Package Insert: Information for the User

Foscarnet Kabi 24 mg/ml Infusion Solution EFG

sodium foscarnet hexahydrate

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.

This medication belongs to a group of medications called antivirals. It acts on certain viruses [all viruses belonging to the herpes group and some retroviruses such as cytomegalovirus (CMV)]. It prevents the virus from reproducing in infected cells.

Foscarnet is used in people with a weakened immune system:

• To treat CMV retinitis in patients with AIDS.
• To treat herpes infection (lips, nose, eyes, and genital herpes).
• Foscarnet is administered to people with CMV infection after a bone marrow transplant. This is also known as hematopoietic stem cell transplant (HSCT, in English). In some cases, the infection may be detected before the patient begins to show symptoms. This is known as CMV viremia.

No use Foscarnet Kabi:

• If you are allergic to foscarnet or any of the other components of this medication (listed in section 6).

CONSULT YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE.

Warnings and precautions

Consult your doctor or nurse before starting to use this medication:

• 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 your blood before receiving this medication, and if you are taking a medication that reduces calcium levels in the blood.
• If you have heart problems.
• If you have tingling in your hands or lips, and nausea. In this case, your 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.

It is recommended to pay close attention to personal hygiene after urinating: wash the penis (or vulva) with running water to avoid genital lesions (genital ulcers),

Blood tests

Your doctor may ask you to have blood and urine tests before and during treatment. These tests aim to check kidney function and mineral levels in the blood.

Other medications and Foscarnet Kabi

Informyour doctor or nurse if you are using, have used recently, or may need to use any other medication, including over-the-counter medications and herbal remedies. This is because foscarnet may affect how some medications work and some medications may have effects on foscarnet.

Inform your doctor or nurse if you are taking any of the following medications:

• Pentamidine (for infections).
• Amphotericin B (for fungal infections).
• Aciclovir (for viral infections).
• Aminoglycoside antibiotics, such as gentamicin or streptomycin (for infections).
• Ciclosporin A, methotrexate, or tacrolimus (used to suppress the immune system).
• Protease inhibitors, such as ritonavir and saquinavir.
• Quinidine, amiodarone, sotalol, or other medications that may affect your heart rate and rhythm.
• Anxiolytics (neuroleptics).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Foscarnet is not recommended during pregnancy.
• You should avoid becoming pregnant during treatment with foscarnet and, therefore, should use effective contraceptive methods while you are being treated with foscarnet and for 7 months after the end of treatment.
• Men treated with foscarnet should use effective contraceptive methods and should not father children during or until 4 months after treatment.
• Do not take foscarnet during breastfeeding.

Driving and operating machinery

Foscarnet may affect your ability to drive or operate machinery. This is due to the risk of seizures, abnormal movements, and dizziness reported with this medication. Consult your doctor before performing any of these activities.

Foscarnet Kabi contains sodium

This medication contains 240 micromoles (5.5 mg) of sodium (main component of table salt/for cooking) in each ml. This should be taken into account by patients following a low-sodium diet, so please inform your doctor or nurse if you follow a low-sodium diet.

The maximum recommended dose of this medication contains 2.89 grams of sodium (present in table salt).

This is equivalent to 144.5% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need foscarnet daily for a prolonged period, especially if you have been recommended a low-salt diet.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

• Foscarnet will be administered by a doctor or nurse. It will be administered as an intravenous infusion (drip). It may be administered through a central line in your chest if you already have one in place.
• Each infusion will last at least 1 hour. Do not interfere with the drip during the infusion.
• The dose of foscarnet you receive will depend on your weight and the functioning of your kidneys.
• It is essential to maintain an adequate intake of fluids during the infusion, which will also help prevent kidney problems. If necessary, your doctor or nurse will administer the necessary hydration regimen at the same time as the foscarnet infusion.

Personal Hygiene

Wash your genital area carefully after urinating. This will help prevent the development of sores.

If the foscarnet solution comes into contact with the skin or eyes

If the foscarnet solution accidentally comes into contact with the skin or eyes, wash the affected area immediately with water.

If you use more Foscarnet Kabi than you should

If you are administered an extremely high dose of foscarnet, inform your doctor or pharmacist immediately.

If you believe you have been given too much foscarnet, inform your doctor immediately.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

• Severe allergic reactions, including a drop in blood pressure, shock, and skin swelling (angioedema). They are known as hypersensitivity, anaphylactic or anaphylactoid reactions.
• Severe skin eruptions. This type of eruption can be associated with redness, swelling, and blisters on the skin, mouth, throat, eyes, and other areas of the body, and in some cases, can cause death. They are called erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

If you experience any of the above side effects, inform your doctor immediately or visit the nearest emergency unit.

Other side effects include:

Very common: may affect more than 1 in 10 people

• Reduction in red blood cell count (shown in blood tests). You may feel tired or look pale.
• Low white blood cell count (granulocytopenia). Signs include infections and high temperature (fever).
• Low potassium levels in the blood.
• Low magnesium levels in the blood.
• Low calcium levels in the blood.
• Dizziness.
• Headache.
• Itching.
• Diarrhea.
• Nausea, vomiting.
• Feeling weak or tired.
• Elevated temperature or chills.
• Skin eruption.
• Changes in kidney function (shown in blood tests), for example, increased serum creatinine, decreased hemoglobin concentration.

Common: may affect up to 1 in 10 people

• Low white blood cell count (leucopenia and/or neutropenia). Signs include infections and high temperature (fever).
• Reduced platelet count in the blood. This can make you bruise more easily.
• Generalized 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 (ALT), aspartate aminotransferase (AST), LDH).
• Mood changes. These include aggression, agitation, anxiety, confusion, depression, nervousness.
• Abnormal movement coordination.
• Seizures.
• Reduced skin sensitivity.
• Unusual heartbeats (palpitations).
• Fast heart rate (tachycardia).
• Nervous system disorders that can cause sensory changes or muscle weakness (neuropathy).
• Tremors.
• Hypertension.
• Hypotension, which can cause dizziness.
• Swelling, pain, and redness along a vein.
• Abdominal pain, constipation, and indigestion.
• Pancreatitis or changes in pancreas function. Signs include severe stomach pain and may have changes in blood tests (increased lipases).
• Itching skin.
• Muscle pain.
• Kidney problems, for example, back pain (lower back pain), kidney failure, protein in the urine.
• Painful urination.
• Genital ulcers or lesions. These are isolated or multiple lesions that resolve upon discontinuing treatment (see "Warnings and precautions").
• General discomfort.
• Pain and inflammation at the injection site.
• Swelling of feet and legs.
• Changes in heart function tests (ECG).

Rare: may affect up to 1 in 100 people

• Reduction in red, white, and platelet blood cells.
• Too much acid in the blood. This can make you breathe faster.
• Itchy rash (urticaria)
• Kidney and urinary tract problems (renal tubular alteration, glomerulonephritis, nephrotic syndrome).
• Increased levels of certain blood enzymes, for example, amylase, creatine, and phosphokinase.

Frequency not known (cannot be estimated from available data)

• Unusual heartbeats.
• Diabetes. Signs include urinating more frequently than usual. Less commonly, you may also feel excessive thirst.
• Increased sodium levels in the blood.
• Encephalopathy.
• Unusual heartbeats or changes in heart rate, for example, torsades de pointes.
• Muscle problems: muscle weakness, muscle tissue destruction (rhabdomyolysis: abnormal urine color and severe muscle stiffness, sensitivity, or weakness).
• Kidney problems, for example, pain, blood in urine, tubular necrosis, nephropathy by crystals.
• Extravasation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerateor freeze.If it is stored in the refrigerator or exposed to temperatures below the freezing point, it may precipitate. This precipitate can be redissolved by keeping the bottle at room temperature and shaking it repeatedly.
• Chemical and physical stability has been demonstrated in use of the product for 9 days at 25 °C. From a microbiological standpoint, the product must be used immediately unless the opening and dilution have been carried out in conditions that exclude the risk of microbial contamination. If not used immediately, the time and storage conditions, prior to use, are the responsibility of the user.
• Foscarnet can be mixed with another liquid by a pharmacist. This is to provide a ready-to-use medication. The pharmacist will inform you on how to store and when to use the medication.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Foscarnet Kabi

The active ingredient is foscarnet.

Each ml contains 24 mg of foscarnet sodium hexahydrate

The other components are water for injection and hydrochloric acid.

Appearance of the product and contents of the container

Foscarnet is a sterile infusion solution.

The solution is transparent and colorless.

Foscarnet is presented in 250 ml bottles.

Marketing Authorization Holder

Fresenius Kabi España, S.A.U

Torre Mapfre – Vila Olímpica

Marina 16-18

08005 Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

A-8055 Graz

Austria

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

Belgium: Foscarnet Fresenius Kabi 24 mg/ml solution for infusion; Foscarnet Fresenius Kabi 24 mg/ml solution for perfusion; Foscarnet Fresenius Kabi 24 mg/ml Infusionslösung

France: FOSCARNET KABI 24 mg/ml, solution for perfusion

Germany: Foscarnet Kabi 24 mg/ml Infusionslösung

Italy: Foscarnet Kabi

Luxembourg: Foscarnet Sodium 24 mg/ml Solution for Infusion

Portugal: Foscarneto sódico Kabi

Spain: Foscarnet Kabi 24 mg/ml solution for perfusion EFG

United Kingdom: Foscarnet Sodium 24 mg/ml Solution for Infusion

Last review date of this leaflet:August 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Be particularly careful with Foscarnet Kabi

• In patients with renal impairment:
• • Serum creatinine levels must be monitored regularly.
  • A dose adjustment should be made in patients with altered renal function. To prevent renal function changes that may occur during treatment, adequate hydration should be maintained.
• Do not use solutions that may contain calcium.
• In case of accidental contact, rinse the affected skin or mucous membranes with water.

Administration form

Foscarnet should be administered only by intravenous route, either through a central venous catheter or a peripheral vein.

Warning: Do not administer foscarnet by rapid intravenous injection.

Do not administer foscarnet without a hydration regimen.

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

As with all infusions, strict aseptic conditions must be met during handling.

When using peripheral veins, the foscarnet 24 mg/ml solution must be diluted. Hospital pharmacy services must transfer the individual doses of foscarnet aseptically to plastic infusion bags, as well as dilute it in equal parts of sodium chloride 0.9% (9 mg/ml) or dextrose 5% (50 mg/ml). The physical and chemical stability of foscarnet, foscarnet dilutions, and PVC bag dilutions is 9 days. Diluted solutions should be used as soon as possible after preparation, but may be stored for up to 24 hours if refrigerated.

Foscarnet renal toxicity can be reduced with adequate patient hydration. See the "Hydration" section below.

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

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

Y-type infusion system scheme

Hydration:

Special attention should be paid to the importance of preventing foscarnet renal toxicity by ensuring that patients receive adequate hydration.

If a Y-type infusion system is used, 0.5 to 1 liter of NaCl 0.9% or glucose 5% should be infused simultaneously. In patients who meet the requirements, oral hydration with similar hydration regimens has been used. Clinically dehydrated patients should have their condition corrected before starting foscarnet treatment.

Each foscarnet bottle should only be used to treat a single patient with a single infusion.

Accidental contact with the skin or eyes of the foscarnet sodium solution can cause local irritation and burning sensation. In case of accidental contact, the affected area should be rinsed with water.

Foscarnet refrigerated or exposed to temperatures below the freezing point may precipitate. By maintaining the bottle at room temperature with constant agitation, the precipitate may revert to solution.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.