Pepaxti 20 mg polvo par… – інструкція – Іспанія

Інструкція із застосування Pepaxti 20 mg polvo para concentrado para solucion para perfusion

Introduction

Prospect: information for the patient

Pepaxti 20 mg powder for concentrate for solution for infusion

Melfalán flufenamida

Read the entire prospect carefully before this medication is administered to you, because it contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor or nurse.
If you experience any type of adverse effect, consult your doctor or nurse, even if it is an adverse effect that does not appear in this prospect. See section 4.

1. What is Pepaxti and how is it used

Pepaxti belongs to a group of cancer medications called alkylating agents. It works by binding to DNA (the genetic instruction necessary for cells to survive and multiply) and damaging it, thus helping to stop the growth of cancer cells.

Pepaxti is administered with the steroid dexamethasone to treat adults with multiple myeloma, a type of blood cancer. It is used when the disease does not respond to at least three types of cancer medications. If you have been treated with a stem cell blood transplant (a procedure in which the cells that produce blood are removed and replaced), the time until the reappearance of multiple myeloma after the transplant must be at least 3 years.

2. What you need to know before starting to use Pepaxti

Do not use Pepaxti

if you are allergic to melfalan flufenamida or any of the other components of this medication (listed in section 6);
if you are breastfeeding.

Warnings and precautions

Consult your doctor or nurse before Pepaxti is administered to you.

Bleeding and abnormal bruising and low platelet count (blood cells)

Pepaxti may reduce the number of blood cells called platelets, which help the blood to clot. Inform your doctor or nurse immediately if you start bleeding, for example, if you experience nasal bleeding or observe bruises on the skin.

Fever and low white blood cell count

Pepaxti may reduce the number of white blood cells, which are important for fighting infections. Inform your doctor or nurse immediately if you have symptoms of infection, such as fever, chills, or cough.

Low red blood cell count

Pepaxti may reduce the number of red blood cells, which transport oxygen to the cells of your body. Your doctor will take blood samples periodically to monitor your blood cells. Inform your doctor or nurse immediately if you feel weak or tired, if you look pale or if you feel short of breath.

Infections

Infections such as pneumonia and upper respiratory tract infections (which cause symptoms similar to the common cold) are very common with Pepaxti. Inform your doctor or nurse immediately if you present fever or other signs of infection. Your doctor may recommend preventive antibiotics to reduce the risk of developing infections.

Risk of diarrhea, nausea, or vomiting

Inform your doctor if you experience diarrhea, nausea, or vomiting.

Risk of blood clots

The use of Pepaxti in combination with dexamethasone may increase the risk of blood clots. Inform your doctor or nurse if you have ever had a blood clot in a vein (thrombosis). Inform your doctor or nurse immediately if you experience swelling of a leg or arm, if you find it harder to breathe, or if you experience chest pain.

Risk of additional cancer

It is essential to note that patients with multiple myeloma treated with Pepaxti may develop other types of cancer, so your doctor must carefully evaluate the benefits and risks for you when prescribing this medication.

Renal disease

If you have reduced renal function, the adverse effects of Pepaxti on your blood cells may be worse. There is very little information available on the use of the medication in patients with severe renal failure, so it is not possible to recommend a safe and effective dose.

Vaccinations

Live attenuated vaccines (such as vaccines against measles, mumps, and rubella) should not be used during treatment with Pepaxti, as they may cause infection. However, other types of vaccines, such as inactivated vaccines or mRNA-based vaccines, may be used. Inform your healthcare professional that you are being treated with Pepaxti before being vaccinated.

Children and adolescents

Pepaxti is not indicated for children or adolescents under 18 years old.

Other medications and Pepaxti

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medication should not be used during pregnancy unless it is clearly necessary. Avoid becoming pregnant while being treated with this medication, as it may harm the fetus. Your doctor will explain the possible risks of using Pepaxti during pregnancy.

If you are a woman who may become pregnant:

Your doctor will ask you to undergo a pregnancy test before starting treatment with Pepaxti.
You must use an effective contraceptive method during treatment and for 6 months after the last dose of Pepaxti. Consult your doctor about effective contraceptive methods that may be suitable for you.

If you are a man who may father a child:

You must use an effective contraceptive method during treatment and for 6 months after the last dose of Pepaxti.

Breastfeeding

You should not breastfeed during treatment with Pepaxti, as it may be harmful to your baby.

Fertility

Pepaxti may affect the ovaries or sperm, leading to infertility (inability to have children). Women may experience menstrual interruption. In men, permanent inability to father a child (sterility) due to a lack of sperm may occur. Consult your doctor about sperm conservation before treatment.

Driving and operating machinery

Pepaxti may cause nausea and dizziness, which may reduce your ability to drive or operate machinery.

3. How to Use Pepaxti

Pepaxti is prepared in a solution and will be administered by your doctor or nurse through intravenous infusion over 30 minutes. Your doctor will decide on the correct dose of Pepaxti. The recommended initial dose is 40 mg once every 4 weeks. If you weigh 60 kg or less, the recommended initial dose is 30 mg once every 4 weeks. Treatment will continue as long as it is beneficial and you do not experience unacceptable side effects. As part of your treatment, you will also take another medication, dexametasona, orally.

If you receive more Pepaxti than you should

This medication will be administered by your doctor or nurse. In the unlikely event that you are given too much (an overdose), your doctor will examine you, which may include taking blood samples to monitor your blood cells.

If you forget a dose of Pepaxti

It is very important that you attend all your appointments to ensure that your treatment is working. If you miss an appointment, contact your doctor or hospital as soon as possible.

4. Possible Adverse Effects

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

Seek immediate medical attention if you notice any of the following severe side effects: you may need urgent medical treatment:

Fever, chills, sore throat, cough, or any other sign of infection (due to a lack of white blood cells called neutrophils, which fight infections).
Fast breathing, rapid pulse, fever, and chills, urinating very little or not at all, nausea, and vomiting, confusion, loss of consciousness (due to a severe bacterial blood infection called sepsis or septic shock).
Bleeding or bruising without cause, such as nasal hemorrhages (due to a low platelet count [thrombocytopenia]).
Difficulty breathing (due to a severe chest infection, lung inflammation, or blood clot in the lungs).
Pain and swelling in the legs or arms, especially in the lower leg or calf (caused by blood clots).

Other side effects that may occur

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

Reduction in the number of platelets in the blood (thrombocytopenia)
Lower number of a type of white blood cell called neutrophils (neutropenia)
Reduction in the number of red blood cells that transport oxygen in the blood (anemia), which causes weakness and fatigue.
Lung infection (pneumonia)
Respiratory tract infection with, for example, fever, cough, and symptoms similar to the common cold
Diarrhea
Nausea
Fever
Cough
Shortness of breath
Extreme fatigue (fatigue)
Weakness

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

Severe bacterial blood infection (sepsis)
Fever with a reduced number of some white blood cells (neutropenia)
Lower number of a type of white blood cell called lymphocytes (lymphopenia), which also helps fight infections
General reduction in the number of white blood cells
Loss of appetite
Low potassium levels (may cause muscle weakness and irregular heartbeats)
Elevated uric acid levels in the blood (may cause gout and kidney problems)
Headache
Dizziness
Difficulty breathing when active
Nasal hemorrhage
Vomiting
Deep vein thrombosis (blood clot in a vein)
Bruises

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

Severe bacterial blood infection with a dangerously low blood pressure (septic shock) that may be potentially fatal or even fatal
Blood clot in the lungs
A type of blood cancer called myelodysplastic syndrome (MDS).
A type of blood cancer called acute myeloid leukemia (AML)

Your doctor or nurse may administer additional medications to treat your symptoms and/or prevent side effects.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

5. Conservation of Pepaxti

Pepaxti will be stored in the hospital or clinic, so these instructions are intended for healthcare professionals.

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

Do not use this medication after the expiration date that appears on the vial label and on the box after CAD. The expiration date refers to the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze.

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drain or in the trash. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Pepaxti

The active ingredient is melfalan flufenamida. A vial contains 20 mg of melfalan flufenamida (in the form of hydrochloride).
The other component is sucrose (sugar).

Appearance of the product and contents of the package

Pepaxti is a white to off-white powder contained in a glass vial.

Each box contains one vial.

Marketing Authorization Holder

Oncopeptides AB (publ)

Luntmakargatan 46

111 37 Stockholm

Sweden

Responsible for manufacturing

Eumedica NV

Chemin de Nauwelette 1

7170 Manage

Belgium

For more information about this medication, please contact the local representative of the marketing authorization holder:

Oncopeptides AB (publ)

Email:[email protected]

Last review date of this leaflet: 01/2025.

Other sources of information

Further information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended solely for healthcare professionals:

Step-by-step instructions for use and handling, reconstitution, and administration

Pepaxti must be prepared by a healthcare professional and using an aseptic technique to ensure the sterility of the prepared solution.

Additional solvents required for preparation:

Glucose 5% injectable solution (at room temperature).

250 ml bag of 0.9% sodium chloride injectable solution (cold, between 2°C and 8°C) (refrigerate for at least 4 hours).

Table 1 Volumes of dilution by Pepaxti dose

Description of the volume	Pepaxti dose
40 mg (2 vials)	30 mg (1.5 vials)	20 mg (1 vial)	15 mg (0.75 vial)
Volume of reconstituted Pepaxti solution required for the final product	80 ml	60 ml	40ml	30 ml
Total final volume of the infusion bag after dilution	250 ml	230 ml	210 ml	200 ml
Concentration of Pepaxti after dilution	0.16 mg/ml	0.13 mg/ml	0.10 mg/ml	0.08 mg/ml

Preparation steps

Read the complete instructions before starting preparation.

Steps 3 to 5 must be completed within 30 minutes.

Reconstitution and dilution steps

Step 1

Determine the number of vials required for the dose according to Table 1 "Volumes of dilution by Pepaxti dose". Place the vial(s) at room temperature for at least 30 minutes.

Step 2

Agitate vigorously the vial or agitate in a vortex to disintegrate the lyophilized powder cake into a loose powder.

Steps 3 to 5 must be performed within a 30-minute timeframe

Third stage

For a Pepaxti dose of 40 mg	For a Pepaxti dose of 30 mg	For a Pepaxti dose of 20 mg	For a Pepaxti dose of 15 mg
Reconstitute each of the 2 vials aseptically with 40 ml of 5% glucose injectable solution to obtain a final concentration of 0.5 mg/ml.	Reconstitute each of the 2 vials aseptically with 40 ml of 5% glucose injectable solution to obtain a final concentration of 0.5 mg/ml.	Reconstitute 1 vial aseptically with 40 ml of 5% glucose injectable solution to obtain a final concentration of 0.5 mg/ml.	Reconstitute 1 vial aseptically with 40 ml of 5% glucose injectable solution to obtain a final concentration of 0.5 mg/ml.

Ensure that the 5% glucose injectable solution is at room temperature (between 20°C and 25°C). Agitate the vial or vials vigorously until the solution is transparent.

Leave the vial(s) to allow air bubbles to dissipate and confirm that a transparent solution has been obtained.

Step 4

Extract 80 ml from a refrigerated (between 2°C and 8°C) 250 ml bag of 0.9% sodium chloride injectable solution. Discard the 80 ml extracted.

Step 5

For a Pepaxti dose of 40 mg	For a Pepaxti dose of 30 mg	For a Pepaxti dose of 20 mg	For a Pepaxti dose of 15 mg
Extract 80 ml of reconstituted Pepaxti solution from the vials and transfer them to an intravenous (IV) injectable solution containing sodium chloride 9 mg/ml (0.9%) to obtain a final concentration of 0.16 mg/ml.	Extract 60 ml of reconstituted Pepaxti solution from the vials and transfer them to an intravenous (IV) injectable solution containing sodium chloride 9 mg/ml (0.9%) to obtain a final concentration of 0.12 mg/ml.	Extract 40 ml of reconstituted Pepaxti solution from the vials and transfer them to an intravenous (IV) injectable solution containing sodium chloride 9 mg/ml (0.9%) to obtain a final concentration of 0.10 mg/ml.	Extract 30 ml of reconstituted Pepaxti solution from the vials and transfer them to an intravenous (IV) injectable solution containing sodium chloride 9 mg/ml (0.9%) to obtain a final concentration of 0.08 mg/ml.

Discard any unused portion remaining in the vial or vials.

Invert the bag gently to mix the solution. Do not agitate. Check that the solution is transparent and colorless, or pale yellow. Do not use if the solution is decolorized or contains particles.

Shelf life

Pepaxti degrades in the solution, especially at room temperature, and the dilution solution shelf life should not be exceeded.

For immediate administration

The infusion of the diluted solution must beginwithin 60 minutesafter the start of reconstitution (step 3).

For delayed administration

If not used for immediate administration, the diluted solution must be stored in a refrigerator (between 2°C and 8°C) within 30 minutes after the initial reconstitution (step 3) and kept fora maximum of 6 hours.

Administration

Before administration, parenteral medications must be visually inspected for the presence of particles and color changes. Do not use if particles are visibly opaque, decolorized, or foreign particles are observed.

Administration steps

Step 6

Administer Pepaxti as a 30-minute intravenous infusion through a peripheral venous access or a central venous access device, for example, a PICC or a tunneled central venous catheter. If the infusion bag has been stored in the refrigerator, allow it to reach room temperature (between 20°C and 25°C). Initiate the infusion within 30 minutes after removing the diluted solution from the refrigerator.

Step 7

Once the Pepaxti infusion is completed, wash the central catheter with a 0.9% sodium chloride injectable solution.

Elimination

Pepaxti is a cytotoxic medication for single use. Follow the procedure for safe handling and disposal of mustard nitrogen analogs by healthcare professionals or medical personnel and comply with current guidelines for cytotoxic medications. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.