Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pepaxti

Document Subject

Generated Narrative: MedicinalProductDefinition mp4b3bf4fa95ca1e8fab427d9644d69f2c

identifier: http://ema.europa.eu/identifier/EU/1/22/1669/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pepaxti 20 mg powder for concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4b3bf4fa95ca1e8fab427d9644d69f2c

identifier: http://ema.europa.eu/identifier/EU/1/22/1669/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - pepaxti

Attesters

What is in this leaflet

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

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. 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.

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 bruises 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.

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 regularly 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 Pepaxti. Tell your doctor or nurse immediately if you develop fever or other signs of infection. Your doctor might recommend preventive antibiotics to lower the risk of developing infections.

Risk 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 you 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 too 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 live attenuated vaccines (like measles, mumps, and rubella vaccines) should not be used while you are being treated with Pepaxti, as they may lead to an infection. Some other types of vaccines known as inactivated 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 during 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 months after your last dose of Pepaxti. Talk to your doctor about effective contraception methods that may be right for you.

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-feeding You should 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.

Pepaxti is made up into 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 every 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 another 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.

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 infections).
• Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to serious 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 [thrombocytopenia]).
• Shortness of breath (from serious chest infection, inflammation of the lungs, 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 people):

• Lower number of blood platelets (thrombocytopenia)
• Lower number of a type of white blood cells called neutrophils (neutropenia)
• 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 lower 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
• Nosebleed
• Vomiting
• Deep vein thrombosis (blood clot in a vein)
• Bruises

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 lungs
• A type of blood cancer called myelodysplastic syndrome (MDS)
• A type of blood cancer called acute 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. This 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. By reporting side effects, you can help provide more information on the safety of this medicine.

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 C 8 C). Do not freeze. 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.

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 111 37 Stockholm Sweden

Manufacturer Eumedica NV Chemin de Nauwelette 1 7170 Manage Belgium

For any information about this medicine, please contact the Marketing Authorisation Holder:

Oncopeptides AB (publ) Tel: +46 8 615 20 e-mail: info@oncopeptides.com

This leaflet was last revised in MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: