Remodulin

Package leaflet: Information for the user

REMODULIN 1 mg/ml solution for infusion, 2.5 mg/ml solution for infusion, 5 mg/ml solution for infusion, 10 mg/ml solution for infusion

(treprostinil)
Please 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 questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects not listed in this leaflet, contact your doctor, pharmacist, or nurse (see section 4).

Contents of this leaflet:

1. What Remodulin is and what it is used for
2. Before you use Remodulin
3. How to use Remodulin
4. Possible side effects
5. How to store Remodulin
6. Contents of the pack and other information

1. What Remoduin is and what it is used for

What Remoduin is
The active substance in Remoduin is treprostinil.
Treprostinil belongs to a class of medicines that act similarly to natural prostacyclins.
Prostacyclins are hormone-like substances that lower blood pressure by causing relaxation and thus dilation of blood vessels, improving blood flow.
Prostacyclins may also prevent blood from clotting.

What Remoduin is used for
Remoduin 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, causing shortness of breath, dizziness, fatigue, fainting, palpitations or cardiac arrhythmias, dry cough, chest pain, and swelling of the ankles or legs.

Remoduin is initially administered as a continuous subcutaneous infusion (under the skin). Some patients may no longer be able to tolerate it due to local pain and swelling. If necessary, your doctor will decide whether your Remoduin can be administered by continuous intravenous infusion (directly into a vein) via a central venous 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 choose the best option for you.

How Remoduin works
Remoduin reduces blood pressure in the pulmonary artery, improving blood flow and reducing the workload on the heart. Improved blood flow results in better oxygen delivery to the body, while reduced strain on the heart allows it to function more effectively. Remoduin improves the symptoms associated with pulmonary arterial hypertension and increases exercise capacity in patients with limited physical ability.

2. Before using Remodulin

Do not use Remodulin

• if you are allergic (hypersensitive) to treprostinil or to any of the excipients of this medicine listed in section 6
• if you have been diagnosed with a condition called "pulmonary veno-occlusive disease". This is a disease in which the blood vessels carrying blood to the lungs become swollen and blocked, causing increased pressure in the blood vessels between the heart and lungs.
• if you have severe liver disease
• if you have a heart condition, for example: myocardial infarction (heart attack) within the last six months, severe disturbances in heart rate, severe coronary heart disease or unstable angina, or if you have been diagnosed with a heart defect, such as a valvular defect causing impaired heart function, or any untreated or poorly controlled heart disease
• if you are at specific risk of bleeding – for example, if you have active gastric ulcer, lesions, or other bleeding conditions
• if you have had a stroke within the last three months or any other condition that has interrupted blood flow to the brain.

Warnings and precautions
Before starting Remodulin, inform your doctor:

• if you have liver disease
• if you have been diagnosed with obesity (BMI greater than 30 kg/m²)
• if you have Human Immunodeficiency Virus (HIV) infection
• if you have high blood pressure in the hepatic veins (portal hypertension)
• if you have a congenital heart defect affecting the way your heart circulates blood.

During treatment with Remodulin, inform your doctor:

• if your blood pressure decreases (hypotension)
• if you experience a sudden worsening of breathing difficulty or persistent cough (this may be due to pulmonary congestion, asthma, or other conditions); seek immediate medical attention.
• if you experience excessive bleeding, as treprostinil may increase this risk by interfering with your blood's ability to clot.
• if you develop fever during intravenous administration of Remodulin or if the intravenous infusion site becomes red, swollen, and/or painful to touch, as this may indicate infection.

Other medicines and Remodulin
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are using:

• medicines used to treat high blood pressure (antihypertensives or other vasodilators)
• drugs used to increase urine production (diuretics), including furosemide
• medicines that prevent blood clotting (anticoagulants) such as warfarin, heparin, or nitric oxide-based products
• any non-steroidal anti-inflammatory drugs ( NSAIDs ) (e.g., acetylsalicylic acid, ibuprofen)
• any medicines that may increase or decrease the effect of Remodulin (e.g., gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort), as your doctor may need to adjust the dose of Remodulin.

Pregnancy and breastfeeding
The use of Remodulin is not recommended during pregnancy or if you are planning to become pregnant, unless your doctor considers it necessary. The safety of this medicine during pregnancy has not been established.
The use of Remodulin is not recommended during breastfeeding unless your doctor considers it necessary. If Remodulin is prescribed to you, it is advisable to stop breastfeeding, as it is not known whether this medicine is excreted in breast milk.
While being treated with Remodulin, effective contraception is strongly recommended.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Remodulin may cause low blood pressure with dizziness or fainting. If this occurs, do not drive or operate machinery and consult your doctor.

Remodulin contains sodium
This medicine contains up to 78.4 mg of sodium (the main component of table salt) per 20 ml. This corresponds to 4% of the maximum daily recommended dietary intake for an adult.

3. How to use Remodulin

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Remodulin is administered by continuous infusion:

• either subcutaneously (under the skin) via a thin tube (catheter) inserted into the abdomen or thigh;
• or intravenously via a tube (catheter) usually placed in the neck, chest, or groin.

In both cases, Remodulin is delivered through the tube by a small portable pump positioned outside the body.
Flushing the infusion cannula while it is connected may cause accidental overdose of the medicine.

Alternatively, Remodulin may be administered intravenously via an implantable infusion pump, which is typically surgically placed under the skin of the abdomen. In this case, both the pump and the tube are entirely internal. You will need to go to the hospital periodically (e.g., every 4 weeks) to have the internal reservoir refilled.

You must also be provided with information on the correct use of the pump and what to do in case of pump malfunction. Among the information provided, you will be told who to contact in an emergency.

Remodulin is diluted only when administered by continuous intravenous infusion:

For intravenous infusion via external portable pump: the Remodulin solution should be diluted only with sterile water for injection or with 0.9% sodium chloride for injection, as directed by your doctor.

For intravenous infusion via implantable infusion pump: you must go to the hospital periodically (e.g., every 4 weeks), where healthcare personnel will dilute the Remodulin solution with 0.9% sodium chloride for injection and refill the internal reservoir.

Adult patients
Remodulin is available as an infusion solution at concentrations of 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml. Your doctor will determine the appropriate infusion rate and dose based on your condition.

Overweight patients
If you are overweight (body weight exceeding 30% or more of 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 based on your condition.

Children and adolescents
Available data on the use of this medicine in children and adolescents are limited.

Dose adjustment
The infusion rate may be increased or decreased on an individual basis only under medical supervision.

The aim of adjusting the infusion rate is to establish an effective maintenance rate that improves the symptoms of pulmonary arterial hypertension while minimizing any adverse effects.

If your symptoms worsen, or if you require complete bed rest, or if any physical activity increases your symptoms, or if your symptoms occur even at rest, do not increase the dose without consulting your doctor. It is possible that Remodulin is no longer sufficient to treat your condition, and another treatment may need to be initiated.

How can I prevent bloodstream infections during intravenous Remodulin treatment?
As with any long-term intravenous therapy, there is a risk of bloodstream infections. Your doctor will instruct you on how to avoid this.

If you use more Remodulin than you should
If you accidentally use more Remodulin than prescribed, you may experience nausea, vomiting, diarrhoea, low blood pressure (dizziness, confusion, or fainting), flushing, and/or headache.
If any of these effects become severe, contact your doctor or hospital immediately. Your doctor may reduce or temporarily stop the infusion until symptoms resolve. The Remodulin infusion solution will then be restarted at a dose level recommended by your doctor.

If you stop treatment with Remodulin
Always use Remodulin exactly as instructed by your doctor or hospital specialist. Do not stop using Remodulin unless your doctor tells you to do so.
Sudden discontinuation or abrupt dose reductions of Remodulin may cause a recurrence of pulmonary arterial hypertension, possibly leading to a sudden and severe deterioration of your condition.

If you have any doubts about using this product, consult your doctor.

4. Possible side effects

Like all medicines, Remodulin can cause side effects, although not everybody gets them.

Very common side effects (more than 1 in 10 people)

• dilation of blood vessels with skin flushing
• pain or tenderness at the infusion site
• skin discoloration or bruising at the infusion site
• headaches
• rashes
• nausea
• diarrhoea
• jaw pain

Common side effects (more than 1 in 100 people)

• dizziness
• vomiting
• mental confusion or fainting due to low blood pressure
• itching or skin redness
• swelling of feet, ankles or legs or fluid retention
• episodes of bleeding such as nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in faeces
• joint pain
• muscle pain
• pain in legs and/or arms

Other possible side effects with unknown frequency (frequency cannot be estimated from the available data)

• infection at the infusion site
• abscess at the infusion site
• decrease in blood cells responsible for clotting (platelets) in the blood (thrombocytopenia)
• bleeding at the infusion site
• bone pain
• skin rash with skin discoloration or formation of papules
• infection of the tissue beneath the skin (cellulitis)
• due to the heart pumping excessive blood, shortness of breath, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough

Additional side effects associated with intravenous administration

• inflammation of the vein (thrombophlebitis)
• bacterial infection of the bloodstream (bacteraemia)* (see section 3)
• sepsis (serious bacterial infection of the blood)

* Potentially life-threatening or fatal cases of bacterial bloodstream infections have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor.
You can also report side effects directly via the national reporting system at: "www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Remodulin

Keep Remodulin out of the reach and sight of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
Do not use Remodulin if you notice any damage to the vial, any change in the colour of the product, or other visible signs of deterioration.
A vial of Remodulin must be used or discarded within 30 days of first opening.
During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Remodulin must be used within 14 days.
During continuous intravenous infusion using external portable pumps, a single reservoir (syringe) of diluted Remodulin must be used within 24 hours.
During continuous intravenous infusion using implantable infusion pumps, the diluted Remodulin solution filled into the pump reservoir must be used within a maximum of 35 days.
The healthcare professional at the hospital will inform you of the duration of the interval before the next reservoir refill.
Any remaining diluted solution must be discarded.
For instructions on use, refer to section 3 “How to use Remodulin”.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Remodulin contains
The active substance is treprostinil sodium 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
The excipients in Remodulin are:
Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, m-cresol, and water for injections.

Description of the appearance of Remodulin and contents of the pack
Remodulin is a clear, colourless to slightly yellow solution, available in a 20 ml colourless glass vial sealed with a rubber stopper and a coloured coded closure cap:

• Remodulin 1 mg/ml solution for infusion has a yellow rubber closure cap.
• Remodulin 2.5 mg/ml solution for infusion has a blue rubber closure cap.
• Remodulin 5 mg/ml solution for infusion has a green rubber closure cap.
• Remodulin 10 mg/ml solution for infusion has a red rubber closure cap.

Each carton contains one vial.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028 - Barcelona
Spain

Concessionaire for sale: Dompé farmaceutici S.p.A – Via San Martino, 12 – 20122 Milan, Italy

Manufacturer and responsible for batch release:
Ferrer Internacional, S.A.
Joan Buscallà, 1-9
08173 - Sant Cugat del Vallès (Barcelona)
Spain

Kwizda Pharmadistribution GmbH
Achauerstrasse 2
Leopoldsdorf 2333 bei Wien
Austria

This Patient Information Leaflet was last approved in 02/2026.