Tresuvi 2.5 mg/ml solution for infusion EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tresuvi 1mg/ml solution for infusion EFG
Tresuvi 2.5mg/ml solution for infusion EFG
Tresuvi 5mg/ml solution for infusion EFG
Tresuvi 10mg/ml solution for infusion EFG
Treprostinil
Read all of this leaflet carefully before you start using 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 pharmacist.
- This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Tresuvi is and what it is used for
- What you need to know before using Tresuvi
- How to use Tresuvi
- Possible side effects
- How to store Tresuvi
- Contents of the pack and other information
1. What Tresuvi is and what it is used for
What Tresuvi is
The active substance of Tresuvi is treprostinil.
Treprostinil belongs to a group of medicines whose action is similar to that of natural prostacyclins. Prostacyclins are hormone-like substances that reduce blood pressure by relaxing blood vessels, causing them to widen and allowing blood to flow more easily. Prostacyclins may also prevent blood from clotting.
What Tresuvi is used for
Treprostinil is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate symptoms. Pulmonary arterial hypertension is a disease in which blood pressure is too high in the blood vessels between the heart and the lungs. This causes difficulty breathing, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swelling of the ankles or legs.
Tresuvi is initially administered as a continuous subcutaneous infusion (under the skin). Some patients may not tolerate this route of administration due to pain and swelling. Your doctor will decide whether it is possible to administer this medicine instead as a continuous intravenous infusion (directly into a vein) via a central intravenous line (catheter), connected to an external pump, or, depending on your condition, to a pump surgically implanted under the skin of the abdomen. Your doctor will determine which option is best for you.
How Tresuvi works
Tresuvi reduces blood pressure in the pulmonary artery by improving blood flow and reducing the workload on the heart. Improved blood flow leads to better oxygen delivery to the body and reduced strain on the heart, allowing it to function more effectively. Tresuvi improves symptoms associated with PAH and increases exercise capacity in patients whose activity is limited.
2. What you need to know before using Tresuvi
Do not use Tresuvi:
- if you are allergic to treprostinil or any of the other ingredients of this medicine (listed in section 6).
- if you have been diagnosed with a condition called "pulmonary veno-occlusive disease". In this disease, the blood vessels carrying blood through the lungs become swollen and blocked, increasing pressure in the blood vessels between the heart and lungs.
- if you have severe liver failure
- if you have a heart condition, for example:
- a heart attack (myocardial infarction) within the last six months
- serious changes in heart rate
- severe coronary heart disease or unstable angina
- a diagnosis of a heart defect, such as a faulty heart valve causing improper heart function
- any heart disease that is not being treated or closely monitored by a physician
- if you are at specific risk of bleeding; for example, active stomach ulcers, injuries, or other hemorrhagic conditions
- if you have had a stroke within the last 3 months, or any interruption of blood supply to the brain
Warnings and precautions
Talk to your doctor before starting to use Tresuvi if:
- you have any liver disease
- you have been diagnosed as clinically obese (BMI greater than 30 kg/m²)
- you have HIV infection (human immunodeficiency virus)
- you have high blood pressure in the liver's veins (portal hypertension)
- you have a congenital heart defect affecting blood circulation through the heart
During treatment with this medicine, inform your doctor:
- if your blood pressure drops (hypotension)
- if you experience a rapid worsening of breathing difficulties or persistent cough (this may be related to lung congestion, asthma, or another condition); consult your doctor immediately.
- if you experience excessive bleeding, as treprostinil may increase the risk by inhibiting blood clotting
- if you develop fever while receiving treprostinil intravenously, or if the intravenous administration site becomes red, swollen, and/or tender to touch, as this could be a sign of infection
Other medicines and Tresuvi
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor if you are taking:
- medicines used to treat high blood pressure (antihypertensives or other vasodilators)
- medicines used to increase urine output (diuretics), including furosemide
- medicines that prevent blood clotting (anticoagulants), such as warfarin, heparin, or medicines containing nitric oxide
- any non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., acetylsalicylic acid, ibuprofen)
- medicines that may increase or decrease the effect of treprostinil (e.g., gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort), as your doctor may need to adjust your treprostinil dose
Pregnancy and breastfeeding
Use of this medicine is not recommended if you are pregnant, think you may be pregnant, or plan to become pregnant, unless considered essential by your doctor. The safety of this medicine during pregnancy has not been established.
It is strongly recommended to use contraceptive methods during treatment with treprostinil.
Use of treprostinil during breastfeeding is not recommended unless considered essential by your doctor. You are advised to discontinue breastfeeding if treprostinil is prescribed, as it is unknown whether this medicine passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Driving and use of machines
This medicine may cause low blood pressure with dizziness and fainting. If this occurs, do not drive or operate machinery, and consult your doctor.
Tresuvi contains sodium
Inform your doctor if you are on a sodium-controlled diet. Your doctor will take into account that one vial of Tresuvi contains the following amounts of sodium:
Tresuvi 1 mg/ml solution for infusion:
This medicine contains up to 36.8 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 1.8% of the maximum daily recommended sodium intake for an adult.
Tresuvi 2.5 mg/ml solution for infusion:
This medicine contains up to 37.3 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 1.9% of the maximum daily recommended sodium intake for an adult.
Tresuvi 5 mg/ml solution for infusion:
This medicine contains up to 39.1 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 2.0% of the maximum daily recommended sodium intake for an adult.
Tresuvi 10 mg/ml solution for infusion:
This medicine contains up to 37.4 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 1.9% of the maximum daily recommended sodium intake for an adult.
3. How to use Tresuvi
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.
Tresuvi is administered as a continuous infusion:
- subcutaneously (under the skin) through a small tube (cannula) placed in the abdomen or thigh;
or
- intravenously through a tube (catheter) usually placed in the neck, chest, or groin.
In both cases, a portable pump placed outside your body (external) pumps treprostinil through the tube.
Before leaving the hospital or clinic, your doctor will inform you how to prepare this medicine and at what rate the pump should deliver the treprostinil.
Purging the infusion line while connected may lead to accidental overdose.
Alternatively, Tresuvi may be administered intravenously using an implantable infusion pump, which is usually surgically inserted under the skin of the abdomen. In this case, the pump and catheters are entirely inside your body (internal), and you will need to visit the hospital or clinic periodically (e.g., every 4 weeks) to have the internal reservoir refilled.
In either case, you must also be given information on how to use the pump correctly and what to do if it stops working. This information should also indicate whom to contact in an emergency.
Tresuvi is diluted only when administered as a continuous intravenous infusion:
For intravenous infusion with an external portable pump: The treprostinil solution should be diluted only with sterile water for injections or 0.9% sodium chloride solution for injections, as directed by your doctor.
For intravenous infusion with an implantable infusion pump: You must visit the hospital or clinic periodically (e.g., every 4 weeks), where healthcare professionals will dilute your treprostinil solution with 0.9% sodium chloride solution for injection and refill the internal reservoir.
Adult patients
Tresuvi is available as a 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml solution for infusion. Your doctor will determine the appropriate infusion rate and dose for your condition.
Overweight patients
If you are overweight (30% or more above your ideal body weight), your doctor will determine the initial and subsequent doses based on your ideal body weight. See also section 2, "Warnings and precautions."
Elderly patients
Your doctor will determine the appropriate infusion rate and dose for your condition.
Use in children and adolescents
Data available for children and adolescents are limited.
Dose adjustment
The infusion rate may be individually reduced or increased only under medical supervision.
The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves the symptoms of PAH while minimizing any undesirable effects.
If your symptoms worsen, or if you require bed rest, are confined to bed or a chair, or if any physical activity causes discomfort and your symptoms occur at rest, do not increase the dose without consulting your doctor. This medicine may no longer be sufficient to treat your condition, and additional treatment may be necessary.
How can bloodstream infections with intravenous Tresuvi be prevented?
As with any long-term intravenous treatment, there is a risk of developing bloodstream infections. Your doctor will advise you on how to prevent them.
If you use more Tresuvi than you should
If you receive an accidental overdose of this medicine, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, lightheadedness, or fainting), skin flushing, and/or headache.
If any of these symptoms become severe, you must contact your doctor or hospital immediately. The doctor may reduce the dose or interrupt administration until symptoms resolve. Then, treprostinil administration will be resumed at the dose recommended by your doctor.
If you stop treatment with Tresuvi
Always use treprostinil exactly as instructed by your doctor or hospital specialist. Do not stop treatment with Tresuvi unless your doctor tells you to do so.
Sudden withdrawal or rapid dose reductions of treprostinil may cause recurrence of pulmonary arterial hypertension, possibly leading to rapid and severe deterioration of your condition.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people)
- widening of blood vessels with skin flushing
- pain or tenderness around the site of administration
- skin discoloration or bruising around the site of administration
- headaches
- skin rashes
- nausea
- diarrhea
- jaw pain
Common (may affect up to 1 in 10 people)
- dizziness
- vomiting
- lightheadedness or fainting due to low blood pressure
- itching or redness of the skin
- swelling of feet, ankles, legs, or fluid retention
- bleeding episodes, such as nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in stools
- joint pain
- muscle pain
- pain in legs and/or arms
Other possible adverse effects (frequency cannot be estimated from available data)
- infection at the site of administration
- abscess at the site of administration
- decrease in blood clotting cells (platelets) (thrombocytopenia)
- bleeding at the site of administration
- infection of the tissues beneath the skin (cellulitis)
- bone pain
- skin rashes with discoloration or raised bumps
heart failure with a high volume of blood pumped by the heart over a period of time, causing difficulty breathing, fatigue, swelling of legs and abdomen, and persistent cough (high-output heart failure)
Other adverse effects associated with intravenous administration route (frequency cannot be estimated from available data)
-
inflammation of the veins (thrombophlebitis)
-
bacterial infection of the bloodstream (bacteremia)* (see section 3)
-
sepsis (serious bacterial infection of the blood)
-
Potentially fatal or fatal cases of bloodstream bacterial infection have been reported
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tresuvi
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any damage to the vial, change in colour or other signs of deterioration. The Tresuvi vial should be used or discarded within 30 days of first opening.
During continuous subcutaneous infusion, a single undiluted Tresuvi reservoir (syringe) must be used within 14 days.
During continuous intravenous infusion, a single diluted Tresuvi reservoir (syringe) must be used within 24 hours.
During continuous intravenous infusion using implantable infusion pumps, the diluted Tresuvi solution introduced into the pump reservoir must be used within a maximum of 30 days. Your healthcare professional will advise you on the duration of the interval until the next reservoir refill.
Any unused diluted solution should be discarded.
Instructions for use can be found in section 3, "How to use Tresuvi".
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Contents of Tresuvi
The active substance is treprostinil (1 mg/ml, 2.5 mg/ml, 5 mg/ml,
The other components are:
Sodium citrate (E331), sodium chloride, sodium hydroxide (E-524), hydrochloric acid (for pH adjustment), m-cresol, and water for injections.
Appearance of the product and pack contents
Tresuvi is a clear, colourless to slightly yellowish solution, free from visible particles, supplied in a 10 ml clear glass vial sealed with a rubber stopper and a colour-coded closure cap:
- Tresuvi 1 mg/ml solution for infusion has a yellow closure cap.
- Tresuvi 2.5 mg/ml solution for infusion has a blue closure cap.
- Tresuvi 5 mg/ml solution for infusion has a green closure cap.
- Tresuvi 10 mg/ml solution for infusion has a red closure cap.
Each carton contains one vial.
Marketing Authorisation Holder
Amomed Pharma GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
Manufacturer
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals Iberia S.L.U.
Calle de Cólquide nº6, Edif. Prisma – Portal 2, 1º F
28231 Las Rozas, Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Treposa 1/2.5/ 5/ 10 mg/ ml Infusionslösung
Bulgaria Tresuvi 1/2.5/ 5/ 10 mg/ ml ?????????? ???????
Czech Republic Tresuvi 1/2.5/ 5/ 10 mg/ ml Infuzní roztok
Denmark Tresuvi 1/2.5/ 5/ 10 mg/ ml Infusionsvæske, opløsning
Greece Tresuvi 1/2.5/ 5/ 10 mg/ ml Διάλυμα για έγχυση
Spain Tresuvi 1/2.5/ 5/ 10 mg/ ml Solución para perfusión
Finland Treposa 1/2.5/ 5/ 10 mg/ ml Infuusioneste, liuos
Hungary Tresuvi 1/2.5/ 5/ 10 mg/ ml Oldatos infúzió
Norway Tresuvi 1/2.5/ 5/ 10 mg/ ml Infusionsvæske, oppløsning
Poland Tresuvi 1/2.5/ 5/ 10 mg/ ml Roztwór do infuzji
Portugal Tresuvi 1/2.5/ 5/ 10 mg/ ml solução para perfusão
Romania Tresuvi 1/2.5/ 5/ 10 mg/ ml Solutie perfuzabila
Slovakia Tresuvi 1/2.5/ 5/ 10 mg/ ml Infúzny roztok
Slovenia Treprostinil Amomed 1/2.5/ 5/ 10 mg/ ml Raztopina za infundiranje
Date of the most recent revision of this leaflet: 08/2023
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)