Treprostinil Reddi

Leaflet accompanying the packaging: information for the user

Treprostinil Reddy, 1 mg/ml, solution for infusion

Treprostinil Reddy, 2.5 mg/ml, solution for infusion

Treprostinil Reddy, 5 mg/ml, solution for infusion

Treprostinil Reddy, 10 mg/ml, solution for infusion

Treprostinil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Treprostinil Reddy and what is it used for
• 2. Important information before using Treprostinil Reddy
• 3. How to use Treprostinil Reddy
• 4. Possible side effects
• 5. How to store Treprostinil Reddy
• 6. Contents of the packaging and other information

1. What is Treprostinil Reddy and what is it used for

What is Treprostinil Reddy

The active substance of Treprostinil Reddy is treprostinil. Treprostinil belongs to a group of medicines that work in a similar way to naturally occurring prostacyclins in the body. Prostacyclins are hormone-like substances that lower blood pressure by relaxing blood vessels, making it easier for blood to flow. Additionally, prostacyclins may also help prevent blood clotting.

What diseases is Treprostinil Reddy used to treat

Treprostinil Reddy is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate symptoms. Pulmonary arterial hypertension is a condition where the blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or irregular heartbeat, dry cough, chest pain, and swelling of the ankles or legs. Treprostinil Reddy is initially administered as a continuous subcutaneous infusion. Some patients may not be able to tolerate such an infusion due to local pain and swelling. The doctor will decide whether Treprostinil Reddy can be administered as a continuous infusion directly into a vein. This will require the insertion of a central venous catheter, which is usually located in the neck, chest, or groin.

How does Treprostinil Reddy work

Treprostinil Reddy lowers blood pressure in the pulmonary artery, improving blood flow and reducing the workload of the heart. Improved blood flow leads to better oxygen supply to the body and reduces the strain on the heart muscle, improving the efficiency of the heart's work. Treprostinil Reddy alleviates symptoms associated with PAH and improves exercise tolerance in patients who must limit physical activity.

2. Important information before using Treprostinil Reddy

When not to use Treprostinil Reddy

• if the patient is allergic (hypersensitive) to treprostinil, metacresol, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with pulmonary veno-occlusive disease. This is a disease where the blood vessels in the lungs become swollen and blocked, causing increased blood pressure in the vessels between the heart and lungs.
• if the patient has severe liver disease.
• if the patient has heart disease, such as:
• heart attack (myocardial infarction) in the last six months,
• serious changes in heart rate,
• severe coronary artery disease or unstable angina,
• diagnosed heart valve defect causing impaired heart function,
• heart disease that is not being treated or is not under close medical supervision.
• if the patient is at risk of significant bleeding - e.g., active stomach ulcer, injuries, or other types of bleeding.
• if the patient has had a stroke in the last 3 months or other cerebral circulation disorders.

Warnings and precautions

Before starting treatment with Treprostinil Reddy, the patient should discuss the following with their doctor:

• if the patient has liver disease,
• if the patient has been medically diagnosed with obesity (BMI over 30 kg/m2),
• if the patient has HIV infection,
• if the patient has high blood pressure in the liver veins (portal hypertension),
• if the patient has a congenital heart defect that affects blood flow through the heart.

During treatment with Treprostinil Reddy, the patient should inform their doctor if:

• they experience low blood pressure (hypotension),
• they experience sudden worsening of breathing difficulties or persistent cough (may be related to pulmonary edema, asthma, or other disease), they should contact their doctor immediately,
• they experience excessive bleeding, as treprostinil may increase the risk of bleeding due to its anti-clotting effect,
• they develop fever or redness, swelling, and (or) tenderness at the infusion site during intravenous administration, as this may be a sign of infection.

Treprostinil Reddy and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor if they are taking:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine. Treprostinil Reddy is not recommended for women who are pregnant, plan to become pregnant, or suspect they are pregnant, unless the doctor considers it necessary. The safety of Treprostinil Reddy in pregnant women has not been established. Treprostinil Reddy is not recommended for women who are breastfeeding, unless the doctor considers it necessary. If Treprostinil Reddy is prescribed to a breastfeeding woman, she should stop breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Treprostinil Reddy may cause low blood pressure with dizziness and fainting. In such cases, the patient should not drive or operate machinery and should consult their doctor for advice.

Treprostinil Reddy contains sodium and metacresol

The medicine contains 74.0 mg (1 mg/ml), 74.9 mg (2.5 mg/ml), 78.4 mg (5 mg/ml), and 74.8 mg (10 mg/ml) of sodium (the main component of common salt) per vial. This corresponds to 3.7% (1 mg/ml, 2.5 mg/ml, and 10 mg/ml) and 3.9% (5 mg/ml) of the maximum recommended daily intake of sodium in the diet of adults. Metacresol may cause allergic reactions.

3. How to use Treprostinil Reddy

This medicine should always be used exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor. Treprostinil Reddy is administered as a continuous infusion:

• subcutaneously using a small tube (cannula) inserted under the skin of the abdomen or thigh, or
• intravenously using a venous catheter in the neck, chest, or groin.

For subcutaneous infusion, the medicine should be administered undiluted. For intravenous infusion, the medicine should be diluted according to the doctor's instructions. The medicine can only be diluted with sterile water for injection or 0.9% (w/v) sodium chloride solution for injection. In both cases, Treprostinil Reddy is pumped through a drip using a portable pump. Before leaving the hospital, the doctor will inform the patient how to prepare Treprostinil Reddy and at what rate the pump should deliver it. Additionally, the patient will receive information on how to properly use the pump and what to do in case of pump failure. The provided information should also include instructions on who to contact in case of an emergency. Flushing the connected infusion line can cause accidental overdose. Treprostinil Reddy is diluted only when administered intravenously in continuous infusion: In the case of intravenous administration using a portable external pump:The patient must dilute the Treprostinil Reddy solution with sterile water for injection or 0.9% sodium chloride solution for injection (as instructed by the doctor), if it is administered as a continuous intravenous infusion.

Adult patients Treprostinil Reddy is available as a 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml solution for infusion. The doctor will determine the infusion rate and dose suitable for the patient's clinical condition. Patients with obesity If the patient has obesity (body weight exceeding ideal body weight by 30% or more), the doctor will determine the initial dose and subsequent doses based on the target body weight. See also section 2 "Warnings and precautions". Elderly patients The doctor will determine the infusion rate and dose suitable for the patient's clinical condition. Children and adolescents There are limited data available on the use of the medicine in children and adolescents. Dose adjustments The infusion rate can be decreased or increased individually only under the supervision of a doctor.The goal of adjusting the infusion rate is to establish an effective maintenance dose that alleviates PAH symptoms while minimizing side effects. If symptoms worsen or the patient requires complete rest or is limited to bed or chair rest, or if any physical exertion causes discomfort, and symptoms occur at rest, the dose should not be increased without consulting a doctor. Treprostinil Reddy may not be sufficient to treat the condition, and other medicines may be indicated.

How to prevent blood infections during intravenous treatment with Treprostinil Reddy

Treprostinil Reddy?

As with any long-term intravenous treatment, there is a risk of blood infection. The doctor will train the patient on how to prevent such infections.

Using a higher dose of Treprostinil Reddy than recommended

If the patient accidentally overdoses on Treprostinil Reddy, they may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, feeling of emptiness in the head, or fainting), flushing of the skin, and (or) headaches. If any of these symptoms are severe, the patient should immediately contact their doctor or hospital. The doctor may reduce the dose or stop the infusion until the symptoms subside. Then, the Treprostinil Reddy infusion solution will be administered again at the dose prescribed by the doctor.

Stopping treatment with Treprostinil Reddy

Treprostinil Reddy should always be used as prescribed by the doctor or a specialist in the hospital. The patient should not stop using Treprostinil Reddy without the doctor's advice. Suddenly stopping or reducing the dose of Treprostinil Reddy may cause a relapse of pulmonary hypertension, possibly with a sudden and severe worsening of the patient's condition. If the patient has any further doubts about using this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Treprostinil Reddy can cause side effects, although not everybody gets them. Very common side effects (may affect more than 1 in 10 people)

• vasodilation with flushing of the skin,
• pain or tenderness at the infusion site,
• discoloration of the skin or extravasation around the infusion site,
• headaches,
• skin rash,
• nausea,
• diarrhea,
• jaw pain.

Common side effects (may affect up to 1 in 10 people)

• dizziness,
• vomiting,
• feeling of emptiness in the head or fainting due to low blood pressure,
• itching or flushing of the skin,
• swelling of the feet, ankles, legs, or fluid retention,
• bleeding, e.g., nosebleeds, coughing up blood, blood in urine, bleeding gums, blood in stool,
• joint pain, muscle pain, pain in the legs and (or) arms.

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

• infection at the infusion site,
• abscess at the infusion site,
• decreased platelet count (thrombocytopenia),
• bleeding at the infusion site,
• bone pain,
• skin rash with discoloration or nodules,
• infection of the tissue under the skin (cellulitis),
• excessive blood pumped by the heart, leading to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid accumulation, and persistent cough.

Additional side effects related to intravenous administration

• phlebitis (thrombophlebitis),
• bacterial infection of the blood (bacteremia)* (see section 3),
• sepsis (severe blood infection).

* Life-threatening or fatal bacterial infections of the blood have been reported.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Treprostinil Reddy

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. During continuous subcutaneous infusion, one container (syringe) of undiluted Treprostinil Reddy must be used within 72 hours. During continuous intravenous infusion using a portable external infusion pump, one container (syringe) of diluted Treprostinil Reddy must be used within 24 hours. The vial of Treprostinil Reddy should be used or discarded within 30 days of first opening. Unused diluted solution should be disposed of. 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 stated. Do not use Treprostinil Reddy if the vial is damaged, discolored, or shows other signs of deterioration (e.g., presence of particles). Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Treprostinil Reddy contains

• The active substance of Treprostinil Reddy is treprostinil. Each milliliter contains 1 mg; 2.5 mg; 5 mg; 10 mg of treprostinil (as treprostinil sodium). Each 20 ml vial contains 20 mg, 50 mg, 100 mg, 200 mg of treprostinil (as treprostinil sodium).
• The other ingredients are: sodium citrate, sodium chloride, metacresol, water for injection, and sodium hydroxide (to adjust pH) and hydrochloric acid (to adjust pH).

What Treprostinil Reddy looks like and contents of the pack

Treprostinil Reddy is a clear, colorless to slightly yellow solution, available in a Type I glass vial with a chlorobutyl rubber stopper, closed with a plastic flip-off cap (in a specific color) with an aluminum seal:

• Treprostinil Reddy 1 mg/ml solution for infusion with a yellow cap.
• Treprostinil Reddy 2.5 mg/ml solution for infusion with a blue cap.
• Treprostinil Reddy 5 mg/ml solution for infusion with a green cap.
• Treprostinil Reddy 10 mg/ml solution for infusion with a red cap.

Each carton contains one vial with 20 ml of solution for infusion.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Holding GmbH Kobelweg 95 86156 Augsburg Germany Tel.: +49 821 74881 0

Manufacturer/Importer

betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Treprostinil Reddy 1 mg/ml oplossing voor infusie Treprostinil Reddy 2,5 mg/ml oplossing voor infusie Treprostinil Reddy 5 mg/ml oplossing voor infusie Treprostinil Reddy 10 mg/ml oplossing voor infusie Belgium: Treprostinil Reddy 1 mg/ml infuzní roztok Treprostinil Reddy 2,5 mg/ml infuzní roztok Treprostinil Reddy 5 mg/ml infuzní roztok Treprostinil Reddy 10 mg/ml infuzní roztok Czech Republic: Treprostinil Reddy 1 mg/ml infusionvæske, opløsning Treprostinil Reddy 2,5 mg/ml infusionvæske, opløsning Treprostinil Reddy 5 mg/ml infusionvæske, opløsning Treprostinil Reddy 10 mg/ml infusionvæske, opløsning Denmark: Treprostinil Reddy 1 mg/ml Infusionslösung Treprostinil Reddy 2,5 mg/ml Infusionslösung Treprostinil Reddy 5 mg/ml Infusionslösung Treprostinil Reddy 10 mg/ml Infusionslösung Germany: Treprostinil Reddy 1 mg/ml infuusioneste, liuos Treprostinil Reddy 2,5 mg/ml infuusioneste, liuos Treprostinil Reddy 5 mg/ml infuusioneste, liuos Treprostinil Reddy 10 mg/ml infuusioneste, liuos Finland: Treprostinil Reddy 1 mg/ml oldatos infúzió Treprostinil Reddy 2,5 mg/ml oldatos infúzió Treprostinil Reddy 5 mg/ml oldatos infúzió Treprostinil Reddy 10 mg/ml oldatos infúzió Hungary: Treprostenil Reddy 1 mg/ml solution for infusion Treprostenil Reddy 2.5 mg/ml solution for infusion Treprostenil Reddy 5 mg/ml solution for infusion Treprostenil Reddy 10 mg/ml solution for infusion Ireland: Treprostinil Reddy 1 mg/ml oplossing voor infusie Treprostinil Reddy 2,5 mg/ml oplossing voor infusie Treprostinil Reddy 5 mg/ml oplossing voor infusie Treprostinil Reddy 10 mg/ml oplossing voor infusie Netherlands: Treprostinil Reddy 1 mg/ml infusjonsvæske, oppløsning Treprostinil Reddy 2,5 mg/ml infusjonsvæske, oppløsning Treprostinil Reddy 5 mg/ml infusjonsvæske, oppløsning Treprostinil Reddy 10 mg/ml infusjonsvæske, oppløsning Poland: Treprostinil Reddy 1 mg/ml roztwór do infuzji Norway: Treprostinil Reddy 2,5 mg/ml roztwór do infuzji Treprostinil Reddy 5 mg/ml roztwór do infuzji Treprostinil Reddy 10 mg/ml roztwór do infuzji Portugal: Treprostinil Reddy 1 mg/ml solução para perfusão Treprostinil Reddy 2,5 mg/ml solução para perfusão Treprostinil Reddy 5 mg/ml solução para perfusão Treprostinil Reddy 10 mg/ml solução para perfusão Slovakia: Treprostinil Reddy 1 mg/ml infúzny roztok Treprostinil Reddy 2,5 mg/ml infúzny roztok Treprostinil Reddy 5 mg/ml infúzny roztok Treprostinil Reddy 10 mg/ml infúzny roztok Sweden: