1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml solution for
What Treprostinil Tillomed is and what it is used for
What Treprostinil Tillomed is
The active substance in Treprostinil Tillomed is treprostinil.
Treprostinil belongs to a group of drugs that work in a similar way to naturally occurring prostacyclins. Prostacyclins are hormone-like substances that lower blood pressure by causing the blood vessels to relax so that they widen, which makes blood flow easier. Prostacyclin er may also have an effect by preventing the blood from clotting.
What Treprostinil Tillomed is used to treat
Treprostinil Tillomed is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderately severe symptoms. Pulmonary arterial hypertension is a condition where the blood pressure is too high in the blood vessels between the heart and the lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swollen ankles or legs.
Treprostinil Tillomed is initially given as a continuous subcutaneous infusion ( infusion under the skin). Some patients may not tolerate this due to pain and swelling at the administration site. Your doctor will decide whether Treprostinil Tillomed can instead be given as a continuous intravenous infusion ( infusion into a vein). This requires a central venous catheter (CVK) to be inserted, which is usually done in the neck, chest, or groin area.
How Treprostinil Tillomed works
Treprostinil Tillomed lowers blood pressure et in the pulmonary artery by improving blood flow and reducing the work of the heart. Improved blood flow leads to improved oxygen supply to the body and reduced strain on the heart, making it work more efficiently. Treprostinil Tillomed improves the symptoms associated with PAH and the ability to exercise in patients who are limited in terms of activity.
Treprostinil may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Treprostinil Tillomed
Do not use Treprostinil Tillomed
- if you are allergic (hypersensitive) 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 transport blood through the lungs become swollen and clogged, which causes increased pressure in the blood vessels between the heart and the lungs.
- if you have severe liver disease
- if you have heart problems, for example:
- myocardial infarction (heart attack) in the last six months
- severe changes in heart rate
- severe coronary artery disease or unstable angina
- if a heart defect has been diagnosed, for example, a valve that makes the heart work poorly
- heart disease that is not treated or not closely monitored by doctors.
- if you have a particularly high risk of bleeding – for example, active peptic ulcers, injuries, or other bleeding conditions
- if you have had a stroke within the last 3 months or any other interruption of the blood supply to the brain.
Warnings and precautions
Talk to your doctor or pharmacist before using Treprostinil Tillomed:
- if you have any liver disease
- if you have any kidney disease
- if you have been told that you suffer from obesity ( BMI of more than 30 kg/m 2 )
- if you have HIV – infection (human immunodeficiency virus)
- if you have high blood pressure in the liver veins (portal hypertension)
- if you have a congenital heart defect that affects blood flow through the heart
- if you follow a low-sodium diet.
During treatment with Treprostinil Tillomed, you must tell your doctor:
- 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 another condition), consult your doctor immediately.
- if you have heavy bleeding, treprostinil may increase the risk by preventing the blood from clotting
- if you develop a fever while receiving treprostinil intravenously or if the site of the intravenous catheter becomes red, swollen, and/or painful to the touch, these may be signs of infection.
Other medicines and Treprostinil Tillomed
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you use:
- medicines used to treat high blood pressure (antihypertensives or other vasodilators)
- medicines used to increase urine output ( diuretics ), including furosemide
- medicines that prevent the blood from clottings (blood thinners), such as warfarin, heparin, or nitric oxide-based agents
- non-steroidal anti-inflammatory drugs ( NSAIDs ) (eg aspirin, ibuprofen )
- medicines that can increase or decrease the effect of treprostinil (eg gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John’s wort ) because your doctor may need to adjust the dose of treprostinil.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Treprostinil 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 used during pregnancy, has not been established.
The use of treprostinil is not recommended during breastfeeding unless considered necessary by your doctor. You should stop breastfeeding if you have been prescribed treprostinil, as it is not known whether this medicine is excreted in breast milk.
The effect of treprostinil on human fertility is currently unknown. Therefore, contraception is strongly recommended during treatment with treprostinil.
Driving ability and use of machinery
Treprostinil may cause low blood pressure with dizziness or fainting. If you experience this, you should not drive or use machines and you should ask your doctor for advice.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Treprostinil Tillomed contains sodium
Tell your doctor if you are on a low-salt diet. He will take into account that a vial of Treprostinil Tillomed contains the following amounts of sodium.
Treprostinil Tillomed 1 mg/ml, solution for infusion
This medicine contains 74.16 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.71% of the recommended maximum intake of sodium per day for an adult.
Treprostinil Tillomed 2.5 mg/ml solution for infusion
This medicine contains 75.08 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.75% of the recommended maximum intake of sodium per day for an adult.
Treprostinil Tillomed 5 mg/ml solution for infusion
This medicine contains 78.16 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.91% of the recommended maximum intake of sodium per day for an adult.
Treprostinil Tillomed 10 mg/ml solution for infusion
This medicine contains 75 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.75% of the recommended maximum intake of sodium per day for an adult.
How to use Treprostinil Tillomed
Always use this medicine as directed by your doctor or pharmacist. Consult a doctor if you are unsure.
Treprostinil Tillomed is given as a continuous infusion, either:
- subcutaneously (under the skin) through a narrow tube (cannula) placed in the abdomen or thigh
- intravenously via a plastic tube ( catheter ) which is usually inserted into the neck, chest, or groin area.
In both cases, treprostinil is pushed through the tube using a portable pump.
Before you leave the hospital or clinic, the doctor will tell you how to prepare treprostinil and at what rate the pump should give you treprostinil. You also get information on how to use the pump correctly and what to do if it stops working. You also get information about who to contact in an emergency.
Flushing the infusion line while it is connected can cause an accidental overdose.
Treprostinil is diluted only when given intravenously:
For intravenous infusion only: If treprostinil is given as a continuous intravenous infusion, dilute the treprostinil solution only with sterile water for injections or with 9 mg/ml (0.9%) sodium chloride solution for injections (provided by your doctor).
Adult patients
Treprostinil Tillomed 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 infusion rate and infusion dose that is appropriate for your condition.
Obese patients
If you are overweight (weighing 30% or more than your ideal body weight), your doctor will decide on the first dose and subsequent doses e based on your ideal body weight. See also section 2, “Warnings and precautions”.
Elderly
Your doctor will determine the infusion rate and infusion dose that is appropriate for your condition.
Children and young people
There are limited data for children and adolescents.
Dose adjustment
The infusion rate can be lowered 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 pulmonary arterial hypertension while minimizing potential side effects.
If your symptoms increase you need complete rest or are bed or chair-bound, or if all physical activity causes discomfort and your symptoms occur at rest, do not increase the dose without a doctor’s prescription. Treprostinil may no longer be enough to treat your disease and other treatment may be needed.
The maximum dose that can be given depends on the patient’s condition and any other concomitant diseases.
How can infection in the bloodstream be prevented during treatment with treprostinil given intravenously?
As with any long-term intravenous treatment, there is a risk of infection in the bloodstream. Your doctor will instruct you on how to avoid this.
If you have used too much Treprostinil Tillomed
If you accidentally overdose on treprostinil, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, intoxication, or fainting), flushing, and/or headache.
If any of these effects become severe, contact a doctor or hospital immediately. Your doctor may reduce the dose or stop the infusion until the symptoms have disappeared. Treatment with Treprostinil Tillomed solution for infusion is then restarted with a dose determined by your doctor.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you stop using Treprostinil Tillomed
Always use Treprostinil Tillomed as directed by your doctor or hospital specialist. Do not stop using treprostinil unless your doctor tells you to.
On the contrary, discontinuation of treatment or sudden dose reductions of treprostinil may cause pulmonary arterial hypertension to return, with the risk of rapid and serious deterioration of your condition.
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 side effects (may affect more than 1 in 10 patients)
- dilated blood vessels with skin redness
- pain or tenderness at the infusion site
- skin discoloration or bruising at the infusion site
- headache
- rash
- nausea
- diarrhea
- pain in the jaws
Common side effects (may affect up to 1 in 10 patients)
- dizziness
- vomiting
- feeling intoxicated or fainting due to low blood pressure
- itching or redness of the skin
- swelling of the feet, ankles, and legs, or fluid retention
- bleeding such as epistaxis, coughing up blood, blood in the urine, bleeding in the gums, blood in the stool
- joint pain ( arthralgia )
- muscle pain (myalgia)
- pain in legs and/or arms
Other possible side effects (have been reported (occurring in an unknown number of patients))
- infusion site infection
- wart formation at the infusion site
- reduced number of blood cells that cause the blood to clot ( platelets ) ( thrombocytopenia )
- bleeding at the infusion site
- bone pain
- skin redness with discoloration or raised nodules (maculopapular rash)
- tissue infection under the skin ( cellulitis )
- too much blood being pumped from the heart leading to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid retention, persistent cough
Additional side effects associated with intravenous administration
- inflammation of the vein ( thrombophlebitis )
- bacterial infection in the bloodstream (bacteremia)* (see section 3)
- severe bacterial infection in the blood ( septicemia )
* life-threatening or fatal cases of bacterial infection in the bloodstream have been reported
How to store Treprostinil Tillomed
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the outer carton after “EXP”. The expiration date is the last day of the specified month.
Do not use Treprostinil Tillomed if you notice any damage to the vial, discoloration, or other signs of deterioration.
No special temperature instructions. Stored in the original box. Light sensitive. Shelf life of treprostinil after first opening: 30 days
For continuous subcutaneous infusion, a reservoir ( syringe ) of undiluted Treprostinil Tillomed must be used within 72 hours.
Durability with continuous subcutaneous administration
Chemical and physical in-use stability has been demonstrated for 72 hours at 37 °C. For microbiological reasons, the product should be used immediately, unless the opening method excludes the risk of microbial contamination. If the product is not used immediately, the user is responsible for storage time and storage conditions.
In the case of continuous intravenous infusion, the maximum time of use of a reservoir ( syringe ) of diluted Treprostinil Tillomed should not exceed 24 hours to minimize the risk of infection in the bloodstream.
Durability with continuous intravenous administration
After dilution:
Chemical and physical in-use stability of diluted Treprostinil has been demonstrated for 48 hours at 2-8°C, 20-25°C, and 40°C. For microbiological reasons, the product should be used immediately, unless the dilution method excludes the risk of microbial contamination. If the user does not take place immediately, the user is responsible for storage time and storage conditions after opening. Normally, the storage time should not be longer than 24 hours at 2-8 °C, unless dilution has been carried out under controlled and validated aseptic conditions. Any diluted solution left over must be discarded.
For instructions on use, see section 3, “How to use Treprostinil Tillomed”.
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 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
Other ingredients in Treprostinil Tillomed are sodium chloride, metacresol, sodium citrate, sodium hydroxide, concentrated hydrochloric acid, and water for injections.
Appearance and package sizes of the medicine
Treprostinil Tillomed 1 mg/ml, solution for infusion
Clear, colorless to the slightly yellow solution, essentially free of visible particles, in a 20 ml clear glass vial with a 20 mm dark gray bromobutyl rubber stopper with four markings at 90° and a central ring, sealed with a yellow 20 mm flip cap.
Treprostinil Tillomed 2.5 mg/ml, solution for infusion
Clear, colorless to the slightly yellow solution, essentially free of visible particles, in a 20 ml clear glass vial with a 20 mm dark gray bromobutyl rubber stopper with four markings at 90° and a central ring, sealed with a blue 20 mm flip cap.
Treprostinil Tillomed 5 mg/ml, solution for infusion
Clear, colorless to the slightly yellow solution, essentially free of visible particles, in a 20 ml clear glass vial with a 20 mm dark gray bromobutyl rubber stopper with four markings at 90° and a central ring, sealed with a green 20 mm flip cap.
Treprostinil Tillomed 10 mg/ml, solution for infusion
Clear, colorless to the slightly yellow solution, essentially free of visible particles, in a 20 ml clear glass vial with a 20 mm dark gray bromobutyl rubber stopper with four markings at 90° and a central ring, sealed with a red 20 mm flip cap.
Each bottle is packed in an outer carton.
Marketing Authorisation Holder
Tillomed Pharma GmbH
Mittelstrasse
12529 Schönefeld
Germany
Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House
Strand Road, Portmarnock
Co. Dublin, Ireland