Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Foscarnet sodium Tillomed 24 mg/ml solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Foscarnet sodium hexahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Foscarnet contains a medicine called foscarnet sodium hexahydrate. This belongs to a group of medicines called antivirals. It works by stopping viruses from multiplying in number. Foscarnet 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. Foscarnet stops the infection from getting worse but it cannot repair the damage that has already happened.
- Herpes Simplex Virus (HSV). Foscarnet 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.
What you need to know before you take it
e Foscarnet Do not use Foscarnet:
- If you are allergic (hypersensitive) to foscarnet sodium hexahydrate or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or nurse before you are given foscarnet. Warnings and precautions Talk to your doctor or nurse before using Foscarnet if. • •
You have problems with your kidneys. You have problems with your heart.
If you are not sure if this applies to you, talk to your doctor or nurse before you are given foscarnet. Children and adolescents The safety and efficacy of foscarnet sodium hexahydrate in children have not been established. Other medicines and Foscarnet Tell your doctor or pharmacist 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. In particular, tell your doctor or nurse if you are already taking any of the following medicines: − Pentamidine (for infections) − Amphotericin B (for fungal infections) − Acyclovir (for viral infections) − Antibiotics called aminoglycosides, such as gentamicin and streptomycin (for infections) − Cyclosporine A, methotrexate, or tacrolimus (used to suppress the immune system) − Medicines called protease inhibitors such as ritonavir and saquinavir − Laxatives − Quinidine, amiodarone, sotalol or any other medicines which may affect your heart rate or rhythm − Tranquilisers (neuroleptics) Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Foscarnet is not recommended during pregnancy. Trying to become pregnant during Foscarnet therapy is not recommended so you should use effective contraception methods during and up to 6 months after therapy. Men treated with Foscarnet should not father a child during or up to 6 months after therapy. Do not use Foscarnet if you are breastfeeding. Driving and using machines Foscarnet may affect you being able to drive or use tools and machines. Talk to your doctor before you do any of these activities. Tests before and during your treatment with Foscarnet Your doctor may do blood and urine tests before and during your treatment with Foscarnet. This is to check how well your kidneys are working and the level of minerals in your blood. Foscarnet contains sodium
This medicine contains 1375 mg sodium (main component of cooking/table salt) in each 250 ml bottle. This is equivalent to 69% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 71 ml or more daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
How to take it
Foscarnet Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. • • • •
Foscarnet 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 Foscarnet 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 Foscarnet.
Use of Foscarnet for CMV infection If you are having Foscarnet 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. Induction therapy • • •
During induction therapy, you will be given an infusion every 8 hours. This will usually happen for 2 or 3 weeks. The usual dose for induction therapy is 60 mg of Foscarnet for every kilogram that you weigh (60 mg/kg). Your doctor will tell you when you are ready to change to maintenance therapy.
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 Foscarnet for every kilogram that you weigh (60 to 120 mg/kg).
Your doctor will tell you if you need to have more or less Foscarnet 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. Use of Foscarnet for Herpes Simplex Virus • • • •
If you are being given Foscarnet 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 taking Foscarnet for 2 to 3 weeks or until your wounds have healed. The usual dose is 40 mg of Foscarnet 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 Foscarnet on your skin or in your eyes If you get Foscarnet on your skin or in your eyes by mistake, rinse your skin or your eyes straight away with water. Use in children and adolescents: The safety and efficacy of Foscarnet has not been established in children and adolescents below 18 years of age have not been established. If you use more Foscarnet than you should If you think you have been given too much Foscarnet, talk to your doctor straight away. If you forget to use Foscarnet If you think you have missed a dose, talk to your doctor straight away. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and need immediate medical attention:
- Severe allergic reactions including a fall in blood pressure, shock and swelling of the skin (angioedema). They are known as hypersensitivity, anaphylactic or anaphylactoid reactions.
- Severe skin rashes. These types of rashes can be associated with redness, swelling, and blisters of the skin, mouth, throat, eyes and other places inside the body and can sometimes result in death. They are called erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. If you get any of the above, tell your doctor straight away or go to the nearest emergency unit. Other side effects include: Very common: (may affect 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: (may affect up to 1 in 10 people)
- Pain in the tummy (abdomen), constipation, indigestion or gastrointestinal bleeding
- Inflamed pancreas (pancreatitis) or changes in how well your pancreas is working. The signs include severe stomach pain and there may be changes that are shown in blood tests
- 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 heartbeat (palpitations) or change in rhythm e.g torsade de pointes or fast heartbeat (tachycardia)
- High blood pressure
- Low blood pressure. This may make you feel dizzy
- Changes in tests that show how well your heart is working (ECG)
- 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, pain, and redness along a vein or where the injection needle is inserted
- 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
- Kidney problems. This includes pain in your kidneys (you may feel this in your lower back) and kidney failure. There may be changes that are shown in blood or water (urine) tests
- Pain when you pass water (urine)
- Passing water (urine) more often than normal. Rarely you may also feel very thirsty or dehydrated
- Pain in your chest Uncommon: (may affect up to 1 in 100 people)
- An itchy rash (urticaria)
- Too much acid in the blood. This may make you breathe more quickly
- Reduction of all blood cells (pancytopenia) Not known: frequency cannot be estimated from the available data •
Unusual heartbeat
• •
•
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. Blood in your water (urine)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Foscarnet 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 label after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze. Foscarnet should not be kept below 8°C as precipitation can occur at lower temperatures. Precipitation remains even if the infusion solution is frozen and thawed again.
Foscarnet can be made ready for use again if it has been accidentally stored at refrigerator temperatures or if the infusion solution has been exposed to temperatures below freezing. The bottle should then be shaken vigorously several times and kept at room temperature for 4 hours until all precipitation has completely dissolved. After opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. After dilution: Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8°C and 20-25°C when solution is diluted from 24 mg/ml to 12 mg/ml of foscarnet sodium hexahydrate in PVC bags. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
• •
Do not use Foscarnet if you notice any damage to the bottle, discolouration or other signs of deterioration. 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 Foscarnet contains • • •
The active substance is foscarnet sodium hexahydrate. One ml of solution contains 24 mg foscarnet sodium hexahydrate. One 250 ml bottle contains 6000 mg foscarnet sodium hexahydrate. The other ingredients are hydrochloric acid, dilute for pH adjustment and water for injections.
What Foscarnet looks like and contents of the pack
Foscarnet is a clear, colourless solution for infusion in glass bottles. Each pack contains 1 bottle or 10 bottles of 250 ml.
Not all pack sizes may be marketed. Marketing Authorisation Holder Tillomed Laboratories Limited 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom Manufacturer 1 Siegfried Hameln GmbH Langes Feld 13 31789 Hameln Germany Tillomed Laboratories Limited 220 Butterfield, Great Marlings Luton, LU2 8DL, United Kingdom
This leaflet was last revised in <{01/2026}> ————————————————————————————————————
1
Only actual manufacturer stated on printed leaflet
The following information is intended for healthcare professionals only: Instructions for use and handling When infused into peripheral veins, the solution should be diluted from 24 mg/ml to 12 mg/ml of Foscarnet sodium hexahydrate before use. Individually dispensed doses of Foscarnet should be aseptically transferred to plastic infusion bags (PVC bags) and diluted with equal parts of 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution. Storage and shelf-life of the medicinal product and diluted solution: see section 5. Each bottle of Foscarnet should only be used to treat one patient with a single infusion. Accidental skin and eye contact with the Foscarnet sodium hexahydrate solution may cause local irritation and burning sensation. If accidental contact occurs, the exposed area should be rinsed with water. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Frequently asked questions about Foscarnet sodium Tillomed 24 mg/ml solution for infusion
How do I take Foscarnet sodium Tillomed 24 mg/ml solution for infusion?
Foscarnet sodium Tillomed 24 mg/ml solution for infusion comes as infusion containing 24mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Foscarnet sodium Tillomed 24 mg/ml solution for infusion?
The active substance in Foscarnet sodium Tillomed 24 mg/ml solution for infusion is foscarnet sodium hexahydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Foscarnet sodium Tillomed 24 mg/ml solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Foscarnet sodium Tillomed 24 mg/ml solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: foscarnet sodium hexahydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Foscarnet is indicated for induction and maintenance therapy of cytomegalovirus (CMV) retinitis in patients with AIDS.
Foscarnet is also indicated for the treatment of mucocutaneous Herpes Simplex Virus (HSV) infections, clinically unresponsive to aciclovir in immunocompromised patients. The safety and efficacy of foscarnet sodium hexahydrate for the treatment of other HSV infections (e.g. retinitis, encephalitis); congenital or neonatal disease; or HSV in immunocompetent individuals has not been established.
The diagnosis of aciclovir unresponsiveness can be made either clinically by treatment with intravenous aciclovir (5–10 mg/kg t.i.d) for 10 days without response or by in vitro testing.
Foscarnet is not recommended for treatment of CMV infections other than retinitis or HSV or for use in non-AIDS or non-immunocompromised patients
4.2. Posology and method of administration
Method of administration: Foscarnet should be administered by the intravenous route only, either by a central venous line or in a peripheral vein.
When peripheral veins are used, the solution of foscarnet 24 mg/ml must be diluted. Individually dispensed doses of foscarnet sodium hexahydrate should be aseptically transferred and diluted with equal parts of 0.9% sodium chloride (9 mg/ml) or 5% glucose (50 mg/ml) by the hospital pharmacy. The diluted solutions should be used as soon as possible after preparation but can be stored for up to 24 hours if kept refrigerated.
The solution of Foscarnet 24 mg/ml may be given without dilution via a central vein.
Adults: Induction therapy for CMV retinitis: Foscarnet is administered over 2–3 weeks depending on the clinical response, as intermittent infusions every 8 hours at a dose of 60 mg/kg in patients with normal renal function. Dosage must be individualised for patient's renal function (see dosing chart below). The infusion time should not be shorter than 1 hour.
Maintenance therapy: For maintenance therapy, following induction therapy of CMV retinitis, Foscarnet is administered seven days a week as long as therapy is considered appropriate. In patients with normal renal function, it is recommended to initiate therapy at 60 mg/kg. Increase to a dose of 90–120 mg/kg may then be considered in patients tolerating the initial dose level and/or those with progressive retinitis. A number of patients have received 90 mg/kg over a 2 hour period as a starting dose for maintenance therapy. Dosage must be reduced in patients with renal insufficiency (see dosage chart at end of dosage section).
Patients who experience progression of retinitis while receiving maintenance therapy may be re-treated with the induction regimen.
Induction therapy of mucocutaneous HSV infections unresponsive to aciclovir:
Foscarnet is administered for 2–3 weeks or until healing of lesions, as intermittent infusions at a dose of 40 mg/kg over one hour every 8 hours in patients with normal renal function. Dosage must be individualised for patients renal function (see dosing chart below). The infusion time should not be shorter than 1 hour.
Efficacy of foscarnet sodium hexahydrate maintenance therapy following induction therapy of aciclovir unresponsive HSV infections has not been established.
Caution: Do not administer Foscarnet by rapid intravenous injection.
Table 1 Foscarnet Dosing chart
Induction Therapy
Creatinine Clearance
(ml/kg/min)
CMV
Every 8 Hours
(mg/kg)
HSV
Every 8 Hours
(mg/kg)
>1.6
60
40
1.6-1.4
55
37
1.4-1.2
49
33
1.2-1.0
42
28
1.0-0.8
35
24
0.8-0.6
28
19
0.6-0.4
21
14
<0.4
Treatment not recommended
CMV Maintenance therapy
Creatinine Clearance
(ml/kg/min)
One Infusion Dose
(mg/kg/day in not less than one hour)
>1.6
60*
1.6-1.4
55
1.4-1.2
49
1.2-1.0
42
1.0-0.8
35
0.8-0.6
28
0.6-0.4
21
<0.4
Treatment not recommended
*A number of patients have received 90 mg/kg as a starting dose for maintenance therapy.
Foscarnet is not recommended in patients undergoing haemodialysis since dosage guidelines have not been established.
Hydration: Renal toxicity of foscarnet sodium hexahydrate can be reduced by adequate hydration of the patient. It is recommended to establish diuresis by hydration with 0.5–1.0 litre of normal saline at each infusion. In compliant patients, oral hydration with similar hydration regimens has been used. Clinically dehydrated patients should have their condition corrected before initiating Foscarnet therapy.
Special population
Elderly: as for adults
Paediatric population: The safety and efficacy of foscarnet sodium hexahydrate in children have not been established. Please refer to sections 4.4 and 5.3.
Renal or hepatic insufficiency: The dose must be reduced in patients with renal insufficiency according to the creatinine clearance level as described in the table above. Dose adjustment is not required in patients with hepatic insufficiency.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Foscarnet should be used with caution in patients with reduced renal function. Since renal function impairment may occur at any time during Foscarnet administration, serum creatinine should be monitored every second day during induction therapy and once weekly during maintenance therapy and appropriate dose adjustments should be performed according to renal function. Adequate hydration should be maintained in all patients (see section 4.2). The renal function of patients with renal disease or receiving concomitant treatment with other nephrotoxic medical products must be closely monitored (see section 4.5).
Due to foscarnet sodium hexahydrate's propensity to chelate bivalent metal ions, such as calcium, Foscarnet administration may be associated with an acute decrease of ionized serum calcium, proportional to the rate of Foscarnet infusion, which may not be reflected in total serum calcium levels. The electrolytes, especially calcium and magnesium, should be assessed prior to and during Foscarnet therapy and deficiencies corrected.
Foscarnet sodium hexahydrate has been associated with cases of prolongation of QT interval and more rarely with cases of torsade de Pointes (see section 4.8). Patients with known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances (hypokalemia, hypomagnesaemia), bradycardia, as well as patients with underlying cardiac diseases such as congestive heart failure, or who are taking medications known to prolong the QT interval should be carefully monitored due to increased risk of ventricular arrhythmia. Patients should be advised to promptly report any cardiac symptoms.
Foscarnet sodium hexahydrate is deposited in teeth, bone and cartilage. Animal data show that deposition is greater in younger animals. The safety of foscarnet sodium hexahydrate and its effects on skeletal development have not been investigated in children. Please refer to section 5.3.
Seizures related to alterations in plasma minerals and electrolytes have been associated with foscarnet sodium hexahydrate treatment. Cases of status epilepticus have been reported. Therefore, patients must be carefully monitored for such changes and their potential sequelae. Mineral and electrolyte supplementation may be required.
Foscarnet use should be avoided when a saline load cannot be tolerated (e.g. in cardiomyopathy)
Foscarnet sodium hexahydrate is excreted in high concentrations in the urine and may be associated with significant genital irritation and/or ulceration. To prevent irritation and ulceration, close attention to personal hygiene is recommended and cleaning of the genital area after each micturition is recommended.
Should patients experience extremity paresthesia or nausea, it is recommended to reduce the speed of infusion.
When diuretics are indicated, thiazides are recommended.
Development of resistance: If the administration of Foscarnet does not lead to a therapeutic response or leads to a worsened condition after an initial response, this may result from a reduced sensitivity of viruses towards foscarnet sodium hexahydrate. In this case, termination of Foscarnet therapy and a change to an appropriate other medicinal product should be considered.
This medicinal product contains 1375 mg of sodium per 250 ml bottle, equivalent to 69% of the WHO recommended maximum daily intake of 2g sodium for an adult.
The maximum daily dose of this product during maintenance treatment (i.e. 120mg/kg/day) and without dilution for a patient of 70 kg body weight is equivalent to 96% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product during maintenance treatment (i.e. 120mg/kg/day) and diluted with sodium chloride 9 mg/ml (0.9%) solution to concentration 12 mg/ml for a patient of 70 kg body weight is equivalent to 158% of the WHO recommended maximum daily intake for sodium.
Foscarnet is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
4.5. Interaction with other medicinal products and other forms of interaction
Since foscarnet sodium hexahydrate can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs such as aminoglycosides, amphotericin B, ciclosporin A, aciclovir, methotrexate and tacrolimus. Moreover, since foscarnet sodium hexahydrate can reduce serum levels of ionized calcium, extreme caution is advised when used concurrently with other drugs known to influence serum calcium levels, like i.v. pentamidine. Renal impairment and symptomatic hypocalcaemia (Trousseau's and Chvostek's signs) have been observed during concurrent treatment with foscarnet sodium hexahydrate and i.v. pentamidine. Abnormal renal function has been reported in connection with the use of foscarnet sodium hexahydrate in combination with ritonavir and/or saquinavir.
Due to the potential increased risk of QT prolongation and torsade de pointes, Foscarnet should be used with caution with drugs known to prolong QT interval, notably class IA (e.g. quinidine) and III (e.g. amiodarone, sotalol), antiarrhythmic agents or neuroleptic drugs. Close cardiac monitoring should be performed in cases of co-administration.
There is no pharmacokinetic interaction with zidovudine (AZT), ganciclovir, didanosine (ddI), zalcitabine (ddC) or probenecid.
Pharmaceutical interactions (incompatibilities for infusion) are described in section 6.2.
4.6. Fertility, pregnancy and lactation
Fertility
There are no data available regarding the influence of foscarnet sodium hexahydrate on fertility.
No effects on fertility were observed in animal studies (see section 5.3).
Women of child-bearing potential/contraception in men and women
Women of childbearing potential and sexually active men have to use effective contraception during and up to 6 months after therapy.
Pregnancy
There are no or limited amount of data from the use of foscarnet sodium hexahydrate in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Foscarnet is not recommended during pregnancy.
Lactation
There is insufficient information on the excretion of foscarnet sodium hexahydrate in human milk.
Available pharmacodynamic/toxicological data in animals have shown excretion of foscarnet sodium hexahydrate in milk (for details see section 5.3).
A risk to the newborns/infants cannot be excluded.
Foscarnet should not be used during breast-feeding.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from foscarnet sodium hexahydrate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman must be taken into account.
4.7. Effects on ability to drive and use machines
Foscarnet sodium hexahydrate has moderate influence on the ability to drive and use machines. Due to the disease itself and possible undesirable effects of foscarnet sodium hexahydrate (such as dizziness and convulsions, see section 4.8) the ability to drive and use machines can be impaired. The physician is advised to discuss this issue with the patient and based upon the condition of the disease and the tolerance of medication, give a recommendation in the individual case.
4.8. Undesirable effects
The majority of patients who receive Foscarnet are severely immuno-compromised and suffering from serious viral infections. Patient's physical status, the severity of the underlying disease, other infections and concurrent therapies contribute to adverse events observed during use of Foscarnet .
The undesirable effects reported with foscarnet sodium hexahydrate during clinical trials and post-marketing surveillance are shown in the table below. They are listed by System-Organ Class (SOC) and in order of frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Please note that in these clinical trials, hydration and attention to electrolyte balance was not consistently given; the frequency of some adverse events will be lower when current recommendations are followed (see sections 4.2 and 4.4).
Table 2: Frequency of adverse events.
MedDRA system organ class
Frequency
Adverse event
Blood and lymphatic system disorders
Very common
Granulocytopenia, anemia
Common
Leukopenia, thrombocytopenia, neutropenia
Uncommon
Pancytopenia
Immune system disorders
Common
Sepsis
Not known
Hypersensitivity (including anaphylactic reactions), anaphylactoid reactions
Endocrine disorders
Not known
Diabetes insipidus
Metabolism and nutrition disorders
Very common
Decreased appetite, hypokalaemia, hypomagnesaemia, hypocalcaemia
Common
Hyperphosphataemia, hyponatraemia, hypophosphataemia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hypercalcaemia, dehydration
Uncommon
Acidosis
Not known
Hypernatremia
Psychiatric disorders
Common
Aggression, anxiety, agitation, confusional state, depression, nervousness
Nervous system disorders
Very common
Dizziness, headache, paraesthesia
Common
coordination abnormal, convulsion, hypoesthesia, muscle contractions involuntary, neuropathy peripheral, tremor
Cardiac disorders
Common
Palpitations, tachycardia
Not known
Electrocardiogram QT prolonged, ventricular arrhythmia, torsade de pointes
Vascular disorders
Common
Hypertension, Hypotension, Thrombophlebitisa
Gastrointestinal disorders
Very common
Diarrhea, nausea, vomiting
Common
Abdominal pain, constipation, dyspepsia, pancreatitis, gastrointestinal haemorrhage
Not known
Oesophageal ulceration
Hepatobiliary disorders
Common
hepatic function abnormal
Skin and subcutaneous tissue disorders
Very common
Rash
Common
Pruritus
Uncommon
Urticaria, angioedema
Not known
Erythema multiforme, toxic epidermal Necrolysis, Stevens- Johnson-Syndromeb
Musculoskeletal and connective tissue disorders
Common
Myalgia
Not known
Muscle weakness, myopathy, myositis, rhabdomyolysis
Renal and urinary disorders
Common
renal impairment, renal failure acute, dysuria, polyuria, proteinuria
Uncommon
glomerulonephritis, nephrotic syndrome
Not known
Renal pain, renal tubular acidosis, crystal nephropathy, hematuria
Reproductive system and breast disorders
Common
Genital discomfort and ulcerationc
General disorders and administration site conditions
Very common
Asthenia, chills, fatigue, pyrexia
Common
Malaise, oedema, chest paind, injection site pain, injection site inflammation
Not known
Extravasation
Investigations
Very common
Blood creatinine increased, hemoglobin decreased
Common
Creatinine renal clearance decreased, electrocardiogram abnormal, gammaglutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased
Uncommon
amylase increased, blood creatine phosphokinase increased
aThrombophlebitis in peripheral veins following infusion of undiluted foscarnet sodium hexahydrate solution has been observed.
b Cases of vesiculobullous eruptions including erythema multiforme, toxic epidermal necrolysis, and Stevens Johnson syndrome have been reported. In most cases, patients were taking other medications that have been associated with toxic epidermal necrolysis or Stevens Johnson syndrome.
c Foscarnet sodium hexahydrate is excreted in high concentrations in the urine and may be associated with significant irritation and ulceration in the genital area, especially after prolonged therapy
d Transient chest pain has been reported as part of infusion reactions to foscarnet sodium hexahydrate.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose has been reported during the use of foscarnet sodium hexahydrate, the highest being some 20 times the recommended dose. Some of the cases were relative overdoses, in that the dose of drug used had not been promptly adjusted for a patient experiencing reduced renal function.
There are cases where it has been reported that no clinical sequelae were consequent on the overdose.
The pattern of adverse events reported in association with an overdose of foscarnet sodium hexahydrate is in accordance with the known adverse event profile of the drug.
Hemodialysis increases foscarnet sodium hexahydrate elimination and may be of benefit in relevant cases.
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