Foscarnet sodium hexahidrate Tillomed

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Foscarnet sodium hexahydrate Tillomed, 24 mg/mL, solution for infusion

Foscarnet sodium hexahydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1.

What is Foscarnet sodium hexahydrate Tillomed and what is it used for

2.

Important information before using Foscarnet sodium hexahydrate Tillomed

3.

How to use Foscarnet sodium hexahydrate Tillomed

4.

Possible side effects

5.

How to store Foscarnet sodium hexahydrate Tillomed

6.

Contents of the packaging and other information

1. What is Foscarnet sodium hexahydrate Tillomed and what is it used for

Foscarnet sodium hexahydrate Tillomed contains the active substance foscarnet sodium hexahydrate. It belongs to a group of antiviral medicines. It works by preventing the multiplication of viruses.
Foscarnet sodium hexahydrate Tillomed is used to treat the following infections in patients with AIDS:

• Life-threatening or sight-threatening eye infection, called cytomegalovirus (CMV) retinitis, caused by the CMV virus in patients with AIDS, which can lead to loss of vision and eventually blindness. This virus is called cytomegalovirus (CMV), and the infection is known as CMV retinitis. Foscarnet sodium hexahydrate Tillomed prevents the worsening of the infection, but it cannot repair the damage that has already occurred.
• Herpes simplex virus (HSV). Foscarnet sodium hexahydrate Tillomed is given to patients infected with the HSV virus who have a weakened immune system. It is given to patients who have not recovered from HSV after treatment with acyclovir.

2. Important information before using Foscarnet sodium hexahydrate Tillomed

Tillomed

When not to use Foscarnet sodium hexahydrate Tillomed

In case of doubts before taking foscarnet, consult a doctor or nurse.

Warnings and precautions

Before starting treatment with Foscarnet sodium hexahydrate Tillomed, discuss with your doctor or nurse if you have:

• Kidney problems.
• Heart problems.

If the patient is not sure if this applies to them, they should consult a doctor or nurse before using foscarnet.

Children and adolescents

The safety and efficacy of foscarnet sodium hexahydrate in children have not been established.

Foscarnet sodium hexahydrate Tillomed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• Pentamidine (used to treat infections)
• Amphotericin B (used to treat fungal infections)
• Acyclovir (used to treat viral infections)
• Antibiotics called aminoglycosides, such as gentamicin and streptomycin (used to treat infections)
• Cyclosporin A, methotrexate, or tacrolimus (used to suppress the immune system)
• Protease inhibitors, such as ritonavir and saquinavir
• Laxatives
• Quinidine, amiodarone, sotalol, or other medicines that may affect heart rate or rhythm
• Sedatives (neuroleptics).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
The use of Foscarnet sodium hexahydrate Tillomed is not recommended during pregnancy.
It is not recommended to try to become pregnant while being treated with Foscarnet sodium hexahydrate Tillomed, so effective contraceptive methods should be used during treatment and for 6 months after its completion.
Men treated with Foscarnet sodium hexahydrate Tillomed should not father a child during treatment or for 6 months after its completion.
Foscarnet sodium hexahydrate Tillomed should not be used during breastfeeding.

Driving and using machines

Foscarnet may affect the ability to drive or operate tools and machines. Consult a doctor before engaging in such activities.

Tests before and during treatment with Foscarnet sodium hexahydrate Tillomed

Tillomed

Your doctor may order blood and urine tests before starting treatment and during treatment with Foscarnet sodium hexahydrate Tillomed. This is to check kidney function and mineral levels in the blood.

Foscarnet sodium hexahydrate Tillomed contains sodium

The medicine contains 1375 mg of sodium (the main component of common salt/sodium chloride) in each 250 mL vial. This corresponds to 69% of the maximum recommended daily intake of sodium in the diet for adults.
If the patient is taking 71 mL or more of the medicine per day for a long time, they, especially those controlling sodium intake in their diet, should consult a doctor or pharmacist.

3. How to use Foscarnet sodium hexahydrate Tillomed

This medicine should always be used exactly as prescribed by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

• Foscarnet sodium hexahydrate Tillomed will be administered by a doctor or nurse. It will be given as an intravenous infusion. It can be given into a central line in the chest if one is already in place.
• Each infusion will last at least 1 hour. Do not interfere with the infusion in any way during administration.
• The amount of foscarnet given depends on kidney function. It also depends on the patient's body weight.
• Good hydration during infusion is important to prevent kidney problems. If the patient needs fluids, the doctor or nurse will give them at the same time as foscarnet.

Using Foscarnet sodium hexahydrate Tillomed for CMV infection

CMV

If the patient is taking Foscarnet sodium hexahydrate Tillomed for CMV retinitis, treatment will be in two stages.
The first stage is induction therapy, and the second is maintenance therapy.

Induction therapy

• During induction therapy, the infusion will be given every 8 hours. This therapy usually lasts 2 or 3 weeks.
• The usual dose used for induction therapy is 60 mg of Foscarnet sodium hexahydrate Tillomed per kilogram of body weight (60 mg/kg) three times a day (every 8 hours) or 90 mg/kg body weight twice a day (every 12 hours).
• The doctor will inform the patient when it is possible to switch to maintenance therapy.

Maintenance therapy

• During maintenance therapy, the infusion will be given once a day.
• The usual dose used for maintenance therapy is 90 to 120 mg of Foscarnet sodium hexahydrate Tillomed per kilogram of body weight (90 to 120 mg/kg).

The doctor will inform the patient if they need to take Foscarnet sodium hexahydrate Tillomed in a smaller or larger dose and how often they should take it.
This is to ensure the patient receives the correct dose for them.
Sometimes the doctor may ask the patient to take ganciclovir. This is to ensure the treatment is suitable for the patient.

Using Foscarnet sodium hexahydrate Tillomed for herpes simplex virus

• If the patient is receiving Foscarnet sodium hexahydrate Tillomed for herpes simplex virus, there is only one stage.
• The infusion will be given every 8 hours.
• Sores (lesions) may start to heal after about 1 week. However, it may be necessary to continue taking Foscarnet sodium hexahydrate Tillomed for 2 to 3 weeks or until the sores have healed.
• The usual dose is 40 mg of Foscarnet sodium hexahydrate Tillomed per kilogram of body weight (40 mg/kg).

Personal hygiene

After urinating, wash the genital area thoroughly. This will help prevent the development of sores.

If Foscarnet sodium hexahydrate Tillomed gets on the skin or in the eyes

If Foscarnet sodium hexahydrate Tillomed is accidentally administered on the skin or in the eyes, flush the skin or eyes with water immediately.

Use in children and adolescents:

The safety and efficacy of Foscarnet sodium hexahydrate Tillomed in children and adolescents under 18 years of age have not been established.

Using more than the recommended dose of Foscarnet sodium hexahydrate Tillomed

Tillomed

If the patient thinks they have received too much Foscarnet sodium hexahydrate Tillomed, they should contact their doctor immediately.

Missing a dose of Foscarnet sodium hexahydrate Tillomed

If the patient thinks they have missed a dose, they should talk to their doctor immediately.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

• Severe allergic reactions, including a drop in blood pressure, shock, and skin swelling (angioedema). These are known as hypersensitivity reactions, anaphylactic reactions, or anaphylactoid reactions.
• Severe skin rashes. These rashes can be associated with redness, swelling, and blisters on the skin, mouth, throat, eyes, and other areas inside the body, and can sometimes lead to death. They are called erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

In case of any of the above, inform your doctor or go to the nearest emergency department immediately.

Other side effects include:

Very common: (may affect more than 1 in 10 people)

• Lack of appetite
• Diarrhea
• Nausea or vomiting
• Weakness or fatigue
• High temperature or chills
• Dizziness
• Headache
• Tingling
• Skin rash
• Changes in kidney function (shown in blood tests)
• Low white blood cell count. Symptoms include infections and high temperature (fever)
• Changes in red blood cells (shown in blood tests). This can cause fatigue or pallor
• Imbalance of salts and minerals in the blood. Symptoms include weakness, cramps, thirst, tingling or itching of the skin, and muscle twitching.

Common: (may affect up to 1 in 10 people)

• Abdominal pain, constipation, indigestion, or gastrointestinal bleeding
• Pancreatitis or changes in pancreatic function. Symptoms include severe abdominal pain and changes visible in blood tests
• Feeling anxious, nervous, depressed, agitated, or disoriented
• Coordination problems
• Seizures
• Decreased sensation in the skin
• Itchy skin
• General feeling of being unwell
• Swelling of the feet and ankles
• Palpitations or changes in heart rhythm, such as torsade de pointes, or rapid heartbeat (tachycardia)
• High blood pressure
• Low blood pressure. This can cause dizziness
• Changes in tests (ECG) that measure how well the heart is working
• Muscle problems. These include changes visible in blood tests and painful, sore, weak, or twitching muscles
• Tremors
• Nerve damage, which can cause changes in sensation or muscle weakness (neuropathy)
• Swelling, pain, and redness along the vein or at the injection site
• Ulcers on the genitals
• Changes in liver function (shown in blood tests)
• Low platelet count. This can cause easy bruising
• Blood infection
• Kidney problems. These include kidney pain (which can be felt in the lower back) and kidney failure. Changes may be visible in blood or urine tests
• Frequent urination. Rarely, this can also cause severe thirst or dehydration
• Chest pain.

Uncommon: (may affect up to 1 in 100 people)

• Itchy rash (hives)
• Too much acid in the blood. This can cause rapid breathing
• Decrease in the number of all blood cells (pancytopenia).

Unknown: frequency cannot be estimated from the available data

• Abnormal heart rhythm
• Ulceration of the esophagus (the tube that food passes through from the throat to the stomach). This can be painful
• Severe muscle problems related to the breakdown of muscle tissue (rhabdomyolysis). Symptoms include abnormal urine color and severe muscle weakness, and muscle tenderness or stiffness
• Blood in the urine.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foscarnet sodium hexahydrate Tillomed

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month stated.
• Do not store in a refrigerator and do not freeze.
• Foscarnet sodium hexahydrate Tillomed should not be stored at temperatures below 8°C, as precipitation may occur at lower temperatures. The precipitate persists even if the infusion solution is frozen and then thawed.
• The medicinal product Foscarnet sodium hexahydrate Tillomed can be reconstituted for use if it has been accidentally stored in refrigerated conditions or if the infusion solution has been exposed to temperatures below zero. The vial should then be shaken vigorously several times and stored at room temperature for 4 hours, until the precipitate is 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 the product is not used immediately, the user is responsible for assigning the storage period and conditions during use.

After dilution:

Chemical and physical stability for use has been demonstrated for 36 hours at 2-8°C and 20-25°C, after dilution of the solution 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 it is not used immediately, the user is responsible for the storage time and conditions before use, and this time should not normally exceed 24 hours at 2-8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

• Do not use Foscarnet sodium hexahydrate Tillomed if you notice any damage to the vial, discoloration, or other signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Foscarnet sodium hexahydrate Tillomed contains

• The active substance is foscarnet sodium hexahydrate.
• One mL of the solution contains 24 mg of foscarnet sodium hexahydrate. One vial of 250 mL contains 6000 mg of foscarnet sodium hexahydrate.
• The other ingredients are hydrochloric acid diluted to adjust pH and water for injections.

What Foscarnet sodium hexahydrate Tillomed looks like and contents of the pack

Foscarnet sodium hexahydrate Tillomed is a clear, colorless solution for infusion in glass vials. Each pack contains 1 vial or 10 vials of 250 mL. Not all pack sizes may be marketed.

Marketing authorization holder

Tillomed Pharma GmbH
Mittelstrasse 5/5a
12529 Schönefeld
Germany
Phone: +48 88 55 00 706

Manufacturer

MIAS Pharma Limited
Suite 2, Stafford House,
Strand Road Portmarnock,
Co. Dublin
Ireland
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53,
Budapest XIX,1193,
Hungary
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

In the leaflet, only the actual manufacturer's data should be provided
Austria
: Foscarnet Tillomed 24 mg / ml Infusionslösung
Denmark
: Foscarnet “Tillomed”
Estonia
: Foscarnet sodium Tillomed
Finland
: Foscarnet Tillomed 24 mg/ml infuusioneste, liuos
France
: Foscarnet Tillomed 24 mg/ml solution pour perfusion
Greece
: Foscarnet Tillomed
Spain
: Foscarnet Tillomed 24 mg/ml solución para perfusión EFG
Netherlands
: Foscarnet Tillomed 24 mg / ml oplossing voor infusie
Ireland
: Foscarnet sodium hexahydrate Tillomed 24 mg/ml solution for infusion
Lithuania
: „Foscarnet Tillomed” 24 mg / ml infuzinis tirpalas
Latvia
: Foscarnet sodium Tillomed
Germany
: Foscarnet Tillomed 24 mg / ml Infusionslösung
Norway
: Foskarnetnatriumheksahydrat Tillomed
Poland
: Foscarnet sodium hexahydrate Tillomed
Portugal
: Foscarnet Tillomed 24 mg / ml solução para perfusão
Czech Republic
: Foscarnet Tillomed
Slovakia
: Foscarnet Tillomed
Sweden
: Foscarnet Tillomed 24 mg/ml infusionsvätska, lösning
Italy
: Foscarnet Tillomed
Date of last revision of the leaflet: July 2024
------------------------------------------------------------------------------------------------------------
Information intended only for healthcare professionals:

Instructions for use and handling

In the case of peripheral vein infusions, before use, the solution should be diluted from 24 mg/mL to 12 mg/mL of foscarnet sodium hexahydrate. Individually dosed doses of the medicinal product Foscarnet sodium hexahydrate Tillomed should be aseptically transferred to plastic infusion bags (PVC bags) and diluted with equal parts of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution.
Storage and shelf-life of the medicinal product and the diluted solution: see section 5.
Each vial of Foscarnet sodium hexahydrate Tillomed should only be used for the treatment of one patient during one infusion.
Accidental contact of the skin and eyes with foscarnet sodium hexahydrate solution may cause local irritation and burning. In case of accidental contact, the contaminated area should be flushed with water.
Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.