Pepaxti – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Pepaxti, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this lea flet. See section 4.
ℹ️ 1. What Pepaxti is and what it is used for
Pepaxti belongs to a group of cancer medicines called alkylating agents. It works by attaching to DNA (the genetic instruction needed for cells to survive and multiply ) and damaging it , thereby helping to stop the cancer cells from growing.
Pepaxti is given with the steroid dexamethasone, to treat adults with the blood cancer multiple myeloma . It is used when the disease does not respond to at least three types of cancer medicine s. If you have been treated with a blood stem cell transplant (a procedure where the cells that make your blood are cleared out and replaced) , the time to when the multiple myeloma came back after transplantation should be at least 3 years.
⚠️ 2. What you need to know before you are given 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 breast -feeding .
Warnings and precautions
Talk to your doctor or nurse before you are given Pepaxti.
Abnormal bleeding and bruising and low number of platelets (blood cells) Pepaxti can lower the number of blood cells called platelets that help to clot your blood. Tell your doctor or nurse immediately if you start bleeding e.g. a nosebleed or get bruis es on your skin.
Fever and low number of white blood cells Pepaxti can lower the number of white blood cells that are important for fighting infections. Tell your doctor or nurse immediately if you have symptoms of infection such as fever, chills or cough.
26 Low number of red blood cells Pepaxti can lower the number of red blood cells , which transport oxygen to the cells in your body.
Your doctor will regular ly take blood samples to monitor your blood cells. Tell 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 lung infection (pneumonia) and upper respiratory tract infection (causing cold- like symptoms) are very common with Pepax ti. Tell your doctor or nurse immediately if you develop fever or other signs of infection. Your doctor mi ght recommend preventive antibiotics to lower the risk of developing infections.
Ris k of diarrhoea, nausea or vomiting You should tell your doctor if you get diarrhoea, nausea , or vomiting.
Risk of development of blood clots The use of Pepaxti in combination with dexamethasone may increase the risk of developing blood clots. Tell your doctor or nurse if you have ever had a blood clot in a vein (thrombosis) . Tell your doctor or nurse immediately if you develop a swelling of a leg or an arm, if y ou find it harder to breathe , or experience chest pain.
Risk of additional cancer It is important to note that patients with multiple myeloma treated with Pepaxti may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk for you when you are prescribed this medicine.
Kidney disease If you have lowered kidney function, the side effects of Pepaxti on your blood cells may be worse .
There is to o little information available on use of the medicine in patients with severely lowered kidney function to be able to recommend a safe and effective dose .
Vaccinations Vaccines that contain live but weakened organisms, known as l ive attenuated vaccines (like measles, mumps , and rubella vaccines ) should not be u sed while you are being treated with Pepaxti, as they may lead to an infection. Some other types of vaccines known as i nactivated vaccines or mRNA based vaccines can, however, be used. Tell your healthcare provider you are being treated with Pepaxti before you get vaccinated.
Children and adolescents
Pepaxti is not intended for use in children or adolescents below 18 years of age.
Other medicines and Pepaxti
Tell your doctor if you are taking, have recently taken or might take any other medicines.
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 for advice before you are given this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless clearly necessary. Avoid becoming pregnant while being treated with this medicine as it may harm your unborn baby. Your doctor will discuss with you the potential risks of using Pepaxti durin g pregnancy.
If you are a woman who could become pregnant:
- Your doctor will ask you to take a pregnancy test before you start treatment with Pepaxti.
- You must use effective contraception during treatment and for 6 month s after your last dose of Pepaxti . Talk to your doctor about effective contraception methods that may be right for you.
27 If you are a man who could father a child:
- You must use effective contraception during treatment and for 6 months after your last dose of Pepaxti.
Breast -f eeding You sho uld not breast -feed during treatment with Pepaxti since it may be harmful for your baby .
Fertility
Pepaxti can affect ovaries or sperm, which may cause infertility (inability to have a baby). In women, menstruation can stop. In men, inability to father a child (sterility ) due to lack of sperm can be permanent . Ask your doctor for advice on sperm preservation before treatment.
Driving and using machines
Pepaxti can cause nausea and dizziness, which may reduce your ability to drive or use machines.
💊 3. H ow Pepaxti is given
Pepaxti is made up in to a solution and given by your doctor or nurse as a drip into a vein (intravenous infusion) over 30 minutes. Your doctor will decide on the correct dose of Pepaxti . The recommended starting dose is 40 mg once ev ery 4 weeks. If you have a body weight of 60 kg or less, the recommended starting dose is 30 mg once every 4 weeks. Treatment will carry on as long as you are benefitting from it and do not have unacceptable side effects . As part of your treatment , you will also take anothe r medicine, dexamethasone , by mouth.
If you are given more Pepaxti than you should
This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you, including taking blood samples to monitor your blood cells .
If a dose of Pepaxti is missed It is very important to go to all your appointments, to make sure your treatment works. If you miss an appointment, contact your doctor or hospital as soon as possible.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- Fever, chills, sore throat, cough, or any other signs of infection (due to lack of white blood cells called neutrophils , which fight infection s).
- Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to s erious bacterial infection of the blood called sepsis or septic shock).
- Bleeding or bruising without a cause, including nosebleeds (due to low number of blood platelets [thrombocytopeni a]).
- Shortness of breath (from serious chest infection, inflammation of the lung s, or blood clot in the lungs ).
- Leg or arm pain and swelling, especially in your lower leg or calves (caused by blood clots).
Other side effects that can occur
Very common (may affect more than 1 in 10 peopl e)
- Lower number of bl ood platelets (thrombocytopenia)
- Lower number of a type of white blood cells called neutrop hils (neutrop enia) 28 • Lower number of red blood cells which carry oxygen in the blood (anaemia) , causing weakness and fatigue
- Infection of the lungs (pneumonia)
- Infection of the airways presenting with e.g. fever, cough, and cold -like symptoms
- Diarrhoea
- Nausea
- Fever
- Cough
- Shortness of breath
- Extreme tiredness (fatigue)
- Weakness
Common (may affect up to 1 in 10 people)
- Serious bacterial infection of the blood (sepsis)
- Fever together with reduced number of some white blood cells ( neutropenia)
- Lower number of a type of white blood cells called lymphocytes ( lymphopenia) , which also help fight infections
- Overall l ower number of white blood cells
- Decreased appetite
- Low potassium level (may cause muscle weakness and irregular heartbeat )
- High uric acid level in the blood (may cause gout and kidney problems)
- Headache
- Dizziness
- Shortness of breath when active
- Noseb leed
- Vomiting
- Deep vein thrombosis (blood clot in a vein)
- Bruise s
Uncommon (may affect up to 1 in 100 people)
- Serious bacterial infection of the blood with dangerously low blood pressure (septic shock) which can be life threatening or even fatal
- Blood clot in the lung s
- A type of blood cancer called m yelodysplastic syndrome (MDS)
- A type of blood cancer called a cute myeloid leukaemia (AML) Your doctor or nurse may give you additional medicines to treat your symptoms and/or prevent side effects .
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. T his includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . B y reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Pepaxti
Pepaxti will be stored at the hospital or clinic so these instructions are for the healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and carton after “EXP”.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 ºC – 8 ºC). Do not freeze.
29 Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Pepaxti contains
- The active substance is melphalan flufenamide. One vial contains 20 mg of melphalan flufenamide (as hydrochloride).
- The other ingredient is sucrose (sugar) .
What Pepaxti looks like and contents of the pack
Pepaxti is a white to off -white powder in a glass vial.
Each carton contains one vial.
Marketing Authorisation Holder
Oncopeptides AB (publ) Luntmakargatan 46 111 37 Stockholm Sweden
Manufacturer
Eumedica NV Chemin de Nauwelette 1 7170 Manage Belgium For any information about this medicine, please contact the Marketing Authori sation Holder:
Oncopeptides AB (publ) e-mail: [email protected]
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu This leaflet is available in all EU/EEA languages on the European Medicines Agency website. ————————————————————————————————————————
🩺 Information intended for healthcare professionals only
Step-by-s tep instructions for use and handling, reconstitution and administration Pepaxti should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Additional solvents r equired for preparation 5% glucose solution for injection/infusion (room temperature).
30 250 mL bag of cold (2 °C – 8 °C) sodium chloride 9 mg/mL ( 0.9%) solution for injection (refrigerate for at least 4 hours) .
Table 1 Dilution volumes per Pepaxti dose 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 needed 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 st eps Read the complete instructions prior to starting preparation.
Steps 3 to 5 must be completed within 30 minutes.
Reconstitution and dilution steps Step 1 Determine the number of vials needed for the dose as per Table 1 “ Dilution volumes per Pepaxti dose”. Place vial(s) at room temperature for at least 30 minutes.
Step 2 Shake the vial(s) vigorously or vortex to disintegrate the lyophili sed powder cake into a loose powder.
Steps 3 to 5 must be completed within 30 minutes .
Step 3 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 Aseptically reconstitute each of the 2 vials with 40 mL of 5% glucose solution for infusion to obtain a final concentration of 0.5 mg/mL. Aseptically reconstitute each of the 2 vials with 40 mL of 5% glucose solution for infusion to obtain a final concentration of 0.5 mg/mL. Aseptically reconstitute 1 vial with 40 mL of 5% glucose solution for infusion to obtain a final concentration of 0.5 mg/mL . Aseptically reconstitute 1 vial with 40 mL of 5% glucose solution for infusion to obtain a final concentration of 0.5 mg/mL .
Ensure the 5% glucose solution for infusion is at room temperature (20 °C – 25 °C ). Shake the vial(s) vigorously until solution is clear.
Let the vial(s) stand to allow air bubbles to dissipate to confirm a clear solution.
Step 4 Withdraw 80 mL from a refrigerated (2 °C – 8 °C) 250 mL bag sodium chloride 9 mg/m L (0.9%) solution for injection. Discard the withdrawn 80 mL.
31 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 Withdraw 80 mL of reconstituted solution from the Pepaxti vials and transfer into an intravenous (IV) solution for injection containing sodium chloride 9 mg/mL (0.9%) to obtain a final concentration of 0.16 mg/m L. Withdraw 60 mL of reconstituted solution from the Pepaxti vials and transfer into an intravenous (IV) solution for injection containing sodium chloride 9 mg/mL (0.9%) to obtain a final concentration of 0.13 mg/m L. Withd raw 40 mL of reconstituted solution from the Pepaxti vial and transfer into an intravenous (IV) solution for injection containing sodium chloride 9 mg/mL (0.9%) to obtain a final concentration of 0.10 mg/m L. Withdraw 30 mL of reconstituted solution from th e Pepaxti vial and transfer into an intravenous (IV) solution for injection containing sodium chloride 9 mg/mL (0.9%) to obtain a final concentration of 0.08 mg/m L.
Discard any unused portion left in the vial(s).
Gently invert the bag to mix the solution. Do not shake. Check that the solution is clear and colourless to pale yellow. Do not use if solution discolouration or particles are observed.
Storage timelines Pepaxti degrades in solution, especially at room temperature, and the storage timelines for diluted solution should not be exceeded .
For immediate administration Infusion of the diluted solution must begin within 60 minutes of start of reconstitution (step 3).
For delayed administration If not used for immediate administration, the diluted solution should be placed in a refrigerator (2 °C – 8 °C) within 30 minutes after initial reconstitution (step 3) and store for up to 6 hours.
Administration Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Administration steps Step 6 Administer Pepaxti as a 30 -minute intravenous infusion via peripheral venous route or a central venous access device, for example PICC or tunnel led central venous catheter. If the infusion bag has been stored in a refrigerator, allow to reach to room temperature (20 °C – 25 °C). Sta rt infusion within 30 minutes of removing the diluted solution from the refrigerator.
Step 7 Upon completion of Pepaxti infusion, flush the catheter with sodium chloride 9 mg/mL (0.9%) solution for injection.
Disposal Pepaxti is a cytotoxic medicinal product for single use only. The procedure for the safe handling and disposal of nitrogen mustard analogues must be followed by healthcare professionals or medical personnel and should comply with the current recommendations for cy totoxic medicinal products. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pepaxti (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1669).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.