Farmorubicin Pfs

Package Leaflet: Information for the User

FARMORUBICIN PFS, 2 mg/ml, Solution for Injection and Infusion

Epirubicin Hydrochloride

Read All of This Leaflet Carefully Before You Start Using This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of the Pack

• 1. What Farmorubicin PFS is and what it is used for
• 2. Before you are given Farmorubicin PFS
• 3. How Farmorubicin PFS is given
• 4. Possible side effects
• 5. How to store Farmorubicin PFS
• 6. Further information

1. What Farmorubicin PFS is and what it is used for

The active substance of Farmorubicin PFS, epirubicin, is a cytotoxic anthracycline antibiotic with antineoplastic activity.

Farmorubicin PFS can be given alone or in combination with other cytotoxic drugs.

Farmorubicin PFS is used to treat the following types of cancer:

• transitional cell carcinoma of the urinary bladder
• breast cancer (early, advanced, and/or metastatic)
• gastric cancer
• palliative chemotherapy of oesophagogastric junction cancer
• head and neck cancer
• leukaemia
• non-small cell lung cancer
• small cell lung cancer
• malignant non-Hodgkin's lymphoma, Hodgkin's disease
• multiple myeloma
• ovarian cancer
• pancreatic cancer in combination therapy according to the PEFG scheme (cisplatin, epirubicin, 5-fluorouracil, and gemcitabine)
• colon and rectal cancer
• soft tissue sarcoma

2. Before You Are Given Farmorubicin PFS

Do not use Farmorubicin PFS if you are allergic to epirubicin or any of the other ingredients of this medicine.

Farmorubicin PFS must not be used:

• in patients with severe myocardial insufficiency
• in patients with severe liver dysfunction
• in patients with cardiomyopathy
• in patients with recent myocardial infarction
• in patients with severe arrhythmias
• in patients who have previously received maximum cumulative doses of this drug and/or other anthracyclines or anthracenediones
• in patients with acute systemic infections
• in patients with unstable angina pectoris

Administration of Farmorubicin PFS into a small vein or repeated administration into the same vein can cause vein sclerosis.

Extravasation of the drug during injection can cause pain, severe tissue damage (formation of blisters, severe inflammation of the subcutaneous tissue), and necrosis.

Special Warnings and Precautions

Use of Farmorubicin PFS should only be started after the acute toxic effects of any previous cytotoxic treatment have subsided, such as stomatitis, neutropenia, thrombocytopenia, and generalised infections.

Farmorubicin PFS should only be administered under the supervision of a doctor with experience in the use of cytotoxic drugs.

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Farmorubicin PFS is mainly used in combination with other cytotoxic drugs. Increased toxicity may occur, particularly in terms of bone marrow suppression, blood cell elements, and gastrointestinal tract.

When used in combination with other potentially cardiotoxic drugs, as well as other cardioactive compounds (e.g., calcium channel blockers), your doctor should monitor cardiac function during treatment.

Farmorubicin PFS is primarily metabolized in the liver. Patients should inform their doctor, pharmacist, or healthcare provider about the use of Farmorubicin PFS.

Changes in liver function caused by concomitantly used other drugs may affect the metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity of Farmorubicin PFS.

Interactions with Other Medicinal Products

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Farmorubicin PFS should not be administered simultaneously with other cardiotoxic drugs, until cardiac function is strictly monitored.

Patients receiving anthracyclines after the end of treatment with other cardiotoxic drugs (e.g., trastuzumab) may also be at increased risk of cardiotoxic effects (see section "Special Warnings and Precautions").

Live or live attenuated vaccines should not be administered to patients receiving Farmorubicin PFS.

Inactivated or killed vaccines may be administered, but the response to such vaccines may be diminished.

Use in Patients with Renal and Hepatic Impairment

Renal Impairment

Before starting treatment and during treatment, your doctor should evaluate your serum creatinine levels.

In patients with serum creatinine levels > 5 mg/dl, dose adjustment is necessary.

Hepatic Impairment

Farmorubicin PFS is contraindicated in patients with severe liver dysfunction.

In patients with elevated bilirubin levels, your doctor should consider using lower doses of Farmorubicin PFS (see section "Special Warnings and Precautions" and section "Dose Adjustment").

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.

Pregnancy

Farmorubicin PFS may cause harm to the unborn child.

Your doctor should inform you about the potential risk to the fetus if Farmorubicin PFS is used during pregnancy or if you become pregnant while taking this medicine.

This medicine should not be used during pregnancy unless your doctor considers it essential.

Women of childbearing age should use effective contraception during treatment with Farmorubicin PFS and for at least 6.5 months after the last dose.

Men should use effective contraception during treatment with Farmorubicin PFS and for at least 3.5 months after the last dose.

Breast-Feeding

Do not breast-feed while taking Farmorubicin PFS and for at least 7 days after the last dose, as it is not known whether the active substance passes into breast milk.

Fertility

Both men and women should seek advice on conservation of fertility before starting treatment.

Driving and Using Machines

No studies on the effects on the ability to drive and use machines have been performed.

Farmorubicin PFS Contains Sodium

This medicine contains 17.7 mg of sodium (a major component of common salt) per 5 ml vial, corresponding to 0.9% of the maximum recommended daily intake of sodium for adults.

3. How Farmorubicin PFS is Given

Farmorubicin PFS should only be administered under the supervision of a doctor with experience in the use of cytotoxic drugs.

Farmorubicin PFS is usually given as an intravenous infusion.

Intravenous Administration

The total dose of Farmorubicin PFS in one treatment cycle may vary depending on the treatment regimen used (e.g., Farmorubicin PFS may be given alone or in combination with other cytotoxic drugs) and the indication.

Farmorubicin PFS should be administered into a vein with a freely flowing intravenous infusion of a sodium chloride 0.9% solution or glucose 5% solution.

The infusion time is usually between 3 and 20 minutes (depending on the dose of Farmorubicin PFS and the volume of the solution), in order to reduce the risk of thrombophlebitis or extravasation.

Direct injection of Farmorubicin PFS is not recommended due to the risk of extravasation, which can occur even if blood is aspirated into the syringe before injection.

Dose Adjustment

Renal Impairment

Although data in patients with renal impairment are limited and do not allow for strict dosing recommendations, your doctor should consider using lower initial doses in patients with severe renal impairment (serum creatinine > 5 mg/dl).

Hepatic Impairment

Your doctor should reduce the dose of Farmorubicin PFS in patients with the following bilirubin and AST values:

• bilirubin 1.2-3 mg/dl or AST 2-4 times the upper limit of normal: 50% of the recommended initial dose;
• bilirubin > 3 mg/dl or AST > 4 times the upper limit of normal: 25% of the recommended initial dose.

Intravesical Administration

Farmorubicin PFS should be administered through a catheter and retained in the bladder for 1 hour.

During the infusion, the patient should change position to ensure optimal contact between the bladder mucosa and the solution.

To avoid excessive dilution of Farmorubicin PFS in the urine, the patient should be informed not to drink any fluids for 12 hours before the infusion.

After the procedure, the patient should urinate.

Intravesical administration of Farmorubicin PFS should not be used to treat invasive tumours infiltrating the bladder muscle.

Overdose

Administration of higher doses than recommended may result in severe bone marrow suppression (mainly leucopenia and thrombocytopenia), gastrointestinal disorders (mainly stomatitis), and cardiotoxicity.

Treatment: Symptomatic. The drug cannot be removed by dialysis.

Missed Dose

As Farmorubicin PFS will be administered under strict medical supervision, missed doses are unlikely.

However, if a dose is missed, you should always inform your doctor or nurse.

Discontinuation of Treatment

Discontinuation of treatment is decided by your doctor.

Do not stop treatment without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Farmorubicin PFS can cause side effects, although not everybody gets them.

Frequency of side effects:

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

• infection
• conjunctivitis
• anaemia
• leucopenia
• neutropenia and granulocytopenia
• thrombocytopenia
• febrile neutropenia
• keratitis
• flushing
• phlebitis
• nausea
• vomiting
• stomatitis
• mucositis
• diarrhoea
• alopecia
• skin damage
• urine discolouration
• amenorrhoea
• malaise
• fever
• liver enzyme changes
• chemical cystitis after intravesical administration

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

• decreased appetite
• dehydration
• ventricular arrhythmia
• conduction disorders (atrioventricular block, bundle branch block)
• bradycardia
• heart failure
• haemorrhage
• flushing
• oesophagitis
• ulcers in the gastrointestinal tract
• rash
• pruritus
• nail hyperpigmentation
• skin changes
• skin hyperpigmentation
• chills
• cardiac function changes (reduced left ventricular ejection fraction)
• injection site reaction

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

• sepsis
• pneumonia
• acute myeloblastic and lymphoblastic leukaemia
• thromboembolism
• vasculitis
• pulmonary embolism
• gastrointestinal haemorrhage
• urticaria
• erythema
• fatigue

Rare (may affect up to 1 in 1,000 people):

• anaphylactic reaction
• hyperuricaemia
• vertigo
• cardiotoxicity (e.g., ECG changes, arrhythmias, cardiomyopathy)
• azoospermia

Frequency not known (cannot be estimated from the available data):

• shock
• abdominal discomfort
• oral mucosal melanin deposits
• skin reactions resembling sunburn upon exposure to sunlight or ultraviolet radiation
• radiation recall (inflammation of the skin in previously irradiated areas)
• septic shock
• bleeding and tissue hypoxia due to bone marrow suppression
• vein sclerosis
• local pain
• severe soft tissue necrosis
• tissue necrosis after accidental extravasation

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

5. How to Store Farmorubicin PFS

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

Do not use Farmorubicin PFS after the expiry date which is stated on the carton and vial after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

The solution should be used within 24 hours after the first piercing of the rubber stopper.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Farmorubicin PFS Contains

• The active substance is epirubicin hydrochloride.
• Each ml of solution contains 2 mg of epirubicin hydrochloride.
• The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

What Farmorubicin PFS Looks Like and Contents of the Pack

Farmorubicin PFS is a red, clear solution.

It is available in packs containing 1 polypropylene vial of 5 ml, 25 ml, or 100 ml, closed with a rubber stopper (siliconised, halobutyl) and an aluminium cap with a plastic flip-off cap, in a cardboard box.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Importer

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

For Further Information

Pfizer Polska Sp. z o.o.

tel. 22 335 61 00

Date of Last Revision of the Leaflet

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Information Intended for Healthcare Professionals Only

Farmorubicin PFS should not be mixed with other drugs.

Avoid contact with alkaline solutions, as this may cause hydrolysis of the drug.

Farmorubicin PFS should not be mixed with heparin due to chemical incompatibility, which may lead to precipitation.

Preparation of the Solution for Intravenous Administration

Storage of the solution in the refrigerator may cause the drug to precipitate.

This precipitate will dissolve (from slightly viscous to completely fluid) after 2 to 4 hours at controlled room temperature (15-25°C).

Farmorubicin PFS should be used within 24 hours after the first piercing of the rubber stopper.

Any unused solution should be discarded.

Any remaining unused medicinal product or waste material should be disposed of in accordance with local requirements.

The following safety precautions should be taken into account for all cytotoxic drugs:

• personnel should be trained in the proper technique for reconstituting and handling the drug;
• women of childbearing potential should not be allowed to handle the drug;
• personnel handling the drug should wear protective clothing: goggles, gowns, disposable gloves, and masks;
• reconstitution of the drug should be performed in a designated area (preferably with a laminar flow system); the work surface should be protected with disposable paper with a plastic coating underneath;
• all materials used for reconstitution, administration, or cleaning up should be placed in high-risk waste disposal bags and then incinerated at high temperature;
• spills or leaks of the drug should be cleaned up with a diluted sodium hypochlorite solution (1% available chlorine), followed by water;
• all materials used for cleaning up spills should be disposed of as described above;
• in case of skin contact, the area should be thoroughly washed with soap and water, but not with a brush, to avoid skin abrasion;
• in case of eye contact, the eye should be flushed with plenty of water for at least 15 minutes, and medical attention should be sought;
• after removing gloves, hands should always be washed.