Foscarnet Kabi

Package leaflet: Information for the user

Foscarnet Kabi 24 mg/ml infusion solution

Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse.
See section 4.
Contents of this leaflet

1. What Foscarnet Kabi is and what it is used for
2. What you need to know before being given Foscarnet Kabi
3. How to use Foscarnet Kabi
4. Possible side effects
5. How to store Foscarnet Kabi
6. Contents of the pack and other information

1. What Foscarnet Kabi is and what it is used for

Foscarnet Kabi belongs to a group of medicines called antivirals. It acts against certain viruses
[all viruses belonging to the herpes group and some retroviruses such as cytomegalovirus (CMV)]. It blocks viral replication in infected cells.
Foscarnet Kabi is used in individuals with a weakened immune system:
To treat CMV retinitis in patients affected by AIDS.
To treat herpes infections (of the lips, nose, eyes, and genitals).
Foscarnet is administered to individuals with CMV infections following bone marrow transplantation. This is also known as hematopoietic stem cell transplantation (HSCT). The infection may sometimes be detected before the patient starts experiencing symptoms.
This is known as CMV viremia.

2. What you need to know before taking Foscarnet Kabi

Do not use Foscarnet Kabi:
If you are allergic to foscarnet or to any of the other ingredients of this medicine
(listed in section 6).
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE UNSURE.
Warnings and precautions
Talk to your doctor or nurse before using foscarnet:
If you have kidney problems. In this case, your doctor may adjust the dose according to your condition.
If you have low levels of calcium in the blood before receiving this medicine, or if you are taking a medicine that lowers calcium levels in the blood.
If you have heart problems.
If you experience tingling in your hands or lips and nausea. In this case, the nurse will reduce the infusion rate.
In case of accidental contact with the product, rinse the exposed skin or mucous membranes (inside the mouth, nose, ears, or genitals) with water.
Good personal hygiene after urination is recommended: wash the penis (or vulva) with running water to avoid genital lesions (genital ulcerations).
Blood tests
Before and during treatment, your doctor may ask you to undergo blood and urine tests. These tests are intended to monitor kidney function and blood mineral levels.
Children and adolescents
Not applicable.
Other medicines and foscarnet
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.
This is because foscarnet may affect how some medicines work, and some of these medicines may affect foscarnet.
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).
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.
Quinidine, amiodarone, sotalol, or any other medicine that may affect heart rate or rhythm.
Anxiolytics (neuroleptics).
Pregnancy and breastfeeding
Foscarnet Kabi is not recommended during pregnancy.
You must avoid becoming pregnant during treatment with foscarnet and should therefore use effective contraception during treatment and for 7 months after completion of treatment.
Men taking foscarnet are advised to use effective contraception and must not father a child during or for up to 4 months after completion of treatment.
Do not take foscarnet while breastfeeding.
Driving and using machines
Foscarnet may affect your ability to drive or use tools or machinery. This is due to the risk of seizures, abnormal movements, and dizziness reported with this medicine. Consult your doctor before performing any of these activities.
Foscarnet Kabi contains sodium
Foscarnet Kabi contains 240 micromoles (5.5 mg) of sodium per ml. This should be taken into consideration by patients on a low-sodium diet; therefore, inform your doctor or nurse if you are following a low-sodium diet.
The recommended maximum daily dose of this medicine contains 2.89 grams of sodium (which is found in table salt). This corresponds to 144.5% of the maximum recommended daily dietary intake for an adult.
Talk to your pharmacist or doctor if you need foscarnet every day for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to use Foscarnet Kabi

Always use this medicine exactly as your doctor has told you. Check with your
doctor if you are unsure.
Foscarnet will be administered to you by a doctor or nurse. It will be given by
intravenous infusion (drip) into a vein. It may be administered by injection into a central
venous catheter in the chest if you already have one.
Each infusion will take at least 1 hour. Do not interfere with the infusion during administration.
The dose of foscarnet you receive depends on your body weight and kidney function.
It is important to maintain adequate fluid intake during the infusion, which will also help
prevent kidney problems. If needed, your doctor or nurse will administer the necessary
hydration therapy alongside foscarnet.
Personal hygiene
Wash the genital area thoroughly after urination. This will help prevent the development of sores.
If foscarnet solution comes into contact with skin or eyes
If foscarnet solution accidentally comes into contact with skin or eyes, immediately rinse the
skin or eyes with water.
If you take more foscarnet than you should
If you have been given a very large dose of foscarnet, inform your doctor or pharmacist immediately.
Cases of overdose have been reported. The highest dose reported was 20 times the normal dose.
Symptoms resemble acute hypocalcaemia, with sensations of tingling and occasionally
seizures and functional kidney failure.
Haemodialysis increases the elimination of foscarnet and may be beneficial in some cases.
If you forget to take foscarnet
Not applicable.
If you stop taking foscarnet
Not applicable

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention.
Severe allergic reactions, including low blood pressure, shock, and skin swelling (angioedema). These are known as hypersensitivity, anaphylactic, or anaphylactoid reactions.
Severe skin rashes. These types of rashes may be associated with redness, swelling, and blisters on the skin, mouth, throat, eyes, and other internal parts of the body, and may sometimes lead to death. These are known as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
If you experience any of the side effects described above, inform your doctor immediately or go to the nearest emergency room.
Other side effects include:
Very common: may affect more than 1 in 10 people
Reduced number of red blood cells (shown in blood tests). You may feel tired or look pale.
Low levels of white blood cells (granulocytopenia). Signs include infections and high temperature (fever).
Loss of appetite.
Low potassium levels in the blood.
Low magnesium levels in the blood.
Low calcium levels in the blood.
Dizziness.
Headache.
Tingling.
Diarrhea.
Nausea and vomiting.
Weakness or fatigue.
High fever or chills.
Skin rash.
Changes in kidney function (shown in blood tests), e.g., elevated creatinine in the blood, reduced hemoglobin.
Common: may affect up to 1 in 10 people
Low levels of white blood cells (leukopenia and/or neutropenia). Signs include infections and high temperature (fever).
Reduced platelet count in the blood. This may make you bruise more easily.
Blood infection (sepsis).
Increased or decreased phosphate levels in the blood.
Low sodium levels in the blood.
Increased calcium levels in the blood.
Dehydration.
Abnormal liver function.
Elevated liver enzymes (gamma-GT, alanine aminotransferase, aspartate aminotransferase, LDH).
Changes in mental state: for example, aggression, agitation, anxiety, confusion, depression, nervousness.
Coordination problems.
Seizures.
Reduced sensation on the skin.
Irregular heartbeat (palpitations).
Fast heartbeat (tachycardia).
Nerve disorders that may cause sensory changes or muscle weakness (neuropathy).
Tremor.
Hypertension.
Hypotension, which may cause dizziness.
Swelling, pain, and redness along a vein.
Stomach (abdominal) pain, constipation, and indigestion.
Gastrointestinal bleeding.
Inflammation of the pancreas (pancreatitis) or changes in pancreatic function. Signs include severe stomach pain and may include changes detectable by blood tests (increased lipase).
Itching.
Muscle pain.
Kidney problems, e.g., kidney pain (lower back pain), kidney failure, presence of protein in the urine.
Pain during urination.
Genital sores or ulcers. These are single or multiple lesions that resolve upon discontinuation of treatment (see "Precautions for use").
General feeling of being unwell.
Pain at the injection site and inflammation.
Chest pain.
Swelling of the legs and feet.
Changes in tests showing heart activity (ECG).
Uncommon: may affect up to 1 in 100 people
Reduced red blood cells, white blood cells, and platelets.
Excess acid in the blood. This may cause you to breathe more rapidly.
Itchy skin rash (urticaria).
Kidney problems (renal tubular disorder, glomerulonephritis, nephrotic syndrome).
Increased levels of certain enzymes in the blood, e.g., amylase, creatine phosphokinase.
Not known: frequency cannot be estimated from the available data
Diabetes. Signs include more frequent urination than usual. More rarely, you may also have excessive thirst.
Increased sodium levels in the blood.
Encephalopathy.
Abnormal heartbeat or changes in heartbeat, e.g., torsades de pointes.
Esophageal ulcer.
Muscle problems: painful, tender, weak, or trembling muscles, destruction of muscle tissue (rhabdomyolysis: abnormal urine color and severe muscle stiffness, tenderness, or weakness).
Kidney problems, e.g., pain, blood in the urine, tubular necrosis, crystal nephropathy.
Extravasation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foscarnet Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not refrigerate or freeze. If refrigerated or exposed to temperatures below freezing point, precipitation may occur. By keeping the vial at room temperature with repeated agitation, the precipitate may redissolve.
Chemical and physical in-use stability has been demonstrated for 9 days at 25°C. From a microbiological standpoint, unless the method of opening and dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.
Foscarnet Kabi may be mixed with another liquid by a pharmacist to provide you with a ready-to-use medicine. The pharmacist will inform you how to store it and by when it should be used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Foscarnet Kabi contains
The active substance is foscarnet.
Each ml contains 24 mg of fosfarnet sodium hexahydrate.
The other components are water for injections and hydrochloric acid.
Description of the appearance of Foscarnet Kabi and contents of the pack
Foscarnet Kabi is a sterile infusion solution.
The solution is clear and colourless.
Foscarnet Kabi is available in 250 ml vials.
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala – Verona
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
This medicinal product is authorised in the European Economic Area Member States under the following names:

The following information is intended exclusively for healthcare professionals:

Exercise particular caution with Foscarnet

• In patients with impaired renal function:
  • Serum creatinine must be monitored regularly.
  • Dose adjustment must be considered in patients with impaired renal function. To prevent renal function abnormalities that may occur during treatment, adequate hydration must be maintained.
• Do not use solutions that may contain calcium.
• In case of accidental contact, rinse exposed skin or mucous membranes with water.

Route of administration
Foscarnet must be administered exclusively by intravenous infusion, either through a central venous line (catheter) or into a peripheral vein.
Warning: Do not administer foscarnet by rapid intravenous injection.
Do not administer foscarnet without a hydration regimen.
Do not use solutions containing calcium, 30% glucose, amphotericin B, sodium aciclovir, ganciclovir, pentamidine isethionate, trimethoprim-sulfamethoxazole, or vancomycin hydrochloride.
As with all intravenous infusions, strict aseptic handling procedures must be followed.
When peripheral veins are used, the 24 mg/ml foscarnet solution must be diluted.
Individual doses of foscarnet must be aseptically transferred from the hospital pharmacy into plastic infusion bags and diluted with equal volumes of 0.9% sodium chloride (9 mg/ml) or 5% dextrose (50 mg/ml) provided by the hospital pharmacy. The physico-chemical stability of foscarnet and its dilutions in PVC bags is 9 days. Diluted solutions should be used as soon as possible after preparation but may be stored for up to 24 hours if kept refrigerated.
Renal toxicity of foscarnet can be reduced by ensuring adequate patient hydration. See the section "Hydration" below.
If using a Y-site infusion system, simultaneously infuse 0.5 to 1 liter of 0.9% NaCl or 5% glucose.
Do not administer other products in the same infusion. When the product is administered via infusion into a peripheral vein, simultaneous intravenous hydration acts as a dilution (see “Hydration”).

Diagram of a Y-site infusion system

Hydration:
Particular attention should be given to preventing foscarnet-induced renal toxicity by ensuring patients receive adequate hydration.
If using a Y-site infusion system, 0.5 to 1 liter of 0.9% NaCl or 5% glucose must be infused simultaneously. In cooperative patients, oral hydration with similar hydration regimens has been used. Clinically dehydrated patients should have their condition corrected before starting foscarnet therapy.
Each vial of foscarnet must be used only for a single infusion in one patient.
Accidental contact of foscarnet sodium solution with skin or eyes may cause local irritation and a burning sensation. In case of accidental contact, the exposed area must be rinsed thoroughly with water.
If foscarnet has been refrigerated or exposed to temperatures below freezing, precipitation may occur. By allowing the vial to reach room temperature with repeated agitation, the precipitate may redissolve.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.