1 mg/ml, 2.5 mg/ml, 5 mg/ml and 10 mg/ml respectively , solution for
What Trepulmix is and what it is used for
What Trepulmix is
The active substance in Trepulmix is treprostinil.
Treprostinil belongs to a group of drugs that act in a similar way to naturally occurring prostacyclins. Prostacyclins are hormone-like substances that lower blood pressure by reducing the resistance in the blood vessels, causing them to widen so that blood flows more easily. Prostacyclin er can also prevent the blood from clotting.
What Trepulmix is used to treat
Trepulmix is used to treat adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) that cannot be cured by surgery, or CTEPH that persists or recurs after surgery (severity classified as WHO functional class III or IV), to improve exercise capacity and disease symptoms. Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition in which blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, fatigue, fainting spells, palpitations or abnormal heartbeats, dry cough, chest pain, and swollen ankles or legs.
How Trepulmix works
Trepulmix lowers blood pressure inside the pulmonary artery by improving blood flow and reducing the heart’s workload. Improved blood flow leads to an increased supply of oxygen to the body and reduced strain on the heart, making it work more efficiently. Trepulmix improves symptoms associated with CTEPH and exercise capacity in patients with limited activity capacity.
What you need to know before using 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”, which is a disease in which the blood vessels that carry blood through the lungs swell and become blocked, leading to higher pressure in the blood vessels between the heart and the lungs,
- if you have severe liver disease,
- if you have any heart problems, for example
- a heart attack (myocardial infarction) in the last 6 months,
- severe changes in heart rate,
- severe coronary artery disease or unstable angina (angina),
- a heart defect has been diagnosed, e.g. a defect in a heart valve that causes the heart to function poorly,
- any heart disease that is not under treatment or closes medical supervision.
- if you run a particularly high risk of bleeding – for example in the case of active stomach ulcers, injuries, or other bleeding conditions,
- if you have had a stroke in the last 3 months or any other interruption of the blood supply to the brain.
Warnings and precautions
Talk to your doctor before using Trepulmix if you
- suffer from any liver disease,
- suffering from kidney disease,
- have been informed that you are medically overweight ( BMI over 30 kg/m 2 ),
- are on a low-sodium diet.
Inform your doctor during treatment with Trepulmix
- if your blood pressure drops ( hypotension ),
- if you experience rapidly increasing difficulty breathing or persistent cough (this may be related to congestion in the lungs or asthma or any other condition), contact a doctor immediately,
- if you have heavy bleeding, treprostinil may increase the risk of this by preventing the blood from clotting.
Children and young people
Trepulmix must not be given to children and adolescents.
Other medicines and Trepulmix
Tell the doctor if you are taking/using, have recently taken/used, or maybe taking/using other medicines. Tell your doctor if you are taking
- medicines used to treat high blood pressure (antihypertensives or other vasodilators),
- medicines used to increase the production of urine ( diuretics ) including furosemide,
- medicines that prevent blood clots ( anticoagulants ) such as warfarin, heparin, or nitric oxide-based products,
- all NSAID medicines (“non-steroidal anti-inflammatory drugs”) (e.g. acetylsalicylic acid , ibuprofen ),
- medicines that can enhance or weaken the effects of Trepulmix (eg gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John’s wort ), as your doctor may need to adjust the dose of Trepulmix.
Pregnancy, breastfeeding, and fertility
Trepulmix is not recommended if you are pregnant, planning to become pregnant, or think you may be pregnant unless your doctor considers it necessary. The safety of this medicine, when given to pregnant women, has not been established.
Contraception is strongly recommended during treatment with Trepulmix.
Use of Trepulmix is not recommended during breastfeeding unless the doctor considers it necessary. You are advised to stop breastfeeding if you have been prescribed Trepulmix. It is not known whether this medicine passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Trepulmix can cause low blood pressure with dizziness or fainting. In this case, you must not drive vehicles or use machines. Ask your doctor for advice
Trepulmix contains excipients
Trepulmix contains sodium
Tell your doctor if you are on a low salt (low sodium) diet. They will take this into account.
Trepulmix 1 mg/ml solution for infusion
This medicine contains 36.8 mg of sodium (the main ingredient in common/table salt) in each vial. This corresponds to 1.8 percent of the maximum recommended daily intake of dietary sodium for adults.
Trepulmix 2.5 mg/ml solution for infusion
This medicine contains 37.3 mg of sodium (the main ingredient in common/table salt) in each vial. This corresponds to 1.9 percent of the maximum recommended daily intake of dietary sodium for adults.
Trepulmix 5 mg/ml solution for infusion
This medicine contains 39.1 mg of sodium (the main ingredient in common/table salt) in each vial. This is equivalent to 2.0 percent of the maximum recommended daily intake of dietary sodium for adults.
Trepulmix 10 mg/ml solution for infusion
This medicine contains 37.4 mg of sodium (the main ingredient in common/table salt) in each vial. This corresponds to 1.9 percent of the maximum recommended daily intake of dietary sodium for adults.
How to use Trepulmix
Always use this medicine as directed by your doctor. Consult your doctor if you are unsure.
Trepulmix is given undiluted as a continuous subcutaneous infusion (under the skin) via a thin tube (a cannula) placed in the abdomen or thigh.
Trepulmix is pushed through the tube by a portable pump.
Before you leave the hospital or clinic, your doctor will tell you how to prepare Trepulmix and at what rate the pump should deliver your treprostinil. You should also receive information on how to use the pump correctly and what to do if it stops working. The information must also explain who to contact in an emergency.
Flushing the infusion set while it is connected can cause an accidental overdose.
Adult patients
Trepulmix is available as 1 mg/ml, 2.5 mg/ml, 5 mg/ml or 10 mg/ml infusion solution , solution. Your doctor will determine the appropriate infusion rate and dose for your condition.
Elderly patients
No special dose adjustments are needed for these patients.
Patients with liver or kidney disease
Your doctor will determine the appropriate infusion rate and dose for your condition.
Infusion rate
The infusion rate can be decreased or increased based on an individual assessment only under medical supervision.
The purpose of adjusting the infusion rate is to establish an effective maintenance rate at which CTEPH symptoms improve while minimizing potential side effects.
If your symptoms increase you need complete rest, or are bedridden or confined to a chair, or if any physical activity causes discomfort and your symptoms occur at rest, do not increase the dose without consulting a doctor. Trepulmix may no longer be enough to treat your illness, and another treatment may be needed.
If you have used too much Trepulmix
If you have accidentally overdosed on Trepulmix, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, lightheadedness, or fainting), skin flushing, and/or headache.
If any of these effects become serious, contact your doctor or hospital immediately. The doctor may lower or stop the infusion until your symptoms have disappeared. Trepulmix solution for infusion will then be reintroduced at a dose level recommended by the doctor.
If you stop using Trepulmix
Always use Trepulmix as directed by your doctor or hospital specialist. Do not stop taking Trepulmix unless your doctor tells you to.
Abrupt discontinuation or sudden dose reductions of Trepulmix may lead to a return of pulmonary arterial hypertension and your condition may rapidly and severely deteriorate.
If you have any further questions about this medicine, ask your doctor.
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 users):
- dilation of blood vessels
- 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 users):
- dizziness
- lightheadedness or fainting due to low blood pressure
- rash
- muscle pain ( myalgia )
- joint pain ( arthralgia )
- swelling of the feet, ankles, legs, or fluid retention
- flushing
- pain in arms and/or legs
Uncommon (may affect up to 1 in 100 users):
- swollen eyelids (eyelid edema)
- indigestion
- vomiting
- itching
- rash
- back pain
- decreased appetite
- fatigue
Other possible side effects were seen in patients with pulmonary arterial hypertension (PAH):
- bleeding episodes such as nosebleeds, coughing up blood, blood in the urine, bleeding gums, blood in the stool
Other possible side effects were seen in clinical practice:
- infusion site infection
- wart formation at the infusion site
- decrease in the number of clotting cells ( platelets ) in the blood ( thrombocytopenia )
- bone ache
- skin rash with discoloration or raised nodules
- tissue infection under the skin ( cellulitis )
How to store Trepulmix
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vial after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions apply to this medicine.
A vial of Trepulmix must be used or discarded within 30 days of opening.
During a continuous subcutaneous infusion, a single reservoir ( syringe ) of undiluted Trepulmix must be used within 72 hours.
Do not use this medicine if you notice any damage to the vial, discoloration, or other signs of deterioration.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance 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
Each ml of solution contains 2.5 mg 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 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).
Other ingredients are:
sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol, and water for injections. See section 2 “Trepulmix contains sodium”.
Appearance and package sizes of the medicine
Trepulmix is a clear, colorless to slightly yellowish solution in a 10 ml clear 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 cap.
Trepulmix 2.5 mg/ml solution for infusion
Trepulmix 2.5 mg/ml solution for infusion has a blue rubber cap.
Trepulmix 5 mg/ml solution for infusion
Trepulmix 5 mg/ml solution for infusion has a green rubber cap.
Trepulmix 10 mg/ml solution for infusion
Trepulmix 10 mg/ml solution for infusion has a red rubber cap.
Each carton contains 1 vial.
Not all pack sizes may be marketed.
SciPharm Sàrl
7, Fausermillen
L-6689 Mertert
Luxembourg
Manufacturer
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria