TREPULMIX 2.5 mg/ml SOLUTION FOR INFUSION
How to use TREPULMIX 2.5 mg/ml SOLUTION FOR INFUSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Trepulmix 1mg/ml solution for infusion
Trepulmix 2.5mg/ml solution for infusion
Trepulmix 5mg/ml solution for infusion
Trepulmix 10mg/ml solution for infusion
treprostinil
Read all of this leaflet carefully before you start using 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.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Trepulmix and what is it used for
- What you need to know before you use Trepulmix
- How to use Trepulmix
- Possible side effects
- Storing Trepulmix
- Contents of the pack and other information
1. What is Trepulmix and what is it used for
What is Trepulmix
The active substance of Trepulmix is treprostinil.
Treprostinil belongs to a group of medicines that work in a similar way to natural prostacyclins. Prostacyclins are hormone-like substances that lower blood pressure by relaxing blood vessels, making them wider and allowing blood to flow more easily. Prostacyclins may also prevent blood from clotting.
What is Trepulmix used for
Trepulmix is used to treat adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) that cannot be operated on or in patients with persistent or recurrent CTEPH after surgical treatment (classified as WHO functional class III or IV), to improve exercise capacity and symptoms of the disease. Chronic thromboembolic pulmonary hypertension is a condition where blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, tiredness, fainting, palpitations or irregular heartbeats, dry cough, chest pain, and swollen ankles or legs.
How Trepulmix works
Trepulmix reduces blood pressure inside the pulmonary artery by improving blood flow and reducing the amount of work the heart has to do. By improving blood flow, it increases oxygen supply to the body and reduces stress on the heart, making it work more efficiently. Trepulmix improves symptoms associated with CTEPH and exercise capacity in patients with activity limitations.
2. What you need to know before you use Trepulmix
Do not use Trepulmix
- 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 disease called "pulmonary veno-occlusive disease"; This is a disease where the blood vessels that carry blood through the lungs become swollen and blocked, causing higher pressure in the blood vessels between the heart and lungs;
- if you have severe liver disease;
- if you have a heart problem, such as:
- a heart attack (myocardial infarction) in the last 6 months;
- severe irregular heartbeat;
- severe ischemic heart disease or unstable angina;
- a heart defect, such as a faulty heart valve that makes the heart work poorly;
- any heart disease that is not being treated or is not under close medical supervision.
- if you have a high risk of bleeding, such as active stomach ulcers, wounds, or other bleeding conditions;
- if you have had a stroke in the last 3 months or any other interruption of blood supply to the brain.
Warnings and precautions
Talk to your doctor before starting Trepulmix if you:
- have liver disease;
- have kidney disease;
- have been told you are medically obese (BMI over 30 kg/m2);
- are on a low-sodium diet.
During treatment with Trepulmix, tell your doctor:
- if your blood pressure drops (hypotension);
- if you experience a rapid increase in breathing difficulties or persistent cough (this may be related to congestion in the lungs, asthma, or other conditions), consult your doctor immediately;
- if you experience excessive bleeding, as treprostinil may increase the risk by preventing blood from clotting.
Children and adolescents
Trepulmix should not be used in children and adolescents.
Other medicines and Trepulmix
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Tell your doctor if you are taking:
- medicines used to treat high blood pressure(antihypertensive medicines or other vasodilators);
- medicines used to increase urination(diuretics), including furosemide;
- medicines that prevent blood clotting(anticoagulants) such as warfarin, heparin, or nitric oxide products;
- any non-steroidal anti-inflammatory drug (NSAID) (e.g., acetylsalicylic acid or ibuprofen);
- medicines that may increase or decrease the effects of Trepulmix (e.g., gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, hypericum), as your doctor may need to adjust the dose of Trepulmix.
Pregnancy and breastfeeding
Trepulmix is not recommended if you are pregnant, plan to become pregnant, or think you may be pregnant, unless your doctor considers it essential. The safety of this medicine during pregnancy has not been established.
It is recommended to use contraceptive methods during treatment with treprostinil.
Trepulmix is not recommended during breastfeeding, unless your doctor considers it essential. You should stop breastfeeding if you are prescribed Trepulmix, as it is not known whether this medicine passes into breast milk.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.
Driving and using machines
Trepulmix may cause low blood pressure with dizziness or fainting. In this case, do not drive or operate machinery and consult your doctor.
Trepulmix contains sodium
Tell your doctor if you are on a low-sodium diet. He will take this into account.
Trepulmix 1 mg/ml solution for infusion
This medicine contains 36.8 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 1.8% of the maximum recommended daily sodium intake for an adult.
Trepulmix 2.5 mg/ml solution for infusion
This medicine contains 37.3 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 1.9% of the maximum recommended daily sodium intake for an adult.
Trepulmix 5 mg/ml solution for infusion
This medicine contains 39.1 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 2.0% of the maximum recommended daily sodium intake for an adult.
Trepulmix 10 mg/ml solution for infusion
This medicine contains 37.4 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 1.9% of the maximum recommended daily sodium intake for an adult.
3. How to use Trepulmix
Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor again.
Trepulmix is administered undiluted by continuous subcutaneous infusion (under the skin) through a small tube (cannula) in your abdomen or thigh;
Trepulmix is driven through the tube by a portable pump.
Before you leave the hospital or clinic, your doctor will tell you how to prepare Trepulmix and the rate at which the pump should administer treprostinil. You will also be given information on how to use the pump correctly and what to do if it stops working. You will also be told who to contact in case of an emergency.
Flushing the infusion line while it is connected can cause an accidental overdose.
Adult patients
Trepulmix is available as a solution for infusion of 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml. Your doctor will determine the infusion rate and dose suitable for your condition.
Elderly patients
No special dose adjustment is needed in these patients.
Patients with severe liver or kidney disease
Your doctor will determine the infusion rate and dose suitable for your condition.
Infusion rate
The infusion rate can be reduced or increased individually only under medical supervision.
The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves the symptoms of CTEPH while minimizing adverse reactions.
If your symptoms worsen or if you need to rest completely, or if you are confined to bed or a chair, or if any physical activity causes discomfort and you experience symptoms at rest, do not increase the dose without consulting a doctor. It may be that Trepulmix is no longer sufficient to treat your disease and that you need another treatment.
If you use more Trepulmix than you should
If you accidentally overdose on Trepulmix, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, lightheadedness, or fainting), flushing of the skin, and/or headache.
If any of these effects worsen, you should contact your doctor or hospital immediately. Your doctor may reduce or interrupt the infusion until your symptoms have disappeared. The Trepulmix solution for infusion will be reintroduced at the dose recommended by your doctor.
If you stop treatment with Trepulmix
Always use Trepulmix following the instructions of your doctor or hospital specialist. Do not stop using Trepulmix unless your doctor has told you to.
Sudden withdrawal or rapid reduction of the dose of Trepulmix can cause pulmonary hypertension to return, with the possibility of rapid and severe worsening of your condition.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
- vasodilation
- pain around the infusion site
- reaction around the infusion site
- bleeding or bruising around the infusion site
- headache
- nausea
- diarrhea
- jaw pain
Common (may affect up to 1 in 10 people)
- dizziness
- lightheadedness or fainting due to low blood pressure
- skin rash
- infection at the infusion site
- abscess (pus) around the infusion site
- muscle pain (myalgia)
- joint pain (arthralgia)
- swelling of feet, ankles, legs, or fluid retention
- flushing
- pain in arms and/or legs
Uncommon (may affect up to 1 in 100 people)
- swollen eyelids (eyelid edema)
- indigestion
- vomiting
- itching of the skin
- rash
- back pain
- decreased appetite
- fatigue
Other possible side effects observed in patients with pulmonary arterial hypertension (PAH):
- bleeding episodes such as: nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in stool
Other possible side effects observed in clinical practice:
- a decrease in blood cells responsible for blood clotting (platelets) in the blood (thrombocytopenia)
- bone pain
- skin rash with discoloration or raised areas
- infection of the tissue under the skin (cellulitis)
Reporting of side effects
If you experience any side effects, talk to your doctor, even if they are 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.
5. Storing Trepulmix
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 carton and vial after "EXP". The expiry date is the last day of the month shown.
This medicine does not require any special storage conditions.
A vial of Trepulmix should be used or discarded within 30 days after first opening.
During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Trepulmix should be used within 72 hours.
Do not use this medicine if you notice damage to the vial, discoloration, or other signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Packaging Contents and Additional Information
Trepulmix Composition
- The active ingredient is treprostinil
Trepulmix 1 mg/ml solution for infusion
Each ml of solution contains 1 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 10 mg of treprostinil (as sodium salt).
Trepulmix 2.5 mg/ml solution for infusion
One ml of solution contains 2.5 mg of treprostinil (as sodium salt)
Each 10 ml vial of solution contains 25 mg of treprostinil (as sodium salt).
Trepulmix 5 mg/ml solution for infusion
Each ml of solution contains 5 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 50 mg of treprostinil (as sodium salt).
Trepulmix 10 mg/ml solution for infusion
Each ml of solution contains 10 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 100 mg of treprostinil (as sodium salt).
- The other ingredients are:
- Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol, and water for injectable preparations. See section 2 "Trepulmix contains sodium".
Product Appearance and Packaging Contents
Trepulmix is a clear, colorless to slightly yellowish solution, available in a 10 ml transparent glass vial sealed with a rubber stopper and a color-coded cap:
Trepulmix 1 mg/ml solution for infusion
Trepulmix 1 mg/ml solution for infusion has a yellow rubber stopper.
Trepulmix 2.5 mg/ml solution for infusion
Trepulmix 2.5 mg/ml solution for infusion has a blue rubber stopper.
Trepulmix 5 mg/ml solution for infusion
Trepulmix 5 mg/ml solution for infusion has a green rubber stopper.
Trepulmix 10 mg/ml solution for infusion
Trepulmix 10 mg/ml solution for infusion has a red rubber stopper.
Each box contains one vial.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
SciPharm Sàrl
7, Fausermillen
L-6689 Mertert
Luxembourg
Manufacturer
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz
21190 Vienna
Austria
You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:
Belgium AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Lithuania AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Bulgaria AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Luxembourg AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Czech Republic AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Hungary AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Denmark AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Malta AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Germany AOP Orphan Pharmaceuticals Germany GmbH Tel: +49 89 99 740 7600 | Netherlands AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Estonia AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Norway AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Greece AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Austria AOP Orphan Pharmaceuticals GmbH Tel: +43 1 5037244 |
Spain AOP Orphan Pharmaceuticals Iberia S.L.U Tel: +34 91 449 19 89 | Poland AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
France AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Portugal AOP Orphan Pharmaceuticals Iberia S.L.U. (Spain) Tel: +34 91 449 19 89 |
Croatia AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Romania AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Ireland AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Slovenia AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Iceland AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Slovakia AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Italy AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Finland AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Cyprus AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 | Sweden AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Latvia AOP Orphan Pharmaceuticals GmbH (Austria) Tel: +43 1 5037244 |
Date of Last Revision of this Leaflet:.
Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TREPULMIX 2.5 mg/ml SOLUTION FOR INFUSIONDosage form: INJECTABLE INFUSION, 1 mg/mlActive substance: treprostinilManufacturer: Reddy Pharma Iberia S.A.Prescription requiredDosage form: INJECTABLE PERFUSION, 10 mg/mlActive substance: treprostinilManufacturer: Reddy Pharma Iberia S.A.Prescription requiredDosage form: INJECTABLE PERFUSION, 2.5 mg/mlActive substance: treprostinilManufacturer: Reddy Pharma Iberia S.A.Prescription required
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