Treprostinil reddy

Package leaflet: 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
Treprostinilum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for you personally. Do not give it to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Treprostinil Reddy is and what it is 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 pack and other information

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

What Treprostinil Reddy is
The active substance in Treprostinil Reddy is treprostinil.
Treprostinil belongs to a group of medicines that work similarly to naturally occurring prostacyclins in the body. Prostacyclins are hormone-like substances. They lower blood pressure by relaxing blood vessels, causing them to widen, thereby improving blood flow. Additionally, prostacyclins may also help prevent blood clotting.

For which conditions is Treprostinil Reddy used
Treprostinil Reddy 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, causing shortness of breath, dizziness, fatigue, fainting, palpitations, 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 tolerate this infusion due to local pain and swelling. Your doctor will decide whether Treprostinil Reddy can be given as a continuous intravenous infusion. This will require the insertion of a central venous catheter, usually placed in the neck, chest, or groin.

How Treprostinil Reddy works
Treprostinil Reddy lowers blood pressure in the pulmonary artery, improving blood flow and reducing the workload on the heart. Improved blood flow leads to better oxygen delivery throughout the body and reduces strain on the heart muscle, thereby improving cardiac efficiency. Treprostinil Reddy alleviates symptoms associated with PAH and improves exercise tolerance in patients who must limit their 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 condition in which 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 diseases, for example:
• myocardial infarction (heart attack) within the last six months,
• serious disturbances in heart rate,
• severe coronary artery disease or unstable angina pectoris,
• diagnosed heart defect such as valvular heart disease causing impaired heart function,
• heart disease that is not being treated or is not under close medical supervision.
• if the patient is at significant risk of bleeding – for example, active peptic ulcer disease, wounds, or other types of bleeding.
• if the patient has had a stroke within the last 3 months or other cerebral ischemic events.

Warnings and precautions
Before starting treatment with Treprostinil Reddy, discuss with the doctor:

• if the patient has liver disease,
• if the patient has been medically diagnosed with obesity (BMI over 30 kg/m²),
• if the patient is infected with human immunodeficiency virus (HIV),
• if the patient has high blood pressure in the liver veins (portal hypertension),
• if the patient has a congenital heart defect affecting the direction of blood flow through the heart.

During treatment with Treprostinil Reddy, inform the doctor if:

• low blood pressure (hypotension) occurs,
• sudden worsening of breathing difficulties or persistent cough occurs (this may be related to pulmonary congestion, asthma, or another disease); seek immediate medical advice,
• excessive bleeding occurs, as treprostinil may increase this risk due to its anticoagulant effect,
• fever, redness, swelling, and/or tenderness at the infusion site occurs during intravenous administration of Treprostinil Reddy, as this may indicate infection.

Treprostinil Reddy with other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking:

• medicines used to treat high blood pressure (antihypertensives or other vasodilating agents),
• medicines used to increase urine output (diuretics), including furosemide,
• medicines preventing blood clotting (anticoagulants), such as those containing warfarin, heparin, or nitric oxide,
• any non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. acetylsalicylic acid, ibuprofen),
• any 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 dose adjustment of Treprostinil Reddy may be necessary.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Treprostinil Reddy is not recommended for women who are pregnant, planning pregnancy, or suspect they may be pregnant, unless the doctor considers treatment necessary. The safety of Treprostinil Reddy in pregnant women has not been established.
Treprostinil Reddy is not recommended for breastfeeding women unless the doctor considers its use necessary. If Treprostinil Reddy is prescribed to a patient, breastfeeding should be discontinued, as it is unknown whether the medicine passes into breast milk.

Women of childbearing potential
It is strongly recommended to use contraceptive measures during treatment with Treprostinil Reddy.

Driving and operating machinery
Treprostinil Reddy may cause low blood pressure with dizziness and fainting. In such cases, driving and operating machinery should be avoided, and medical advice should be sought.

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 (a main component of table 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 dietary intake of sodium for adults.
Metacresol may cause allergic reactions.

3. How to use Treprostinil Reddy

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.

Treprostinil Reddy is administered as a continuous infusion:

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

For subcutaneous infusion, Treprostinil Reddy must be administered undiluted.
For intravenous infusion, Treprostinil Reddy must be diluted according to your doctor's instructions. The medicine may only be diluted with sterile water for injection or 0.9% (w/v) sodium chloride solution for injection.
In both cases, Treprostinil Reddy is delivered through a line by a portable pump.
Before discharge from hospital, your doctor will inform you how to prepare Treprostinil Reddy and at which rate the pump should deliver the medicine.
You will also receive instructions on how to properly use the pump and what to do in case of pump malfunction. These instructions should include information on whom to contact in an emergency. Flushing the connected infusion line may result in accidental overdose.

Treprostinil Reddy is diluted only when administered intravenously as a continuous infusion:
For intravenous administration using a portable external pump: The patient must dilute the Treprostinil Reddy solution exclusively with sterile water for injection or 0.9% sodium chloride solution for injection (as directed by the doctor) when administered as a continuous intravenous infusion.

Adults
Treprostinil Reddy 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 infusion rate and dose appropriate for your 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 and subsequent doses based on target body weight. See also section 2 "Warnings and precautions".

Elderly
The doctor will determine the infusion rate and dose appropriate for the patient's clinical condition.

Children and adolescents
Limited data are available on the use of this medicine in children and adolescents.

Dose modifications
The infusion rate may be individually increased or decreased only under the supervision of a doctor.
The aim of adjusting the infusion rate is to establish an effective maintenance dose that alleviates PAH symptoms while minimizing adverse effects.

If symptoms worsen or the patient requires complete rest or is confined to bed or chair, or if any physical exertion causes discomfort and symptoms occur at rest, the dose must not be increased without contacting the doctor.
Treprostinil Reddy may not be sufficient to treat the disease condition, and additional medications may be required.

How can blood infections be prevented during intravenous treatment with Treprostinil Reddy?
As with any long-term intravenous therapy, there is a risk of blood infection. Your doctor will train you on how to prevent such infections.

Taking more Treprostinil Reddy than prescribed
If you accidentally overdose on Treprostinil Reddy, symptoms such as nausea, vomiting, diarrhoea, low blood pressure (dizziness, lightheadedness, or fainting), skin flushing, and/or headache may occur.
If any of these symptoms are severe, contact your doctor or hospital immediately. The doctor may reduce the dose or temporarily discontinue the infusion until symptoms resolve. The Treprostinil Reddy infusion solution will then be restarted at the dose prescribed by the doctor.

Stopping treatment with Treprostinil Reddy
Always use Treprostinil Reddy exactly as prescribed by your doctor or hospital specialist. Do not stop using Treprostinil Reddy without consulting your doctor.
Sudden discontinuation or reduction of Treprostinil Reddy may lead to recurrence of pulmonary arterial hypertension, possibly with rapid and severe deterioration of the patient's condition.

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

4. Possible adverse reactions

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

Very common adverse reactions (may occur in more than 1 in 10 people):

• Vasodilation with skin flushing,
• Pain or tenderness at the infusion site,
• Skin discoloration or pallor around the infusion site,
• Headache,
• Skin rash,
• Nausea,
• Diarrhoea,
• Jaw pain.

Common adverse reactions (may occur in up to 1 in 10 people):

• Dizziness,
• Vomiting,
• Feeling faint or fainting due to low blood pressure,
• Itching or redness of the skin,
• Swelling of the feet, ankles, legs or fluid retention,
• Bleeding, e.g. nosebleeds, coughing up blood, blood in urine, bleeding from gums, blood in stool,
• Joint pain, muscle pain, pain in legs and (or) arms.

Other possible adverse reactions (frequency unknown – cannot be estimated from available data):

• Infection at the infusion site,
• Abscess at the infusion site,
• Decreased platelet count (thrombocytopenia),
• Bleeding at the infusion site,
• Bone pain,
• Skin rashes with discoloration or nodularity,
• Infection of subcutaneous tissue (cellulitis),
• Excessive blood volume pumped by the heart leading to breathlessness, fatigue, swelling of legs and abdomen due to fluid accumulation, persistent cough.

Additional adverse reactions associated with intravenous administration:

• Vein inflammation (thrombophlebitis),
• Bacterial blood infection (bacteraemia)* (see section 3),
• Sepsis (severe blood infection).

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Treprostinil Reddy

Keep this medicine out of the sight and reach of children.
No special precautions for storage are required.
During continuous subcutaneous infusion, one cartridge (syringe) of undiluted Treprostinil Reddy must be used within 72 hours.
During continuous intravenous infusion using an external portable infusion pump, one cartridge (syringe) of diluted Treprostinil Reddy must be used within 24 hours.
The vial of Treprostinil Reddy must be used or discarded within 30 days of first opening.
Any unused portion of the diluted solution must be discarded.
Do not use this medicine after the expiry date stated on the outer carton and on the vial after "EXP". The expiry date refers to the last day of the stated month.
Do not use Treprostinil Reddy if the vial is damaged, discoloured, or shows any other signs of deterioration (e.g. presence of particles).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Treprostinil Reddy contains

• The active substance is treprostinil. Each millilitre 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 injections, and sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).

What Treprostinil Reddy looks like and contents of the pack
Treprostinil Reddy is a clear, colourless to slightly yellow solution for infusion, available in a
type I glass vial with a chlorobutyl rubber stopper, sealed with a plastic "flip-off" cap (in a specific
colour) and an aluminium seal:

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

Each cardboard box contains one vial with 20 ml of solution for infusion.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Treprostinil Reddy 1 mg/ml solution for infusion
Treprostinil Reddy 2.5 mg/ml solution for infusion
Belgium:
Treprostinil Reddy 5 mg/ml solution for infusion
Treprostinil Reddy 10 mg/ml solution for infusion
Treprostinil Reddy 1 mg/ml infusion concentrate
Treprostinil Reddy 2.5 mg/ml infusion concentrate
Czech Republic:
Treprostinil Reddy 5 mg/ml infusion concentrate
Treprostinil Reddy 10 mg/ml infusion concentrate
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Denmark:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Germany:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution
Treprostinil Reddy 1 mg/ml for infusion concentrate
Treprostinil Reddy 2.5 mg/ml for infusion concentrate
Finland:
Treprostinil Reddy 5 mg/ml for infusion concentrate
Treprostinil Reddy 10 mg/ml for infusion concentrate
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Hungary:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution
Treprostinil Reddy 1 mg/ml solution for infusion
Treprostinil Reddy 2.5 mg/ml solution for infusion
Ireland:
Treprostinil Reddy 5 mg/ml solution for infusion
Treprostinil Reddy 10 mg/ml solution for infusion
Treprostinil Reddy 1 mg/ml solution for infusion
Treprostinil Reddy 2.5 mg/ml solution for infusion
Netherlands:
Treprostinil Reddy 5 mg/ml solution for infusion
Treprostinil Reddy 10 mg/ml solution for infusion
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Norway:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution
Poland: 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 Reddy 1 mg/ml concentrate for solution for infusion
Treprostinil Reddy 2.5 mg/ml concentrate for solution for infusion
Portugal:
Treprostinil Reddy 5 mg/ml concentrate for solution for infusion
Treprostinil Reddy 10 mg/ml concentrate for solution for infusion
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Slovakia:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution
Treprostinil Reddy 1 mg/ml infusion solution
Treprostinil Reddy 2.5 mg/ml infusion solution
Sweden:
Treprostinil Reddy 5 mg/ml infusion solution
Treprostinil Reddy 10 mg/ml infusion solution