Remodulin (treprostinil) belongs to the drug class known as prostacyclin analogs. It's used for treating pulmonary arterial hypertension (PAH) in adults. It's an injection that goes under your skin or into a vein that's administered using a special pump. Side effects can include pain at the injection site, headache, and diarrhea. It's available as a brand-name and generic medication.
Remodulin (treprostinil) is a prostacyclin analog, which means that it acts like prostacyclin. Prostacyclin is a natural hormone in your body that helps widen or open up the blood vessels leading to your lungs from your heart. As a result, blood can flow through these blood vessels better, which lowers the blood pressure in those vessels. This helps your body get more oxygen and your heart to work more efficiently.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Note: Side effects were reported by people who injected Remodulin (treprostinil) underneath the skin.
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
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
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:
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.
If you stop taking Remodulin (treprostinil) all of a sudden, your PAH symptoms could get worse. This is why it isn't recommended to stop taking the medication without speaking to your provider. Your provider will probably want to lower your dose slowly first and keep a close eye on your symptoms.
Remodulin (treprostinil) is administered as an injection under the skin or into a vein continuously using a special infusion pump. Your provider will teach you how to use your pump.
The effectiveness of Remodulin (treprostinil) was measured by a 6-minute walk test. People who took Remodulin (treprostinil) for 12 weeks were able to walk 10 meters farther than those who took a placebo. Remodulin (treprostinil) also improved PAH symptoms like shortness of breath and feeling tired. Another 8-week study showed that people who took Remodulin (treprostinil) for PAH could walk farther and the distance that those who didn't take the medication could walk became less by the end of the study. As you take Remodulin (treprostinil), make sure to follow up with your provider and discuss how well the medication is working for your PAH.
A Remodulin (treprostinil) pump is a device called an infusion pump that you wear on your body. This makes it possible for you to get the medication into your bloodstream around the clock to help with your PAH symptoms. There are a few different infusion pumps that you can use with Remodulin (treprostinil). Some of them infuse the medication under your skin and others infuse it into a vein. Your provider will help you decide which pump is best for you.
While hot flashes weren't reported as a side effect during clinical studies of Remodulin (treprostinil), they appear to be common with the inhaled version of this medication called Tyvaso (treprostinil). Flushing could be a sign that your dose of Remodulin (treprostinil) is too high), so let your provider know if you experience warmth or reddening of the skin.
Discuss all of your medications with your healthcare provider. Studies showed that when treprostinil tablets are taken by mouth, it can interact with some medications, such as gemfibrozil (Lopid) and rifampin (Rifadin). But it isn't known whether Remodulin (treprostinil) has the same drug interactions when it's injected into the veins or under the skin. Remodulin (treprostinil) can also raise the risk of bleeding, so let your provider know if you're taking a blood thinner. Additionally, you might be at risk for very low blood pressure if you're also taking blood pressure medications.
Store unopened vials of Remodulin (treprostinil) at room temperature until the expiration date written on the vial or carton. Once it's been opened, each multi-dose vial can be stored at room temperature for 30 days. If your Remodulin (treprostinil) solution needs to be mixed with a special diluent (fluid), the mixture can be stored for up to 14 days at room temperature. And if your Remodulin (treprostinil) solution needs to be mixed with sterile water or sodium chloride, the mixture can be stored for 4 hours at room temperature or 24 hours in the refrigerator. Ask your provider how long your Remodulin (treprostinil) vial lasts since it depends on whether it's used alone or mixed and on what diluent you use to mix it with.
Remodulin (treprostinil) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infusing Remodulin (treprostinil) into your vein for a long time can potentially put you at risk for bloodstream infections. These infections can sometimes be life-threatening. To lower your risk of infections, wash your hands before you use Remodulin (treprostinil). Make sure that the area by your catheter is clean and pain-free. It's preferred to infuse the medication underneath your skin because there's a lower risk of bloodstream infections when the medication is given this way.
Your symptoms of PAH can worsen if you lower your dose or stop taking Remodulin (treprostinil) suddenly. Make sure you have a backup infusion pump in case your pump stops working during administration. Don't lower your dose or stop taking the medication without talking to your provider first. Your provider should give you instructions how to do so safely.
Your liver helps break down Remodulin (treprostinil) in your body. Having liver problems can affect your body's ability to clear the medication, which can lead to higher levels of Remodulin (treprostinil) in your body. This can lead to more unwanted side effects. Let your healthcare provider know if you have a history of liver problems before you start Remodulin (treprostinil). Your dose might need to be adjusted to make sure you're safe.
Remodulin (treprostinil) can cause your blood pressure to drop because medication helps relax and widen your blood vessels. Low blood pressure can sometimes lead to symptoms like dizziness or feeling faint. Let your provider know if you feel dizzy or lightheaded while you're taking this medication.
The dose depends on your body weight. The typical starting dose is 1.25 nanograms (ng)/kg of weight per minute. It's injected underneath your skin or into a vein using a special pump. Your healthcare provider will prescribe the right dose for you and explain how to use the pump.
Your dose might differ if you have liver problems.
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.
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.