Description
Treprostinil injection is used to treat the symptoms of pulmonary arterial hypertension. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs.
Treprostinil belongs to the group of agents called prostaglandins, which occur naturally in the body and are involved in many biological functions. Treprostinil works by relaxing blood vessels and increasing the supply of blood to the lungs, which reduces the workload of the heart.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of treprostinil injection in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of treprostinil injection in the geriatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving treprostinil.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abrocitinib
- Defibrotide
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amtolmetin Guacil
- Anagrelide
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Bemiparin
- Betrixaban
- Bivalirudin
- Bromfenac
- Bufexamac
- Caplacizumab-yhdp
- Celecoxib
- Certoparin
- Choline Salicylate
- Citalopram
- Clonixin
- Clopidogrel
- Curcumin
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Desirudin
- Desvenlafaxine
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyridamole
- Dipyrone
- Droxicam
- Duloxetine
- Edoxaban
- Enoxaparin
- Eptifibatide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Garlic
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems or
- Hypotension (low blood pressure)—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will teach you or a caregiver how to give this medicine. It is given as an infusion through a catheter that is placed directly under your skin or into a vein. Do not use more medicine than your doctor tells you to.
Your doctor or nurse will teach you how to prepare the medicine and how to use the pump for the infusion. Treprostinil must be given continuously by a portable pump. The instructions for the pump may vary depending on the particular make and model. You will be given detailed instructions on how to use and care for your pump and accessories. Make sure you understand all of the instructions before giving yourself an infusion.
If you are receiving the medicine under your skin, you will be shown the body areas where the infusion can be given. Use a different body area each time you start an infusion. Keep track of where you give each infusion to make sure you rotate body areas.
Check the liquid in the vial. If the liquid has changed color, is cloudy, or has particles in it, do not use it.
Ask your doctor who to call if you have any problems with the infusion pump. You may be given a second infusion pump to have in case the first pump stops working. Make sure you have access to this pump as a backup at all times.
You will need to continue using this medicine for a long period of time, possibly for many years. Talk with your doctor if you have any concerns about this.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For pulmonary arterial hypertension:
- Adults—Dose is based on body weight and must be determined by your doctor. The initial dose is usually 1.25 nanograms (ng) per kilogram (kg) of body weight per minute. Your doctor may increase or decrease your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For pulmonary arterial hypertension:
Missed Dose
Call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.
You may keep the medicine for up to 30 days at room temperature after you open the vial and use your first dose. You will use a syringe to take medicine from the vial and insert the syringe into the pump.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dose as needed. Blood tests may be needed to check for unwanted effects.
Report any signs of an infection or reaction at the catheter site to your doctor right away. Also, if you develop a sudden fever, check with your doctor right away.
This medicine may cause your blood pressure to decrease, which can cause dizziness, lightheadedness, or fainting. Avoid getting overheated during exercise or hot weather while you are using this medicine. Saunas, hot baths, or sunbathing may make you feel dizzy or faint if you get overheated.
This medicine may increase your risk of bleeding. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.
Do not suddenly stop using this medicine. Stopping the medicine suddenly may worsen the symptoms of your condition, which can be dangerous. Check with your doctor first before stopping it completely.
Your doctor may want you to carry a medical identification card stating that you are using this medicine in case of emergencies.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Accumulation of blood at the site of injection
- dry, red, hot, or irritated skin
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- redness, hardening of the skin, or rash at the site of injection
- swelling
Less common
- Blurred vision
- confusion
- dizziness, faintness, lightheadedness when getting up suddenly from a lying or sitting position
- sudden sweating
- unusual tiredness or weakness
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- bone pain
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- chest pain
- decreased urine output
- difficult or labored breathing
- dilated neck veins
- extreme tiredness or weakness
- irregular breathing
- irregular heartbeat
- itching, pain, redness, swelling, or tenderness on the skin
- paleness of the skin
- pinpoint red spots on the skin
- tightness in the chest
- troubled breathing
- unusual bleeding or bruising
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Loss of consciousness
- seizure
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- headache
- jaw pain
- nausea
Less common
- Lack or loss of strength
- loss of appetite
- stomach pain
- vomiting
- weight loss
Incidence not known
- Difficulty in moving
- dizziness
- joint pain
- muscle ache, cramp, pain, spasm, or stiffness
- pain in the arms or legs swollen joints
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20068380
