1 mg / ml, 2.5 mg / ml, 5 mg / ml and 10 mg / ml solution for infusion treprostinil
What Remodulin is and what it is used for
What Remodulin is
The active substance in Remodulin is treprostinil.
Treprostinil belongs to a group of medicines that work in almost the same way as naturally occurring prostacyclins. Prostacyclins are hormone-like substances that lower blood pressure by causing the blood vessels to relax so that they dilate, which facilitates blood flow. Prostacyclins can also have an effect by preventing the blood from clotting.
What Remodulin is used to treat
Remodulin is used to treat idiopathic or hereditary pulmonary arterial hypertension (PAH) in patients with moderate to severe symptoms. Pulmonary arterial hypertension is a condition in which blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeat, dry cough, chest pain, and swollen ankles or legs.
Remodulin is initially given as a continuous subcutaneous infusion ( infusion under the skin). Some patients may not tolerate this due to pain and swelling at the site of administration. Your doctor will decide if Remodulin can instead be given as a continuous intravenous infusion ( infusion into a vein) with a central venous catheter connected to an external pump or, depending on your condition, a pump that is implanted under the skin of the stomach (an implantable pump ). Your doctor will decide what is the best option for you.
How Remodulin works
Remodulin lowers blood pressure in the pulmonary artery by improving blood flow and reducing the work of the heart. Improved blood flow leads to improved oxygen supply to the body and reduced strain on the heart, making it work more efficiently. Remodulin improves the symptoms associated with PAH and the ability to exercise in patients with limited activity.
Before you use Remodulin
Do not use Remodulin
- if you are allergic (hypersensitive) to treprostinil or any of the other ingredients of this medicine (listed in section 6).
- if you have been diagnosed with a disease called “pulmonary venous occlusive disease”. This is a disease in which the blood vessels that carry blood through the lungs become swollen and clogged, which increases the pressure in the blood vessels between the heart and the lungs.
- if you have severe liver disease
- if you have heart problems, for example:
- myocardial infarction (heart attack) within the last six months
- severe changes in heart rate
- severe coronary heart disease or unstable angina
- heart defects have been diagnosed, such as a valve that causes the heart to work poorly
- heart disease that is not treated or not carefully monitored by a doctor
- if you have a particularly high risk of bleeding – for example, active stomach ulcers, injuries, or other bleeding conditions
- if you have had a stroke within the last 3 months or any other interruption in the blood supply to the brain.
Warnings and cautions
Before you take Remodulin, tell your doctor:
- if you have any liver disease
- if you have been told that you are medically overweight ( BMI more than 30 kg / m 2 )
- if you have HIV (human immunodeficiency virus) infection
- if you have high blood pressure in the hepatic veins (portal hypertension)
- if you have a congenital heart defect that affects blood flow through the heart
During treatment with Remodulin, tell your doctor:
- if your blood pressure drops ( hypotension )
- if you experience rapidly increasing difficulty breathing or persistent cough (this may be related to blood clots in the lungs or asthma or some other condition), consult your doctor immediately
- if you experience heavy bleeding, treprostinil may increase the risk by preventing the blood from clotting
- if you get a fever when you receive Remodulin intravenously or if the site of the intravenous catheter becomes red, swollen, and/or painful to the touch, then this may be a sign of infection.
Other medicines and Remodulin
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking:
- medicines used to treat high blood pressure (blood pressure-lowering agents or other vasodilators)
- drugs used to increase urinary excretion ( diuretics ), including furosemide
- anticoagulants ( blood thinners), such as warfarin, heparin, or nitric oxide
- non-steroidal anti-inflammatory drugs ( NSAIDs ) (eg acetylsalicylic acid, ibuprofen )
- medicines that may increase or decrease the effect of Remodulin (eg gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John’s wort ) as your doctor may need to adjust the dose of Remodulin.
Pregnancy and breastfeeding
Remodulin is not recommended if you are pregnant, planning to become pregnant, or think you may be pregnant unless your doctor considers it necessary. The safety of this medicine, when used during pregnancy, has not been established.
The use of Remodulin is not recommended during breastfeeding unless your doctor considers it necessary. You should stop breastfeeding if you have been prescribed Remodulin, as it is not known if this medicine is excreted in human milk.
The use of contraceptives is strongly recommended during treatment with Remodulin.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
Remodulin may cause low blood pressure with dizziness or fainting. Under such conditions, do not drive or use machines and ask your doctor for advice.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections.
Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Remodulin contains sodium
This medicine contains up to 78.4 mg of sodium (the main ingredient in table salt/table salt) per 20 ml. This corresponds to 4% of the maximum recommended daily sodium intake for adults.
How to use Remodulin
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Remodulin is given as a continuous infusion either:
- subcutaneously (under the skin) through a narrow tube (cannula) that is placed in the abdomen or thigh
- intravenously via a plastic tube ( catheter ), that is usually inserted in the neck, chest, or groin area.
In both cases, Remodulin is pushed through the tube using a portable pump that is placed outside your body (external).
Before leaving the hospital or clinic, your doctor will tell you how to prepare Remodulin and at what rate the pump will give you Remodulin.
Flushing the infusion line while it is connected may cause an accidental overdose.
Alternatively, Remodulin can be administered intravenously via an implantable infusion pump that is usually operated on under the skin of the stomach (abdomen). In this case, the pump and the tube are both completely inside your body (internal) and you must visit the hospital regularly (eg every four weeks) to have the internal container filled.
Regardless of how you receive Remodulin, you should get information on how to use the pump correctly and what to do if it stops working. You should also receive information about who to contact in an emergency.
Remodulin is diluted only when given intravenously as a continuous intravenous infusion:
For intravenous infusion with an external portable pump only: the Remodulin solution should only be diluted with sterile water for injections or with 9 mg/ml sodium chloride solution for injection (given by your doctor).
For intravenous infusion with an implantable infusion pump: You must visit the hospital regularly (eg every four weeks). During the visit, the caregiver should dilute your Remodulin solution with 9 mg/ml sodium chloride solution for injections and refill the internal container.
Adult patients
Remodulin is available as 1 mg / ml, 2.5 mg / ml, 5 mg / ml or 10 mg / ml solution for infusion . Your doctor will determine the infusion rate and infusion dose appropriate for your condition.
Obese patients
If you are overweight (weighing 30% or more than your ideal body weight), your doctor will determine the first and following doses based on your ideal body weight. See also section 2, “Warnings and Precautions”.
Elderly
Your doctor will determine the infusion rate and infusion dose appropriate for your condition.
Children and young people
There are limited data for children and adolescents.
Dose adjustment
The infusion rate can be lowered or increased individually only under medical supervision.
The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves the symptoms of pulmonary arterial hypertension while minimizing any side effects.
If your symptoms increase or if you need complete rest, or are confined to the bed or chair, or if any physical activity causes discomfort and your symptoms occur at rest, do not increase the dose without a doctor’s prescription. Remodulin may no longer be sufficient to treat your illness and other treatment may be needed.
How can your bloodstream infection be prevented during treatment with Remodulin given intravenously?
As with any long-term intravenous treatment, there is a risk of infection in your bloodstream. Your doctor will instruct you on how to avoid this.
If you use more Remodulin than you should
If you accidentally overdose on Remodulin, you may experience nausea, vomiting, diarrhea, low blood pressure (dizziness, intoxication, or fainting), reddening of the skin, and/or headache.
If any of these effects become severe, contact your doctor or hospital immediately. Your doctor may reduce the dose one or discontinue the infusion one until the symptoms have disappeared. Treatment with Remodulin infusion solution is restarted at a dose recommended by your doctor.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If you stop using Remodulin
Always use Remodulin exactly as your doctor or hospital specialist has told you. Do not stop using Remodulin unless your doctor tells you to.
Sudden interruption or sudden dose reductions of Remodulin may cause recurrent pulmonary arterial hypertension, with the risk of rapid and severe deterioration of your condition.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects ( may affect more than 1 user in 10)
- dilated blood vessels with reddening of the skin
- pain or redness at the infusion site
- discoloration of the skin or bruising at the infusion site
- headache
- rash
- nausea
- diarrhea
- pain in the jaws
Common side effects ( may affect up to 1 in 10 people)
- dizziness
- vomiting
- feeling drunk or fainting due to low blood pressure
- itching or redness of the skin
- swelling of the feet, ankles, and legs or fluid retention
- bleeding such as nosebleeds, coughing up of blood, blood in the urine, bleeding in the gums, blood in the stool
- joint pain
- muscle pain
- pain in legs and/or arms
Other possible side effects ( no known frequency (can not be calculated from the available data))
- infection at the infusion site
- warping at the infusion site
- decreased number of blood cells ( platelets ) that cause the blood to clot ( thrombocytopenia )
- bleeding at the infusion site
- skeletal pain
- reddening of the skin with discoloration or raised lumps
- tissue infection under the skin ( cellulite )
- too much blood pumped from the heart leads to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid retention, persistent cough
Additional side effects are associated with intravenous administration
- inflammation of the vein
- bacterial infection in the bloodstream (bacteremia) * (see section 3)
- severe bacterial infection in the blood ( septicemia )
* life-threatening show larRemodulisho or fatal cases of bacterial infection in the bloodstream have been reported
How to store Remodulin
Keep out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and vial. The expiration date is the last day of the specified month.
Do not use Remodulin if you notice any damage to the vial, discoloration, or other signs of deterioration.
A vial of Remodulin must be used or discarded within 30 days of the first opening.
For continuous subcutaneous infusion, the reservoir (syringe) with undiluted Remodulin must be used within 72 hours.
For continuous intravenous infusion with an external portable pump, the reservoir (syringe) with diluted Remodulin must be used within 24 hours.
For continuous intravenous infusion with implantable infusion pumps, diluted Remodulin inserted into the container of the pump must be used within a maximum of 35 days. The healthcare staff at the hospital will inform you about the time interval for the next filling of the container.
The diluted solution that may be left over must be discarded.
For instructions on use, see section 3, “How to use Remodulin”.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is treprostinil 1 mg / ml, 2.5 mg / ml, 5 mg / ml, 10 mg / ml.
The other ingredients are sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol, and water for injections.
What the medicine looks like and the contents of the pack
Remodulin is colorless to the slightly yellow solution, contained in a 20 ml clear glass vial sealed with a rubber stopper and a color-coded cap.
- Remodulin 1 mg/ml solution for infusion has a yellow rubber cap.
- Remodulin 2.5 mg/ml solution for infusion has a blue rubber cap.
- Remodulin 5 mg/ml solution for infusion has a green rubber cap.
- Remodulin 10 mg/ml solution for infusion has a red rubber cap.
Each carton contains one vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ferrer Internacional, SA
Gran Vía Carlos III, 94
08028 – Barcelona
Spain
Manufacturer:
Ferrer Internacional, SA
Joan Buscallà, 1-9
08173 – Sant Cugat del Vallès (Barcelona)
Spain