Pepaxti 20 mg powder for concentrate for solution for infusion
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Pepaxti 20 mg powder for concentrate for solution for infusion
Melphalan flufenamide
Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Pepaxti is and what it is used for
- What you need to know before being given Pepaxti
- How Pepaxti is given
- Possible side effects
- How to store Pepaxti
- Contents of the pack and other information
1. What Pepaxti is and what it is used for
Pepaxti belongs to a group of anticancer medicines called alkylating agents. It works by binding to DNA (the genetic instructions required for cells to survive and multiply) and damaging it, thereby helping to stop the growth of cancer cells.
Pepaxti is given together 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 different types of anticancer medicines. If you have been treated with a blood stem cell transplant (a procedure in which the cells that produce blood are removed and replaced), the time until multiple myeloma returns after the transplant must be at least 3 years.
2. What you need to know before using Pepaxti
Do not use Pepaxti
- if you are allergic to melphalan flufenamide or any of the other ingredients of this medicine (listed in section 6);
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or nurse before you are given Pepaxti.
Bleeding and bruising and low platelet count (blood cells)
Pepaxti may reduce the number of blood cells called platelets, which help blood to clot. Immediately inform your doctor or nurse if you start bleeding, for example, if you have a nosebleed or notice bruising 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. Immediately inform your doctor or nurse if you have signs of infection, such as fever, chills, or cough.
Low red blood cell count
Pepaxti may reduce the number of red blood cells, which carry oxygen to the cells in your body. Your doctor will take blood samples periodically to monitor your blood cells. Immediately inform your doctor or nurse if you feel weak or tired, look pale, or have shortness of breath.
Infections
Infections such as lung infection (pneumonia) and upper respiratory tract infection (causing cold-like symptoms) are very common with Pepaxti. Immediately inform your doctor or nurse if you develop 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). Immediately inform your doctor or nurse if you experience swelling in one leg or arm, have difficulty breathing, or have chest pain.
Risk of additional cancer
It is important to note that patients with multiple myeloma treated with Pepaxti may develop other types of cancer. Therefore, your doctor must carefully evaluate the benefits and risks for you when prescribing this medicine.
Kidney disease
If you have reduced kidney function, the adverse effects of Pepaxti on your blood cells may be worse. There is very limited information on the use of this medicine in patients with severe renal impairment to recommend a safe and effective dose.
Vaccines
Vaccines containing live but weakened organisms, known as 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 known as inactivated vaccines or mRNA-based vaccines may be used. Inform your healthcare professional that you are being treated with Pepaxti before receiving any vaccination.
Children and adolescents
Pepaxti is not indicated in children or adolescents under 18 years of age.
Other medicines and Pepaxti
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Pregnancy
The use of this medicine during pregnancy is not recommended unless clearly necessary. Avoid becoming pregnant while being treated with this medicine, as it may harm the fetus. Your doctor will explain the potential risks of using Pepaxti during pregnancy.
If you are a woman who can become pregnant:
- Your doctor will ask you to have a pregnancy test before starting treatment with Pepaxti.
- You must use an effective method of contraception during treatment and for 6 months after the last dose of Pepaxti. Talk to your doctor about effective contraceptive methods that may be suitable for you.
If you are a man who can father a child:
- You must use an effective method of contraception during treatment and for 6 months after the last dose of Pepaxti.
Breastfeeding
You must 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 cessation of menstruation. In men, inability to father a child (sterility) due to absence of sperm may be permanent. Talk to your doctor about sperm preservation before treatment.
Driving and using machines
Pepaxti may cause nausea and dizziness, which may reduce your ability to drive or operate machinery.
3. How to use Pepaxti
Pepaxti is prepared as a solution and will be administered by your doctor or nurse as an intravenous infusion (drip into a vein) over 30 minutes. Your doctor will decide the correct dose of Pepaxti. The recommended starting dose is 40 mg once every 4 weeks. If your body weight is 60 kg or less, the recommended starting dose is 30 mg once every 4 weeks. Treatment will continue for as long as you benefit from it and do not experience unacceptable side effects. As part of your treatment, you will also take another medicine, dexamethasone, by mouth.
If you receive more Pepaxti than you should
This medicine will be administered by your doctor or nurse. In the unlikely event that you receive too much (an overdose), your doctor will examine you, including taking blood samples to monitor your blood cells.
If you miss a dose of Pepaxti
It is very important that you attend all your appointments to ensure your treatment is effective. If you miss an appointment, contact your doctor or hospital as soon as possible.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact a doctor immediately if you notice any of the following serious adverse 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 that fight infections).
- Rapid breathing, fast 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 nosebleeds (due to 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 calves (caused by blood clots).
Other possible adverse effects
Very common (may affect more than 1 in 10 people):
- Decrease in the number of platelets in the blood (thrombocytopenia)
- Lower number of a type of white blood cells called neutrophils (neutropenia)
- Reduction in the number of red blood cells that carry oxygen in the blood (anemia), causing weakness and fatigue.
- Lung infection (pneumonia)
- Respiratory tract infection, for example with fever, cough, and cold-like symptoms
- Diarrhea
- Nausea
- Fever
- Cough
- Shortness of breath
- Extreme tiredness (fatigue)
- Weakness
Common (may affect up to 1 in 10 people):
- Severe bacterial blood infection (sepsis)
- Fever together with a reduced number of certain white blood cells (neutropenia)
- Lower number of a type of white blood cells called lymphocytes (lymphopenia), which also help fight infections
- General reduction in white blood cell count
- Loss of appetite
- Low potassium levels (may cause muscle weakness and irregular heartbeat)
- Elevated levels of uric acid in the blood (may cause gout and kidney problems)
- Headache
- Dizziness
- Difficulty breathing during physical activity
- Nosebleeds
- Vomiting
- Deep vein thrombosis (blood clot in a vein)
- Bruising
Uncommon (may affect up to 1 in 100 people):
- Severe bacterial blood infection with 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 give you additional medicines to treat your symptoms and/or prevent adverse effects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pepaxti
Pepaxti will be stored in the hospital or clinic; therefore, these instructions are intended for healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and the carton after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Doing so helps protect the environment.
6. Contents of the pack and other information
Composition of Pepaxti
- The active substance is melphalan flufenamide. One vial contains 20 mg of melphalan flufenamide (as hydrochloride).
- The other component is sucrose (sugar).
Appearance of the product and contents of the container
Pepaxti is a white to off-white powder contained in a glass vial.
Each carton contains one vial.
Marketing Authorization Holder
Oncopeptides AB (publ)
Luntmakargatan 46
111 37 Stockholm
Sweden
Manufacturer
Eumedica NV
Chemin de Nauwelette 1
7170 Manage
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Oncopeptides AB (publ)
Email: [email protected]
Date of the most recent review of this leaflet: 01/2025.
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
This leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.
This information is intended for healthcare professionals only:
Step-by-step instructions for use, handling, reconstitution, and administration
Pepaxti must be prepared by a healthcare professional using an aseptic technique to ensure sterility of the prepared solution.
Additional diluents required for preparation:
5% glucose injection/perfusion solution (at room temperature).
250 ml bag of 9 mg/ml (0.9%) sodium chloride injection solution, cold (2°C to 8°C) (refrigerate for at least 4 hours).
Table 1 Dilution volumes per dose of Pepaxti
Volume description | 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 final product | 80 ml | 60 ml | 40 ml | 30 ml |
Final total volume of infusion bag after dilution | 250 ml | 230 ml | 210 ml | 200 ml |
Pepaxti concentration 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 the 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 "Dilution volumes per Pepaxti dose". Allow the vial(s) to stand at room temperature for at least 30 minutes. | ||||||||
Step 2 Vigorously shake the vial or vortex it to break up the lyophilized powder cake into a loose powder. | ||||||||
Steps 3 to 5 must be performed within 30 minutes | ||||||||
Step 3
Ensure that the 5% glucose infusion solution is at room temperature (between 20 °C and 25 °C). Shake the vial(s) vigorously until the solution becomes clear. Allow the vial(s) to stand to let any air bubbles dissipate and confirm that a clear solution has been obtained. |
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Step 4 Withdraw 80 ml from a refrigerated (between 2 °C and 8 °C) 250 ml bag of 9 mg/ml (0.9%) sodium chloride injection solution. Discard the 80 ml withdrawn. |
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Step 5
Discard any unused portion remaining in the vial or vials. Gently invert the bag to mix the solution. Do not shake. Check that the solution is clear and colorless or pale yellow. Do not use if discoloration or particles are observed. |
Storage periods
Pepaxti degrades in solution, particularly at room temperature, and the storage periods for the diluted solution must not be exceeded.
For immediate administration |
The infusion of the diluted solution must begin within 60 minutes after 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 initial reconstitution (step 3) and kept for a maximum of 6 hours. |
Administration
Parenteral medications should be visually inspected for the presence of particles and discoloration prior to administration. Do not use if visibly opaque particles, discoloration, or foreign particles are observed.
Administration steps |
Step 6 Administer Pepaxti as a 30-minute intravenous infusion through a peripheral venous line 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). Begin the infusion within 30 minutes after removing the diluted solution from the refrigerator. |
Step 7 After completion of the Pepaxti infusion, flush the central catheter with a 9 mg/mL (0.9%) sodium chloride injectable solution. |
Disposal
Pepaxti is a cytotoxic medicinal product for single use. The procedure for safe handling and disposal of nitrogen mustard analogues must be followed by healthcare professionals or medical personnel, in accordance with current recommendations for cytotoxic medicinal products. Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.