Treprostinil Dr. Reddy's 10 mg/ml solution for infusion EFG

Package Leaflet: Information for the user

Introduction

Package Leaflet: information for the user

Treprostinil Dr. Reddy's 1 mg/ml solution for infusion EFG

Treprostinil Dr. Reddy's 2.5 mg/ml solution for infusion EFG

Treprostinil Dr. Reddy's 5 mg/ml solution for infusion EFG

Treprostinil Dr. Reddy's 10 mg/ml solution for infusion EFG

Treprostinil

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Treprostinil Dr. Reddy's is and what it is used for

2. What you need to know before using Treprostinil Dr. Reddy's

3. How to use Treprostinil Dr. Reddy's

4. Possible side effects

5. Storage of Treprostinil Dr. Reddy's

6. Contents of the pack and other information

1. What Treprostinil Dr. Reddy's is and what it is used for

The active substance of this medicine is treprostinil.

Treprostinil belongs to a group of medicines whose action is similar to that of natural prostacyclins. Prostacyclins are hormone-like substances that lower blood pressure by relaxing blood vessels, causing them to widen and allowing blood to flow more easily. Prostacyclins may also prevent blood from clotting.

What treprostinil is used for

Treprostinil is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate symptoms. Pulmonary arterial hypertension is a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. This causes shortness of breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swelling of the ankles or legs.

Treprostinil Dr. Reddy's is initially administered by continuous subcutaneous infusion (under the skin). Some patients may not tolerate this route of administration due to local pain and swelling. Your doctor will decide whether you can receive Treprostinil Dr. Reddy's by continuous intravenous infusion directly into a vein, using a central venous catheter connected to an external pump or, depending on your condition, an implanted pump surgically placed under the skin of your abdomen. Your doctor will determine the best option for you.

How treprostinil works

Treprostinil reduces blood pressure in the pulmonary artery by improving circulation and reducing the workload of the heart. Improved blood circulation increases oxygen delivery to the body and reduces the effort required by the heart, allowing it to work more efficiently. Treprostinil improves symptoms associated with PAH and exercise capacity in patients with limited activity.

2. What you need to know before using Treprostinil Dr. Reddy's

Do not use Treprostinil Dr. Reddy's:

• if you are allergic to treprostinil or to any of the other ingredients of this medicine (listed in section 6);

• if you have been diagnosed with a condition called "pulmonary veno-occlusive disease". In this disease, the blood vessels carrying blood through the lungs become swollen and blocked, increasing pressure in the blood vessels between the heart and the lungs;

• if you have severe liver impairment;

• if you have a heart condition, for example:

  • a myocardial infarction (heart attack) within the last six months
  • significant changes in heart rate
  • severe coronary artery disease or unstable angina
  • a diagnosed heart defect, such as a faulty heart valve causing improper heart function
  • any untreated heart disease or heart condition under close medical observation;

• if you are at specific high risk of bleeding, for example, due to active stomach ulcers, injuries, or other bleeding disorders;

  • if you have had a stroke within the last 3 months, or any interruption of blood supply to the brain.

Warnings and precautions

Talk to your doctor before starting to use Treprostinil Dr. Reddy's:

• if you have any liver disease
• if you have been diagnosed as clinically obese (BMI greater than 30 kg/m²)
• if you have human immunodeficiency virus (HIV) infection
• if you have high blood pressure in the liver's veins (portal hypertension)
• if you have a congenital heart defect affecting blood flow through the heart

While being treated with this medicine, inform your doctor:

• if your blood pressure drops (hypotension)
• if you experience a rapid worsening of breathing difficulties or persistent cough (this may be related to pulmonary congestion, asthma, or another condition); contact your doctor immediately.
• if you experience excessive bleeding, as treprostinil may increase the risk by inhibiting blood clotting.
• if you develop fever while receiving intravenous treprostinil, or if the intravenous administration site becomes red, swollen, or painful to touch, as this may indicate infection.

Using Treprostinil Dr. Reddy's with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Tell your doctor if you are taking:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Treprostinil is not recommended during pregnancy, if planning to become pregnant, or if you think you may be pregnant, unless considered essential by your doctor. The safety of this medicine during pregnancy has not been established.

Treprostinil is not recommended during breastfeeding unless considered essential by your doctor. You are advised to discontinue breastfeeding if prescribed treprostinil, as it is unknown whether this medicine is excreted in breast milk.

It is highly advisable to use contraceptive methods during treatment with treprostinil.

Driving and using machines

Treprostinil Dr. Reddy's may cause low blood pressure, dizziness, and fainting. In such cases, do not drive or operate machinery and consult your doctor.

Treprostinil Dr. Reddy's contains sodium

This medicine contains up to 78.4 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 3.9% of the maximum daily recommended sodium intake for an adult.

3. How to use Treprostinil Dr. Reddy's

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

Treprostinil Dr. Reddy's is administered as a continuous infusion:

• Subcutaneously (under the skin) via a small tube (cannula) placed in the abdomen or thigh; or,
• Intravenously via a tube (catheter) usually placed in the neck, chest, or groin.

For subcutaneous infusion, the product must be administered undiluted.

For intravenous infusion, the product must be diluted according to the prescriber's instructions and may only be diluted with sterile water for injection or 0.9% (w/v) sodium chloride injection solution.

In both cases, Treprostinil Dr. Reddy's will be delivered through the tube by a portable pump placed outside your body (external).

Before leaving the hospital or clinic, your doctor will instruct you on how to prepare Treprostinil Dr. Reddy's and at what rate the pump should deliver the medication.

Purging the infusion tubing while connected may lead to accidental overdose.

Alternatively, Treprostinil Dr. Reddy's may be administered intravenously via an implantable infusion pump, which is usually surgically inserted under the skin of the abdomen. In this case, the pump and tubing are completely inside your body (internal), and you will need to visit the hospital periodically (e.g., every 4 weeks) to have the internal reservoir refilled.

In any case, you should also be given information on how to properly use the pump and what to do if it stops working. This information should also indicate whom to contact in an emergency.

Treprostinil Dr. Reddy's is diluted only when administered via continuous intravenous infusion:

For intravenous infusion with an external portable pump: You must dilute your Treprostinil Dr. Reddy's solution only with sterile water for injection or 0.9% sodium chloride injection (as directed by your doctor).

For intravenous infusion with an implantable infusion pump: You must visit the hospital periodically (e.g., every 4 weeks), where the doctor will dilute your Treprostinil Dr. Reddy's solution with 0.9% sodium chloride injection and refill the internal reservoir.

Adult patients

Treprostinil Dr. Reddy's is available as a 1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL infusion solution. Your doctor will determine the appropriate infusion rate and dose based on your condition.

Patients who are overweight

If you are overweight (weighing 30% or more above your ideal body weight), your doctor will determine the initial and subsequent doses based on your ideal body weight. See section 2, "Warnings and precautions."

Elderly patients

Your doctor will determine the appropriate infusion rate and dose for your condition.

Dose adjustment

The infusion rate for each individual patient may be decreased or increased only under medical supervision.

The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves PAH symptoms while minimizing adverse effects.

If your symptoms worsen, or if you require complete rest, are confined to bed or a chair, or if any physical activity causes discomfort and your symptoms occur at rest, do not increase the dose without consulting your doctor. Treprostinil may no longer be sufficient to treat your condition, and you may require additional therapy.

How can bloodstream infections be prevented during intravenous treprostinil administration?

As with all long-term intravenous therapies, there is a risk of developing a bloodstream infection. Your doctor will advise you on how to prevent such infections.

If you use more Treprostinil Dr. Reddy's than you should

If you accidentally receive an overdose of treprostinil, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, lightheadedness, or fainting), flushing, or headache.

If any of these symptoms become severe, contact your doctor or hospital immediately. The doctor may reduce the dose or temporarily interrupt administration until symptoms resolve. Treatment with treprostinil will then be resumed at the dose recommended by your doctor.

In case of overdose, contact your doctor immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the name of the medicine and the amount taken.

If you stop using Treprostinil Dr. Reddy's

Always use treprostinil exactly as directed by your doctor or hospital specialist. Do not stop using treprostinil unless instructed to do so by your doctor.

Sudden interruption or rapid reduction in the dose of Treprostinil Dr. Reddy's may cause a recurrence of pulmonary arterial hypertension, potentially leading to rapid and severe deterioration of your condition.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people)

• widening of blood vessels with flushing
• pain or tenderness around the site of administration
• skin discoloration or bruising around the site of administration
• headache
• skin rashes
• nausea
• diarrhea
• jaw pain

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

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

Other possible adverse effects (frequency cannot be estimated from available data)

• infection at the site of administration
• abscess at the site of administration
• reduction in blood cells responsible for clotting (platelets) in the blood (thrombocytopenia)
• bleeding at the site of administration
• bone pain
• skin rashes with discoloration or bumps
• infection of the tissue beneath the skin (cellulitis)
• excessive pumping of blood from the heart leading to difficulty breathing, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough.

Other side effects associated with intravenous administration

• inflammation of the vein (thrombophlebitis)

• bacterial infection in the bloodstream (bacteremia)*. See section 3.

• sepsis (serious bacterial infection of the blood)

• Fatal and potentially fatal cases of bacterial infection in the bloodstream have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Treprostinil Dr. Reddy's

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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 indicated.

Do not use this medicine if you notice damage to the vial, change in colour or any other signs of deterioration.

Treprostinil Dr. Reddy's vials must be discarded 30 days after first opening.

During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Treprostinil Dr. Reddy's should be used within 72 hours.

During continuous intravenous infusion using portable external pumps, a single reservoir (syringe) of diluted Treprostinil Dr. Reddy's should be used within 24 hours.

During continuous intravenous infusion using implantable infusion pumps, Treprostinil Dr. Reddy's placed in the pump reservoir may be used for up to 39 days (chemical, physical and microbiological in-use stability has been demonstrated for Treprostinil Dr. Reddy's solution administered by intravenous infusion for up to 39 days at 40 °C, at diluted concentrations as low as 0.5 mg/ml and up to 10 mg/ml, in a titanium drug reservoir of an implantable pump). The healthcare professional at the hospital will inform you of the duration of the interval before each subsequent reservoir refill.

Any unused diluted solution must be discarded.

For instructions on use, see section 3 "How to use Treprostinil Dr. Reddy's".

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Treprostinil Dr. Reddy's

The active substance is treprostinil 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.

The other components are:

Sodium citrate dihydrate (E331), sodium chloride, metacresol, water for injections and, for pH adjustment: sodium hydroxide (E524) and hydrochloric acid (E507).

Appearance of the product and contents of the container

Treprostinil Dr. Reddy's is a clear, colourless to slightly yellowish solution, available in a 20 ml transparent glass vial closed with a rubber stopper and a colour-coded cap:

• Treprostinil Dr. Reddy's 1 mg/ml solution for infusion has a yellow rubber cap.
• Treprostinil Dr. Reddy's 2.5 mg/ml solution for infusion has a blue rubber cap.
• Treprostinil Dr. Reddy's 5 mg/ml solution for infusion has a green rubber cap.
• Treprostinil Dr. Reddy's 10 mg/ml solution for infusion has a red rubber cap.

Each carton contains one vial.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer:

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: July 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/