Treprostinil Injection is a prescription medication used in adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to reduce symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Treprostinil was studied mainly in patients with New York Heart Association (NYHA) Functional Class II-IV symptoms.
In people with PAH who need to switch from epoprostenol sodium, Treprostinil Injection is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
|• || Treprostinil Injection can be delivered using a tube placed in a big blood vessel (vein) within the chest. This type of delivery is associated with the risk of bloodstream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion delivered just beneath the skin is the preferred method of delivery.|
|• || You should not stop or change your Treprostinil Injection dose without consulting your doctor first, as this may cause your PAH symptoms to worsen.|
|• || Treprostinil Injection acts by lowering your blood pressure. In some cases, your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.|
|• || If you have liver or kidney problems, your ability to tolerate Treprostinil Injection may be affected.|
|• || Because Treprostinil Injection can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).|
|• || Other medical conditions and medicines may affect your use of Treprostinil Injection by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.|
During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (eg, redness of the skin, hardness of the skin, or rash) were the most common adverse events and occurred in the majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and low blood pressure (14% and 4%, respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥9% of patients in the treprostinil arm) with either SC or IV treprostinil included headache, diarrhea, jaw pain, edema (swelling), vasodilatation (widening of the blood vessels), and nausea. The adverse reactions with treprostinil IV included bloodstream infections, arm swelling, tingling or prickling sensation, bruising, and pain.
If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Treprostinil Injection dosage.
USE IN SPECIFIC POPULATIONS
If you are pregnant, planning to become pregnant, or breast-feeding, talk with your doctor about whether you should use Treprostinil Injection.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or contact Sandoz Inc. at 1-800-525-8747.