Perfan

Package leaflet: Information for the user

Perfan 100 mg/20 ml concentrate for solution for infusion

Enoximone
Please read this leaflet carefully before you start taking this medicine, as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Perfan is and what it is used for

What Perfan is
Perfan contains a substance called enoximone that helps the heart function better by acting directly on its contraction and on the blood vessels.
Perfan is indicated for short-term treatment (48 hours) of severe congestive heart failure when standard therapies have not produced positive effects, or in cases of acute heart failure following cardiac surgery. These conditions are characterized by the heart's inability to pump sufficient blood to other parts of the body.

2. What you need to know before taking Perfan

Do not take Perfan

• if you are allergic to enoximone or to any of the other ingredients of this medicine (listed in section 6);
• if you have diseases that severely impair the function of your heart valves (severe obstructive cardiomyopathy or valvulopathy);
• if there is a significant decrease in the amount of blood circulating in your body (severe uncompensated hypovolemia);
• if certain areas of your heart are contracting too rapidly (ventricular tachyarrhythmias);
• if you have a condition characterized by dilation of certain areas of the heart (ventricular aneurysm);
• if you have a disease affecting the heart due to inadequate blood supply (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or nurse before using Perfan.
Pay special attention to the use of Perfan:

• if you have a condition characterized by thickening of the heart muscle (hypertrophic cardiomyopathy);
• if you have narrowing or obstruction of your heart valves (stenotic or obstructive valvular disease), or if your blood vessels are obstructed due to other factors. During treatment with Perfan, regular monitoring is required to assess:
• blood pressure and heart rate. If your blood pressure becomes too low, healthcare professionals will reduce the infusion rate of Perfan or may suspend administration. If you have heart failure, you may be more susceptible to developing heart rhythm problems (arrhythmias);
• heart rhythm (electrocardiogram [ECG]);
• electrolyte levels (certain chemical components in the blood) and kidney function. Concomitant use of drugs that increase urine volume (diuretics) may cause a reduction in blood potassium levels;
• platelet count (a type of cell involved in blood clotting). A decrease in the number of platelets in your blood may occur;
• liver enzymes. If you develop a significant increase in liver enzyme levels, your doctor may decide to discontinue treatment with Perfan.

Children
The use of Perfan is not recommended in children. For further information, consult your doctor.
Other medicines and Perfan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
During therapy with Perfan, you will likely be given other medicines at the same time, including diuretics such as amiloride, triamterene, furosemide, and spironolactone (medicines that increase urine volume), other heart medications such as digitalis glycosides (digoxin), antiarrhythmics (diltiazem, propranolol, lidocaine, nifedipine, procainamide, and quinidine), vasodilators (captopril, hydralazine, and nitrates), anticoagulants (warfarin and heparin), or positive inotropic agents (such as dobutamine and dopamine), pain-relieving medicines (analgesics such as acetylsalicylic acid, paracetamol, and codeine), potassium, and sedatives (chloral hydrate, diazepam, and lorazepam).
Perfan with food and drink
Consult your doctor for advice regarding food and drink consumption while using Perfan.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will only decide to administer Perfan during pregnancy or breastfeeding if the benefits of using the medicine outweigh the possible risks to you or your baby.
Driving and using machines
Not applicable, as Perfan is administered only in a hospital setting.
Perfan contains ethanol, propylene glycol, and sodium
This medicine contains 1684 mg of alcohol (ethanol) per vial, equivalent to less than 43 ml of beer or 17 ml of wine.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor if you are taking other medicines.
If you have epilepsy or liver problems, or if you are pregnant or breastfeeding, talk to your doctor before using this medicine.
When administered by slow infusion, the effects of alcohol may be reduced.
The propylene glycol contained in this medicine may produce effects similar to those of alcohol and may increase the likelihood of side effects. Do not use this medicine in children under 5 years of age. Use this medicine only if recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you have liver or kidney disease, are pregnant, or are breastfeeding, do not use this medicine unless otherwise advised by your doctor.
This medicine contains 29.6 mg of sodium (a component of common salt) per maximum dose for initial therapy (based on a standard body weight of 70 kg). This corresponds to 1.48% of the maximum daily dietary intake recommended for an adult.
For maintenance therapy, you may receive multiple vials several times within 24 hours. In such cases, talk to your doctor (see also “The following information is intended exclusively for doctors or healthcare professionals”).

3. How to use Perfan

Your doctor or nurse will administer Perfan to you as an intravenous infusion, exclusively in a hospital setting.
Perfan must be appropriately diluted before use.
The dose of the medicine you will receive depends on your condition, your response to treatment, and any concomitant therapies.
The duration of treatment and frequency of administrations will be determined based on your response to therapy.
If you take more Perfan than you should
If you receive an excessive dose of Perfan, your blood pressure may drop, causing symptoms such as dizziness, lightheadedness, nausea, and palpitations.
If you experience these symptoms, your doctor will stop the administration of Perfan or decide to reduce the dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported during administration of Perfan:
Cardiovascular system: ectopic beats (premature heartbeats perceived as a "thumping" sensation in the chest), arrhythmias (abnormal heart rhythms), hypotension (a condition in which blood pressure is lower than normal values)
Nervous system: headache, insomnia
Gastrointestinal system: nausea, vomiting, diarrhoea
Other symptoms: chills, pain in arms and legs, fever, inability to normally expel urine from the body (urinary retention), reduced volume of urine excreted (oliguria), reduced platelet count, increased liver enzymes and bilirubin.

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 via the national reporting system at 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 Perfan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
After dilution, the medicine should be kept at room temperature for no longer than 24 hours and must not be refrigerated due to the possible formation of crystals.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Perfan contains

• The active substance of Perfan is enoximone. Each vial contains 100 mg of enoximone.
• The other components are sodium hydroxide, anhydrous ethanol, propylene glycol, water for injections.

Description of the appearance of Perfan and the contents of the pack
When appropriately diluted, Perfan is a clear yellow solution.
Perfan is supplied in 20 ml vials containing 100 mg of enoximone, in packs of 5 vials.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
INCA-Pharm S.r.l.
Via Marittima, 38 – 03100 Frosinone, Italy

Responsible manufacturer for batch release
Solupharm Pharmazeutische Erzeugnisse GmbH, Industriestraße 3 - 34212 Melsungen, Germany

The following information is intended exclusively for physicians or healthcare professionals:

Dosage and method of administration
Perfan must be diluted before use and administered to the patient by slow or continuous intravenous infusion.

Dilution
Perfan has a pH of approximately 12.0.
Perfan must be diluted 1:1 with 0.9% sodium chloride for injection or water for injections before administration.
Other diluents must not be used, particularly dextrose, as crystallization may occur.
For dilution, plastic containers or syringes must be used, since crystallization has been observed approximately one hour after diluting Perfan in glass containers or syringes.
If not used immediately, the 1:1 solution must be stored at room temperature and used within 24 hours. Do not refrigerate diluted Perfan, as crystallization may occur.
Other medicinal products or fluids must not be mixed in the same container or administered simultaneously via the same infusion line as Perfan.
It is good practice to always visually inspect the appearance of parenteral solutions prior to administration.
Diluted Perfan is a clear yellow solution.

Administration
The following dosage regimen is recommended for the administration of Perfan.

Loading therapy
Perfan diluted 1:1 with 0.9% sodium chloride for injection or with water for injections.
The initial dose should be 0.5–1 mg/kg administered at a rate not exceeding 12.5 mg/min.
Subsequent doses of 0.5 mg/kg may be given every 30 minutes until a satisfactory hemodynamic response is achieved or until a cumulative dose of 3.0 mg/kg is reached. Alternatively, treatment may be initiated by administering the drug as an infusion at a rate of 90 mcg/kg/min for a period of 10 to 30 minutes, until the required hemodynamic response is obtained.

Maintenance therapy
The effects achieved with Perfan may be maintained by repeated administration (4 to 8 times within 24 hours) of the doses that proved effective in achieving the required hemodynamic response during the initial phase.
Alternatively, maintenance therapy may be performed either by continuous or intermittent infusion at a rate of 5 to 20 mcg/kg/min, up to a total treatment duration of 48 hours.
In patients with renal impairment, dosage reduction or less frequent administration may be necessary.
Particular care must be taken to avoid perivascular leakage of the product during administration.
The recommended dosage regimen produces, in most patients, an increase of 30% or more in cardiac output and/or a decrease of approximately 30% in pulmonary capillary wedge pressure and approximately 40% in right atrial pressure.
Based on the initial hemodynamic response, the subsequent frequency of administration and duration of treatment can be determined.
The infusion rate may be adjusted according to the clinical response and the possible occurrence of undesirable hemodynamic effects.