TREPROSTINIL DR REDDYS 2.5 mg/mL SOLUTION FOR INFUSION

Introduction

Leaflet: Information for the user

Treprostinil Dr. Reddys 1 mg/ml solution for infusion EFG

Treprostinil Dr. Reddys 2.5 mg/ml solution for infusion EFG

Treprostinil Dr. Reddys 5 mg/ml solution for infusion EFG

Treprostinil Dr. Reddys 10 mg/ml solution for infusion EFG

Treprostinil

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, consult your doctor.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Treprostinil Dr. Reddys and what is it used for
2. What you need to know before starting to use Treprostinil Dr. Reddys
3. How to use Treprostinil Dr. Reddys
4. Possible side effects

5 Conservation of Treprostinil Dr. Reddys

1. Package contents and additional information

1. What is Treprostinil Dr. Reddys and what is it used for

The active substance of this medication is treprostinil.

Treprostinil belongs to a group of medications whose action is similar to that of natural prostacyclins. Prostacyclins are hormone-like substances that reduce blood pressure by relaxing blood vessels, so they widen and allow blood to flow more easily. Prostacyclins can also prevent blood clotting.

What is treprostinil used for

Treprostinil 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 lungs. This causes difficulty breathing, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swelling of ankles or legs.

Treprostinil Dr. Reddys is initially administered through continuous subcutaneous infusion (under the skin). Some patients may not tolerate this administration because it causes local pain and swelling. The doctor will decide if you can be administered Treprostinil Dr. Reddys through continuous intravenous infusion directly into a vein with the insertion of a central venous catheter (tube) connected to an external pump or, depending on your condition, a surgically implanted pump 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 heart's workload. Improved blood circulation increases oxygen supply to the body and requires less effort from the heart, so it works more efficiently. Treprostinil improves symptoms associated with PAH and exercise capacity in patients with reduced activity.

2. What you need to know before starting to use Treprostinil Dr. Reddys

Do not use Treprostinil Dr. Reddys:

• if you are allergic to treprostinil or any of the other components of this medication (listed in section 6);
• if you have been diagnosed with a disease called "pulmonary veno-occlusive disease". In this disease, the blood vessels that carry blood through the lungs become swollen and blocked, increasing pressure in the blood vessels between the heart and lungs;
• if you have severe liver failure;
• if you have a heart problem, such as:
• • myocardial infarction (heart attack) in the last six months
  • severe changes in heart rate
  • severe coronary heart disease or unstable angina
  • a diagnosed heart defect, such as a faulty heart valve that causes the heart to malfunction
  • any untreated or closely monitored heart disease;

• if you have a high specific risk of bleeding, such as active stomach ulcers, injuries, or other bleeding disorders;
  • if you have had a stroke in the last three months or any interruption of blood supply to the brain.

Warnings and precautions

Consult your doctor before starting to use Treprostinil Dr. Reddys:

• if you have any liver disease
• if you have been told you are clinically obese (BMI over 30 kg/m2)
• if you have human immunodeficiency virus (HIV) infection
• if you have high blood pressure in the liver veins (portal hypertension)
• if you have a congenital heart defect that affects how blood circulates through it

During treatment with this medication, inform your doctor:

• if your blood pressure drops (hypotension)
• if you experience rapid worsening of breathing difficulties or persistent cough (may be related to pulmonary congestion, asthma, or other disease), consult your doctor immediately.
• if you experience excessive bleeding, as treprostinil may increase the risk by preventing blood clotting.
• if you have a fever while receiving treprostinil intravenously, or if the intravenous administration site becomes red, swollen, or painful to the touch, as it may be a sign of infection.

Using Treprostinil Dr. Reddys with other medications

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

Inform your doctor if you are taking:

• medications to treat high blood pressure(antihypertensive medications or other vasodilators)
• medications used to increase urine output(diuretics), including furosemide
• medications that interrupt blood clotting(anticoagulants), such as products containing warfarin, heparin, or nitric oxide
• any non-steroidal anti-inflammatory drug (NSAID) (such as acetylsalicylic acid or ibuprofen)
• medications 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 medication.

Treprostinil is not recommended during pregnancy, unless your doctor considers it essential. The safety of this medication during pregnancy has not been established.

Treprostinil is not recommended during breastfeeding, unless your doctor considers it essential. You are advised to stop breastfeeding if you are prescribed treprostinil, as it is unknown whether this medication is excreted in breast milk.

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

Driving and using machines

Treprostinil Dr. Reddys may cause low blood pressure, with dizziness and fainting. In this case, do not drive or operate machinery and consult your doctor.

Treprostinil Dr. Reddys contains sodium

This medication contains up to 78.4 mg of sodium (main component of table salt) per vial. This is equivalent to 3.9% of the maximum recommended daily sodium intake for an adult.

3. How to use Treprostinil Dr. Reddys

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor again.

Treprostinil Dr. Reddys is administered as a continuous infusion:

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

For subcutaneous infusion, the product should be administered undiluted.

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

In both cases, Treprostinil Dr. Reddys will be delivered through the tube using a portable pump that is placed outside your body (external).

Before leaving the hospital or clinic, your doctor will instruct you on how to prepare Treprostinil Dr. Reddys and at what speed the pump should administer Treprostinil Dr. Reddys.

Flushing the infusion tube while connected can cause accidental overdose.

Alternatively, Treprostinil Dr. Reddys can be administered intravenously using an implantable infusion pump that is usually surgically inserted under the skin of your abdomen. In this case, the pump and tube 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 will also be given information on how to use the pump correctly and what to do if it stops working. The information should also tell you who to contact in case of an emergency.

Treprostinil Dr. Reddys is diluted only when administered with continuous intravenous infusion:

For intravenous infusion with an external portable pump:You should only dilute your Treprostinil Dr. Reddys solution with sterile water for injection or 0.9% sodium chloride injection solution (as indicated by your doctor).

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

Adult patients

Treprostinil Dr. Reddys is available as a solution for infusion of 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml. Your doctor will determine the infusion rate and suitable dose for your disease.

Overweight patients

If you are overweight (weigh 30% or more of 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 infusion rate and suitable dose for your disease.

Dose adjustment

The infusion rate in each individual patient may be reduced 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 side effects.

If your symptoms worsen or if you need complete rest, are confined to bed or a chair, or if any physical activity causes discomfort and your symptoms appear at rest, do not increase the dose without consulting your doctor. It may be that treprostinil is no longer sufficient to treat your disease and you need other treatment.

How can bloodstream infections be avoided during intravenous administration of treprostinil?

As with all long-term intravenous treatments, there is a risk of contracting a bloodstream infection. Your doctor will instruct you on how to avoid them.

If you use more Treprostinil Dr. Reddys than you should

If treprostinil is accidentally administered in excess, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, fainting), flushing, or headache.

If any of these symptoms become severe, you should contact your doctor or hospital immediately. Your doctor may reduce the dose or interrupt administration until the symptoms disappear. Then, the administration of treprostinil will be resumed with the dose recommended by your doctor.

In case of overdose, consult your doctor or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you stop treatment with Treprostinil Dr. Reddys

Always use treprostinil as indicated by your doctor or hospital specialist. Do not stop using treprostinil unless your doctor tells you to.

Sudden interruption or rapid reduction of the dose of Treprostinil Dr. Reddys can cause PAH to recur, with possible rapid and severe deterioration of your condition.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• vasodilation with flushing
• pain or tenderness at the administration site
• skin discoloration or bruising at the administration site
• headaches
• skin rash
• nausea
• diarrhea
• jaw pain

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

• dizziness
• vomiting
• low blood pressure (dizziness, fainting)
• 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 gums, blood in stool
• joint pain, muscle pain, pain in legs and/or arms

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

• infection at the administration site
• abscess at the administration site
• reduced platelet count in the blood (thrombocytopenia)
• bleeding at the administration site
• bone pain
• skin rash with discoloration or bumps
• infection of the tissue under the skin (cellulitis)
• excessive blood flow from the heart, causing difficulty breathing, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough.

Other side effects associated with intravenous administration

• vein inflammation (thrombophlebitis)
• bacterial infection in the bloodstream (bacteremia)*. See section 3.
• septicemia (severe bacterial infection of the blood)

• There have been reports of fatal and potentially fatal bacterial infections in the bloodstream.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Treprostinil Dr. Reddys

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box and vial after EXP. The expiration date is the last day of the month indicated.

Do not use this medication if you notice damage to the vial, color change, or other signs of deterioration.

Treprostinil Dr. Reddys vials should be discarded 30 days after opening.

During continuous subcutaneous infusion, a single container (syringe) of undiluted Treprostinil Dr. Reddys should be used within 72 hours.

During continuous intravenous infusion with external portable pumps, a single container (syringe) of diluted Treprostinil Dr. Reddys should be used within 24 hours.

During continuous intravenous infusion using implantable infusion pumps, Treprostinil Dr. Reddys introduced into the pump reservoir should be used for a maximum of 39 days (chemical, physical, and microbiological stability of the Treprostinil Dr. Reddys solution has been demonstrated for up to 39 days at 40°C in concentrations as low as 0.5 mg/ml and up to 10 mg/ml in an implantable pump with a titanium drug reservoir). The healthcare professional at the hospital will tell you the duration of the interval before each subsequent reservoir refill.

Discard any unused diluted solution.

For instructions on use, see section 3 "How to use Treprostinil Dr. Reddys".

Medications should not be disposed of through wastewater or household waste. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Treprostinil Dr. Reddys

The active ingredient 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 injection, and for pH adjustment: sodium hydroxide (E524) and hydrochloric acid (E507).

Appearance of the Product and Container Contents

Treprostinil Dr. Reddys is a clear, colorless to slightly yellowish solution, available in a 20 ml transparent glass vial closed with a rubber stopper and a colored cap:

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

Each box contains one vial.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer:

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

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

Date of the last revision of thisleaflet:July 2023

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