Foscavir 24 mg/ml solucion para perfusion

Prospecto: information for the patient

Foscavir 24 mg/ml infusion solution

Foscarnet sodium hexahydrate

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, 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 prospectus. See section 4.

1. What is Foscavir 24 mg/ml infusion solution and for what it is used

2. What you need to know before starting to use Foscavir 24 mg/ml infusion solution

3. How to use Foscavir 24 mg/ml infusion solution

4. Possible adverse effects

5. Storage of Foscavir 24 mg/ml infusion solution

6. Contents of the package and additional information

The active ingredient foscarnet is an antiviral agent that acts by inhibiting the multiplication of certain viruses.

Foscavir is used to treat the following viral infections:

• An eye infection (retinitis) or gastrointestinal infection, caused by the CMV virus, in patients with HIV infection.

Foscavir is indicated for the treatment of induction and maintenance of the disease, although it cannot repair the damage caused.

• Skin or mucous membrane infections caused by the herpes simplex virus (HSV) that have not improved with aciclovir, in immunosuppressed patients (the immune system does not function properly).

• A viral infection caused by the cytomegalovirus (CMV) after receiving a bone marrow transplant when other treatments have not been adequate.

No use Foscavir24 mg/ml solution for infusion

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

Warnings and precautions

Consult your doctor or nurse before starting to useFoscavir24 mg/ml solution for infusion

• If you have renal insufficiency, since analytical controls should be performed during treatment. Adequate hydration should be maintained in all patients.
• If you have heart problems.

Foscavir is eliminated in high concentrations by the urine and may cause significant genital irritation and/or ulcers. To avoid irritation and ulcers, it is recommended to maintain personal hygiene and genital area cleaning after urination.

Foscavir is deposited in teeth, bones, and cartilage. Animal data show that the deposit is greater in young animals. The safety of Foscavir and its effect on skeletal development have not been investigated in children.

The administration of the drug may be associated with a sudden reduction in calcium. For this reason, calcium and magnesium levels should be controlled before and during treatment with Foscavir to correct deficiencies if any. Similarly, electrolyte and mineral concentrations in blood should be monitored periodically, especially calcium and magnesium.

Children and adolescents

The safety and efficacy of Foscavir in children have not been established.

Other medications and Foscavir

Inform your doctor or pharmacist if you are using, have used recently, or may use other medications, even those acquired without a prescription..Especially if you are taking aminoglycosides (group of antibiotics); amphotericin B (for fungal infections); cyclosporine A, methotrexate, tacrolimus (immunosuppressants); acyclovir (antiviral); pentamidine (injections); quinidine, amiodarone, sotalol, or other medications that may affect your heart rate and rhythm; tranquilizers (neuroleptics); as well as some protease inhibitors such as ritonavir and saquinavir.

Pregnancy and breastfeeding

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

• Foscavir is not recommended during pregnancy.
• Foscavir should not be used during pregnancy, and therefore effective contraceptive methods should be employed.
• Males being treated with Foscavir should not father children during or until 6 months after treatment.
• Do not take Foscavir if you are breastfeeding.

Driving and operating machinery

Foscavir may affect your ability to drive oruse machinery.Consult your doctor before performing any of these activities.

Foscavir contains sodium

The maximum daily dose recommended for this medication contains 2.75 g of sodium (which is found in table salt). This is equivalent to 138% of the maximum daily sodium intake recommended for adults.

Consult your doctor or pharmacist if you need Foscavir daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Foscavir should be administered by a healthcare professional, intravenously.

Your doctor will calculate the correct amount of Foscavir for you, based on your body weight and blood test results.

Your doctor will follow the guidelines indicated below, depending on the infection, for as long as they deem necessary.

If you are being treated due to acytomegalovirus (CMV) retinitis,treatment will be performed in two stages: induction, and then maintenance. Induction is the initial stage in which infusions of more than one hour in duration will be administered at intervals of 8 or 12 hours a day, for two or three weeks. Depending on how the virus responds, you may or may not progress to the maintenance stage, in which infusions will be administered once a day. If the viral infection worsens at any time, treatment may be reinstated in the induction stage. Your doctor will inform you at all times of any necessary changes to infusion times, modifying the dose as needed to increase antiviral effect or reduce the risk of kidney damage.

If you are being treated due to acytomegalovirus (CMV) gastrointestinal infection,treatment will be performed in a single stage. The infusion will be administered at intervals of 12 hours for 2-4 weeks.

If you are being treated due toskin or mucous membrane infections caused by the herpes simplex virus (HSV),treatment will also be performed in a single stage. The infusion will be administered at intervals of 8 hours for 2-3 weeks, or until healing.

If you are being treatedafter receiving a bone marrow transplant, for a viral infection caused by cytomegalovirus (CMV),treatment will be performed in two stages: induction, and then maintenance. Induction is the initial stage in which infusions of more than one hour in duration will be administered at intervals of 12 hours a day, for two weeks. Depending on how the virus responds, you may or may not progress to the maintenance stage, in which infusions will be administered 5 days a week for two weeks. If the viral infection worsens at any time, treatment may be reinstated in the induction stage. Your doctor will inform you at all times of any necessary changes to infusion times, modifying the dose as needed to increase antiviral effect or reduce the risk of kidney damage.

Hydration

The renal toxicity of this medication can be reduced by adequate hydration. Your doctor will follow the most suitable guidelines for you.

Patients with renal function impairment

Your doctor will take into account the degree of renal insufficiency for dose adjustment according to the table above. It is not recommended to use this medication in patients undergoing hemodialysis.

Patients with liver function impairment

No dose reduction is necessary for patients with liver insufficiency.

Geriatric patients

No dose adjustment is required.

If you are administered more Foscavirthan you should

Relative overdoses have occurred in some patients with kidney problems due to inadequate dose adjustment; however, note that in some cases no clinical sequelae have originated after this overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:91 562 04 20, indicating the medication and the amount ingested.

Information for the healthcare professional

Hemodialysis increases the elimination of the medication, and may be beneficial in cases.

Like all medicines, this medicinecan causeside effects, although not everyone will experience them.

The side effects observed with Foscavir are:

Note: In these clinical trials, hydration or systematic attention to electrolyte balance was not provided, so the frequency of some adverse reactions may be lower when following current recommendations (see section 3).

Reporting of adverse reactions

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

Keep this medication out of the sight and reach of children.

Before opening: Store at a temperature below 25°C. Do not store in the refrigerator.

If 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.

Before opening: Do not use this medication after the expiration date shown on the bottle.The expiration date is the last day of the month indicated.

After the first opening: the solution must be used within 24 hours (does not contain preservatives).

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage conditions and time, before use, are the responsibility of the professional and should not exceed 24 hours stored between 2 and 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition ofFoscavir24 mg/ml solution for infusion

- The active ingredient is foscarnet sodium hexahydrate. 1 ml of solution contains 24 mg of foscarnet sodium hexahydrate. See section 2 ‘Foscavir contains sodium’.

- The other components are: hydrochloric acid (E507) and water for injection.

Appearance of the product and contents of the pack

This medicinal product is a solution for infusion, which is presented in a 250 ml bottle.

Holder of the marketing authorisation and responsible for manufacturing

Holder of the marketing authorisation

Clinigen Healthcare B.V.

Schiphol Boulevard 359

WTC Schiphol Airport, D Tower 11thfloor

1118BJ Schiphol

Netherlands

Responsible for manufacturing

Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Austria

Date of the last review of this leaflet:May 2023

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

This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR CORRECT ADMINISTRATION

Foscavir does not contain preservatives and once the sterility seal is broken, the solution must be used within 24 hours.

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage conditions and time before use are the responsibility of the professional and should not exceed 24 hours stored between 2 and 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.The individual doses of Foscavir to be dispensed can be transferred aseptically to infusion bags by hospital pharmacy services. The physical-chemical stability of Foscavir and of dilutions in equal parts with sodium chloride 9% (9 mg/ml) or glucose 50 mg/ml, in PVC bags, is 7 days.

Dosage

Adults

Cytomegalovirus (CMV) retinitis in HIV patients

Treatment of induction:Foscavir will be administered for 2-3 weeks depending on the clinical response in the form of intermittent infusions every 8 hours at a dose of 60 mg/kg or every 12 hours at a dose of 90 mg/kg in patients with normal renal function. The dose must be adjusted individually according to renal function (see Dose Table below). The duration of each infusion should not be less than 2 hours for the 90 mg/kg dose or 1 hour for the 60 mg/kg dose.

Maintenance treatment:Once the induction treatment for CMV retinitis has been completed, Foscavir will be administered 7 days a week for as long as considered appropriate. In patients with normal renal function, the dose is between 90 and 120 mg/kg, in the form of a single daily infusion of 2 hours' duration. The dosage should be individualized according to the patient's renal function (see Dose Table below). It is recommended to start treatment with 90 mg/kg. The dose can be gradually increased to 120 mg/kg in patients who have a good tolerance to the previous dose.

Patients who experience a progression of the retinitis during maintenance treatment may be switched back to induction treatment or to a combination of Foscavir and ganciclovir. Once stabilised, the maintenance treatment with Foscavir or a combination of Foscavir and ganciclovir should be established.

Due to physical incompatibility, Foscavir and ganciclovir should not be mixed.

CMV infections in the upper and lower gastrointestinal tract in HIV patients

Foscavir will be administered as intermittent infusions every 12 hours at a dose of 90 mg/kg in patients with normal renal function. Most patients will experience a remission of their symptoms within 2 to 4 weeks. The dose should be individualized according to the patient's renal function (see Dose Table below). The infusion time should not be less than 2 hours.

Herpes simplex virus (HSV) mucocutaneous infections that do not respond to aciclovir

For the treatment of induction, Foscavir will be administered in the form of intermittent infusions for 1 hour at a dose of 40 mg/kg, every 8 hours, in patients with normal renal function. The dose should be adjusted individually according to renal function (see Dose Table below). The duration of each infusion should not be less than 1 hour.

The time to healing depends on the initial lesion size and Foscavir treatment should continue until complete reepithelialisation, usually 2-3 weeks. Clinical response to Foscavir should be evident after one week of treatment; treatment should be reconsidered in patients who do not respond within that time period.

The efficacy of Foscavir maintenance therapy after induction treatment in HSV infections that do not respond to aciclovir has not been established. In case of recurrence, the lack of response to aciclovir should be confirmed.

Prophylactic treatment in high-risk patients and treatment of CMV infection in patients with TCMH

Treatment of induction:A dose of 60 mg/kg will be administered for 14 days in the form of intermittent infusions every 12 hours, in patients with normal renal function.

The dose should be adjusted individually according to renal function (see Dose Table below).

The duration of each infusion should not be less than 1 hour.

Treatment of maintenance:Once the induction treatment for CMV infection has been completed, 90 mg/kg will be administered 5 days a week for 14 days in patients with normal renal function, in the form of a single daily infusion of 2 hours' duration.

The dosage should be individualized according to the patient's renal function (see Dose Table below).

Patients who experience a progression of the infection during maintenance treatment may be switched back to induction treatment.

Table1Dose Table for Foscavir

Treatment of induction

Treatment of maintenance

Hydration

Patients who are clinically dehydrated should correct their state before starting treatment with Foscavir.

The renal toxicity of Foscavir can be reduced by adequate hydration of the patient. To this end, it is recommended to favour diuresis by hydrating the patient with 0.5 -1.0 litreof physiological serum before the first infusion of Foscavir and adding 0.5 -1.0 litreof physiological serum to each infusion. In cooperative patients, a similar hydration schedule can be used although by oral route.

Patients with renal impairment

The dose should be reduced for patients with renal insufficiency according to the creatinine clearance indices described in the table above. Foscavir should not be used in patients undergoing haemodialysis, as the dosage guidelines have not been established.

Patients with hepatic impairment

No dose adjustment is necessary for patients with hepatic insufficiency.

Geriatric patients

No dose adjustment is required.

Pediatric population

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

Administration

Foscavir should only be administered byintravenous route,either via a central venous catheter or in a peripheral vein.

DO NOT administer this medicinal product by rapid intravenous injection.

To administer in aperipheral vein,the solution must be diluted immediately before administration in 5% glucose or physiological serum to a concentration of 12 mg/ml.

Foscavir solution can be administered undiluted viacentral venous route.

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