Treprostinil Dr. Reddy's

Package leaflet: Information for the user

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

Treprostinil Dr. Reddy’s 2.5 mg/ml solution for infusion
Treprostinil Dr. Reddy’s 5 mg/ml solution for infusion
Treprostinil Dr. Reddy’s 10 mg/ml solution for infusion
Generic medicine
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 pass it on to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this 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. How to store 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

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

What Treprostinil Dr. Reddy’s is used for
Treprostinil Dr. Reddy’s is used for the treatment of 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. This condition causes shortness of breath, dizziness, fatigue, fainting, palpitations or cardiac arrhythmias, dry cough, chest pain, and swelling of the ankles or legs.

Treprostinil Dr. Reddy’s 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 Treprostinil Dr. Reddy’s can be administered by continuous intravenous infusion (directly into a vein) instead. This will require the insertion of a central venous catheter, usually placed in the neck, chest, or groin.

How Treprostinil Dr. Reddy’s works
Treprostinil Dr. Reddy’s 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 and reduced strain on the heart, allowing the heart to function more effectively. Treprostinil Dr. Reddy’s improves symptoms associated with PAH and enhances exercise capacity in patients with limited physical ability.

2. What you should know before using Treprostinil Dr. Reddy’s

Do not use Treprostinil Dr. Reddy’s

• 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 condition 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 the 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 artery disease or unstable angina
  • you have been diagnosed with a heart defect, such as a heart valve defect that impairs heart function
  • any untreated or poorly controlled heart disease
• if you are at high risk of bleeding – for example, if you have active stomach ulcers, injuries, or other bleeding conditions
• if you have had a stroke within the last 3 months or any other condition that interrupted blood flow to the brain.

Warnings and precautions
Before starting Treprostinil Dr. Reddy’s, inform your doctor:

• if you have liver disease
• if you have kidney disease
• if your doctor has told you that you are obese (BMI greater than 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 affecting blood circulation
• if you are on a low-sodium diet. During treatment with Treprostinil Dr. Reddy’s, inform your doctor:
  • if your blood pressure decreases (hypotension)
  • if you experience a rapid worsening of breathing difficulty or persistent cough (this may be due to pulmonary congestion, asthma, or other conditions); seek immediate medical advice
  • if you experience excessive bleeding, as treprostinil may increase this risk by interfering with blood clotting
• if you develop fever during intravenous administration of Treprostinil Dr. Reddy’s or if the intravenous infusion site becomes red, swollen and/or painful to touch, as this could be a sign of infection.

Other medicines and Treprostinil Dr. Reddy’s
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)
• medicines 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)
• medicines that may increase or decrease the effect of Treprostinil Dr. Reddy’s (e.g. gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort), as your doctor may need to adjust the dose of Treprostinil Dr. Reddy’s.

Pregnancy and breastfeeding
Treprostinil Dr. Reddy’s is not recommended during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, unless your doctor considers it necessary. The safety of this medicine during pregnancy has not been established.
The use of Treprostinil Dr. Reddy’s is not recommended during breastfeeding unless your doctor considers it necessary. If Treprostinil Dr. Reddy’s is prescribed for you, breastfeeding should be discontinued, as it is unknown whether this medicine is excreted in breast milk.

During treatment with Treprostinil Dr. Reddy’s, the use of an effective contraceptive method 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
Treprostinil Dr. Reddy’s may cause low blood pressure, dizziness, and fainting.
If this occurs, do not drive or operate machinery and consult your doctor.

Treprostinil Dr. Reddy’s contains sodium
Inform your doctor if you are on a low-sodium diet. Your doctor should be aware that a vial of Treprostinil Dr. Reddy’s contains up to 58.7 mg of sodium.

3. How to use Treprostinil Dr. Reddy’s

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Treprostinil Dr. Reddy’s is administered by continuous infusion:

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

In both cases, Treprostinil Dr. Reddy’s is delivered through the tube by a portable pump.

Before leaving the hospital or clinic, your doctor will inform you how to prepare Treprostinil Dr. Reddy’s and at which rate the pump should deliver the dose. You must also be given instructions on the correct use of the pump and what to do in case of malfunction. Among the information provided, you must be told who to contact in an emergency.
Flushing the infusion cannula while it is connected may cause accidental overdose of the medicine.

Treprostinil Dr. Reddy’s is diluted only when administered intravenously:
Intravenous use only: the Treprostinil Dr. Reddy’s solution must be diluted only with sterile water for injection or with 0.9% sodium chloride for injection (as directed by the doctor) when administered by continuous intravenous infusion.

Adult patients
Treprostinil Dr. Reddy’s 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 PAH while minimizing adverse effects.

If your symptoms worsen, if you require complete bed rest, if you are confined to bed or a chair, or if any physical activity increases your symptoms or if symptoms occur even at rest, do not increase the dose without consulting your doctor. Treprostinil Dr. Reddy’s may no longer be sufficient to treat the disease, and additional treatment may be necessary.

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

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

If you stop treatment with Treprostinil Dr. Reddy’s
Always use Treprostinil Dr. Reddy’s exactly as instructed by your doctor or hospital specialist. Do not stop treatment with Treprostinil Dr. Reddy’s unless instructed to do so by your doctor.
Sudden discontinuation or abrupt reduction in the dose of Treprostinil Dr. Reddy’s may cause a relapse of pulmonary arterial hypertension, possibly leading to rapid and severe deterioration of your condition.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

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

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

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

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

Not known (frequency cannot be estimated from the available data):

• excessive pumping of blood from the heart leading to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid accumulation, persistent cough

Other possible side effects:

• infections 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 rashes with skin discoloration or formation of papules
• infection of the tissue beneath the skin (cellulitis)

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 infection of the bloodstream have been reported.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Treprostinil Dr. Reddy’s

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use this medicinal product after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
Do not use Treprostinil Dr. Reddy’s if you notice any damage to the vial, change in colour of the product, or signs of deterioration.
A vial of Treprostinil Dr. Reddy’s must be used or discarded within 30 days of first opening.
During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Treprostinil Dr. Reddy’s must be used within 72 hours.
During continuous intravenous infusion, a single reservoir (syringe) of diluted Treprostinil Dr. Reddy’s must be used within 24 hours.
Any unused portion of diluted solution must be discarded.
For instructions on use, refer to section 3 “How to use Treprostinil Dr. Reddy’s”.
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 Treprostinil Dr. Reddy’s contains
The active substance is treprostinil 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
The other components of Treprostinil Dr. Reddy’s are:
Disodium edetate dihydrate, sodium chloride, metacresol, water for injections and for pH adjustment: sodium hydroxide and hydrochloric acid.

Description of the appearance of Treprostinil Dr. Reddy’s and contents of the pack
Treprostinil Dr. Reddy’s is a clear, colourless to slightly yellow solution, available in a 20 ml transparent glass vial sealed with a rubber stopper and an aluminium cap with colour-coded closures:

• Treprostinil Dr. Reddy’s 1 mg/ml solution for infusion has a yellow rubber closure cap.
• Treprostinil Dr. Reddy’s 2.5 mg/ml solution for infusion has a blue rubber closure cap.
• Treprostinil Dr. Reddy’s 5 mg/ml solution for infusion has a green rubber closure cap.
• Treprostinil Dr. Reddy’s 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:
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1 – 20123 Milano (MI), Italy

Manufacturer:
Dr. Reddy’s Laboratories (UK) Ltd
6 Riverview Road, Beverley, HU17 0LD, United Kingdom
betapharm Arzneimittel GmbH
Kobelweg 95
D - 86156 Augsburg, Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany:
Treprostinil beta 1 mg/ml Infusionslösung
Treprostinil beta 2.5 mg/ml Infusionslösung
Treprostinil beta 5 mg/ml Infusionslösung
Treprostinil beta 10 mg/ml Infusionslösung

France:
TREPROSTINIL DR REDDY’S 1 mg/ml, solution for infusion
TREPROSTINIL DR REDDY’S 2.5 mg/ml, solution for infusion
TREPROSTINIL DR REDDY’S 5 mg/ml, solution for infusion
TREPROSTINIL DR REDDY’S 10 mg/ml, solution for infusion

Italy:
Treprostinil Dr. Reddy’s 1 mg/ml solution for infusion
Treprostinil Dr. Reddy’s 2.5 mg/ml solution for infusion
Treprostinil Dr. Reddy’s 5 mg/ml solution for infusion
Treprostinil Dr. Reddy’s 10 mg/ml solution for infusion