotension, which ca
• Swelling, pain and red
• Stomach (abdomina indigestion.
• Gastrointestinal bleedi
• Inflamed pancreas (pa well your pancreas is
• include severe stoma changes in blood tests
• Itchy skin.
• Muscle pain.
• Kidney problems, e.g. your lower back), kidn in the urine.
• Pain when passing uri
• Genital sores or ulcer multiple lesions which (see “Precautions for u
• Generally feeling unw
• Injection site pain and
• Chest pain.
• Swelling of the feet an

• Changes in tests that working (ECG).

  neuropathy).

  n cause dizziness.

  ness along a vein.

  1. l) pain, constipation and ng.

ncreatitis) or changes in how working. The signs

ch pain and there may be (increased lipases).

pain in your kidneys (pain in ey failure, presence of protein ne.

ation. These are isolated or subside on stopping treatment se”).

ell.

inflammation.

d legs.

show how well your heart is

Uncommon: may affec

• Reduced red blood platelets.
• Too much acid in the breathe more quickly.
• Itchy skin rash (hives).
• Kidney problems glomerulonephritis, ne
• Elevation of certain amylase, creatine pho

Not known: frequency the available data

• Diabetes. The signs often than usual. Mo excessively thirsty.
• Increased sodium leve
• Encephalopathy.
• Unusual heartbeat or torsades de pointes.
• Oesophageal ulcer.
• Muscle problems: trembling muscles, d (rhabdomyolysis: abno muscle stiffness, tende
• Kidney problems, e.g. necrosis, crystal nephr

• Extravasation.

  t up to 1 in 100 people

  cells, white blood cells and blood. This may make you

  (renal tubular disorder, phrotic syndrome).

  enzymes in the blood, e.g. sphokinase.

  cannot be estimated from include passing urine more re rarely, you may also feel l in the blood.

  changes in heart rate, e.g.

  painful, aching, weak or estruction of muscle tissue rmal urine colour, and severe rness or weakness).

  pain, blood in urine, tubular opathy.

Reporting of side effec

If you get any side eff

ts

ects, talk to your doctor or pharmacist. This include

s any possible side effects not listed in the leaflet. You

can also report side effects directly via The Yellow C

ard Scheme

Website www.mhra.gov

.uk/yellowcard or search or

MHRA Yellow Card in th

e Google Play or Apple App

Store.

By reporting side effects

you can help provide more information on the safety

of this medicine.

5. How to store Fosca

rnet

• Keep this medicine o

  ut of the sight and reach of children.

• Do not use this medici

  ne after the expiry date which is stated on the label.

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

• Do not refrigerate o

  r freeze. If refrigerated or exposed to tempera

  tures below freezing point precipitation may oc

  cur. By keeping the bottle at room temperature

  with repeated shaking, the precipitate can be bro

  ught into solution again.

• Chemical and phy

  sical in-use stability has been demonstrated f

  or 9 days at 25°C. From a microbiological point of opening and dilu microbial contaminati used immediately. If storage times and co responsibility of the us

• Foscarnet may be mi pharmacist. This is to use. The pharmacist w when to use it by.

  of view, unless the method tion precludes the risk of on, the product should be not used immediately, in-use nditions prior to use are the er.

  xed with another liquid by a give you a medicine ready to ill tell you how to store it and

  • Do not throw away any m or household waste. Ask throw away medicines yo measures will help protect

6. Contents of the pack an

What Foscarnet sodium co

The active substance is fosca Each ml contains 24 mg hexahydrate

The other ingredients are hydrochloric acid.

What Foscarnet sodium loo the pack

Foscarnet is a sterile solution The solution is clear and colo Foscarnet comes in bottles c

Marketing Authorisation Ho

Fresenius Kabi Ltd

edicines via wastewater your pharmacist how to u no longer use. These the environment.

d other information ntains rnet.

of foscarnet sodium water for injection and ks like and contents of for infusion.

urless.

ontaining 250 ml.

lder

Cestrian Court

Eastgate Way, Manor Park Runcorn, Cheshire

WA7 1NT

United Kingdom

Manufacturer

Fresenius Kabi Austria GmbH Hafnerstrasse 36

A-8055 Graz

Austria

This leaflet was last revised

in October 2025.

Diagram of a Y-infusion

system

Hydration:

Particular attention shou of preventing renal toxi patients receive adequat

If a Y-infusion system is u or 5% glucose should b compliant patients, oral h regimens has been patients should have the initiating foscarnet thera

ld be given to the importance city of foscarnet by ensuring e hydration.

sed, 0.5 to 1 litre of 0.9% NaCl e infused simultaneously. In ydration with similar hydration used. Clinically dehydrated ir condition corrected before py.

Each bottle of foscarnet sho one patient with a single infus

Accidental skin and eye co sodium solution may cause l sensation. If accidental cont area should be rinsed with w

If foscarnet refrigerated or e below freezing point preci

uld only be used to treat ion.

ntact with the foscarnet ocal irritation and burning act occurs, the exposed ater.

xposed to temperatures pitation may occur. By keeping the bottle at room te shaking, the precipitate can again.

Any unused medicinal produc be disposed of in accordance

mperature with repeated be brought into solution t or waste material should with local requirements.